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In advanced breast cancer, progression-free survival was significantly longer with vepdegestrant than with fulvestrant among patients with ESR1 mutations but not in the full patient population.

In patients with advanced breast cancer, switching to camizestrant with a CDK4/6 inhibitor after ESR1-mutation detection (and before disease progression) led to significantly longer progression-free survival.

The author describes the scientific foundations of a clinical trial of a first-in-class small-molecule estrogen receptor degrader to treat patients with metastatic breast cancer.

A 76-year-old woman with a history of smoking, diabetes mellitus, and hypertension presented to the hospital with dyspnea. She also had weakness that had progressed during the previous several months.

In a patient with pathogenic ZAP70 mutations and HPV19-integrated SCC, restoring T-cell receptor signaling by stem-cell transplantation resolved HPV-related disease, revealing a direct oncogenic role for β-HPV in immunodeficiency.

In this trial involving adult patients undergoing elective cardiac surgery, acute normovolemic hemodilution did not reduce the number of patients receiving allogeneic red-cell transfusion.

In newly diagnosed myeloma, ASCT showed no benefit over chemotherapy in patients without postinduction measurable residual disease, and tandem ASCT was not more effective than single ASCT in those with postinduction MRD.

This Double Take video explores the link between certain strains of human papillomavirus and cancer and reviews the evidence behind the HPV vaccine, as well as who should receive it and when.

A 19-year-old woman with a history of depression and anxiety symptoms was admitted to the hospital because of seizure, abnormal behavior, and disorganized thoughts. MRI of the head was normal. A diagnosis was made.

How much is enough in the treatment of newly diagnosed multiple myeloma? As clinicians, we want to provide efficacious treatments for our patients to avoid undertreating them. However, we also want to avoid overtreatment with intensive therapy that has limited extra benefit but an increased risk of toxic effects that...

The extreme reductions that the Trump administration is making at the vital, mission-driven Centers for Disease Control and Prevention amount to unilateral disarmament against health hazards.

Among patients with relapsed small-cell lung cancer after the failure of platinum-based chemotherapy, tarlatamab therapy led to a greater overall and progression-free survival benefit than chemotherapy, with fewer severe adverse events.

In HER2-positive metastatic gastric cancer, trastuzumab deruxtecan led to longer survival and better response than ramucirumab–paclitaxel. Adverse events were common. Lung toxic effects with T-DXd were mainly low grade.

After a year of clinical rotations in which a medical student learns to face death up close, her experience on a silent meditation retreat provides her with new perspective on death and life.

Among patients undergoing stem-cell transplantation from matched related donors, cyclophosphamide plus cyclosporin led to significantly longer GVHD-free, relapse-free survival than standard prophylaxis.

In resectable gastric and gastroesophageal junction cancer, adding durvalumab to perioperative chemotherapy improved event-free survival and pathological complete response, with no major increase in high-grade adverse events.

An 86-year-old woman with a complex history that included multinodular goiter presented with neck swelling and dysphagia. A tender submandibular mass was present. A diagnosis was made.

A 55-year-old man with metastatic squamous-cell lung cancer presented with a 6-week history of pain and swelling of the right great toe and the tip of the right middle finger.

Gastric and gastroesophageal junction cancers remain a major global health challenge, with a high risk of recurrence despite surgery and perioperative chemotherapy. The standard perioperative regimen, FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel), has lengthened survival, but further advances in treatment are needed.1 In this issue of the

AI mammography aids are being sold as additions to mammography screening, with direct-to-consumer marketing touting improved cancer-detection rates, despite a lack of evidence of clinical effectiveness.

10 years after the Paris Agreement saw countries commit to historic climate goals, the world is dangerously close to breaching its target to limit global heating to 1·5°C. As reported by the Lancet Countdown on health and climate change, energy-related carbon emissions reached an all-time high in 2023 and adaptation measures have been delayed, resulting in record-breaking threats to health, wellbeing, and survival.

As scientists and members of the Standing Together for Nutrition Consortium (ST4N) who have been Standing Together For Nutrition during recent crises, we use evidence of the impact of crises on nutrition to advocate for the people most affected.1–3 Now, in the face of the world's indifference, we are compelled to speak out about the horrifying human-made famine unfolding in Gaza and other conflict areas, including Sudan, South Sudan, and Yemen.4–9 Widespread starvation is deliberately used as a weapon of war,10 at a scale that we never thought possible.

Despite significant advances in early detection, surgery, radiotherapy, and systemic treatment of breast cancer, late relapse remains an ongoing and significant challenge, particularly in oestrogen receptor (ER)-positive disease.1 Lengthening the period of adjuvant endocrine therapy beyond the initial 5 years, so-called extended adjuvant endocrine therapy, is currently the only available therapeutic intervention to mitigate this risk. In The Lancet, The Early Breast Cancer Trialists' Collaborative Group (EBCTCG) report a meta-analysis of outcomes in 22 031 postmenopausal women with early breast cancer in 12 randomised trials, investigating extended adjuvant endocrine therapy with an aromatase inhibitor treatment (AIT) following at least 5 years of previous adjuvant endocrine therapy with tamoxifen, AIT, or tamoxifen then AIT.

In this issue of the Lancet, Fabrice Barlesi and colleagues1 report the results of KRYSTAL-12: a randomised, open-label, phase 3 trial that investigated the efficacy of the KRASG12C inhibitor, adagrasib, compared with docetaxel for advanced non-small-cell lung cancer (NSCLC). The oncogenic KRAS mutation has been the subject of intense investigation since the early 2000s, as the most frequent mutation observed in patients with NSCLC as well as in a variety of other solid tumours. Due to the mutated KRASG12C picomolar affinity for ATP, it has been a widespread belief that competitive inhibition for its natural substrate, ATP, was not possible.

Human monoclonal antibodies targeting rabies glycoprotein have been proposed as a potential alternative to rabies immunoglobulin to neutralise rabies virus at the wound site until sufficient virus neutralising antibodies are produced after vaccination. Studies in India have shown that the amino acid residues in the rabies glycoprotein necessary for neutralisation by rabies monoclonal antibody (RmAb) of the Serum Institute of India are conserved across all rabies virus isolates in terrestrial animals.

The fourth UN High-Level Meeting (HLM) on Noncommunicable Diseases and Mental Health (NCDs), which will be held on Sept 25, 2025 in New York, NY, USA, will be an important inflection point for the NCD community. Since the last HLM on NCDs in 2018 and its Political Declaration,1 the world has changed. Pandemics, climate change, and conflicts are on the rise, health inequities are widening especially in low-income and middle-income countries (LMICs),2 and the world is alarmingly off-track on the response to NCDs, despite improvements in NCD treatment and prevention.

For the Spanish, French, Arabic, Russian and Chinese translations of the abstract see Supplementary Materials section.

Countries have a legal obligation to combat climate change. The challenge for health is to make sure that they comply. Udani Samarasekera reports.

Trikafta, for cystic fibrosis, is due to be added to WHO's Essential Medicines List. But its pricing means many patients are unable to access it. Sophie Cousins reports.

Professor Sir Tumani Corrah is the Emeritus Director of the Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene & Tropical Medicine (LSHTM) and founder and Co-President of the Africa Research Excellence Fund (AREF), which has offices in the UK and The Gambia. Corrah's interest in medicine began at an early age. Growing up in The Gambia, he noticed young boys “crawling on the floor whilst we were playing football” and then watching his “mother taking my younger siblings to the hospital, where they were given jabs…I realised later that what prevented those boys from playing football was polio, and the injections prevented catastrophes like polio.

A decade ago the psychologist and thriller writer Frank Tallis published The Sleep Room, a disturbing tale of a monomaniacal psychiatrist who subjected female patients to months of high dose sedatives, a bedbound existence, and unchecked experimentation. It is easy to miss a footnote in the novel which explains that the book's protagonist, Dr Hugh Maitland, is based on the British psychiatrist William Sargant (1907–88), whose personality and medical practice offered “a near perfect model” for Tallis' villain.

The practice of emergency medicine relies on clinical judgement, informed by knowledge of medical evidence and guidelines, and acute decision making in high-stakes situations. Emergency physicians must sometimes work with limited information, unable to wait for confirmatory tests before acting. In these moments, the art of emergency medicine partly lies in trusting clinical judgement, using knowledge, experience, and clinical intuition honed over years of practice. The concept of phronesis, or practical wisdom, as defined by Aristotle, is deeply embedded in emergency medicine.

Blood and plasma donor whose blood contained anti-D antibodies and helped save babies' lives. He was born on Dec 27, 1936 in Junee, NSW, Australia, and died on Feb 17, 2025 in Umina Beach, NSW, Australia, aged 88 years.

Neutralising monoclonal antibodies (NAbs) are being developed for future respiratory virus threats, notably highly pathogenic influenza. They were the first effective antiviral treatments for COVID-19. As the pandemic evolved, both natural-induced and vaccine-induced immunity exerted substantial selection pressure on the circulating SARS-CoV-2 viruses, and so the antigenic spike protein NAb target underwent rapid evolution. The in-vitro neutralising potency of the NAbs variably declined as new variants emerged.

We are witnessing a cascade of global crises on every front. War and devastation in Gaza, Sudan, and Ukraine, and forgotten conflicts elsewhere that are rarely acknowledged. Climate-related disasters and the resulting flows of climate refugees are increasing rapidly around the world. Billions of US dollars are projected to be diverted to military spending, whereas funding for social programmes—both domestically and through global aid—are brutally slashed.1

Every day, we are exposed to radiation—when going through security scanners, during routine medical care, or directly from the environment. In each case, our radiation safety limits are based on research originating from a horrific event. This year marks the 80th anniversary of the first and only use of atomic bombs on a civilian population. On Aug 6, 1945, Hiroshima was devastated by the world's first atomic bomb. 3 days later, Nagasaki was also bombed. The resulting blast, heat, and radiation led to the acute deaths of an estimated 50% of people located within 1·2 km of the bomb's impact.

We express concern regarding the conclusions of the Fifth International Workshop on primary hyperparathyroidism, which states that parathyroidectomy is not indicated for improving quality of life or cardiovascular outcomes.1

The Correspondence from Yskert von Kodolitsch and colleagues prompts a critical evaluation of the role of α1-antitrypsin deficiency (AATD) in aortic aneurysms and acute aortic dissection.1 Although the authors express reservations, a robust body of research supports AATD's significance as a genetic risk factor.

The finding from Amanda B Payne and colleagues of 80% respiratory syncytial virus (RSV) vaccine efficacy for adults older than 60 years is encouraging for population health.1 However, given that claims data were used to aggregate patients in the study, establishing baseline characteristics of the two patient groups being compared is imperative.2,3 Although the authors adjusted for confounders, they do not clearly subcategorise the baseline characteristics of patients with RSV who were vaccinated versus unvaccinated patients with RSV.

We thank Jeffrey Wagner for his comments on our real-world investigation of respiratory syncytial virus (RSV) vaccine effectiveness among adults aged 60 years and older in the USA.1 In response to his letter, we would like to clarify three points.

We read with great interest the Article by David J Werring and colleagues1 on their outstanding results from the OPTIMAS randomised trial, which showed how early initiation (within 4 days) of direct oral anticoagulants following ischaemic stroke associated with atrial fibrillation is non-inferior to deferred treatment (7–14 days from symptom onset). The mean age of participants was 78 years, and individuals with moderate-to-severe stroke and minor parenchymal haematomas were included in the trial.

We read with interest the Article by David J Werring and colleagues,1 which provides evidence that early initiation of direct oral anticoagulants (DOACs) after ischaemic stroke associated with atrial fibrillation was non-inferior to delayed initiation. The inclusion of patients with parenchymal haematoma type 1, which has not been done in previous research,2 furthered understanding of the topic. Although we appreciate the authors' comprehensive investigation, we would like to offer observations on some aspects of the study.

We thank Marco Pocar and colleagues and Szu-Ping Cheng and colleagues for their interest in our Article.1 We agree that the topic of anticoagulation in patients with stroke and an indication for cardiac surgery—such as in the setting of infective endocarditis—is important and has an insufficient evidence base to guide clinical decisions.2

Allocation to 5 further years of AIT reduced subsequent distant recurrence rates by about a quarter despite substantial non-adherence. Longer follow-up would have been needed to help assess directly any effects on mortality.

Adagrasib demonstrated a statistically significant improvement in progression-free survival over docetaxel in patients with previously treated KRASG12C-mutated NSCLC, without new safety signals.

RmAb was safe and well tolerated and showed protective efficacy against rabies. A PEP regimen containing RmAb plus PVRV was immunogenic with long-term persistence of immune response.

Epilepsies that present during childhood pose unique challenges and include developmental and epileptic encephalopathies, specific distinctive constellations, and epilepsies with seizure subtypes, such as epileptic spasms, myoclonic-atonic seizures, and myoclonic absences. Self-limited focal epilepsies and genetic generalised epilepsy phenotypes are also evident during childhood. However, determining the cause—whether structural, genetic, metabolic, infectious, or autoimmune—is increasingly relevant.

Advancements over the past decade in understanding vesicular monoamine transporter 2 (VMAT2) inhibitors highlight their key role in the treatment of movement and neuropsychiatric disorders. VMAT2 is crucial for packaging neurotransmitters such as serotonin, dopamine, and norepinephrine into synaptic vesicles, facilitating their release and reuptake in synaptic transmission. VMAT2 inhibitors, such as tetrabenazine, deutetrabenazine, and valbenazine, show therapeutic efficacy in managing hyperkinetic movement disorders, including Huntington's disease, tardive dyskinesia, and Tourette's syndrome.

In April, 2025, Demis Hassabis, the Nobel Prize-winning CEO of Google DeepMind, appeared on the US television show 60 Minutes and suggested that all diseases could be curable with the help of artificial intelligence (AI), “maybe within the next decade or so”. An outlandish claim, certainly, but a study published in Science on June 12, 2025 seems like a step in the right direction. The study describes a first-in-class oral drug, BBO-10203, for difficult-to-treat cancers, designed and tested in record time with the help of AI, and potentially free of side-effects that have plagued similar therapies.

The treatment of metastatic hormone-sensitive prostate cancer has changed substantially over the past decade, with androgen deprivation therapy (ADT) combined with androgen receptor pathway inhibitors (ARPI) with or without docetaxel becoming the standard of care.1 The median overall survival for metastatic hormone-sensitive prostate cancer now exceeds 60 months, with patients living with castration levels of testosterone for many years. Therefore, adjunctive and minimally toxic strategies to mitigate the adverse metabolic effects of low androgen concentrations and improve clinical outcomes and quality of life are huge unmet needs.

In this issue of The Lancet Oncology, Cody Z Watling and colleagues1 investigate the relationship between oral contraceptives and liver cancer. Today there are more than 150 million current users of oral contraceptives worldwide, and an even higher number of people will have used this method of contraception in the years since it became available.2 Despite such widespread use, developing the evidence base regarding combined oral contraceptives and liver cancer has been challenging, partly due to the relatively low incidence of liver cancer in women, especially those of reproductive age.

The type of neoadjuvant treatment for rectal cancer depends on stage, risk criteria, and the intent of treatment.1 The overall goal with neoadjuvant treatment is to balance toxicity and tolerance with a relevant risk reduction of locoregional recurrence and distant metastasis for optimal disease-specific survival. Also, a non-operative (organ-sparing) approach of watch-and-wait surveillance might be offered to select patients with clinical complete response. Although the organ-sparing approach increases the patient's options and offers shared decision making, it might also clutter reporting of endpoints in trials and make clinical interpretation more difficult.

The study by Jinming Li and colleagues1 represents a major step forward in characterising the molecular complexity of early-onset colorectal cancer (EOCRC). Using one of the largest aggregated sequencing datasets to date, the authors reveal striking differences in molecular patterns between EOCRC and late-onset colorectal cancer (LOCRC), particularly when stratified by tumour mutational burden. This approach not only adds depth to our understanding of EOCRC biology but also raises critical questions about tumourigenesis, patient stratification, and future diagnostic and treatment strategies.

In their study in The Lancet Oncology, Allen S Ho and colleagues1 of the AJCC Head and Neck Cancer Staging Core Committee describe a new pathological staging system for human papillomavirus (HPV)-positive oropharyngeal carcinoma. The American Joint Committee on Cancer and Union for International Cancer Control (AJCC/UICC) 8th edition (AJCC8E) for staging HPV-positive oropharyngeal carcinoma was mainly criticised for its hasty changes based on only retrospective data and its major focus on prognosis (mainly after primary irradiation-based therapy) without reliable consequences for treatment decision making.

As early as 2005, Gritz and colleagues drew attention to clinical trialists missing the potential impact of tobacco use on cancer treatment outcomes, as smoking status was rarely recorded in cancer clinical trials.1 Peters and colleagues confirmed this oversight in a 2012 review of actively accruing trials in the National Cancer Institute (NCI) Cooperative Groups Program; only 45 (29%) of the 155 clinical trials reviewed assessed any form of tobacco use at enrolment and only seven (4·5%) of trials assessed tobacco use during follow-up.

In 2019, Graham H Jackson and colleagues1 reported the largest multiple myeloma trial to date to isolate the immunomodulatory treatment effect. Surprisingly, lenalidomide showed significant negative survival interactions by age-related factors without any reflection in the overall progression-free survival outcomes. The worsened survival of older patients with multiple myeloma cannot be explained by patient factors. In 2025, the Danish Medicines Council announced limiting lenalidomide for older patients with multiple myeloma who are transplant eligible.

Jakob Lindberg and Per Sjöberg discuss important issues regarding overall survival confounders and potential age-related heterogeneity in overall survival benefit in registrational trials of immunomodulatory drugs for multiple myeloma. As principal investigators in some of the trials referred to, we wish to help clarify some points and comment further on benefit (or otherwise) in older patients.

We read with great interest the PRODIGE 51-FFCD-GASTFOX trial results published by Aziz Zaanan and colleagues.1 The superiority of perioperative fluorouracil, oxaliplatin, and docetaxel (FLOT) triplet chemotherapy (also known as TFOX) over FOLFOX in patients with advanced HER2-negative gastric or gastro-oesophageal junction adenocarcinoma has the potential to substantially influence clinical practice. However, we would like to raise several points regarding the management of peripheral neuropathy in the trial and its potential implications for the reported outcomes.

We thank Tuba Uğur Tuzcu and colleagues for their relevant Correspondence regarding the management of neurotoxicity in the PRODIGE 51-FFCD-GASTFOX trial.1

We read with interest the Article by Emil Lou and colleagues in The Lancet Oncology, reporting a first-in-human study evaluating the safety and anti-tumour activity of autologous neoantigen-reactive tumour-infiltrating lymphocytes (TILs) engineered via CRISPR-Cas9-mediated knockout of CISH in patients with metastatic colorectal cancer.1 We commend the authors for advancing the clinical translation of CRISPR-Cas9 gene editing by targeting CISH, a novel intracellular immune checkpoint, within a therapeutic TIL platform.

We read with interest the paper by Emil Lou and colleagues1 investigating the safety and antitumour activity of CRISPR-Cas9-edited tumour-infiltrating lymphocytes (TILs) with CISH knockout in metastatic colorectal cancer. We commend the authors for their contributions and offer the following considerations.

We thank Fahreddin Palaz and Ali Zarrinpar for their interest in our Article.1 We acknowledge the cited studies reporting unintended chromosomal alterations observed in some therapeutic products following CRISPR-Cas9 editing in primary peripheral blood T cells and stem cell products. It is important to note that tumour-infiltrating lymphocytes (TILs) are unique in this regard, insofar as their life history involves residence within tumours that have been previously treated with clastogenic chemotherapy and/or radiation.

I read with great interest, Piet Ost and colleagues’ Article on the results of the PEACE V–STORM trial1 comparing whole-pelvis elective nodal radiotherapy (ENRT) with metastasis-directed therapy (MDT) in patients with oligorecurrent nodal prostate cancer. The low incidence of grade 2 or worse toxicity reported for ENRT is impressive and reflects the substantial progress made in radiotherapy techniques.

We read with interest, the Article by Piet Ost and colleagues1 on elective nodal radiotherapy (ENRT) versus salvage metastasis-directed therapy (MDT), both with 6 months of concomitant androgen deprivation therapy (ADT), for the treatment of oligorecurrent nodal prostate cancer metastases. The authors reported a 13% improvement in 4-year metastasis-free survival with ENRT compared with MDT.

We sincerely commend Piet Ost and colleagues for conducting the PEACE V–STORM trial, a well executed phase 2 randomised controlled trial addressing an important clinical question in the management of pelvic nodal oligorecurrent prostate cancer.1 The investigators should be congratulated for their contribution to this area of research. Nonetheless, several aspects warrant further scrutiny.

We thank Francesco Fiorica, Leonardo Quarta and colleagues, and Shafak Aluwini and colleagues for their thoughtful comments on the PEACE V–STORM trial.1

Hassan H, Allen I, Rahman T, et al. Long-term health outcomes of bilateral salpingo-oophorectomy in BRCA1 and BRCA2 pathogenic variant carriers with personal history of breast cancer: a retrospective cohort study using linked electronic health records. Lancet Oncol 2025; 26: 771–80—In this Article, the third sentence of the first paragraph in the Introduction section should read “The relative risk of ovarian cancer, following a breast cancer diagnosis, has been estimated to be 33 (95% CI 19–57) for BRCA1 carriers and 12 (7–22) for BRCA2 carriers3 when compared with non-BRCA1 and non-BRCA2 carriers with personal history of breast cancer.”, the third sentence of the third paragraph should read “Counselling individuals who carry pathogenic mutations in BRCA1 and BRCA2 who opt for BSO regarding their risk of other long-term outcomes is primarily based on evidence derived from studies conducted in the general population.

In June, 2025, 17 scientists from ten countries met at the International Agency for Research on Cancer (IARC) in Lyon, France, to finalise their evaluation of hepatitis D virus (HDV), human cytomegalovirus (HCMV), and Merkel cell polyomavirus (MCPyV).

Globally, 6·1 billion people, three-quarters of the world's population, are now protected by at least one effective tobacco control measure compared with 1 billion in 2007, according to the WHO's 10th report on the global tobacco epidemic released on June 23 at the World Conference on Tobacco Control 2025 (WCTC; Dublin, Ireland; June 23–25). Despite the progress achieved, WHO says urgent action is needed to maintain and accelerate the gains made because of increasing industry interference in tobacco policies and control efforts.

On June 20, 2025, the UK House of Commons voted to legalise assisted dying in England and Wales. The Terminally Ill Adults (End of Life) Bill, which was sponsored by the Labour Member of Parliament (MP) Kim Leadbeater, would allow adults who are expected to die within 6 months to be provided with assistance to end their lives. Leadbeater opened the debate by stating that she was guided by a desire to “correct the profound injustices of the status quo and to offer a compassionate and safe choice to terminally ill people”.

The US Food and Drug Administration (FDA) has granted import exemptions for about 150 drugs or their ingredients from factories, mostly in India, that were banned by the agency itself over safety concerns, according to an investigation by ProPublica, a non-profit journalism organisation (New York, NY, USA).

On June 23, 2025, the French National Assembly (lower house of the French Parliament) voted unanimously in favour of creating an eagerly awaited national cancer registry. The Senate (upper house of the parliament) cast a unanimous vote on the same text 2 years ago in June, 2023, the two houses achieving a rare consensus in a politically divided country.

A staggering £10·3 billion is lost from the UK economy every year due to people dying from cancer, according to a recent analysis from Cancer Research UK (CRUK).

Since entering office in January, 2025, the administration of US President Donald Trump has made sweeping cuts to budgets of multiple government departments and fired thousands of federal employees. Health programmes have been hit particularly hard, with both the US Agency for International Development, responsible for much global health support, butchered; and now many grants and initiatives of the US National Institutes for Health (NIH) being scaled back or axed altogether.

A new piece of proposed legislation, the Cancer Drug Parity Act, will require federally regulated health plans in the USA to offer improved coverage for oral and self-administered anticancer medications.

On July 2, 2025, WHO introduced the 3 by 35 initiative, asking countries to increase the prices of tobacco, alcohol, and sugary beverages by at least 50% by 2035. The plan aimed to increase health taxes in an attempt to contain non-communicable diseases (NCDs) including cancer, and create important public revenue.

On July 3, 2025, the UK Government launched its 10-Year Health Plan for England. The plan starts by warning that the National Health Service (NHS) is confronted with a choice between reform and death. “We can continue down our current path, making tweaks to an increasingly unsustainable model, or we can take a new course and reimagine the NHS through transformational change that will guarantee its sustainability for generations to come. This Plan chooses the latter”, added the authors.

mRNA cancer vaccines show encouraging early promise against challenging malignancies, such as glioblastoma, pancreatic cancer, and advanced melanoma. However, US researchers worry that possible funding cuts and changing regulatory priorities under the Trump Administration could impede progress and damage US leadership in this emerging field.

Maryam B Lustberg

“I've just started a charity. I want to prevent this from happening again.” These poignant words were shared by Amandip Sidhu during a podcast interview reflecting on the tragic death of his brother, Dr Jagdip Sidhu, a consultant cardiologist who died by suicide in November 2018 after enduring severe burnout. From this profound personal loss emerged Doctors in Distress, a UK-based independent charity dedicated to promoting wellbeing and preventing burnout and suicide among NHS health-care workers.

[161Tb]Tb-PSMA-I&T is safe at the maximum administered dose of 7·4 GBq. Further investigation of this promising radionuclide is warranted in larger, randomised clinical trials.

We did not find significant evidence of an overall survival benefit of adding metformin to standard of care in the overall population of patients with metastatic hormone-sensitive prostate cancer. The side-effect profile of metformin was as expected and consisted mainly of diarrhoea. Adverse metabolic side-effects of ADT were significantly reduced in the metformin group compared with the standard of care group.

The totality of observational studies suggests there is no association between ever versus never use of oral contraceptive and liver cancer risk. When looking at associations by duration of oral contraceptive use, there was little or no association with all liver cancer or its two main subtypes. There might be a small increased risk of liver cancer with longer duration of use, but residual confounding cannot be ruled out.

In patients with locally advanced rectal cancer, short-course radiotherapy combined with sintilimab and capecitabine–oxaliplatin as a total neoadjuvant treatment significantly increased the pathological complete response rate while maintaining manageable safety profile. These findings suggest that this regimen might be a promising neoadjuvant treatment approach for locally advanced rectal cancer.

Within hypermutated colorectal cancer, younger patients exhibited a higher mutational burden than older patients. Our study reveals an abnormal accumulation of distinct somatic mutations in hypermutated EOCRC, the pattern of which might be contributing to the alarming rise in the incidence of EOCRC over the past decades. Our results support the need for EOCRC-specific molecular profiling to guide clinical practice.

DREAMM-7 showed significant and clinically meaningful overall survival, progression-free survival, minimal residual disease negativity, and duration of response benefits with BVd versus DVd. BVd could be a new standard of care for RRMM.

Compared with eBEACOPP, BrECADD led to significantly better gonadal function recovery, as well as higher parenthood rates (significantly so in men). These findings support BrECADD as preferred first-line therapy, especially for patients wishing to preserve fertility.

This study is the first to report a comprehensive evaluation of survival parameters for paediatric CNS tumour patients in Europe. These outcomes are important to evaluate advances in care for children with a CNS tumour.

HER2DX provides clinically meaningful prognostic stratification in early-stage HER2-positive breast cancer, beyond standard clinical–pathological variables and pathological response. These results support its use in tailoring treatment intensity and guiding clinical decision making.

The AJCC9V HPV-positive oropharyngeal carcinoma staging classification confers an improved schema for guiding prognostication and management compared to AJCC8E. Incorporating ENE and correcting imbalances will enhance clinical relevance and align pathological staging in a condition whose management continues to evolve.

The disruption of health-care systems in conflict-affected regions creates transnational therapeutic geographies, forcing patients with cancer to navigate complex pathways for diagnosis and treatment. In the Middle East and North Africa (MENA) region, these geographies, shaped by displacement, sociopolitical barriers, and infrastructural collapse, remain underexplored in oncology research and policy. In this Review, we argue that understanding therapeutic geographies is crucial for addressing the challenges faced by conflict-affected populations.

In 2023, based on advances in the understanding of the pathological and molecular features of endometrial carcinoma, an updated International Federation of Gynaecology and Obstetrics (FIGO) staging system was published, aiming to better define prognostic groups and identify relevant treatment subgroups by including factors reflecting tumour biology (histological subtypes, lymphovascular space invasion, and molecular classification) alongside refinements of anatomical factors (peritoneal carcinomatosis and lymph node metastasis).

This Policy Review provides recommendations for the use of PET imaging in patients with gliomas and represents a joint effort of the Response Assessment in Neuro-Oncology (RANO) working group for PET and the European Association for Neuro-Oncology. The initial guideline was published in 2016, and summarised the previously established clinical benefit of PET with radiolabelled glucose and amino acid tracers in patients with gliomas. Since then, numerous additional studies have been published on this topic, focusing on differential diagnosis, prediction of molecular information, and prognostication.

Undocumented immigrants face substantial barriers to affordable health-care coverage in the USA. For people with cancer, federal restrictions on publicly funded health insurance pose serious downstream consequences, including delayed diagnosis, scarce treatment options, and worse health outcomes. In this Policy Review, we examine mechanisms through which undocumented immigrants access cancer care in the USA, focusing on Emergency Medicaid, Medicaid-equivalent plans, and Marketplace-based strategies.

A healthy 57-year-old female patient presented to Chang Gung Memorial Hospital (Kaohsiung, Taiwan) in February, 2025, with a 6-month history of a progressively enlarging wound on her left forearm. She reported no systemic symptoms or prior trauma. Initially, she was treated with wound care, including the application of novel dressings and wound suturing. Despite these efforts, the wound failed to heal and continued to worsen. Physical examination revealed a firm, ulcerated plaque (figure, A). A skin biopsy showed infiltrative spindled and epithelioid tumour cells with pleomorphic vesicular nuclei and eosinophilic nucleoli (figure, B, upper panel), arranged in fascicles and palisading around necrotic tissue (see appendix pp 1–2).

Despite decades of research, multiple myeloma remains an incurable disease. A wide array of therapies, such as proteasome inhibitors, immunomodulatory agents, monoclonal antibodies, antibody–drug conjugates, and CAR T-cell therapies, have transformed the therapeutic landscape. This progress has led to more effective first-line regimens, including quadruplet therapies, but these have also increased treatment complexity. Although many individuals achieve remission, relapse remains common. With each relapse, especially as the disease becomes more refractory, treatment options diminish, underscoring the urgent need for innovative and personalised approaches.

Sexual and reproductive health are negatively affected by haematopoietic stem-cell transplantation (HSCT). The process is arduous, frequently leaving individuals exhausted, and dealing with anxiety and depression alongside concurrent life stress. Common consequences of HSCT are relationship conflicts, a negative body image, and feelings of decreased sexuality and sexual desire.1 Regardless of whether patients undergo allogeneic or autologous HSCT, premature gonadal insufficiency frequently occurs as the majority receive gonadotoxic therapies.

Direct oral anticoagulants (DOACs) have been shown to be at least as effective as and safer than vitamin K-antagonists for preventing cardioembolism in atrial fibrillation and venous thromboembolism.1 Despite DOACs showing a highly relevant reduction of approximately 50% in the incidence of intracranial haemorrhages compared with warfarin,2 a non-negligible incidence rate of 2·7–4·0 intracranial haemorrhages per 1000 person-years in patients receiving DOACs for atrial fibrillation was found.3

The Lancet Haematology's Adverse Events Reporting Series scrutinises an overlooked aspect of clinical trials, emphasising that definitions and reporting systems of adverse events have real-world repercussions.1 We commend the work of the first three articles and we wish to highlight that adverse events reporting should be further scrutinised to account for typical variations across populations and thereby advance health equity. To illustrate this point, we use the example of Duffy-related neutrophil variation.

Cook JA, Patten PEM, Peckham N, et al. A 3-week pause versus continued Bruton tyrosine kinase inhibitor use during COVID-19 vaccination in individuals with chronic lymphocytic leukaemia (IMPROVE trial): a randomised, open-label, superiority trial. Lancet Haematol 2025; 12: e294–303—The appendix of this Article has been corrected as of Aug 4, 2025.

Gail Roboz (Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY, USA) presented results from the ASCERTAIN-V trial (NCT04657081). In this phase 1/2 study, patients with newly diagnosed acute myeloid leukaemia who were aged 75 years or older or had comorbidities precluding first-line intensive chemotherapy were given a fully oral regimen of venetoclax and decitabine–cedazuridine. Primary endpoints were pharmacokinetics and complete response rates. Median follow-up was 34·3 months in phase 1 (n=30), 26·0 months in phase 2a (n=58), and 11·2 months in phase 2b (n=101).

Jason Westin, from the MD Anderson Cancer Center (Houston, TX, USA), presented the primary results of the randomised, open-label, multicentre, phase 3 SUNMO trial (NCT05171647), evaluating efficacy and safety of mosunetuzumab, a CD20 × CD3 bispecific antibody, in combination with polatuzumab vedotin (M-Pola), a CD79b-directed antibody–drug conjugate, versus rituximab plus gemcitabine and oxaliplatin (R-GemOx) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). As of Feb 17, 2025, with a median follow-up of 23·2 months (range 0–32), 208 patients were randomly allocated (M-Pola, n=138; R-GemOx, n=70).

Lana Castellucci (University of Ottawa, ON, Canada) presented results from the phase 3 COBRRA trail (NCT03266783), which compared bleeding in patients with acute venous thromboembolism (VTE) treated with rivaroxaban or apixaban. Patients were treated for 3 months and received either rivaroxaban (15 mg twice a day for 21 days followed by 20 mg daily) or apixaban (10 mg twice a day for 7 days followed by 5 mg twice a day). The primary outcome of clinically relevant bleeding events occurred in 41 (3%) of 1346 patients in the apixaban group compared with 91 (7%) of 1350 patients in the rivaroxaban group (odds ratio [OR] 0·44; 95% CI 0·30–0·63; p<0·0001).

The field of plasma cell disorders has advanced primarily because of the collective efforts of members in cooperative research groups and international academia–industry collaborations. However, barriers to conducting clinical and basic or translational cancer research are encountered by clinicians and scientists in low-income and middle-income countries (LMICs), due to a lack of dedicated research time for clinicians, a dearth of drug development programmes, limited government funding, and lack of adequate research infrastructure and resources.

Final overall survival analysis in the BELLINI study showed overall survival favouring placebo over venetoclax and progression-free survival favouring venetoclax over placebo, indicating venetoclax usage should be avoided in the general relapsed or refractory multiple myeloma population.

KRd and D-KRd were superior to VMP 9–Rd 9 in achieving measurable residual disease negativity after 18 cycles. This study could contribute to incorporation of quadruplet therapy into clinical practice and supports the need for frailty-based assessment in therapy selection.

HRQOL was generally maintained or improved over time with belantamab mafodotin, bortezomib, and dexamethasone treatment. Our findings, in conjunction with previously reported clinical benefits, support the use of belantamab mafodotin as a potential new standard of care in relapsed or refractory multiple myeloma.

A multimodal intervention delivered by trained HSCT clinicians resulted in improvements in global satisfaction with sex. These findings underscore the potential of this intervention to be integrated into routine transplant care to improve sexual health outcomes for HSCT survivors.

With the limitation of a smaller sample size than planned due to the trial's early interruption, these results, to our knowledge, showed for the first-time high rates of MRD negativity with weekly carfilzomib added to lenalidomide–dexamethasone in patients with transplantation-ineligible newly diagnosed multiple myeloma. In the carfilzomib–lenalidomide–dexamethasone group, higher MRD negativity rates were associated with a progression-free survival advantage over lenalidomide–dexamethasone. Toxicities were predictable and generally manageable.

Novel T-cell immunotherapies (chimeric antigen receptor [CAR] T cells and T-cell redirecting bispecific antibodies) are changing the treatment landscape of relapsed or refractory multiple myeloma. In this Review, the European Myeloma Network provides recommendations to optimise both safety and efficacy of T-cell immunotherapy. In patients who are eligible for both CAR T-cell therapy and bispecific antibodies, we recommend using CAR T-cell therapy first due to the high response rate and durable progression-free survival, accompanied by improved quality of life.

Clonal haematopoiesis refers to the presence of somatic mutations in haematopoietic stem and progenitor cells, accompanied by the expansion of high-fitness clones over time. Age-related clonal haematopoiesis arises from ageing-related DNA damage and is associated with haematological neoplasms and coronary artery disease. Genotoxic therapies can promote the selection of somatic mutations, leading to therapy-related clonal haematopoiesis. Clonal haematopoiesis in acquired or inherited bone marrow failure syndromes and germline predispositions leads to clonal expansion, where fitness constraints on haematopoietic stem cells drive mutation acquisition.

An 89-year-old White male underwent routine cataract surgery and insertion of two iStent Inject microstents (Glaukos Corporation, Laguna Hills, CA, USA), for intraocular pressure management in the context of pseudoexfoliation glaucoma in his right eye. Key medical history included chronic lymphocytic leukaemia, for which the standard dose of oral zanubrutinib 160 mg twice daily commenced 4 months before his right eye operation and continued perioperatively. No other antithrombotic therapy was being taken.

The SBI Planning Tool represents a critical advancement in lung cancer control, offering an adaptable framework for states to strengthen their interventions based on real‐world conditions. This tool equips state and local leaders with the resources needed to drive meaningful change, reduce disparities, and improve lung cancer prevention, screening, and treatment efforts nationwide.

FLT3‐TKDmut AML commonly harbors NPM1 co‐mutation, which has key prognostic implications. Lack of NPM1 co‐mutation portends a poor prognosis, and allogenic stem cell transplantation should be strongly considered for patients in first remission.

In the largest cohort study of adult AML patients receiving OP H/IDAC, OP treatment administration was feasible, led to decreased hospital days and cost savings, and did not impact relapse free or overall survival compared to IP administration.

Black Hispanics are significantly less likely to receive PSA screening compared with non‐Black Hispanic counterparts. Cuban heritage and poor primary or routine health care access also predicted lower screening. These findings underscore the screening heterogeneity in this diverse community, and highlight areas of targeted intervention to reduce disparities.

Many patients with cancer are motivated to engage in ACP to decrease burden on others and receive patient‐centered care. A constellation of factors interact as facilitators or barriers to engagement. Therefore, a one‐time, one‐size approach is not recommended; facilitating engagement may require flexible approaches offered at multiple time points.

Low‐intensity venetoclax‐based regimens offer meaningful survival benefits in selected octa‐nonagenarian patients with AML, particularly those with favorable genomic profiles.

Survivors with DM are at increased risk of neurocognitive impairment. Although CVD did not exacerbate concurrent risk for impairment, it was associated with a decline in neurocognitive functioning over time in survivors with DM. Preventing/managing CVD in survivors with DM could mitigate additional neurocognitive decline.

You read with interest the results of two Phase 3 trials that examined whether radiotherapy to the prostate improves overall survival for patients diagnosed with low-volume metastatic disease. One trial randomized 2,061 men, among whom 819 had low metastatic burden, to standard systemic therapy vs. standard therapy plus prostate radiotherapy. This trial showed an improvement in overall survival from prostate radiotherapy for patients with low-metastatic burden, hazard ratio (HR) 0.68 (95% CI 0.52-0.90), p=0.007, with 3-year survival probabilities of 73% vs 81%.

Private equity (PE) acquisitions of physician practices have seen a significant increase in recent years. The surge in PE acquisitions raises concerns about market consolidation, affordability, and quality of care, particularly for disadvantaged patients. This study examines the trend of PE acquisitions in oncology from 2013 to 2022, quantifying market shares, analyzing changes in price and spending with particular focus on radiation oncology., and describing the influence on sociodemographic disparities in health outcomes.

Cranial radiotherapy is commonly used for treatment of patients with head and neck tumors, yet a considerable number of patients encounter long-lasting medical complications, including compromised blood-brain barrier (BBB) function and cognitive impairment. The mechanisms underlying BBB leakage after radiation exposure and potential preventive strategies remain elusive. In this study, we reported persistent accumulation of unrepaired DNA damage and PARP hyperactivation in neurons of both patients with radiation-induced brain injury and a mouse model.

HYPART study aimed to compare 1 week adjuvant radiotherapy schedule with 2 week in high-risk patients with breast cancer. Here we present acute toxicity data of the study.

Radiation oncology is a demanding yet deeply rewarding field, with physicians navigating complex clinical decisions in dynamic environments. Existent literature has focused on the challenges and stressors of the profession, however less attention has been given to the perspective of these who have completed their careers. This study explores the reflections of retired radiation oncologists, highlighting the aspects of their work that brought fulfilment and meaning over time.

To compare the effects of technological vs interpersonal psychoeducational interventions in reducing treatment-related anxiety in breast cancer patients undergoing radiotherapy.

: Patient education is demonstrated to reduce patient anxiety, facilitate shared decision making, and improve treatment outcomes. This scoping review characterizes the state of radiotherapy patient education (RPE) scholarship to identify research trends and knowledge gaps to guide future patient education research efforts.

Radiation-induced lymphopenia (RIL) is a critical adverse factor that worsens outcomes in patients undergoing radiotherapy. Numerous mechanistic models have been proposed to better understand RIL mechanisms or screen patients at risk. This scoping review presents a comprehensive overview of these models, ranging from basic dosimetry approaches to more advanced models that incorporate dose-response relationships, lymphocyte repopulation and homeostasis, and interactions with tumors. We then critically analyze the key components, assumptions, and available data underlying these models.

The impact of preoperative radiotherapy (RT) on early-stage breast cancer (BC) is underexplored but may significantly improve outcomes and offer new therapeutic strategies. The [ANONYMIZED STUDY NAME] trial aimed to characterize the molecular changes induced by preoperative RT across BC subtypes: Luminal A, Luminal B, HER2-enriched, and Basal-like.

Radiation-induced Esophagitis (RE) is a dose-limiting complication associated with chemo-radiation therapy (RT) for Non-Small-Cell Lung Cancer (NSCLC). We aimed to externally validate dose patterns and dosimetric predictors of grade ≥ 2 RE (RE2+) in an independent NSCLC cohort.

To perform a comprehensive network meta-analysis assessing the efficacy and safety of five postoperative adjuvant therapies (PATs) for early-stage cervical cancer, comparing their effects on survival and adverse outcomes to identify the therapy with the most significant survival benefit. We comprehensively searched PubMed, Web of Science, the Cochrane Library, Embase, CNKI, VIP, Wanfang, and CBM for randomized controlled trials (RCTs) on PATs—including concurrent chemoradiotherapy (CCRT), radiotherapy (RT), chemotherapy (CT), sequential chemoradiotherapy (SCRT), and consolidation chemotherapy followed by CCRT (CCRT+CT)—in cervical cancer patients from inception to October 2024.

In ductal carcinoma in situ (DCIS), whole breast radiotherapy (WBRT) reduces local recurrence rates, but ipsilateral breast events at 10 years were observed in 15-19% of 50-year-old patients. The XXXX trial (NCT XXXX) assessed the effect of an additional localized radiation boost on local recurrence-free survival (primary endpoint).

Salvage radiation therapy (RT) is used in men with prostate cancer (PC) recurrence following radical prostatectomy (RP) signaled by a persistent or delayed elevation in PSA. It was previously reported that the use of AAT with RT improved cancer control and overall survival (OS). Long-term follow-up results are presented here.

Neural signals-based respiratory motion tracking offers a potential solution to the system latency issue of medical linear accelerators in respiratory motion tracking radiotherapy. However, decoding respiratory-related neural signals from scalp electroencephalography (sEEG) in real-time is challenging. Herein we propose a clinically applicable neural signals-based respiratory motion tracking approach using surface electromyography (sEMG).

: Locoregionally recurrent squamous cell carcinoma of the head and neck (SCCHN) and second primary tumors (SPTs) in previously irradiated fields, if not resectable, are virtually always fatal. Chemotherapy alone yields a median survival of 10-11 months and 5-year overall survival (OS) rates of <5%. Concurrent re-irradiation and chemotherapy constitutes an alternative, non-standard strategy. Herein, we report the long-term outcomes of NRG Oncology RTOG 9911, a phase II trial of split course radiation (RT) and concurrent paclitaxel and cisplatin.

Microbeam Radiation Therapy (MRT) is a preclinical, spatially fractionated radiotherapy technique that delivers ultra-narrow synchrotron x-ray beams at ultra-high dose rates. MRT has demonstrated superior tumor control compared to synchrotron Broad Beam by triggering infiltration of CD8+ T cells and inducing a transient vascular permeability window. This study aimed to investigate the effects of combining MRT with Gold Nanoparticles (AuNPs) on tumor growth, while also assessing whether MRT could enhance intra-tumoral accumulation of AuNPs.

Clinically significant fatigue was associated with increased inflammation in breast cancer survivors, according to study findings published in BMC Women's Health. The study authors also suggested that an increase in inflammatory markers from clinical fatigue could lead to breast cancer recurrence. ...

In a Korean retrospective study reported in JAMA Network Open, Bong et al found that the addition of oxaliplatin to fluoropyrimidine-based adjuvant chemotherapy was associated with an overall survival benefit in patients with stage III colorectal cancer aged ≤ 70 years but not in those aged > 70 ...

In a study reported as a research letter in JAMA Oncology, Hahn et al found that the proportion of U.S. patients with breast cancer undergoing annual surveillance imaging was lower in the post– vs pre–COVID-19 period, with no significant difference in recurrence or progression being observed.

Various artificial intelligence (AI) algorithms submitted as part of a challenge demonstrated the ability to identify different breast cancers during screening mammography, according to the results of a study published in Radiology. Ensemble models of the top submitted algorithms indicated that the ...

The introduction of artificial intelligence (AI) to assist colonoscopies may be linked to a reduction in the ability of endoscopists to detect adenomas in the colon without AI assistance, according to a paper published by Budzyń et al in The Lancet Gastroenterology & Hepatology.

For the 20th year in a row, major advances in cancer research and practice-changing clinical trials from the 2025 ASCO Annual Meeting (ASCO25) were presented at the ASCO-licensed Best of ASCO meeting, held on July 18–19, 2025, in Beirut, Lebanon. It was indeed a great celebration and commitment to...

In a substudy of the Australian phase II ENZA-p trial reported in The Lancet Oncology, Emmett et al found that baseline prostate-specific membrane antigen (PSMA)–positron-emission tomography (PET) total tumor volume (TTV) was prognostic for overall survival and predictive for a beneficial effect on ...

In a French-Belgian phase III trial (ASTER 70s) reported in The Lancet, Brain et al examined the survival benefit of adding adjuvant chemotherapy to hormone therapy in women aged ≥ 70 years with estrogen receptor–positive, HER2-negative breast cancer with high-risk disease on the basis of genomic...

Remarkable advances in treatments for cancer over the past 2 decades are enabling increased personalized care for patients with the disease. However, the growing complexity of treatment methods, including targeted therapy, immunotherapy, and advanced oral therapy, make it challenging for medical...

Some survivors of childhood cancers face a continued elevated risk of premature mortality, new cancers, chronic conditions, and other adverse health conditions as they grow older, according to new findings published in the Journal of Clinical Oncology. 

John C. Byrd, MD, FASCO, an internationally lauded researcher and clinical specialist in hematologic malignancies, has been appointed Director of UPMC Hillman Cancer Center, effective November 2025.

Experts from the National Lung Cancer Roundtable have created a customizable, web-based platform that allows groups and local leaders to develop state-based action plans for reducing lung cancer mortality rates. The platform, called the SBI Planning Tool, allows users to explore real-world...

Results from a recent study may help to explain why a rare and hyper-aggressive subtype of kidney cancer is susceptible to immunotherapy—information that helped researchers create a first-of-its-kind tool to guide treatment decisions for patients with advanced kidney cancers. The collaborative work ...

In patients with newly diagnosed, PD-L1–positive, advanced non–small cell lung cancer (NSCLC) who tested negative for driver mutations, implementation of plasma-guided treatment intensification—from monotherapy with the PD-1 inhibitor pembrolizumab to platinum doublet chemotherapy plus...

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib (Hernexeos), a kinase inhibitor, for adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine kinase domain (TKD)–activating mutations, as...

In patients with small cell lung cancer, second-line treatment with the bispecific T-cell engager tarlatamab-dlle (which targets the delta-like ligand 3 [DLL3]) vs standard-of-care chemotherapy appeared to significantly improve overall survival, progression-free survival, and patient-reported...

In a cross-sectional study reported in JAMA Network Open, Abel et al found that higher rates of neoadjuvant chemotherapy (NACT) and a higher annual volume of cytoreductive surgery were associated with better survival outcomes in patients treated at Commission on Cancer–accredited cancer programs in ...

Based on the results of a cohort study reported in JAMA Network Open, smoking worsened both cancer symptom burden and severity. However, Rieth et al noted that oncologic surgery may present a unique teachable moment for smoking cessation, as patients appeared to be highly motivated to quit.

A retrospective cohort study published in JAMA Network Open found glucagon-like peptide-1 (GLP-1) receptor agonists to be associated with lower all-cause mortality than dipeptidyl peptidase-4 (DPP-4) inhibitors, with no significant difference from sodium-glucose cotransporter-2 (SGLT-2) inhibitors, ...

For patients with gastrointestinal (GI) cancers, chemotherapy can sometimes cause severe, even life-threatening side effects in those who carry certain genetic variants that may impact how their bodies process the drugs used to treat their disease. Testing for variants in two genes before starting...

Researchers at Dana-Farber Cancer Institute have developed a blood test that may alter the diagnosis and monitoring of multiple myeloma and its precursor conditions. The new method, known as SWIFT-seq, uses single-cell sequencing to profile circulating tumor cells (CTCs) in the blood, offering a...

In an analysis from the phase III DREAMM-7 trial reported in The Lancet Oncology, Hungria et al compared survival outcomes with belantamab mafodotin, bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma...

Researchers have identified age-, sex-, and race-related disparities around treatment with hypomethylating agents for patients with myelodysplastic syndromes in the United States. The receipt of hypomethylating agents was found to favor younger, male, White patients, according to findings published ...

In a phase III trial (EPIK-O/ENGOT-ov61) reported in the Journal of Clinical Oncology, Konstantinopoulos et al compared the survival outcomes of alpelisib plus olaparib vs single-agent chemotherapy in patients with platinum-resistant or -refractory high-grade serous ovarian cancer (HGSOC) with no...

In an interim analysis of a Japanese phase II/III trial (GENERATE, JCOG1611) reported in the Journal of Clinical Oncology, Ohba et al compared the survival benefit of mFOLFIRINOX (modified fluorouracil, leucovorin, irinotecan, oxaliplatin) or S-IROX (S-1, irinotecan, oxaliplatin) vs nab-paclitaxel...

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to dordaviprone (Modeyso) a protease activator, for adult and pediatric patients aged 1 year and older with diffuse midline glioma harboring an H3 K27M mutation who have progressive disease after prior therapy. This...

Right ventricle (RV) dysfunction is associated with poorer outcomes in heart failure with preserved ejection fraction (HFpEF). Females are more likely to have HFpEF but males have worse prognosis and resting RV function. The contribution of dynamic RV-pulmonary artery (RV-PA) coupling between sex and its impact on peak exercise capacity (VO2) in HFpEF is not known.

A Phase I, single-center investigation demonstrated that 8 weeks of antimycobacterial therapy improved sarcoidosis forced vital capacity (FVC). Safety and efficacy assessments have not been performed in a multicenter cohort.

All aspects of medical education were affected by the Novel Coronavirus Infectious Disease-19 (COVID-19) pandemic. Several challenges were experienced by trainees and programs alike due to the economic repercussions of the pandemic, how social distancing affected the delivery of medical education, testing and interviewing, how the surge of patients affected redeployment of personnel, potential compromise in core training and the overall impact on the wellness and mental health of trainees and educators.

In this meta-analysis of observational studies, RV dysfunction was associated with higher short-term and long-term mortality in sepsis and septic shock.

Legionella is an uncommon cause of CAP, occurring primarily from late spring through early autumn. Testing is uncommon, even among patients with risk factors, and many positive patients failed to receive empiric coverage for LP.

The nS classification could be used to provide a more accurate prognosis in patients with resected NSCLC. The nS is worth taking into consideration when defining nodal category in the forthcoming ninth edition of the staging system.

NLP successfully identified a large cohort with CC. Most patients were identified through NLP alone, rather than diagnoses or medications. NLP improved detection of patients nearly seven-fold, addressing the gap in ability to identify and characterize CC disease burden. Nearly all cases appeared to be managed in primary care. Identifying these patients is important for characterizing treatment and unmet needs.

Pulmonary arterial hypertension (PAH) is a rare disease and much of our understanding stems from single-center studies, which are limited by sample size and generalizability. Administrative data offer an appealing opportunity to inform clinical, research, and quality improvement efforts for PAH. Yet, there is currently no standardized, validated method to distinguish PAH from other subgroups of pulmonary hypertension (PH) within this data source.

A transparent DL algorithm improves on traditional clinical criteria to predict the need for MV in hospitalized patients, including in those with COVID-19. Such an algorithm may help clinicians optimize timing of tracheal intubation, better allocate resources and staff, and improve patient care.

To assess airway and lung parenchymal damage non-invasively in cystic fibrosis (CF), chest MRI has been historically out of the scope of routine clinical imaging due to technical difficulties such as the low proton density and respiratory and cardiac motion. However, technological breakthroughs have recently emerged to dramatically improve lung MRI quality (including signal-to-noise ratio, resolution, speed, contrast). At the same time, novel treatments have changed the landscape of CF clinical care.

Bronchoscopic lung volume reduction with one-way endobronchial valves is a guideline treatment option for patients with advanced emphysema, supported by extensive scientific data. Patients limited by severe hyperinflation, with a suitable emphysema treatment target lobe and with absence of collateral ventilation are the responders to this treatment. Detailed patient selection, a professional treatment performance, and dedicated follow-up of the valve treatment, including management of complications, are key ingredients to success.

Chronic Obstructive Pulmonary Disease (COPD) may cause profound dyspnea, functional impairment, and reduced quality of life. Available pharmacologic therapy provides suboptimal symptom improvement in many patients. Bronchoscopic lung volume reduction (BLVR), achieved with endobronchial valve (EBV) placement, can effectively improve dyspnea and functional status in appropriately selected patients. Operationalizing a safe and effective BLVR program requires appropriate oversight which can be achieved by a BLVR Nurse Coordinator (NC).

Empathy-based, stigma-reducing communication may lead to improved assessments of tobacco use and smoking cessation for patients with smoking-related cancers. These findings support the dissemination and further testing of a new ECS model for training OCPs in best practices for assessment of smoking history and engagement of patients who currently smoke in tobacco treatment delivery.

In clinical practice, reslizumab may have been initiated in response to heavy symptom burden and CAEs. Reslizumab was associated with improved clinical and patient-reported outcomes and significant reductions in asthma-related HRU.

Quantitative emphysema measured on LDCT of the chest can be leveraged to improve lung cancer risk prediction and help diagnose COPD in individuals who currently or formerly smoked undergoing lung cancer screening.

The SERENA-6 trial assessed a paradigm-shifting approach to personalized cancer therapy in patients with advanced-stage breast cancer, in which therapy was switched upon the identification of resistance-related mutations in ESR1 in circulating tumour DNA (ctDNA). Herein, we discuss how the results of this trial challenge the standard-of-care management for these patients, in whom therapy changes are otherwise undertaken only after radiographic and/or clinical progression.

Recent clinical data indicate that infection with the common β-herpesvirus cytomegalovirus (CMV) confers beneficial effects on the T cell compartment that are associated with superior outcomes following immunotherapy in patients with melanoma. These findings warrant further studies of novel therapeutic strategies and biomarkers that might better predict clinical response to and toxicities of immunotherapy, based on systemic immune status.

Cancer of unknown primary (CUP) constitutes a diagnostic quandary and has a dismal prognosis, with standard empirical chemotherapy providing limited benefit. This Review outlines diagnostic innovations that are improving tissue-of-origin prediction as well as novel treatment strategies that have shown promise for improving outcomes in patients with CUP.

Despite advances in cancer therapy, the persistent challenge of treatment resistance and particularly multidrug resistance remains a substantial barrier to further improvements in patient outcomes. In this Review, the authors discuss preclinical and clinical advances in understanding multidrug resistance, with an emphasis on resistance to chemotherapies and targeted therapies, as well as the progress made in translating these findings into novel strategies to overcome this challenge and thus improve patient outcomes.

Clarifying the role of SONIA: supporting academic evidence on CDK4/6 inhibitor timing

Next-generation, oral selective oestrogen receptor degraders (SERDs) have been shown to improve outcomes in patients with advanced-stage oestrogen receptor (ER)-positive, HER2-negative breast cancer, particularly those with acquired ESR1 mutations. Now, the proteolysis-targeting chimera (PROTAC) SERD vepdegestrant, which induces ER degradation directly rather than indirectly, has also demonstrated efficacy in this setting, raising questions over the optimal choice and sequencing of treatments.

Despite several decades of research that has revealed roles in the development and progression of many solid tumours, clinical translation of research targeting epithelial–mesenchymal transition (EMT) has thus far been limited. In this Review, the authors provide a summary of the role of EMT in cancer development and progression in the context of this lack of clinical translation, summarize the current status of direct or indirect EMT-modulating agents in clinical development, and highlight the major barriers to the development of EMT-related clinical interventions.

MET mutations, amplifications and fusions and MET overexpression are promising therapeutic targets across various cancers. In this Review, the authors summarize the prevalence, molecular diagnosis and prognostic implications of these alterations and discuss the clinical efficacy and toxicity profiles of diverse MET-targeted therapies, including tyrosine-kinase inhibitors, monoclonal or bispecific antibodies and antibody–drug conjugates.

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Resistance to cytarabine is a key problem in the treatment of acute myeloid leukemia (AML). To understand the molecular biology of resistance to cytarabine, a viability-based chemosensitizer screen was utilized. We screened synthetic lethal targets using 437 different small interfering RNAs (siRNAs) directed against factors involved in DNA repair mechanisms and cytarabine as the chemical compound. Three hits were identified: CUL4A, TP73, and RFC2. We show here that the ubiquitin ligase CULLIN 4A (CUL4A) and the tumor-suppressive transcription factor p73 contribute to drug resistance by modulating DNA damage response. P73 confers resistance to cytarabine therapy by transactivation of REV3L, encoding the catalytic subunit of translesion DNA polymerase ζ, and CUL4A probably by influencing proliferating cell nuclear antigen (PCNA) and the polymerase switch towards error-prone translesion DNA polymerases. Abrogation of the polymerase ζ by siRNA causes identical effects as siRNAs against CUL4A or TP73 and resensitizes cells towards cytarabine therapy in vitro. As CUL4A needs to be activated by neddylation to facilitate the degradation of several proteins including PCNA, we propose a novel explanation for the synergism between cytarabine and the neddylation inhibitor pevonedistat by inhibition of translesion synthesis. In keeping with this, in AML patients treated with cytarabine, we found high expression of CUL4A and TP73 to be associated with poor prognosis.

Data on outcome of patients with mantle cell lymphoma (MCL) and COVID-19 infection are limited. The European MCL (EMCL) registry is a centralized registry of the EMCL network, collecting real-world information about treatments and disease courses. During the COVID-19 pandemic, additional data on MCL patients with COVID-19 infection were collected, aiming to identify risk factors for mortality from COVID-19. In our retrospective, multicenter, international study, we collected data from 63 MCL patients with a median age of 64 years (range, 44–84) in 9 countries with evidence of a COVID-19 infection between February 2020 and October 2021. The overall mortality rate was high (44.4%), especially in hospitalized patients (61%) and in patients with need for intensive care unit care (94%). Patients receiving rituximab had significantly poorer survival than patients not receiving rituximab (P = 0.04). Our data highlight the importance of prevention strategies and underline the need for effective vaccination in this vulnerable cohort.

Immune dysregulation has been highlighted as a key player in the pathogenesis of myelodysplastic syndromes (MDS), but little is known about cytokine profiles in patients with unexplained cytopenia with or without mutations in MDS-associated genes (clonal cytopenias of undetermined significance [CCUS] and idiopathic cytopenias of undetermined significance [ICUS], respectively), which often precede MDS. Here, we study the cytokine profiles in 111 patients with ICUS (N = 41), CCUS (N = 30), lower-risk MDS (LR-MDS; N = 22) and higher-risk MDS (HR-MDS; N = 18), and in healthy elderly controls (N = 21). Twenty cytokines were examined in blood plasma at time of diagnosis using Luminex assays and enzyme linked immunosorbent assays. The cytokine levels were compared between patient groups, and in patients versus controls. Associations between cytokines and MDS-associated mutations were evaluated. An aberrant cytokine profile was observed in all patient groups relative to healthy elderly controls. Patients had significantly higher levels of IL-6 (P< 0 .001), tumor necrosis factor α (P < 0.001), IL-10 (P < 0.001), and C-X-C motif chemokine 10 (P < 0.001) and lower levels of transforming growth factor beta 1 (P < 0.001), CCL5/regulated on activation normal T-cell expressed and secreted (P < 0.001), and S100A4 (P < 0.001) compared with healthy controls. Survival was significantly shorter in CCUS and MDS patients with a high systemic inflammatory cytokine load (median overall survival [OS] 21 months) compared with those with low-moderate systemic inflammatory cytokine load (median OS 64 months; P < 0.0001). These data suggest that patients with ICUS and CCUS have cytokine levels as abnormal as in LR-MDS. Indeed, high cytokine levels are present before MDS is diagnosed and cytokine levels are elevated irrespective of the presence or size of the myeloid clones. Cytokines may have a prognostic impact at a very early premalignant stage of myeloid disorders.

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Musculoskeletal symptoms in chronic graft-versus-host disease (cGVHD) are rare manifestations contributing to disease burden. This study assesses the frequency of muscle cramps, joint and muscle aches, and muscle weakness in a cohort of patients severely affected by cGVHD. Three hundred thirty-four patients participated in the NCI natural history study of cGVHD (NCT00092235) from October 2004 to March 2017. Five-point Lee cGVHD Symptom Scale was dichotomized (less symptom bother—0, 1, 2; severe symptom bother—3, 4) and tested for associations with: Short Form 36 (SF36), 2-minute walk test, grip strength, joint range of motion, and human activity profile, clinical and laboratory data. Seventy-five point four percent of patients reported joint and muscle aches (36.8% severe, Lee Symptom Scale score 3–4), 74.3% muscle cramps (33.5% severe), and 82.34% muscle weakness (45.51% severe), which were associated with reduced functional capacity (SF36 Physical Component Scale, P < 0.0001). Muscle cramps were associated with limited joint movement (P < 0.0001) and skin manifestations (skin thickening, P = 0.0008; itchy skin, P = 0.0003). Muscle cramps did not show association with potential causative agents, such as concomitant calcineurin inhibitors therapy, statins, or use of antidiabetic drugs. Joint and muscle aches showed associations with multiple variables (including strong associations with mood symptoms and fatigue, P < 0.0001). Muscle weakness was not associated with steroid dose, but was significantly associated with depression (P < 0.0001) and anxiety (P = 0.0009). This study documents a high frequency of musculoskeletal symptoms in a cohort of adult patients with cGVHD. The multivariable logistic regression models showed that a joint set of factors were moderately well associated with musculoskeletal symptoms in this study.

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Drug resistance and treatment failure in pediatric acute lymphoblastic leukemia (ALL) are in part driven by tumor heterogeneity and clonal evolution. Although bulk tumor genomic analyses have provided some insight into these processes, single-cell sequencing has emerged as a powerful technique to profile individual cells in unprecedented detail. Since the introduction of single-cell RNA sequencing, we now have the capability to capture not only transcriptomic, but also genomic, epigenetic, and proteomic variation between single cells separately and in combination. This rapidly evolving field has the potential to transform our understanding of the fundamental biology of pediatric ALL and guide the management of ALL patients to improve their clinical outcome. Here, we discuss the impact single-cell sequencing has had on our understanding of tumor heterogeneity and clonal evolution in ALL and provide examples of how single-cell technology can be integrated into the clinic to inform treatment decisions for children with high-risk disease.

Real-world data on the efficacy and tolerability of isatuximab with pomalidomide and dexamethasone (IsaPomDex) in relapsed/refractory myeloma patients have not been reported. In this UK-wide retrospective study, IsaPomDex outcomes were evaluated across 24 routine care cancer centers. The primary endpoint was overall response rate (ORR). Secondary endpoints included progression-free survival (PFS), duration of response (DOR) for patients who achieved an objective response (≥partial response [PR]), and adverse events (AEs). In a total cohort 107 patients, median follow up (interquartile range [IQR]) was 12.1 months (10.1–18.6 mo), median age (IQR) was 69 years (61–77). Median (IQR) Charlson Comorbidity Index (CCI) score was 3 (2–4); 43% had eGFR <60 mL/min. Median (IQR) number of prior therapies was 3 (3–3). Median (IQR) number of IsaPomDex cycles administered was 7 (3–13). ORR was 66.4%, with responses categorized as ≥ very good partial response: 31.8%, PR: 34.6%, stable disease: 15.9%, progressive disease: 15%, and unknown 2.8%. Median PFS was 10.9 months. Median DOR was 10.3 months. There was no statistical difference in median PFS by age (<65: 10.2 versus 65–74 13.2 versus ≥75: 8.5 mo, log-rank P = 0.4157), by CCI score (<4: 10.2 mo versus ≥4: 13.2, log-rank P = 0.6531), but inferior PFS was observed with renal impairment (≥60: 13.2 versus <60: 7.9 mo, log-rank P = 0.0408). Median OS was 18.8 months. After a median of 4 cycles, any grade AEs were experienced by 87.9% of patients. The most common ≥G3 AEs were neutropenia (45.8%), infections (18.7%), and thrombocytopenia (14%). Our UK-wide IsaPomDex study demonstrated encouraging efficacy outcomes in the real world, comparable to ICARIA-MM trial.

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The hierarchical framework of the adult blood system as we know it from current medical and hematology textbooks, displays a linear branching network of dividing and differentiated cells essential for the growth and maintenance of the healthy organism. This view of the hierarchy has evolved over the last 75 years. An amazing increase in cellular complexity has been realized; however, innovative single-cell technologies continue to uncover essential cell types and functions in animal models and the human blood system. The most potent cell of the hematopoietic hierarchy is the hematopoietic stem cell. Stem cells for adult tissues are the long-lived self-renewing cellular component, which ensure that differentiated tissue-specific cells are maintained and replaced through the entire adult lifespan. Although much blood research is focused on hematopoietic tissue homeostasis, replacement and regeneration during adult life, embryological studies have widened and enriched our understanding of additional developmental hierarchies and interacting cells of this life-sustaining tissue. Here, we review the current state of knowledge of the hierarchical organization and the vast heterogeneity of the hematopoietic system from embryonic to adult stages.

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It has been unclear what role metabolism is playing in the pathophysiology of chronic lymphocytic leukemia (CLL). One reason is that the study of CLL metabolism is challenging due to the resting nature of circulating CLL cells. Also, it is not clear if any of the genomic aberrations observed in this disease have any impact on metabolism. Here, we demonstrate that CLL cells in proliferation centers exhibit upregulation of several molecules involved in glycolysis and mitochondrial metabolism. Comparison of CXCR4/CD5 intraclonal cell subpopulations showed that these changes are paralleled by increases in the metabolic activity of the CXCR4lowCD5high fraction that have recently egressed from the lymph nodes. Notably, anti-IgM stimulation of CLL cells recapitulates many of these metabolic alterations, including increased glucose uptake, increased lactate production, induction of glycolytic enzymes, and increased respiratory reserve. Treatment of CLL cells with inhibitors of B-cell receptor (BCR) signaling blocked these anti-IgM-induced changes in vitro, which was mirrored by decreases in hexokinase 2 expression in CLL cells from ibrutinib-treated patients in vivo. Interestingly, several samples from patients with 17p-deletion manifested increased spontaneous aerobic glycolysis in the unstimulated state suggestive of a BCR-independent metabolic phenotype. We conclude that the proliferative fraction of CLL cells found in lymphoid tissues or the peripheral blood of CLL patients exhibit increased metabolic activity when compared with the bulk CLL-cell population. Although this is due to microenvironmental stimulatory signals such as BCR-engagement in most cases, increases in resting metabolic activity can be observed in cases with 17p-deletion.

The rapid evolution of genomic technologies over the last years has led to the development of different methods for the detection, measurement and analysis of cell-free DNA fragments (cfDNA) which are shed into the bloodstream by apoptotic cells and circulate at a low concentration in plasma. In cancer patients, the proportion of tumor-derived cfDNA is defined as circulating tumor DNA. This analysis, commonly known as liquid biopsy, allows to access tumor DNA through a simple blood sampling and therefore without the need of an invasive tissue biopsy. For this reason, this tool may have several clinical applications in terms of diagnosis, prognosis, and monitoring of minimal residual disease. However, there are still several critical issues that need to be resolved. In this review, we will discuss some of the controversies around this method and its potential clinical applications.

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Genotyping is not routinely performed at diagnosis of von Willebrand disease (VWD). Therefore, the association between genetic variants and pathogenic mechanism or the clinical and laboratory phenotype is unknown in most patients, especially in type 1 VWD. To investigate whether genotyping adds to a better understanding of the pathogenic mechanisms and variability in phenotype, we analyzed the VWF gene in 390 well-defined VWD patients, included in the WiN study. A VWF gene variant was found in 155 patients (61.5%) with type 1, 122 patients (98.4%) with type 2, and 14 patients (100%) with type 3 VWD. Forty-eight variants were novel. For each VWF gene variant, the pathogenic mechanisms associated with reduced VWF levels was investigated using the FVIII:C/VWF:Ag and VWFpp/VWF:Ag ratios. In type 1 VWD, reduced synthesis or secretion of VWF was most frequently found in patients with nonsense variants, frameshift variants, and deletions, whereas rapid clearance of VWF was mainly found in patients with missense variants. Furthermore, type 1 VWD patients with and without a VWF gene variant were clearly distinct in their clinical features such as age of diagnosis, laboratory phenotype, and bleeding phenotype. In type 2 VWD, 81% of variants were associated with an increased clearance of VWF. To conclude, we identified the pathogenic mechanisms associated with various VWF gene variants in type 1, 2, and 3 VWD patients. Additionally, major differences in the phenotype of type 1 VWD patients with and without a variant were observed, which may be of importance for clinical management.

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Measurable residual disease (MRD) quantified by multiparameter flow cytometry (MFC) is a strong and independent prognostic factor in acute myeloid leukemia (AML). However, several technical factors may affect the final read-out of the assay. Experts from the MRD Working Party of the European LeukemiaNet evaluated which aspects are crucial for accurate MFC-MRD measurement. Here, we report on the agreement, obtained via a combination of a cross-sectional questionnaire, live discussions, and a Delphi poll. The recommendations consist of several key issues from bone marrow sampling to final laboratory reporting to ensure quality and reproducibility of results. Furthermore, the experiences were tested by comparing two 8-color MRD panels in multiple laboratories. The results presented here underscore the feasibility and the utility of a harmonized theoretical and practical MFC-MRD assessment and are a next step toward further harmonization.

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Mastocytosis is a hematologic neoplasm characterized by expansion and focal accumulation of neoplastic mast cells (MC) in diverse organs, including the skin, bone marrow (BM), spleen, liver, and gastrointestinal tract. The World Health Organization classification divides the disease into prognostically distinct variants of cutaneous mastocytosis (CM) and systemic mastocytosis (SM). Although this classification remains valid, recent developments in the field and the advent of new diagnostic and prognostic parameters created a need to update and refine definitions and diagnostic criteria in MC neoplasms. In addition, MC activation syndromes (MCAS) and genetic features predisposing to SM and MCAS have been identified. To discuss these developments and refinements in the classification, we organized a Working Conference comprised of experts from Europe and the United States in August 2020. This article reports on outcomes from this conference. Of particular note, we propose adjustments in the classification of CM and SM, refinements in diagnostic criteria of SM variants, including smoldering SM and BM mastocytosis (BMM), and updated criteria for MCAS and other conditions involving MC. CD30 expression in MC now qualifies as a minor SM criterion, and BMM is now defined by SM criteria, absence of skin lesions and absence of B- and C-findings. A basal serum tryptase level exceeding 20 ng/mL remains a minor SM criterion, with recognition that hereditary alpha-tryptasemia and various myeloid neoplasms may also cause elevations in tryptase. Our updated proposal will support diagnostic evaluations and prognostication in daily practice and the conduct of clinical trials in MC disorders.

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This expert opinion originally developed by a panel of the Italian Society of Thalassemias and Hemoglobinopathies (SITE), reviewed and adopted by the European Hematology Association (EHA) through the EHA Scientific Working Group on Red Cells and Iron, has been developed as priority decision-making algorithm on evidence and consensus with the aim to identify which patients with transfusion-dependent beta-thalassemia (TDT) could benefit from a gene therapy (GT) approach. Even if the wide utilized and high successful allogeneic hematopoietic stem-cell transplantation provides the possibility to cure several patients a new scenario has been opened by GT. Therefore, it is important to establish the patients setting for whom it is priority indicated, particularly in the early phase of the diffuse use outside experimental trials conducted in high selected centers. Moreover, actual price, limited availability, and resources disposal constitute a further indication to a rational and progressive approach to this innovative treatment. To elaborate this algorithm, the experience with allogeneic transplantation has been used has a predictive model. In this large worldwide experience, it has been clearly demonstrated that key for the optimal transplant outcome is optimal transfusion and chelation therapy in the years before the procedure and consequently optimal patient’s clinical condition. In the document, different clinical scenarios have been considered and analyzed for the possible impact on treatment outcome. According to the European Medicine Agency (EMA) for the GT product, this expert opinion must be considered as a dynamic, updatable, priority-based indications for physicians taking care of TDT patients.

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As a result of significant recent developments, the management of patients with chronic lymphocytic leukemia (CLL) is changing, and new therapeutic options will continue to emerge in the near future. The recommendations of the French Innovative Leukemia Organization (FILO-CLL) group presented here are intended to provide practical recommendations for physicians taking care of CLL patients, taking into account the availability of both biological tests and therapies in daily practice in France at the time of publication. This text details the documented information and guidelines on diagnosis, indications for treatment, infectious complications and therapeutic strategies in frontline and relapsed CLL as well as in particular conditions such as autoimmune cytopenia or Richter syndrome.

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Infections are a major cause of morbidity and mortality in patients with chronic lymphocytic leukemia (CLL). These can be exacerbated by anti-leukemic treatments. In addition, the typical patients with CLL already have fragilities and background risk factors that apply to the general population for severe COVID-19. On these bases, patients with CLL may experience COVID-19 morbidity and mortality. Recurrent seasonal epidemics of SARS-CoV-2 are expected, and doctors taking care of patients with CLL must be prepared for the possibility of substantial resurgences of infection and adapt their approach to CLL management accordingly. In this Guideline Article, we aim at providing clinicians with a literature-informed expert opinion on the management of patients with CLL during SARS-CoV-2 epidemic.

In the light of the COVID-19 pandemic, the International Workshop on Waldenström Macroglobulinemia (IWWM) Treatment Recommendations Panel felt the need to provide a consensus statement for the management of Waldenström Macroglobulinemia (WM) patients during this challenging time. We followed the current recommendations by the American Society of Hematology, which have been modified accordingly to fit the specific realities associated with the management of WM. In this Consensus Statement, the Panel addresses questions related to treatment initiation, preferred therapies, minimizing visit to clinics and infusions centers, supportive care and guidance for WM patients in clinical trials. Finally, we also provide information on timing and appropriateness of testing and management of COVID-19 infected patients, as well as ways to get physicians and patients involved in registry studies that could help others.

The objective of this guideline is to aid clinicians in making individual salvage treatment plans for pediatric and adolescent patients with first relapse or refractory (R/R) classical Hodgkin lymphoma (cHL). While salvage with standard dose chemotherapy followed by high dose chemotherapy and autologous stem cell transplant is often considered the standard of care in adult practice, pediatric practice adopts a more individualized risk stratified and response adapted approach to salvage treatment with greater use of non-transplant salvage. Here, we present on behalf of the EuroNet Pediatric Hodgkin Lymphoma group, evidence and consensus-based guidelines for standardized diagnostic, prognostic and response procedures to allocate children and adolescents with R/R cHL to stratified salvage treatments.

Myeloid neoplasms (MNs) with germline predisposition have recently been recognized as novel entities in the latest World Health Organization (WHO) classification for MNs. Individuals with MNs due to germline predisposition exhibit increased risk for the development of MNs, mainly acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Setting the diagnosis of MN with germline predisposition is of crucial clinical significance since it may tailor therapy, dictate the selection of donor for allogeneic hematopoietic stem cell transplantation (allo-HSCT), determine the conditioning regimen, enable relevant prophylactic measures and early intervention or contribute to avoid unnecessary or even harmful medication. Finally, it allows for genetic counseling and follow-up of at-risk family members. Identification of these patients in the clinical setting is challenging, as there is no consensus due to lack of evidence regarding the criteria defining the patients who should be tested for these conditions. In addition, even in cases with a strong suspicion of a MN with germline predisposition, no standard diagnostic algorithm is available. We present the first version of the Nordic recommendations for diagnostics, surveillance and management including considerations for allo-HSCT for patients and carriers of a germline mutation predisposing to the development of MNs.

Healthy subjects frequently report minor bleedings that are frequently ‘background noise’ of normality rather than a true disorder. Nevertheless, unexpected or unusual bleeding may be alarming. Thus, the distinction between normal and pathologic bleeding is critical. Understanding the underlying pathologic mechanism in patients with an excessive bleeding is essential for their counseling and treatment. Most of these patients with significant bleeding will result affected by non-severe inherited bleeding disorders (BD), collectively denominated mild or moderate BD for their relatively benign course. Unfortunately, practical recommendations for the management of these disorders are still lacking due to the current state of fragmented knowledge of pathophysiology and lack of a systematic diagnostic approach. To address this gap, an International Working Group (IWG) was established by the European Hematology Association (EHA) to develop consensus-based guidelines on these disorders. The IWG agreed that grouping these disorders by their clinical phenotype under the single category of mild-to-moderate bleeding disorders (MBD) reflects current clinical practice and will facilitate a systematic diagnostic approach. Based on standardized and harmonized definitions a conceptual unified framework is proposed to distinguish normal subjects from affected patients. The IWG proposes a provisional comprehensive patient-centered initial diagnostic approach that will result in classification of MBD into distinct clinical-pathological entities under the overarching principle of clinical utility for the individual patient. While we will present here a general overview of the global management of patients with MBD, this conceptual framework will be adopted and validated in the evidence-based, disease-specific guidelines under development by the IWG.

Chronic myelomonocytic leukemia (CMML) is a disease of the elderly, and by far the most frequent overlap myelodysplastic/myeloproliferative neoplasm in adults. Aside from the chronic monocytosis that remains the cornerstone of its diagnosis, the clinical presentation of CMML includes dysplastic features, cytopenias, excess of blasts, or myeloproliferative features including high white blood cell count or splenomegaly. Prognosis is variable, with several prognostic scoring systems reported in recent years, and treatment is poorly defined, with options ranging from watchful waiting to allogeneic stem cell transplantation, which remains the only curative therapy for CMML. Here, we present on behalf of the European Hematology Association and the European LeukemiaNet, evidence- and consensus-based guidelines, established by an international group of experts, from Europe and the United States, for standardized diagnostic and prognostic procedures and for an appropriate choice of therapeutic interventions in adult patients with CMML.

On August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

On August 6, 2025, the Food and Drug Administration granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals, Inc.), a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

On July 2, 2025, the Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).  

On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent.

On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.

On May 15, 2025, the Food and Drug Administration approved retifanlimab-dlwr (Zynyz, Incyte Corporation) with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also approved retifanlimab-dlwr, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.

On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.

On May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This represents the first FDA approval of an oral therapy for PPGL.

On May 8, 2025, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).

On April 11, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).

On April 8, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan.

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).

On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET). 

On March 19, 2025, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1).

On February 14, 2025, the Food and Drug Administration approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.

On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.

Nature. 2025 Aug 6. doi: 10.1038/s41586-025-09335-x.
Aron L, Ngian ZK, Qiu C, Choi J, Liang M, Drake DM, Hamplova SE, Lacey EK, Roche P, Yuan M, Hazaveh SS, Lee EA, Bennett DA, Yankner BA

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