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Oncology
21st Nov, 2025
The Lancet
In August, 2025, the US Food and Drug Administration (FDA) published a draft guidance on the assessment of overall survival in randomised cancer drug trials.1 In essence, the guidance states that overall survival and quality of life are the only clinical endpoints to confirm the benefit of any cancer therapies—ultimately, patients want longer and better lives as a trade-off for the toxic effects of treatment. However, in recent years the FDA has deprioritised the need to show an overall survival improvement from new cancer drugs, with several new cancer drugs receiving full approval on the basis of improvements in putative surrogate endpoints alone, often in the face of negative overall survival results.
Androgen receptor pathway inhibitors (ARPIs) in combination with androgen deprivation therapy (ADT) represent the foundation of treatment for both metastatic castration-sensitive prostate cancer (mCSPC) and metastatic castration-resistant prostate cancer (mCRPC).1 In selected patients with mCSPC, the addition of six cycles of docetaxel further enhances overall survival outcomes.2 However, therapeutic resistance remains common and prostate cancer remains a substantial cause of cancer-related mortality.
In addition to next generation small molecule tyrosine-kinase inhibitors,1,2 large molecular weight antibody–drug conjugates (ADCs) have shown CNS-specific activity, penetrating a blood–brain barrier that is disrupted by local therapies, the presence of brain metastases, or both.3 The adoption of these CNS-penetrant systemic therapies to treat patients with active brain metastases is increasingly accepted in routine practice, despite little data from randomised trials.
Concurrent chemoradiotherapy followed by consolidation with durvalumab is the standard of care for patients with locally advanced non-small-cell lung cancer (NSCLC) who are medically or surgically inoperable, have a good performance status, and do not have actionable EGFR mutations.1 In the PACIFIC trial, consolidation treatment with durvalumab for up to 12 months after platinum-based chemoradiotherapy showed a 5-year progression-free survival rate of 33·1% (95% CI 28·0–38·2) and 5-year overall survival rate of 42·9% (38·2–47·4).
In The Lancet Oncology, Daniella Black and colleagues1 report whole-genome sequencing (WGS) data of 2445 breast cancer tumours from a UK cohort (100 000 Genomes Project [100kGP]). As well as linking these data to clinical and mortality data, the authors externally validated their results in a Swedish cohort (SCAN-B) of 502 cases. By integrating driver mutations, mutational signatures, and structural variation (SV) burden, the authors show that, alongside a handful of drivers known from other tumour types, a single WGS assay could identify potentially actionable alterations in 656 (26·8%) of all 2445 breast cancer cases in the 100kGP cohort.
A side event held by the Bloomberg New Economy International Cancer Coalition and American Society of Clinical Oncology at the 2025 UN General Assembly in New York, New York, USA, saw the launch of the Global Cancer Financing Platform, marking a pivotal step in reshaping how the world funds cancer care. This gathering brought together international stakeholders from across governments, industry, philanthropy, and civil societies to explore innovative financing models for cancer care. One highlight was the potential for diaspora remittances.
General Medicine
29th Oct, 2025
Primary large-vessel vasculitis encompasses conditions that, despite sharing many common features, constitute distinct entities that have their own prognostic implications. These conditions include giant cell arteritis and Takayasu arteritis, with isolated aortitis being increasingly recognised in the literature and studied within this disease spectrum. Epidemiological studies have evidenced a worldwide distribution of Takayasu arteritis. In giant cell arteritis, distinct clinical phenotypes with specific outcomes (ie, cranial and large vessel forms) have been recognised.
Osteoporotic fractures are one of the most common and consequential diseases of advanced ageing and many antifracture therapies are widely available but largely underused. This Seminar presents an updated approach to osteoporosis consultation, drawing upon published evidence and collaborative expert opinion to place the data in a pragmatic and useful context for clinicians. New evidence on osteoporosis screening recommendations, fracture-risk assessment, intervention decisions, nutrition-based therapies, and antiresorptive and anabolic therapies are discussed, along with practical approaches to treatment in the oldest old, those with chronic kidney disease, and patients who continue to fracture despite therapy.
Ye C, Ebeling PR, Kline G. Osteoporosis. Lancet 2025; 406: 2003–16—In this Seminar, the middle initial of author Peter R Ebeling was not included and their affiliation should have been Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, VIC, Australia. These corrections have been made to the online version as of Oct 23, 2025, and the printed version is correct.
We deeply appreciate the feedback provided by Tingquan Zhou, Pitt O Lim, Christian Spaulding and colleagues, Filippo Luca Gurgoglione and Bernardo Cortese, and Tuomas T Rissanen and colleagues. Introduced by Scheller and colleagues1 in 2004, drug-coated balloon (DCB) angioplasty has emerged as an attractive alternative to stent-based interventions. Studies and consensus documents have supported the application of DCBs in de novo small-vessel disease;2,3 nevertheless, a pertinent question remains regarding the applicability of DCB in de novo lesions across all vessel diameters.
In the REC-CAGEFREE I trial by Chao Gao and colleagues,1 an open-label, randomised, non-inferiority trial comparing a drug-coated balloon (DCB) with a drug-eluting stent (DES) in patients with de novo, non-complex coronary lesions, the DCB group did not reach non-inferiority; however, event rates at 2 years were low. The study shows the safety of DCB-only angioplasty: the number of acute occlusions (0 in the DCB group vs 1 in the DES group) and the rate of vessel thrombosis (0·4% vs 0·3%) were very low in both groups.
The REC-CAGEFREE I trial1 by Chao Gao and colleagues describes the results of a multicentre trial in which a paclitaxel drug-coated balloon (DCB) did not reach expected non-inferiority compared with a drug-eluting stent (DES) in terms of the device-oriented composite endpoint (DoCE) assessed at 2 years. Gao and colleagues concluded that DES should remain the preferred treatment for patients with de novo coronary artery disease.
We read with great interest the Article by Chao Gao and colleagues1 and compliment the authors for a large, well designed trial that is the first to compare drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) deployment in patients with de novo, non-complex coronary artery lesions. The results are somewhat disappointing, as a strategy of DCB angioplasty with rescue stenting did not reach non-inferiority compared with DES implantation in terms of the trial's device-oriented composite endpoint at 2 years.
The conclusion in the REC-CAGEFREE-I trial by Chao Gao and colleagues1 that drug-coated balloon (DCB) angioplasty is inferior to drug-eluting stent (DES) deployment in patients with non-complex, de novo coronary artery disease is such a sweeping statement that the linked Comment by Margaret B McEntegart and Ajay J Kirtane2 attempted to rebalance it.
The Lancet Commission on rethinking coronary artery disease: moving from ischaemia to atheroma1 compellingly reframes coronary artery disease as a lifelong continuum, advocating for early prevention strategies rooted in atheroma detection. The Commission's thoughtful and forward-looking reframing of atherosclerotic coronary artery disease (ACAD) as a systemic, lifelong condition marks a major and much-needed shift in cardiovascular care. The emphasis on early detection, risk factor modification, and the life-course approach is commendable and timely.
Medical Journal
15th Jan, 2026
Wiley
What's New: Drugs
FDA
Medical News
phys.org
