The Lancet Oncology Homepage
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Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis
Fewer than a third of indications approved with immature survival data showed a statistically significant overall survival benefit after approval. Notable inconsistencies in timing and availability of information after approval across different sources emphasise the need for better reporting standards. -
Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis
Submission gap and review time for oncology applications at Swissmedic were significantly reduced by participation in Project Orbis, and approval consensus decisions were increased between agencies. These findings suggests that participating in Project Orbis could lead to faster patient access to drugs. -
Global cooperation and early access—clinical outcomes matter
In modern cancer drug development, surrogate measures are commonly used as clinical trial endpoints instead of more definitive clinical outcomes such as overall survival, with the goal of expediting the development and approval of new drugs. The prevalence of surrogate measures is driven by improved understanding of the basis of cancer and a desire to reduce costs and time, resulting in studies that require smaller sample sizes and shorter follow-up. Regulatory bodies around the world, such as the US Food and Drug Administration (FDA), also accept trials using surrogate measures to expedite patient access to new treatments. -
Pembrolizumab monotherapy for high-risk non-muscle-invasive bladder cancer without carcinoma in situ and unresponsive to BCG (KEYNOTE-057): a single-arm, multicentre, phase 2 trial
Pembrolizumab monotherapy showed antitumour activity and manageable toxicity in patients with BCG-unresponsive high-risk Ta or T1 bladder cancer without carcinoma in situ and could potentially be a suitable treatment option for patients who decline or are ineligible for radical cystectomy. Findings will need to be confirmed in a randomised controlled trial.
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Cancer incidence, treatment, and survival in the prison population compared with the general population in England: a population-based, matched cohort study
Cancer incidence increased in people in prisons in England between 1998 and 2017, with patients in prison less likely to receive curative treatments and having lower overall survival than the general population. The association with survival was partly explained by accounting for differences in receipt of curative treatment and adjustment for diagnosis route. Improved routine cancer surveillance is needed to inform prison cancer policies and decrease inequalities for this under-researched population. -
Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial
Overall, GHS and quality of life were maintained for both treatment groups, with prespecified PRO variables favouring trastuzumab deruxtecan over treatment of physician's choice, suggesting that despite a longer treatment duration, there was no detrimental impact on patient health-related quality of life with trastuzumab deruxtecan. When considered with efficacy and safety data from DESTINY-Breast02, these results support the overall benefit of trastuzumab deruxtecan for patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab emtansine. -
Changes in hospital mortality in patients with cancer during the COVID-19 pandemic (ISARIC-CCP-UK): a prospective, multicentre cohort study
People with cancer have a higher risk of mortality from COVID-19 than those without cancer. Patients younger than 50 years with cancer treatment have the highest relative risk of death. Continued action is needed to mitigate the poor outcomes in patients with cancer, such as through optimising vaccination, long-acting passive immunisation, and early access to therapeutics. These findings underscore the importance of the ISARIC-WHO pandemic preparedness initiative. -
Curbing the climb in cancer incidence
The Lancet's Breast Cancer Commission , published on April 15, 2024, predicts that by 2040, the global incidence of new cases of breast cancer will be more than 3 million per year, with the greatest rise in low-income and middle-income countries. Similarly, The Lancet's Commission on prostate cancer , published on April 4, 2024, forecasts the number of new cases of prostate cancer to increase annually worldwide from 1·4 million in 2020, to 2·9 million by 2040, and the number of deaths worldwide is predicted to rise from 375 000 in 2020, to almost 700 000 by 2040.