The lancet oncology
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The lancet oncology · Oct 2024
ReviewInterchangeability of immune checkpoint inhibitors: an urgent need for action.
Prevailing uncertainties regarding the therapeutic interchangeability of PD-1 and PD-L1 inhibitors affect both clinical decision making and health-care budgeting. This Personal View presents a comprehensive assessment of the fragmented regulatory landscape of PD-1 and PD-L1 inhibitors, highlighting the complex dynamics of market competition, pricing, and the effect on health-care budgets. ⋯ To address these challenges, research that will inform us of the extent of interchangeability of PD-1 and PD-L1 inhibitors is needed. We recommend head-to-head randomised controlled trials, standardised study designs for indirect comparisons, trials with monotherapy groups, post-approval trials funded from private or public sources, and adoption of a near-equivalence framework in both conducting and evaluating trials.
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The lancet oncology · Oct 2024
Randomized Controlled Trial Multicenter Study Comparative StudySequential [177Lu]Lu-PSMA-617 and docetaxel versus docetaxel in patients with metastatic hormone-sensitive prostate cancer (UpFrontPSMA): a multicentre, open-label, randomised, phase 2 study.
Lutetium-177 [177Lu]Lu-prostate-specific membrane antigen (PSMA)-617 improves survival and quality of life in patients with metastatic castration-resistant prostate cancer, but whether it confers a benefit in hormone-sensitive disease is unknown. We aimed to evaluate [177Lu]Lu-PSMA-617 before docetaxel treatment in patients with de-novo high-volume metastatic hormone-sensitive prostate cancer. ⋯ Prostate Cancer Research Alliance (Movember Foundation and Australian Government Medical Research Future Fund), US Department of Defence Impact Award-Clinical Trials, Endocyte/Advanced Accelerator Applications (a Novartis company), Australian Nuclear Science and Technology Organization, Victorian Cancer Agency, University of Melbourne, and Peter MacCallum Cancer Foundation.