Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915)
| Autor: | Jeffrey S. Weber, Dirk Schadendorf, Michele Del Vecchio, James Larkin, Victoria Atkinson, Michael Schenker, Jacopo Pigozzo, Helen Gogas, Stéphane Dalle, Nicolas Meyer, Paolo A. Ascierto, Shahneen Sandhu, Thomas Eigentler, Ralf Gutzmer, Jessica C. Hassel, Caroline Robert, Matteo S. Carlino, Anna Maria Di Giacomo, Marcus O. Butler, Eva Muñoz-Couselo, Michael P. Brown, Piotr Rutkowski, Andrew Haydon, Jean-Jacques Grob, Jacob Schachter, Paola Queirolo, Luis de la Cruz-Merino, Andre van der Westhuizen, Alexander M. Menzies, Sandra Re, Tuba Bas, Veerle de Pril, Julia Braverman, Daniel J. Tenney, Hao Tang, Georgina V. Long |
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| Přispěvatelé: | Institut Català de la Salut, [Weber JS] Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY. [Schadendorf D] Department of Dermatology, University of Essen and the German Cancer Consortium, Partner Site, Essen, Germany. [Del Vecchio M] Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. [Larkin J] The Royal Marsden NHS Foundation Trust, London, United Kingdom. [Atkinson V] Division of Cancer Services, Gallipoli Medical Research Foundation and Princess Alexandra Hospital, University of Queensland, Brisbane, Queensland, Australia. [Schenker M] Oncology Center Sf Nectarie Ltd, Craiova, Romania. [Muñoz-Couselo E] Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Jazyk: | angličtina |
| Rok vydání: | 2023 |
| Předmět: |
Cancer Research
Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Immunologic Factors::Adjuvants Immunologic [CHEMICALS AND DRUGS] Neoplasms::Neoplasms by Histologic Type::Neoplasms::Neoplasms by Histologic Type::Neoplasms::Neoplasms by Histologic Type::Nevi and Melanomas::Melanoma [DISEASES] Oncology Melanoma - Tractament Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::factores inmunitarios::adyuvantes inmunitarios [COMPUESTOS QUÍMICOS Y DROGAS] terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] Medizin Medicaments antineoplàstics - Ús terapèutic Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] Other subheadings::Other subheadings::/drug therapy [Other subheadings] neoplasias::neoplasias por tipo histológico::neoplasias::neoplasias por tipo histológico::neoplasias::neoplasias por tipo histológico::nevos y melanomas::melanoma [ENFERMEDADES] |
| Zdroj: | Scientia |
| Popis: | PURPOSE Ipilimumab and nivolumab have each shown treatment benefit for high-risk resected melanoma. The phase III CheckMate 915 trial evaluated adjuvant nivolumab plus ipilimumab versus nivolumab alone in patients with resected stage IIIB-D or IV melanoma. PATIENTS AND METHODS In this randomized, double-blind, phase III trial, 1,833 patients received nivolumab 240 mg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks (916 patients) or nivolumab 480 mg once every 4 weeks (917 patients) for ≤ 1 year. After random assignment, patients were stratified by tumor programmed death ligand 1 (PD-L1) expression and stage. Dual primary end points were recurrence-free survival (RFS) in randomly assigned patients and in the tumor PD-L1 expression-level < 1% subgroup. RESULTS At a minimum follow-up of approximately 23.7 months, there was no significant difference between treatment groups for RFS in the all-randomly assigned patient population (hazard ratio, 0.92; 95% CI, 0.77 to 1.09; P = .269) or in patients with PD-L1 expression < 1% (hazard ratio, 0.91; 95% CI, 0.73 to 1.14). In all patients, 24-month RFS rates were 64.6% (combination) and 63.2% (nivolumab). Treatment-related grade 3 or 4 adverse events were reported in 32.6% of patients in the combination group and 12.8% in the nivolumab group. Treatment-related deaths were reported in 0.4% of patients in the combination group and in no nivolumab-treated patients. CONCLUSION Nivolumab 240 mg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks did not improve RFS versus nivolumab 480 mg once every 4 weeks in patients with stage IIIB-D or stage IV melanoma. Nivolumab showed efficacy consistent with previous adjuvant studies in a population resembling current practice using American Joint Committee on Cancer eighth edition, reaffirming nivolumab as a standard of care for melanoma adjuvant treatment. |
| Databáze: | OpenAIRE |
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