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Artículo
Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915)
Autor/es | Weber, Jeffrey S.
Schadendorf, Dirk Del Vecchio, Michele Larkin, James Atkinson, Victoria Schenker, Michael Cruz Merino, Luis de la Long, Georgina V. |
Departamento | Universidad de Sevilla. Departamento de Medicina |
Fecha de publicación | 2023 |
Fecha de depósito | 2024-03-04 |
Publicado en |
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Resumen | 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 ... 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 5 .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. |
Cita | Weber, J.S., Schadendorf, D., Del Vecchio, M., Larkin, J., Atkinson, V., Schenker, M.,...,Long, G.V. (2023). Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915). Journal of clinical oncology, 41 (3), 517-527. https://doi.org/10.1200/JCO.22.00533. |
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