dc.creator | Weber, Jeffrey S. | es |
dc.creator | Schadendorf, Dirk | es |
dc.creator | Del Vecchio, Michele | es |
dc.creator | Larkin, James | es |
dc.creator | Atkinson, Victoria | es |
dc.creator | Schenker, Michael | es |
dc.creator | Cruz Merino, Luis de la | es |
dc.creator | Long, Georgina V. | es |
dc.date.accessioned | 2024-03-04T16:12:59Z | |
dc.date.available | 2024-03-04T16:12:59Z | |
dc.date.issued | 2023 | |
dc.identifier.citation | 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. | |
dc.identifier.issn | 0732-183X | es |
dc.identifier.issn | 1527-7755 | es |
dc.identifier.uri | https://hdl.handle.net/11441/155802 | |
dc.description.abstract | 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. | es |
dc.format | application/pdf | es |
dc.format.extent | 13 p. | es |
dc.language.iso | eng | es |
dc.publisher | American Society of Clinical Oncology | es |
dc.relation.ispartof | Journal of clinical oncology, 41 (3), 517-527. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Adjuvant therapy of nivolumab combined | es |
dc.subject | Resected stage IIIB-D | es |
dc.subject | Stage IV melanoma | es |
dc.subject | Checkmate 915 | es |
dc.title | Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915) | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://ascopubs.org/doi/10.1200/JCO.22.00533 | es |
dc.identifier.doi | 10.1200/JCO.22.00533 | es |
dc.contributor.group | Universidad de Sevilla. CTS151: Bioquímica médica. | es |
dc.journaltitle | Journal of clinical oncology | es |
dc.publication.volumen | 41 | es |
dc.publication.issue | 3 | es |
dc.publication.initialPage | 517 | es |
dc.publication.endPage | 527 | es |