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Título: | Five-Year Survival Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Metastatic Non-Small-Cell Lung Cancer in CheckMate 227 |
Autor: | Brahmer, Julie R.; Lee, Jong-Seok; Ciuleanu, Tudor-Eliade; Bernabé Caro, Reyes CSIC ORCID; Nishio, Makoto; Urban, Laszlo; Audigier-Valette, Clarisse; Lupinacci, Lorena; Sangha, Randeep; Pluzanski, Adam; Burgers, Jacobus; Mahave, Mauricio; Ahmed, Samreen; Schoenfeld, Adam J.; Paz-Ares, Luis CSIC ORCID; Reck, Martin; Borghaei, Hossein; O'Byrne, Kenneth J.; Gupta, Ravi G.; Bushong, Judith; Li, Li; Blum, Steven I.; Eccles, Laura J.; Ramalingam, Suresh S. | Fecha de publicación: | 20-feb-2023 | Editor: | American Society of Clinical Oncology | Citación: | Journal of Clinical Oncology 41(6): 1200-1212 (2023) | Resumen: | [Purpose] We present 5-year results from CheckMate 227 Part 1, in which nivolumab plus ipilimumab improved overall survival (OS) versus chemotherapy in patients with metastatic non–small-cell lung cancer, regardless of tumor programmed death ligand 1 (PD-L1) status. [Methods] Adults with stage IV/recurrent non–small-cell lung cancer without EGFR mutations or ALK alterations and with tumor PD-L1 ≥ 1% or < 1% (n = 1739) were randomly assigned. Patients with tumor PD-L1 ≥ 1% were randomly assigned to first-line nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. Patients with tumor PD-L1 < 1% were randomly assigned to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy. End points included exploratory 5-year results for efficacy, safety, and quality of life. [Results] At a minimum follow-up of 61.3 months, 5-year OS rates were 24% versus 14% for nivolumab plus ipilimumab versus chemotherapy (PD-L1 ≥ 1%) and 19% versus 7% (PD-L1 < 1%). The median duration of response was 24.5 versus 6.7 months (PD-L1 ≥ 1%) and 19.4 versus 4.8 months (PD-L1 < 1%). Among patients surviving 5 years, 66% (PD-L1 ≥ 1%) and 64% (PD-L1 < 1%) were off nivolumab plus ipilimumab without initiating subsequent systemic anticancer treatment by the 5-year time point. Survival benefit continued after nivolumab plus ipilimumab discontinuation because of treatment-related adverse events, with a 5-year OS rate of 39% (combined PD-L1 ≥ 1% and < 1% populations). Quality of life in 5-year survivors treated with nivolumab plus ipilimumab was similar to that in the general US population through the 5-year follow-up. No new safety signals were observed. [Conclusion] With all patients off immunotherapy treatment for ≥ 3 years, nivolumab plus ipilimumab increased 5-year survivorship versus chemotherapy, including long-term, durable clinical benefit regardless of tumor PD-L1 expression. These data support nivolumab plus ipilimumab as an effective first-line treatment for patients with metastatic non–small-cell lung cancer. |
Versión del editor: | https://doi.org/10.1200/JCO.22.01503 | URI: | http://hdl.handle.net/10261/338548 | DOI: | 10.1200/JCO.22.01503 | ISSN: | 0732-183X | E-ISSN: | 1527-7755 |
Aparece en las colecciones: | (IBIS) Artículos |
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