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Title: | Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score >= 50% | Authors: | Reck, Martin Rodríguez Abreu, Delvys Robinson, Andrew G. Hui, Rina N. Csoszi, Tibor Fulop, Andrea Gottfried, Maya Peled, Nir Tafreshi, Ali Cuffe, Sinead O'Brien, Mary Rao, Suman M. Hotta, Katsuyuk Leal, Ticiana A. Riess, Jonathan W. Jensen, Erin Zhao, Bin Pietanza, M. Catherine Brahmer, Julie R. |
UNESCO Clasification: | 320101 Oncología | Issue Date: | 2021 | Journal: | Journal of Clinical Oncology | Abstract: | PURPOSE: We report the first 5-year follow-up of any first-line phase III immunotherapy trial for non-small-cell lung cancer (NSCLC). KEYNOTE-024 (ClinicalTrials.gov identifier: NCT02142738) is an open-label, randomized controlled trial of pembrolizumab compared with platinum-based chemotherapy in patients with previously untreated NSCLC with a programmed death ligand-1 (PD-L1) tumor proportion score of at least 50% and no sensitizing EGFR or ALK alterations. Previous analyses showed pembrolizumab significantly improved progression-free survival and overall survival (OS). METHODS: Eligible patients were randomly assigned (1:1) to pembrolizumab (200 mg once every 3 weeks for up to 35 cycles) or platinum-based chemotherapy. Patients in the chemotherapy group with progressive disease could cross over to pembrolizumab. The primary end point was progression-free survival; OS was a secondary end point. RESULTS: Three hundred five patients were randomly assigned: 154 to pembrolizumab and 151 to chemotherapy. Median (range) time from randomization to data cutoff (June 1, 2020) was 59.9 (55.1-68.4) months. Among patients initially assigned to chemotherapy, 99 received subsequent anti-PD-1 or PD-L1 therapy, representing a 66.0% effective crossover rate. Median OS was 26.3 months (95% CI, 18.3 to 40.4) for pembrolizumab and 13.4 months (9.4-18.3) for chemotherapy (hazard ratio, 0.62; 95% CI, 0.48 to 0.81). Kaplan-Meier estimates of the 5-year OS rate were 31.9% for the pembrolizumab group and 16.3% for the chemotherapy group. Thirty-nine patients received 35 cycles (ie, approximately 2 years) of pembrolizumab, 82.1% of whom were still alive at data cutoff (approximately 5 years). Toxicity did not increase with longer treatment exposure. CONCLUSION: Pembrolizumab provides a durable, clinically meaningful long-term OS benefit versus chemotherapy as first-line therapy for metastatic NSCLC with PD-L1 tumor proportion score of at least 50%. | URI: | http://hdl.handle.net/10553/112590 | ISSN: | 0732-183X | DOI: | 10.1200/JCO.21.00174 | Source: | Journal of Clinical Oncology [ISSN 0732-183X], v. 39 (21), p. 2339-2349, (Julio 2021) |
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