24-Month Overall Survival from KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin with or without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous Non-Small Cell Lung Cancer.
J Thorac Oncol
; 14(1): 124-129, 2019 01.
Article
en En
| MEDLINE
| ID: mdl-30138764
ABSTRACT
INTRODUCTION:
Cohort G of KEYNOTE-021 (NCT02039674) evaluated the efficacy and safety of pembrolizumab plus pemetrexed-carboplatin (PC) versus PC alone as first-line therapy for advanced nonsquamous NSCLC. At the primary analysis (median follow-up time 10.6 months), pembrolizumab significantly improved objective response rate (ORR) and progression-free survival (PFS); the hazard ratio (HR) for overall survival (OS) was 0.90 (95% confidence interval [CI] 0.42â1.91). Herein, we present an updated analysis.METHODS:
A total of 123 patients with previously untreated stage IIIB/IV nonsquamous NSCLC without EGFR and/or ALK receptor tyrosine kinase gene (ALK) aberrations were randomized 11 to four cycles of PC with or without pembrolizumab, 200 mg every 3 weeks. Pembrolizumab treatment continued for 2 years; maintenance pemetrexed was permitted in both groups. Eligible patients in the PC-alone group with radiologic progression could cross over to pembrolizumab monotherapy. p Values are nominal (one-sided p < 0.025).RESULTS:
As of December 1, 2017, the median follow-up time was 23.9 months. The ORR was 56.7% with pembrolizumab plus PC versus 30.2% with PC alone (estimated difference 26.4% [95% CI 8.9%â42.4%, p = 0.0016]). PFS was significantly improved with pembrolizumab plus PC versus PC alone (HR = 0.53, 95% CI 0.33â0.86, p = 0.0049). A total of 41 patients in the PC-alone group received subsequent antiâprogrammed death 1/antiâprogrammed death ligand 1 therapy. The HR for OS was 0.56 (95% CI 0.32â0.95, p = 0.0151). Forty-one percent of patients in the pembrolizumab plus PC group and 27% in the PC-alone group had grade 3 to 5 treatment-related adverse events.CONCLUSIONS:
The significant improvements in PFS and ORR with pembrolizumab plus PC versus PC alone observed in the primary analysis were maintained, and the HR for OS with a 24-month median follow-up was 0.56, favoring pembrolizumab plus PC.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Protocolos de Quimioterapia Combinada Antineoplásica
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Carboplatino
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Carcinoma de Pulmón de Células no Pequeñas
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Anticuerpos Monoclonales Humanizados
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Pemetrexed
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Neoplasias Pulmonares
Tipo de estudio:
Clinical_trials
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Risk_factors_studies
Límite:
Female
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Humans
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Male
Idioma:
En
Revista:
J Thorac Oncol
Año:
2019
Tipo del documento:
Article