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
| Autor: | Vassiliki A. Papadimitrakopoulou, Ryan D. Gentzler, Lecia V. Sequist, Renato G. Martins, James P. Stevenson, Shirish M. Gadgeel, Matthew A. Gubens, Mark M. Awad, Leena Gandhi, Corey J. Langer, Amita Patnaik, Joseph Fiore, Hossein Borghaei, Steven Francis Powell, Amit Panwalkar, Shadia I. Jalal, James Chih-Hsin Yang, Sanatan Saraf, Steven M. Keller |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Pulmonary and Respiratory Medicine Oncology medicine.medical_specialty Combination therapy medicine.medical_treatment Pembrolizumab 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine medicine Lung cancer Chemotherapy business.industry Hazard ratio medicine.disease Carboplatin Confidence interval 030104 developmental biology Pemetrexed chemistry 030220 oncology & carcinogenesis business medicine.drug |
| Zdroj: | Journal of Thoracic Oncology. 14:124-129 |
| ISSN: | 1556-0864 |
| DOI: | 10.1016/j.jtho.2018.08.004 |
| Popis: | 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]: 0.42‒1.91). 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 1:1 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 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%‒42.4%, p = 0.0016]). PFS was significantly improved with pembrolizumab plus PC versus PC alone (HR = 0.53, 95% CI: 0.33‒0.86, p = 0.0049). A total of 41 patients in the PC-alone group received subsequent anti‒programmed death 1/anti‒programmed death ligand 1 therapy. The HR for OS was 0.56 (95% CI: 0.32‒0.95, 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. |
| Databáze: | OpenAIRE |
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