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  4. Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC
 
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Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC

Journal
Journal of Thoracic Oncology
Journal Volume
16
Journal Issue
1
Pages
162-168
Date Issued
2021
Author(s)
Awad M.M.
Gadgeel S.M.
Borghaei H.
Patnaik A.
CHIH-HSIN YANG  
Powell S.F.
Gentzler R.D.
Martins R.G.
Stevenson J.P.
Altan M.
Jalal S.I.
Panwalkar A.
Gubens M.
Sequist L.V.
Saraf S.
Zhao B.
Piperdi B.
Langer C.J.
DOI
10.1016/j.jtho.2020.09.015
URI
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85093671121&doi=10.1016%2fj.jtho.2020.09.015&partnerID=40&md5=17dd463282c04b6c7ff32b6d4f56cbed
https://scholars.lib.ntu.edu.tw/handle/123456789/557700
Abstract
Introduction: In cohort G of KEYNOTE-021 (NCT02039674), first-line pembrolizumab plus pemetrexed-carboplatin significantly improved the objective response rate and progression-free survival versus chemotherapy alone with manageable toxicity in advanced nonsquamous NSCLC. We report the long-term outcomes from this study. Methods: Patients with previously untreated advanced nonsquamous NSCLC without sensitizing EGFR or ALK alterations were randomly assigned 1:1 to receive open-label pemetrexed 500 mg/m2 plus carboplatin at area under the concentration-time curve of 5 mg/mL/min (four cycles) with or without pembrolizumab 200 mg (up to 2 years), with optional pemetrexed maintenance, each administered every 3 weeks. Eligible patients could crossover from the chemotherapy arm to pembrolizumab monotherapy after progression. Responses were assessed per the Response Evaluation Criteria in Solid Tumors version 1.1. Results: After the median time of 49.4 months from randomization to data cutoff, objective response rate (58% versus 33%) and progression-free survival (median: 24.5 versus 9.9 mo; hazard ratio: 0.54; 95% confidence interval: 0.35?0.83) remained improved with pembrolizumab combination (n = 60) versus chemotherapy (n = 63), regardless of programmed death ligand 1 status. Median overall survival was 34.5 versus 21.1 months (hazard ratio: 0.71; 95% confidence interval: 0.45?1.12), despite a 70% crossover rate from chemotherapy alone to anti?programmed death (ligand) 1 therapy. Among the 12 patients who completed 2 years of pembrolizumab, 92% were alive at data cutoff; the estimated 3-year duration of response rate was 100%. Grade 3 to 5 treatment-related adverse events occurred in 39% of patients receiving pembrolizumab combination and 31% receiving chemotherapy. Conclusions: First-line pembrolizumab plus pemetrexed-carboplatin continued to show improved response and survival versus chemotherapy alone in advanced nonsquamous NSCLC, with durable clinical benefit in patients who completed 2 years of therapy. No new safety signals were observed with longer follow-up. ? 2020 International Association for the Study of Lung Cancer
Subjects
Advanced nonsquamous non?small-cell lung cancer; Chemotherapy; First-line therapy; Long-term survival; Pembrolizumab
SDGs

[SDGs]SDG3

Other Subjects
carboplatin; pembrolizumab; pemetrexed; programmed death 1 ligand 1; antineoplastic agent; carboplatin; monoclonal antibody; pembrolizumab; pemetrexed; adult; advanced cancer; aged; ALK gene; area under the curve; Article; cancer chemotherapy; cancer growth; cohort analysis; controlled study; EGFR gene; female; gene; gene mutation; human; maintenance therapy; major clinical study; male; multiple cycle treatment; non small cell lung cancer; open study; overall survival; phase 2 clinical trial; priority journal; progression free survival; randomized controlled trial; treatment outcome; treatment response; unspecified side effect; lung tumor; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Humans; Lung Neoplasms; Pemetrexed
Publisher
Elsevier Inc.
Type
journal article

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