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Pembrolizumab or pembrolizumab plus chemotherapy vs chemotherapy alone for gastric cancer

JAMA Sep 07, 2020

Shitara K, Van Cutsem E, Bang YJ, et al. - Among patients with untreated, advanced gastric/gastroesophageal junction (G/GEJ) cancer with programmed cell death ligand 1 combined positive score of 1 or greater, this phase 3 KEYNOTE-062 randomized, controlled, partially blinded interventional trial was performed to assess the antitumor activity of pembrolizumab, pembrolizumab plus chemotherapy, or chemotherapy alone. A total of 763 patients were enrolled in this study. Patients were randomly assigned 1:1:1 to receive pembrolizumab 200 mg, pembrolizumab plus chemotherapy (cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1 to 5 or capecitabine 1000 mg/m2 twice daily), or chemotherapy plus placebo, every 3 weeks. Findings demonstrated the noninferiority of pembrolizumab to chemotherapy in patients with untreated, advanced G/GEJ cancer, with fewer adverse events noted. For the overall survival and progression-free survival endpoints examined, no superiority of pembrolizumab or pembrolizumab plus chemotherapy was shown over chemotherapy.

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