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Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: Interim results of a randomized, phase II trial (ATTRACTION-4)

Annals of Oncology Mar 07, 2019

Boku N, et al. - In part 1 (phase II) of ATTRACTION-4, researchers evaluated nivolumab in combination with S-1 plus oxaliplatin (SOX) or capecitabine plus oxaliplatin (CapeOX) as first-line therapy for unresectable advanced or recurrent human epidermal growth factor receptor 2 (HER2)-negative gastric/gastroesophageal junction (G/GEJ) cancer, with a focus on safety and effectiveness in 39 patients (nivolumab plus SOX, 21; nivolumab plus CapeOX, 18) and 38 patients (21 and 17, respectively), respectively. Until disease progression, unacceptable toxicity, or consent withdrawal, patients randomly (1:1) received nivolumab (360 mg intravenously every 3 weeks) plus SOX (S-1, 40 mg/m2 orally twice daily for 14 days followed by 7 days off; oxaliplatin, 130 mg/m2 intravenously on day 1 every 3 weeks) or CapeOX (capecitabine, 1000 mg/m2 orally twice daily for 14 days followed by 7 days off; oxaliplatin, 130 mg/m2intravenously on day 1 every 3 weeks). Findings revealed good tolerability and encouraging effectiveness of nivolumab combined with SOX/CapeOX in unresectable advanced or recurrent HER2-negative G/GEJ cancer. The most frequently seen grade 3/4 treatment-related adverse events in the nivolumab plus SOX group was neutropenia (14.3%), and in the nivolumab plus CapeOX group was neutropenia (16.7%), anemia, peripheral sensory neuropathy, decreased appetite, type 1 diabetes mellitus, and nausea (11.1% each).

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