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Chen, Li-Tzong; Satoh, Taroh; Ryu, Min-Hee; Chao, Yee; Kato, Ken; Chung, Hyun Cheol; Chen, Jen-Shi; Muro, Kei; Kang, Won Ki; Yeh, Kun-Huei; Yoshikawa, Takaki; Oh, Sang Cheul; Bai, Li-Yuan; Tamura, Takao; Lee, Keun-Wook; Hamamoto, Yasuo; Kim, Jong Gwang; Chin, Keisho; Oh, Do-Youn; Minashi, Keiko; Cho, Jae Yong; Tsuda, Masahiro; Sameshima, Hiroki; Kang, Yoon-Koo; Boku, Narikazu
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 05/2020, Volume: 23, Issue: 3Journal Article
Background Nivolumab showed improvement in overall survival (OS) in ATTRACTION-2, the first phase 3 study in patients with gastric/gastroesophageal junction (G/GEJ) cancer treated with ≥ 2 chemotherapy regimens. The 2-year follow-up results of ATTRACTION-2 are presented herein. Methods ATTRACTION-2 was a randomized, double-blind, placebo-controlled, phase 3 trial (49 sites; Japan, South Korea, and Taiwan). The median (min–max) follow-up period was 27.3 (24.1–36.3) months. The primary endpoint was OS. A subanalysis of OS was performed based on best overall response and tumor-programmed death ligand-1 (PD-L1) expression status. Results Overall, 493 of 601 screened patients were randomized (2:1) to receive nivolumab (330) or placebo (163). OS (median 95% confidence interval; CI) was significantly longer in the nivolumab group (5.26 4.60–6.37 vs 4.14 3.42–4.86 months in placebo group) at the 2-year follow-up (hazard ratio 95% CI, 0.62 0.51–0.76; P < 0.0001). A higher OS rate was observed in the nivolumab vs placebo group at 1 (27.3% vs 11.6%) and 2 years (10.6% vs 3.2%). The OS benefit was observed regardless of tumor PD-L1 expression. Among patients with a complete or partial response (CR or PR) in the nivolumab group, the median OS (95% CI) was 26.6 (21.65—not applicable) months; the OS rates at 1 and 2 years were 87.1% and 61.3%, respectively. No new safety signals were identified. Conclusions Nivolumab treatment resulted in clinically meaningful long-term improvements in OS in patients with previously treated G/GEJ cancer. The long-term survival benefit of nivolumab was most evident in patients with a CR or PR.
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