A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data
- Authors
- 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
- Issue Date
- 5월-2020
- Publisher
- SPRINGER
- Keywords
- Gastric cancer; Gastroesophageal junction cancer; Long-term; Nivolumab; Placebo
- Citation
- GASTRIC CANCER, v.23, no.3, pp.510 - 519
- Indexed
- SCIE
SCOPUS
- Journal Title
- GASTRIC CANCER
- Volume
- 23
- Number
- 3
- Start Page
- 510
- End Page
- 519
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/56066
- DOI
- 10.1007/s10120-019-01034-7
- ISSN
- 1436-3291
- Abstract
- 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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