Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab
Journal
Gastric Cancer
Journal Volume
24
Journal Issue
4
Pages
946-958
Date Issued
2021
Author(s)
Boku N.
Satoh T.
Ryu M.-H.
Chao Y.
Kato K.
Chung H.C.
Chen J.-S.
Muro K.
Kang W.K.
Yoshikawa T.
Oh S.C.
Bai L.-Y.
Tamura T.
Lee K.-W.
Hamamoto Y.
Kim J.G.
Chin K.
Oh D.-Y.
Minashi K.
Cho J.Y.
Tsuda M.
Nishiyama T.
Chen L.-T.
Kang Y.-K.
Abstract
Background: ATTRACTION-2 demonstrated that nivolumab improved overall survival (OS) vs placebo in patients with advanced gastric cancer treated with ? 2 chemotherapy regimens. However, its long-term efficacy and outcome of treatment beyond progression (TBP) with nivolumab have not been clarified. Methods: The 3-year follow-up data were collected. A subset analysis was performed to explore the efficacy of TBP by assessing postprogression survival (PPS) after the first event of disease progression. Results: Overall, 493 patients were randomized (2:1) to receive nivolumab (n = 330) or placebo (n = 163). With a median follow-up of 38.5 (range 36.1–47.5) months, OS of the nivolumab group was significantly longer compared to the placebo group (median 5.3 vs 4.1?months; 3-year survival rate, 5.6% vs 1.9%; hazard ratio [HR], 0.62 [95% confidence interval (CI) 0.50–0.75], P < 0.0001). The median OS of responders (n = 32) who achieved complete response or partial response was 26.7?months and the 3-year survival rate was 35.5% in the nivolumab group. Overall, 109 patients in the nivolumab group and 37 patients in the placebo group received TBP. PPS tended to be longer in the nivolumab group vs placebo group (median 5.8 vs 4.5?months; HR [95% CI], 0.69 [0.47–1.01], P = 0.057). In contrast, PPS was similar between both treatment groups in non-TBP patients (median 2.3 vs 2.2?months; HR 0.90, P = 0.42). Conclusions: Long-term efficacy of nivolumab was confirmed at the 3-year follow-up, and a survival benefit of TBP with nivolumab was suggested. Biomarkers for selecting patients suitable for TBP with nivolumab should be identified in the future. ? 2021, The Author(s).
Subjects
ATTRACTION-2; Gastric or gastroesophageal junction cancer; Long-term efficacy; Nivolumab; Treatment beyond progression
SDGs
Other Subjects
biological marker; nivolumab; placebo; immunological antineoplastic agent; nivolumab; acute hepatitis; adenocarcinoma; adult; Article; chemotherapy; colitis; computer assisted tomography; controlled study; disease exacerbation; double blind procedure; drug efficacy; drug safety; drug therapy; female; follow up; gene mutation; hazard ratio; histology; human; human tissue; hyperthyroidism; image analysis; maculopapular rash; major clinical study; male; microsatellite instability; middle aged; multiple cycle treatment; nuclear magnetic resonance imaging; phase 3 clinical trial; pneumonia; randomized controlled trial; solid malignant neoplasm; stomach cancer; survival rate; thyroiditis; toxicity; tumor cell; tumor volume; aged; clinical trial; mortality; stomach tumor; treatment outcome; Adult; Aged; Antineoplastic Agents, Immunological; Disease Progression; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nivolumab; Progression-Free Survival; Stomach Neoplasms; Survival Rate; Treatment Outcome
Publisher
Springer Japan
Type
journal article