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Please use this identifier to cite or link to this item:
http://ir.nhri.org.tw/handle/3990099045/11941
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| Title: | Exploratory subgroup analysis of patients with prior trastuzumab use in the ATTRACTION-2 trial: A randomized phase III clinical trial investigating the efficacy and safety of nivolumab in patients with advanced gastric/gastroesophageal junction cancer |
| Authors: | Satoh, T;Kang, YK;Chao, Y;Ryu, MH;Kato, K;Cheol Chung, H;Chen, JS;Muro, K;Ki Kang, W;Yeh, KH;Yoshikawa, T;Oh, SC;Bai, LY;Tamura, T;Lee, KW;Hamamoto, Y;Kim, JG;Chin, K;Oh, DY;Minashi, K;Cho, JY;Tsuda, M;Tanimoto, M;Chen, LT;Boku, N |
| Contributors: | National Institute of Cancer Research |
| Abstract: | BACKGROUND: Data on immune checkpoint inhibitor efficacy in patients with human epidermal growth factor receptor 2-positive (HER2+) advanced gastric/gastroesophageal junction (G/GEJ) cancer are lacking. Because HER2 status was not captured in the ATTRACTION-2 trial, we used patients with prior trastuzumab use (Tmab+) as surrogate for HER2 expression status to evaluate the efficacy and safety of nivolumab as third- or later-line therapy in these patients. METHODS: In ATTRACTION-2, a randomized, double-blind, placebo-controlled, phase 3 multicenter trial, patients were randomized (2:1) to receive nivolumab (3 mg/kg) or placebo every 2 weeks until disease progression or toxicity requiring study discontinuation. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were assessed. RESULTS: Of 493 enrolled patients, 81 (nivolumab, n = 59; placebo, n = 22) were Tmab+ and 412 (nivolumab, n = 271; placebo, n = 141) were Tmab-. In both groups, patients receiving nivolumab showed a longer median OS vs placebo (Tmab+, 8.3 [95% confidence interval, 5.3-12.9] vs 3.1 [1.9-5.3] months, hazard ratio, 0.38 [0.22-0.66]; P = 0.0006; Tmab-, 4.8 [4.1-6.0] vs 4.2 [3.6-4.9] months, 0.71 [0.57-0.88]; P = 0.0022). PFS was longer in both groups receiving nivolumab vs placebo (Tmab+, 1.6 [1.5-4.0] vs 1.5 [1.3-2.9] months, 0.49 [0.29-0.85]; P = 0.0111; Tmab-, 1.6 [1.5-2.4] vs 1.5 [1.5-1.5] months, 0.64 [0.51-0.80]; P = 0.0001). CONCLUSIONS: Nivolumab was efficacious and safe as third- or later-line therapy regardless of prior trastuzumab use in patients with advanced G/GEJ cancer. |
| Date: | 2020-01 |
| Relation: | Gastric Cancer. 2020 Jan;23(1):143-153. |
| Link to: | http://dx.doi.org/10.1007/s10120-019-00970-8 |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1436-3291&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000511763600018 |
| Cited Times(Scopus): | https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85065787461 |
| Appears in Collections: | [陳立宗] 期刊論文
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| PUB31087200.pdf | | 653Kb | Adobe PDF | 287 | View/Open |
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