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http://ir.nhri.org.tw/handle/3990099045/11884
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| Title: | Nivolumab (ONO-4538/BMS-936558) as salvage treatment after second or later-line chemotherapy for advanced gastric or gastroesophageal junction cancer (AGC): A double-blinded, randomized, phase III trial |
| Authors: | Kang, YK;Satoh, T;Ryu, MH;Chao, Y;Kato, K;Chung, HC;Chen, JS;Muro, K;Kang, WK;Yoshikawa, T;Oh, SC;Tamura, T;Lee, KW;Boku, N;Chen, LT |
| Contributors: | National Institute of Cancer Research |
| Abstract: | Background: Recent clinical trials have established 1st and 2nd line chemotherapy as the standard treatment for advanced gastric or gastro-esophageal junction cancer (AGC). However, prognosis of AGC is still poor. Nivolumab (ONO-4538/BMS-936558) is a human monoclonal IgG4 antibody which blocks the human programmed cell death-1 (PD-1) receptor. We evaluated the efficacy and safety of nivolumab as salvage treatment after failure of the standard chemotherapy for AGC. Methods: 493 patients aged ≥ 20 years with ECOG PS 0-1 and unresectable advanced or recurrent AGC who had failed two or more previous chemotherapy regimens were randomized in a 2:1 ratio to receive 3 mg/kg nivolumab (N=330) or placebo ( N=163) every 2 weeks until unacceptable toxicity or disease progression. Primary endpoint was overall survival (OS) in Intention-to-Treat population. This trial is registered in ClinicalTrials.gov (NCT02267343). Results: As of the data cut-off on Aug 13th2016, 5.6 months after last patient randomized, median OS was 5.32 months with nivolumab versus 4.14 months with placebo (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.50-0.78; p<0.0001), and OS rates at 6 and 12 month were 46.4% versus 34.7% and 26.6% versus 10.9%, respectively. The overall response rate (ORR) was 11.2% (95% CI, 7.7-15.6) with nivolumab versus 0% (95% CI, 0.0-2.8) with placebo (p<0.0001). Median progression-free survival (PFS) was 1.61 months with nivolumab versus 1.45 months with placebo (HR, 0.60; 95% CI, 0.49-0.75; p<0.0001). Grade ≥ 3 drug-related adverse events (AEs) occurred in 11.5 % of nivolumab and 5.5 % of placebo; 2.7% and 2.5%, respectively, discontinued of study treatment due to drug-related AEs (any grade). Conclusions: Nivolumab was effective as the salvage treatment for pretreated AGC with significantly improved OS, PFS and ORR compared to placebo. |
| Date: | 2017-02 |
| Relation: | Journal of Clinical Oncology. 2017 Feb;35(4, Suppl.):2. |
| Link to: | http://dx.doi.org/10.1200/JCO.2017.35.4_suppl.2 |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0732-183X&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000443281700003 |
| Appears in Collections: | [陳立宗] 會議論文/會議摘要
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