Erschienen in:
05.01.2016 | Original Article
Meta-analysis supporting noninferiority of oxaliplatin plus S-1 to cisplatin plus S-1 in first-line treatment of advanced gastric cancer (G-SOX study): indirect comparison with S-1 alone
verfasst von:
Chikuma Hamada, Yasuhide Yamada, Mizutomo Azuma, Kazuhiro Nishikawa, Masahiro Gotoh, Hideaki Bando, Naotoshi Sugimoto, Tomohiro Nishina, Kenji Amagai, Keisho Chin, Yasumasa Niwa, Akihito Tsuji, Hiroshi Imamura, Masahiro Tsuda, Hirofumi Yasui, Hirofumi Fujii, Kensei Yamaguchi, Hisateru Yasui, Shuichi Hironaka, Ken Shimada, Hiroto Miwa, Ichinosuke Hyodo
Erschienen in:
International Journal of Clinical Oncology
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Ausgabe 4/2016
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Abstract
Background
The Randomized Phase III Study Comparing Oxaliplatin plus S-1 with Cisplatin plus S-1 in Chemotherapy-naïve Patients with Advanced Gastric Cancer (G-SOX) showed the noninferiority of S-1 (an oral fluoropyrimidine-derivative dihydropyrimidine dehydrogenase inhibitor) plus oxaliplatin combination therapy (SOX) to S-1 plus cisplatin therapy (CS) in overall survival [hazard ratio (HR) from proportional hazard model 0.958, 95 % confidence interval (CI) 0.803–1.142; noninferiority margin 1.15]. To further clarify the clinical position of SOX in advanced gastric cancer (AGC), a meta-analysis including information from other reported studies was conducted.
Methods
In addition to G-SOX, Japanese phase III clinical trials including S-1 monotherapy were included in the analyses. Individual patient data for SOX (318 patients) and CS (324 patients) from G-SOX, as well as those for S-1 (160 patients) from the Randomized Phase III Study Comparing the Efficacy and Safety of Irinotecan plus S-1 with S-1 Alone as First-line Treatment for Advanced Gastric Cancer (GC0301/TOP-002), were available. Published clinical information for S-1 from other studies (total 705 patients) was also collected. A Weibull distribution was assumed for overall survival time, and parameters for SOX, CS, and S-1 were estimated parametrically. Posterior HR distributions were obtained with a Bayesian approach.
Results
The HR of SOX to S-1 was 0.817 (95 % credible interval 0.704–0.939), and the probability of the HR <1.00 was 99.8 %. The HR of CS to S-1 was 0.871 (95 % credible interval; 0.754–0.998), and the probability of the HR <1.00 was 97.6 %. The HR of SOX to CS in G-SOX was 0.942 (95 % credible interval; 0.789–1.117), and the probability of HR <1.15 was 98.9 %.
Conclusion
This meta-analysis indicates that SOX was superior to S-1 and noninferior to CS in AGC.