Chikuma Hamada1, Yasuhide Yamada2, Mizutomo Azuma3, Kazuhiro Nishikawa4, Masahiro Gotoh5, Hideaki Bando6, Naotoshi Sugimoto7, Tomohiro Nishina8, Kenji Amagai9, Keisho Chin10, Yasumasa Niwa11, Akihito Tsuji12, Hiroshi Imamura13, Masahiro Tsuda14, Hirofumi Yasui15, Hirofumi Fujii16, Kensei Yamaguchi17, Hisateru Yasui18, Shuichi Hironaka19, Ken Shimada20, Hiroto Miwa21, Ichinosuke Hyodo22. 1. Faculty of Engineering, Tokyo University of Science, 1-3, Kagurazaka, Shinjuku-ku, Tokyo, 162-8601, Japan. hamada@ms.kagu.tus.ac.jp. 2. Gastrointestinal Oncology Division, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. 3. Department of Gastroenterology, Kitasato University East Hospital, 2-1-1, Asamizodai, Minami-ku, Sagamihara, 252-0380, Japan. 4. Department of Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka, 558-0056, Japan. 5. Cancer Chemotherapy Center, Osaka Medical College Hospital, 2-7, Daigakumachi, Takatsuki, 569-8686, Japan. 6. Division of Gastrointestinal Oncology and Digestive Endoscopy, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, 277-0882, Japan. 7. Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan. 8. Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, 160, Minamiumemotomachi, Matsuyama, 791-0280, Japan. 9. Department of Gastroenterology, Ibaraki Prefectural Central Hospital, 6528, Koibuchi, Kasama, 309-1703, Japan. 10. Department of Gastroenterology, Cancer Institute Hospital of JFCR, 3-8-31, Ariake, Tokyo, 135-8550, Japan. 11. Department of Endoscopy, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan. 12. Department of Medical Oncology, Kochi Health Sciences Center, 2125-1, Ike, Kochi, 781-8555, Japan. 13. Department of Surgery, Sakai City Hospital, 1-1-1, Minamiyasui-cho, Sakai, 590-0064, Japan. 14. Department of Gastroenterological Oncology, Hyogo Cancer Center, 13-70, Kitaoji-cho, Akashi, 673-0021, Japan. 15. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007, Nagaizumi-cho, Shimonagakubo, Sunto-gun, 411-8777, Japan. 16. Division of Clinical Oncology, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, 329-0498, Japan. 17. Division of Gastroenterology, Saitama Cancer Center, 780, Inamachi, Oaza Komuro, Kita-adachi-gun, 362-0806, Japan. 18. Department of Medical Oncology, National Hospital Organization Kyoto Medical Center, 1-1, Fukakusamukaihata-cho, Fushimi-ku, Kyoto, 612-0861, Japan. 19. Clinical Trial Promotion Department, Chiba Cancer Center, 666-2, Nitona-cho, Chuo-ku, Chiba, 260-0801, Japan. 20. Department of Internal Medicine, Showa University Northern Yokohama Hospital, Chigasakichuo, Tsuzuki-ku, Yokohama, 224-0032, Japan. 21. Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, 1-1, Mukogawa-cho, Nishinomiya, 663-8131, Japan. 22. Division of Gastroenterology, University of Tsukuba, 1-1-1, Tennodai, Tsukuba, 305-8577, Japan.
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.
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.
Authors: Y Yamada; K Higuchi; K Nishikawa; M Gotoh; N Fuse; N Sugimoto; T Nishina; K Amagai; K Chin; Y Niwa; A Tsuji; H Imamura; M Tsuda; H Yasui; H Fujii; K Yamaguchi; H Yasui; S Hironaka; K Shimada; H Miwa; C Hamada; I Hyodo Journal: Ann Oncol Date: 2014-10-14 Impact factor: 32.976