Kazuhiro Nishikawa1, Yasuhide Yamada2, Kenji Ishido3, Masahiro Gotoh4, Hideaki Bando5, Naotoshi Sugimoto6, Tomohiro Nishina7, Kenji Amagai8, Keisho Chin9, Yasumasa Niwa10, Akihito Tsuji11, Hiroshi Imamura12, Masahiro Tsuda13, Hirofumi Yasui14, Hirofumi Fujii15, Kensei Yamaguchi16, Hisateru Yasui17, Shuichi Hironaka18, Ken Shimada19, Hiroto Miwa20, Chikuma Hamada21, Ichinosuke Hyodo22. 1. Department of Surgery, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan. kazuno13@hotmail.co.jp. 2. Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan. 3. Department of Gastroenterology, Kitasato University East Hospital, Sagamihara, Japan. 4. Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan. 5. Division of Gastrointestinal Oncology and Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan. 6. Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. 7. Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan. 8. Department of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama, Japan. 9. Department of Gastroenterology, Cancer Institute Hospital of JFCR, Tokyo, Japan. 10. Department of Endoscopy, Aichi Cancer Center Hospital, Nagoya, Japan. 11. Department of Medical Oncology, Kochi Health Sciences Center, Kochi, Japan. 12. Department of Surgery, Sakai City Hospital, Sakai, Japan. 13. Department of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan. 14. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-Gun, Japan. 15. Division of Clinical Oncology, Jichi Medical University, Shimotsuke, Japan. 16. Division of Gastroenterology, Saitama Cancer Center, Kita-Adachi-Gun, Japan. 17. Department of Medical Oncology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. 18. Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan. 19. Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Japan. 20. Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan. 21. Faculty of Engineering, Tokyo University of Science, Tokyo, Japan. 22. Division of Gastroenterology, University of Tsukuba, Tsukuba, Japan.
Abstract
BACKGROUND: The association between progression type and survival has been reported in breast cancer, but remains unclear in advanced gastric cancer (AGC). Here, this association was assessed using data obtained from an earlier randomized phase III study demonstrating the non-inferiority of S-1 plus oxaliplatin (SOX) to S-1 plus cisplatin (CS) on progression-free survival and overall survival (OS) in the first-line treatment of AGC. METHODS: A Cox regression model including two time-dependent covariates, progression with new lesions and with no new lesions, was used to determine their effect on OS in each treatment group. When both types of progression were detected simultaneously, this was categorized as progression with new lesions. RESULTS: Progression with and with no new lesions was identified in 91 and 167 patients, respectively, in the SOX group (333 patients) and 95 and 147 patients, respectively, in the CS group (330 patients). The association between progression type and OS was similar in both treatment groups; both progression types were strong poor prognostic factors, particularly progression with new lesions [hazard ratio (HR), 7.26; 95% confidence interval (CI), 4.89-10.80 in SOX and HR, 5.78; 95% CI, 4.13-8.08 in CS] compared to no new lesions (HR, 4.66; 95% CI, 3.21-6.77 in SOX and HR, 2.71; 95% CI, 1.95-3.75 in CS). CONCLUSIONS: Progression accompanied by new lesions had a strong negative impact on OS in patients treated with S-1 and platinum for AGC.
RCT Entities:
BACKGROUND: The association between progression type and survival has been reported in breast cancer, but remains unclear in advanced gastric cancer (AGC). Here, this association was assessed using data obtained from an earlier randomized phase III study demonstrating the non-inferiority of S-1 plus oxaliplatin (SOX) to S-1 plus cisplatin (CS) on progression-free survival and overall survival (OS) in the first-line treatment of AGC. METHODS: A Cox regression model including two time-dependent covariates, progression with new lesions and with no new lesions, was used to determine their effect on OS in each treatment group. When both types of progression were detected simultaneously, this was categorized as progression with new lesions. RESULTS: Progression with and with no new lesions was identified in 91 and 167 patients, respectively, in the SOX group (333 patients) and 95 and 147 patients, respectively, in the CS group (330 patients). The association between progression type and OS was similar in both treatment groups; both progression types were strong poor prognostic factors, particularly progression with new lesions [hazard ratio (HR), 7.26; 95% confidence interval (CI), 4.89-10.80 in SOX and HR, 5.78; 95% CI, 4.13-8.08 in CS] compared to no new lesions (HR, 4.66; 95% CI, 3.21-6.77 in SOX and HR, 2.71; 95% CI, 1.95-3.75 in CS). CONCLUSIONS: Progression accompanied by new lesions had a strong negative impact on OS in patients treated with S-1 and platinum for AGC.
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