Hideaki Bando1, Yasuhide Yamada2, Satoshi Tanabe3, Kazuhiro Nishikawa4, Masahiro Gotoh5, 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 Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. hbando@east.ncc.go.jp. 2. Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan. 3. Department of Gastroenterology, Kitasato University Hospital, Sagamihara, Japan. 4. Department of Surgery, Osaka General Medical Center, Osaka, Japan. 5. Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, 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, Tokyo, 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: A randomized phase III study of Japanese patients with advanced gastric cancer, the G-SOX trial, revealed that S-1 and oxaliplatin (SOX) combination therapy was noninferior to S-1 and cisplatin (CS) combination therapy. However, it is unclear whether the efficacy and safety in elderly patients were different between the two regimens. METHODS: A total of 685 patients registered in the G-SOX trial were classified as elderly (70 years or older) or not elderly (younger than 70 years), and 663 patients (SOX therapy, elderly 113 of 333 patients, 34 %; CS therapy, elderly 99 of 330 patients, 30 %) and 673 patients (SOX therapy, elderly 114 of 338 patients, 34 %; CS therapy, elderly 101 of 335 patients, 30 %) were analyzed for efficacy and safety, respectively. Treatment delivery of SOX was also compared between elderly and nonelderly groups. RESULTS: No differences in efficacy were identified between the elderly and nonelderly groups for either regimen. In the elderly groups, SOX therapy showed better trends in progression-free survival (hazard ratio 0.805, 95 % confidence interval 0.588-1.102) and overall survival (hazard ratio 0.857, 95 % confidence interval 0.629-1.167) compared with CS therapy, although there were no significant differences. Grade 3 or worse adverse events were less frequent in the elderly group receiving SOX than in the elderly group receiving CS except for the low incidence of sensory neuropathy (5.3 % vs 0 %), neutropenia (25.4 % vs 42.6 %), anemia (21.1 % vs 42.6 %), febrile neutropenia (1.8 % vs 10.9 %), increased creatinine level (0.9 % vs 3.0 %), and hyponatremia (7.9 % vs 18.8 %). CONCLUSIONS:SOX is an effective and feasible therapy in both nonelderly and elderly patients with advanced gastric cancer. In elderly patients, SOX demonstrated favorable efficacy and safety compared with CS.
RCT Entities:
BACKGROUND: A randomized phase III study of Japanese patients with advanced gastric cancer, the G-SOX trial, revealed that S-1 and oxaliplatin (SOX) combination therapy was noninferior to S-1 and cisplatin (CS) combination therapy. However, it is unclear whether the efficacy and safety in elderly patients were different between the two regimens. METHODS: A total of 685 patients registered in the G-SOX trial were classified as elderly (70 years or older) or not elderly (younger than 70 years), and 663 patients (SOX therapy, elderly 113 of 333 patients, 34 %; CS therapy, elderly 99 of 330 patients, 30 %) and 673 patients (SOX therapy, elderly 114 of 338 patients, 34 %; CS therapy, elderly 101 of 335 patients, 30 %) were analyzed for efficacy and safety, respectively. Treatment delivery of SOX was also compared between elderly and nonelderly groups. RESULTS: No differences in efficacy were identified between the elderly and nonelderly groups for either regimen. In the elderly groups, SOX therapy showed better trends in progression-free survival (hazard ratio 0.805, 95 % confidence interval 0.588-1.102) and overall survival (hazard ratio 0.857, 95 % confidence interval 0.629-1.167) compared with CS therapy, although there were no significant differences. Grade 3 or worse adverse events were less frequent in the elderly group receiving SOX than in the elderly group receiving CS except for the low incidence of sensory neuropathy (5.3 % vs 0 %), neutropenia (25.4 % vs 42.6 %), anemia (21.1 % vs 42.6 %), febrile neutropenia (1.8 % vs 10.9 %), increased creatinine level (0.9 % vs 3.0 %), and hyponatremia (7.9 % vs 18.8 %). CONCLUSIONS: SOX is an effective and feasible therapy in both nonelderly and elderly patients with advanced gastric cancer. In elderly patients, SOX demonstrated favorable efficacy and safety compared with CS.
Authors: Hans Wildiers; Murielle Mauer; Athanasios Pallis; Arti Hurria; Supriya G Mohile; Andrea Luciani; Giuseppe Curigliano; Martine Extermann; Stuart M Lichtman; Karla Ballman; Harvey Jay Cohen; Hyman Muss; Ulrich Wedding Journal: J Clin Oncol Date: 2013-09-09 Impact factor: 44.544
Authors: L Decoster; K Van Puyvelde; S Mohile; U Wedding; U Basso; G Colloca; S Rostoft; J Overcash; H Wildiers; C Steer; G Kimmick; R Kanesvaran; A Luciani; C Terret; A Hurria; C Kenis; R Audisio; M Extermann Journal: Ann Oncol Date: 2014-06-16 Impact factor: 32.976
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
Authors: Salah-Eddin Al-Batran; Joerg Thomas Hartmann; Stephan Probst; Harald Schmalenberg; Stephan Hollerbach; Ralf Hofheinz; Volker Rethwisch; Gernot Seipelt; Nils Homann; Gerhard Wilhelm; Gunter Schuch; Jan Stoehlmacher; Hans Günter Derigs; Susanna Hegewisch-Becker; Johannes Grossmann; Claudia Pauligk; Akin Atmaca; Carsten Bokemeyer; Alexander Knuth; Elke Jäger Journal: J Clin Oncol Date: 2008-03-20 Impact factor: 44.544