title: Efficacy and safety of S-1 and oxaliplatin combination therapy in elderly patients with advanced gastric cancer.
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.
authors.affiliation: 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.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Bando
authors.affiliation: Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yasuhide
authors.initials: Y
authors.lastname: Yamada
authors.affiliation: Department of Gastroenterology, Kitasato University Hospital, Sagamihara, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanabe
authors.affiliation: Department of Surgery, Osaka General Medical Center, Osaka, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Nishikawa
authors.affiliation: Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Gotoh
authors.affiliation: Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Naotoshi
authors.initials: N
authors.lastname: Sugimoto
authors.affiliation: Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Nishina
authors.affiliation: Department of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Amagai
authors.affiliation: Department of Gastroenterology, Cancer Institute Hospital of JFCR, Tokyo, Japan.
authors.forename: Keisho
authors.initials: K
authors.lastname: Chin
authors.affiliation: Department of Endoscopy, Aichi Cancer Center Hospital, Nagoya, Japan.
authors.forename: Yasumasa
authors.initials: Y
authors.lastname: Niwa
authors.affiliation: Department of Medical Oncology, Kochi Health Sciences Center, Kochi, Japan.
authors.forename: Akihito
authors.initials: A
authors.lastname: Tsuji
authors.affiliation: Department of Surgery, Sakai City Hospital, Sakai, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Imamura
authors.affiliation: Department of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuda
authors.affiliation: Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Yasui
authors.affiliation: Division of Clinical Oncology, Jichi Medical University, Shimotsuke, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Fujii
authors.affiliation: Division of Gastroenterology, Saitama Cancer Center, Kita-adachi-gun, Japan.
authors.forename: Kensei
authors.initials: K
authors.lastname: Yamaguchi
authors.affiliation: Department of Medical Oncology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
authors.forename: Hisateru
authors.initials: H
authors.lastname: Yasui
authors.affiliation: Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Hironaka
authors.affiliation: Department of Internal Medicine, Showa University Northern Yokohama Hospital, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Shimada
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: Hiroto
authors.initials: H
authors.lastname: Miwa
authors.affiliation: Faculty of Engineering, Tokyo University of Science, Tokyo, Japan.
authors.forename: Chikuma
authors.initials: C
authors.lastname: Hamada
authors.affiliation: Division of Gastroenterology, University of Tsukuba, Tsukuba, Japan.
authors.forename: Ichinosuke
authors.initials: I
authors.lastname: Hyodo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010094:Oxonic Acid / Q000008:administration & dosage; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000556:secondary; D011379:Prognosis; D012449:Safety; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin
keywords: Cisplatin; Elderly; Gastric cancer; Oxaliplatin; S-1