title: Determination of prognostic factors in Japanese patients with advanced gastric cancer using the data from a randomized controlled trial, Japan clinical oncology group 9912.
abstract: BACKGROUND
  In advanced gastric cancer (AGC), no globally accepted prognostic scoring system has been developed. Therefore, we explored baseline prognostic factors in Japanese AGC patients using the data from a randomized controlled trial, Japan Clinical Oncology Group (JCOG) 9912, which investigated the efficacy of systemic chemotherapy as a first-line treatment.
  
  
  METHODS
  Prognostic factors and prognostic indices for overall survival were screened and evaluated in patients enrolled in JCOG9912 using the Cox proportional hazard model. The Royal Marsden Hospital prognostic model was also applied to the JCOG9912 trial.
  
  
  RESULTS
  A total of 650 (92.3%) of the 704 patients randomized in the JCOG9912 trial, for whom complete data were available for multivariate analyses, was included in the present study (5-fluorouracil arm, n = 215; irinotecan plus cisplatin arm, n = 216; S-1 arm, n = 219). The median survival time (MST) for all patients was 11.8 months. To construct a prognostic index, we selected four risk factors by multivariate analysis: performance status ≥ 1, number of metastatic sites ≥ 2, no prior gastrectomy, and elevated alkaline phosphatase. MSTs were 17.0 months for patients categorized into the low-risk group, who had zero or one risk factor (n = 225); 10.4 months for patients in the moderate-risk group, who had two or three risk factors (n = 368); and 5.0 months for patients in the high-risk group, who had all four risk factors (n = 57).
  
  
  CONCLUSIONS
  In the present study, we propose a new prognostic index for patients with AGC. This can be used for more appropriate patient stratification in future clinical trials.
authors.affiliation: Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan; Department of Clinical Oncology, St. Marianna University School of Medicine, Kanagawa, Japan; JCOG Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo, Japan; Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan; Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan; Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan; Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan; Department of Gastroenterology, Yamagata Prefectural Central Hospital, Yamagata, Japan; Department of Gastroenterology, Saitama Cancer Center Hospital, Saitama, Japan; Cancer Chemotherapy Center, Osaka Medical College, Takatsuki, Japan; Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan; Division of Diabetes, Digestive and Kidney Diseases, Department of Clinical Molecular Medicine, Kobe University Graduate School of Medicine, Hyogo, Japan; Division of Medical Oncology, Kochi Health Sciences Center, Kochi, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Takahari
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.forename: Atsuo
authors.initials: A
authors.lastname: Takashima
authors.forename: Yasuhide
authors.initials: Y
authors.lastname: Yamada
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yoshino
authors.forename: Kentaro
authors.initials: K
authors.lastname: Yamazaki
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Fukase
authors.forename: Kensei
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Masahiro
authors.initials: M
authors.lastname: Goto
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Nishina
authors.forename: Takao
authors.initials: T
authors.lastname: Tamura
authors.forename: Akihito
authors.initials: A
authors.lastname: Tsuji
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002166:Camptothecin / Q000031:analogs & derivatives / Q000627:therapeutic use; D002945:Cisplatin / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D007564:Japan; D008297:Male; D009362:Neoplasm Metastasis / Q000473:pathology; D011379:Prognosis; D012307:Risk Factors; D013274:Stomach Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D005472:Fluorouracil; D002166:Camptothecin
keywords: Advanced gastric cancer; Chemotherapy; Prognostic factor; Prognostic index