title: [Efforts toward qualitative and quantitative improvements of cancer clinical trials at regional designated cancer care hospitals-through full support for cancer clinical trials by oncology pharmacy specialist and data manager].
abstract: BACKGROUND
  S-1, an oral fluoropyrimidine, is one of the standard chemotherapeutic agents for the treatment of metastatic gastric cancer(MGC). However, the most effective second-line regimen after failure of treatment with first-line agents such as S-1 is yet to be determined. The aim of this study was to investigate the various second-line chemotherapy regimens in MGC patients.
  
  
  METHODS
  We retrospectively studied patients with MGC who received second-line treatment after failure of the first-line S-1 or S-1/cisplatin treatment. The overall survival times with each second-line regimen were determined using the Kaplan-Meier method, and the effect on overall survival was analyzed using Cox regression analysis.
  
  
  RESULTS
  The median survival time for all patients was 14. 2 months(95% confidence interval(CI): 12. 88-15. 43 months)with a 1-year survival rate of 60. 4%. Kaplan-Meier analysis revealed that the second-line regimens containing irinotecan significantly improved the median survival time as compared to regimens without irinotecan(median survival time: 16. 5 and 13. 8 months, respectively). Cox regression analysis showed that irinotecan-containing regimens were associated with improved overall survival(hazard ratio: 0. 165; 95% CI: 0. 041-0. 665).
  
  
  CONCLUSIONS
  The use of irinotecan-containing regimens as second-line chemotherapy after failure of first-line S-1 therapy may be beneficial for MGC patients.
authors.affiliation: Dept. of Pharmacy, National Hospital Organization, Osakaminami Medical Center.
authors.forename: Shigefumi
authors.initials: S
authors.lastname: Morimoto
authors.forename: Ryoko
authors.initials: R
authors.lastname: Inoue
authors.forename: Yoshiharu
authors.initials: Y
authors.lastname: Shono
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Horiuchi
authors.forename: Hiroki
authors.initials: H
authors.lastname: Hata
authors.forename: Shuji
authors.initials: S
authors.lastname: Masamichi
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Fujita
authors.forename: Kunio
authors.initials: K
authors.lastname: Yamazaki
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Tabuse
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002173:Cancer Care Facilities; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D010348:Patient Care Team; D010595:Pharmacists
chemical_list: D000970:Antineoplastic Agents