title: A phase 3 non-inferiority study of 5-FU/l-leucovorin/irinotecan (FOLFIRI) versus irinotecan/S-1 (IRIS) as second-line chemotherapy for metastatic colorectal cancer: updated results of the FIRIS study.
abstract: OBJECTIVE
  The FIRIS study previously demonstrated non-inferiority of IRIS (irinotecan plus S-1) to FOLFIRI (5-fluorouracil/leucovorin with irinotecan) for progression-free survival as the second-line chemotherapy for metastatic colorectal cancer (mCRC) as the primary endpoint. The overall survival (OS) data were immature at the time of the primary analysis.
  
  
  METHODS
  Between 30 January 2006 and 29 January 2008, 426 patients with mCRC who failed in first-line chemotherapy were randomly assigned to receive either FOLFIRI or IRIS. After the primary analysis, the follow-up survey was cut off on 29 July 2010, and the final OS data were analysed.
  
  
  RESULTS
  With a median follow-up of 39.2 months, the median OS was 17.4 months in the FOLFIRI group and 17.8 months in the IRIS group [hazard ratio (HR) 0.900; 95% confidence interval (CI) 0.728-1.112]. In the pre-planned subgroup of patients who received prior chemotherapy containing oxaliplatin, the median OS was 12.7 months in the FOLFIRI group and 15.3 months in the IRIS group (HR 0.755; 95% CI 0.580-0.983).
  
  
  CONCLUSIONS
  IRIS is non-inferior to FOLFIRI for OS as second-line chemotherapy for mCRC. IRIS can be an option for second-line chemotherapy of mCRC. (ClinicalTrials.gov Number: NCT00284258).
authors.affiliation: Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan, h.yasui@scchr.jp.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Yasui
authors.forename: Kei
authors.initials: K
authors.lastname: Muro
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.forename: Akihito
authors.initials: A
authors.lastname: Tsuji
authors.forename: Shinichi
authors.initials: S
authors.lastname: Sameshima
authors.forename: Hideo
authors.initials: H
authors.lastname: Baba
authors.forename: Taroh
authors.initials: T
authors.lastname: Satoh
authors.forename: Tadamichi
authors.initials: T
authors.lastname: Denda
authors.forename: Kenji
authors.initials: K
authors.lastname: Ina
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Nishina
authors.forename: Kensei
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Taito
authors.initials: T
authors.lastname: Esaki
authors.forename: Shinya
authors.initials: S
authors.lastname: Tokunaga
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kuwano
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Masahiko
authors.initials: M
authors.lastname: Watanabe
authors.forename: Ichinosuke
authors.initials: I
authors.lastname: Hyodo
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Kenichi
authors.initials: K
authors.lastname: Sugihara
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010094:Oxonic Acid / Q000008:administration & dosage; D011379:Prognosis; 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; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
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