title: A randomized phase II study of biweekly irinotecan monotherapy or a combination of irinotecan plus 5-fluorouracil/leucovorin (mFOLFIRI) in patients with metastatic gastric adenocarcinoma refractory to or progressive after first-line chemotherapy.
abstract: BACKGROUND
  The aim of this study was to evaluate the efficacy of irinotecan (CPT-11) monotherapy and CPT-11 plus 5-fluorouracil (5-FU)/leucovorin (LV) combination (mFOLFIRI) as second-line treatment in patients with advanced gastric cancer (AGC).
  
  
  METHODS
  A total of 59 patients were randomly assigned to either CPT-11 (150 mg/m(2) iv on day 1) or mFOLFIRI (CPT-11 150 mg/m(2) plus LV 20 mg/m(2) on day 1 followed by 5-FU 2,000 mg/m(2) over 48 h), every 2 weeks. The primary end point was objective response rate (ORR).
  
  
  RESULTS
  Following random assignment, 29 patients received CPT-11 and 30 patients mFOLFIRI. The ORR was 17.2 % [95 % confidence interval (CI) 3.4-30.9] and 20.0 % (95 % CI 5.6-34.3) for the CPT-11 and mFOLFIRI arms, respectively (P = 0.525). There was no significant difference in median progression-free survival: 2.2 months (95 % CI 0.2-4.3) for CPT-11 versus 3.0 months (95 % CI 2.0-3.7) for mFOLFIRI (P = 0.481) or in median overall survival: 5.8 months (95 % CI 3.0-8.7), compared with 6.7 months (95 % CI 5.3-8.2) (P = 0.514). Grade 3/4 toxicity was observed in 21 and 28 events in the CPT-11 and mFOLFIRI arms, respectively.
  
  
  CONCLUSIONS
  Although this study had a small sample size and limited statistical power, CPT-11 monotherapy and mFOLFIRI appear to be equally active and tolerable as second-line chemotherapy for AGC. The addition of 5-FU/LV to CPT-11 did not significantly improve efficacy.
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Hospital, 1198 Guwol-Dong, Namdong-Gu, Incheon 405-706, Republic of Korea.
authors.forename: Sun Jin
authors.initials: SJ
authors.lastname: Sym
authors.forename: Junshik
authors.initials: J
authors.lastname: Hong
authors.forename: Jinny
authors.initials: J
authors.lastname: Park
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
authors.forename: Jae Hoon
authors.initials: JH
authors.lastname: Lee
authors.forename: Yeon Ho
authors.initials: YH
authors.lastname: Park
authors.forename: Woon Ki
authors.initials: WK
authors.lastname: Lee
authors.forename: Min
authors.initials: M
authors.lastname: Chung
authors.forename: Hyung-Sik
authors.initials: HS
authors.lastname: Kim
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin