title: Irinotecan combined with 5-fluorouracil and leucovorin as second-line chemotherapy for metastatic or relapsed gastric cancer.
abstract: OBJECTIVE
  We analysed the efficacy and toxicity of irinotecan, leucovorin and 5-fluorouracil (FOLFIRI) chemotherapy as second-line treatment for metastatic or relapsed gastric cancer (MRGC) in a clinical practice setting. Factors to select patients who may benefit from salvage chemotherapy was also analysed.
  
  
  METHODS
  Patients with MRGC with progression on or within 6 months after discontinuing platinum-based chemotherapy received FOLFIRI as second-line therapy. The FOLFIRI regimen consisted of irinotecan (180 mg/m(2); day 1) combined with leucovorin (200 mg/m(2)), followed by 5-fluorouracil (400 mg/m(2)) as a bolus and 600 mg/m(2) as a 22-h infusion on days 1 and 2 every 2 weeks.
  
  
  RESULTS
  Fifty-one patients received a total of 282 courses of chemotherapy. No patients had complete remission (CR), but 9 patients achieved partial remission (PR). Stable disease (SD) was documented in 15 patients. The median progression-free survival (PFS) and overall survival (OS) were 3.2 and 9.1 months, respectively. Toxicities were tolerable and grade 3/4 neutropenia was observed in 49 cycles (17%). In multivariate analysis, patients with less organ involvement by metastasis and good performance status (PS) were independently associated with a longer PFS and OS (P < 0.05). Disease control (CR, PR or SD) after first-line chemotherapy were related to a longer PFS (P = 0.02), but had no effect on OS.
  
  
  CONCLUSIONS
  FOLFIRI was tolerable and showed modest activity as a second-line therapy in MRGC. Less organ involvement by metastasis or good PS may be optimal selection criteria for patients with MRGC who are suitable for second-line chemotherapy.
authors.affiliation: Department of Internal Medicine, Cheju National University Hospital, Jeju, Republic of Korea.
authors.forename: Myung-Deok
authors.initials: MD
authors.lastname: Seo
authors.forename: Keun-Wook
authors.initials: KW
authors.lastname: Lee
authors.forename: Joo Han
authors.initials: JH
authors.lastname: Lim
authors.forename: Hyeon Gyu
authors.initials: HG
authors.lastname: Yi
authors.forename: Dae-Young
authors.initials: DY
authors.lastname: Kim
authors.forename: Do-Youn
authors.initials: DY
authors.lastname: Oh
authors.forename: Jee Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Seock-Ah
authors.initials: SA
authors.lastname: Im
authors.forename: Tae-You
authors.initials: TY
authors.lastname: Kim
authors.forename: Jong Seok
authors.initials: JS
authors.lastname: Lee
authors.forename: Yung-Jue
authors.initials: YJ
authors.lastname: Bang
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D018579:Patient Selection; D016016:Proportional Hazards Models; D016879:Salvage Therapy; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis
chemical_list: D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin