title: Randomized multicenter phase II trial of a biweekly regimen of fluorouracil and leucovorin (LV5FU2), LV5FU2 plus cisplatin, or LV5FU2 plus irinotecan in patients with previously untreated metastatic gastric cancer: a Federation Francophone de Cancerologie Digestive Group Study--FFCD 9803.
abstract: OBJECTIVE
  To determine the efficacy and safety of a biweekly regimen of leucovorin (LV) plus fluorouracil (FU) alone or in combination with cisplatin or irinotecan in patients with previously untreated metastatic gastric adenocarcinoma and to select the best arm for a phase III study.
  
  
  METHODS
  One hundred thirty-six patients (two were ineligible) were enrolled onto the randomized multicenter phase II trial. Patients received LV 200 mg/m(2) (2-hour infusion) followed by FU 400 mg/m(2) (bolus) and FU 600 mg/m(2) (22-hour continuous infusion) on days 1 and 2 every 14 days (LV5FU2; arm A), LV5FU2 plus cisplatin 50 mg/m(2) (1-hour infusion) on day 1 or 2 (arm B), or LV5FU2 plus irinotecan 180 mg/m(2) (2-hour infusion) on day 1 (arm C).
  
  
  RESULTS
  The overall response rates, which were confirmed by an independent expert panel, were 13% (95% CI, 3.4% to 23.3%), 27% (95% CI, 14.1% to 40.4%), and 40% (95% CI, 25.7% to 54.3%) for arms A, B, and C, respectively. Median progression-free survival and overall survival times were 3.2 months (95% CI, 1.8 to 4.6 months) and 6.8 months (95% CI, 2.6 to 11.1 months) with LV5FU2, respectively; 4.9 months (95% CI, 3.5 to 6.3 months) and 9.5 months (95% CI, 6.9 to 12.2 months) with LV5FU2-cisplatin, respectively; and 6.9 months (95% CI, 5.5 to 8.3 months) and 11.3 months (95% CI, 9.3 to 13.3 months) with LV5FU2-irinotecan, respectively.
  
  
  CONCLUSIONS
  Of the three regimens tested, the combination of LV5FU2-irinotecan is the most promising and will be assessed in a phase III trial.
authors.affiliation: Centre Hospitalier Universitaire de Reims, Rims, France. obouche@chu-reims.fr
authors.forename: Olivier
authors.initials: O
authors.lastname: Bouché
authors.forename: Jean Luc
authors.initials: JL
authors.lastname: Raoul
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.forename: Marc
authors.initials: M
authors.lastname: Giovannini
authors.forename: Pierre Luc
authors.initials: PL
authors.lastname: Etienne
authors.forename: Gérard
authors.initials: G
authors.lastname: Lledo
authors.forename: Dominique
authors.initials: D
authors.lastname: Arsène
authors.forename: Jean Francois
authors.initials: JF
authors.lastname: Paitel
authors.forename: Véronique
authors.initials: V
authors.lastname: Guérin-Meyer
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Mitry
authors.forename: Bruno
authors.initials: B
authors.lastname: Buecher
authors.forename: Marie Christine
authors.initials: MC
authors.lastname: Kaminsky
authors.forename: Jean François
authors.initials: JF
authors.lastname: Seitz
authors.forename: Philippe
authors.initials: P
authors.lastname: Rougier
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
authors.forename: Chantal
authors.initials: C
authors.lastname: Milan
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005602:France; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin