title: Evaluation of efficacy and safety of FOLFIRI for elderly patients with gastric cancer: a first-line phase II study.
abstract: OBJECTIVE
  Current chemotherapy protocols for gastric cancer present high toxicity. The FOLFIRI regimen has shown promising results with elderly colorectal cancer patients and for gastric cancer patients but this is the first report on elderly gastric cancer patients.
  
  
  METHODS
  In this multicenter non-randomized phase II trial, we administered the FOLFIRI chemotherapy protocol (irinotecan [180 mg/m(2)], fluorouracil [5-FU] [400 mg/m(2)] and folinic acid 400 mg/m(2) or 200mg/m(2) of l-folinic acid) to patients aged over 70 years with locally-advanced or metastatic gastric cancer combined with Comprehensive Geriatric Assessment (CGA). Responses were assessed at 2 months.
  
  
  RESULTS
  Forty-two patients received eight cycles of the FOLFIRI regimen, with 82.5% of patients showing disease control: 10 patients (26%) showing objective (partial or complete) responses and 23 (57.5%) showing stable disease. One-year overall survival (OS) was 41.5% [95%CI 26.5-56.0] and one-year progression-free survival (PFS) was 31.8% [95%CI 18.4-46.1%]. We observed 10 Grade 3/4 hematologic toxicities with one febrile neutropenia. CGA data demonstrated that geriatric functions were not altered by treatment and that nutritional status improved over treatment.
  
  
  CONCLUSIONS
  Results show excellent disease control and relatively high survival rates with limited toxicity similar to younger patients indicating that this regimen should be considered as a possible treatment in advanced gastric cancer of the elderly.
authors: Department of Medical Oncology, Institut Bergonié, 229, cours de l'Argonne, 33076 Bordeaux cedex, France. fonck@bergonie.org
authors: Marianne
authors: M
authors: Fonck
authors: Réné
authors: R
authors: Brunet
authors: Yves
authors: Y
authors: Becouarn
authors: Jean-Louis
authors: JL
authors: Legoux
authors: Jérôme
authors: J
authors: Dauba
authors: Laurent
authors: L
authors: Cany
authors: Denis
authors: D
authors: Smith
authors: Dominique
authors: D
authors: Auby
authors: Eric
authors: E
authors: Terrebonne
authors: Laurent
authors: L
authors: Traissac
authors: Cécile
authors: C
authors: Mertens
authors: Pierre
authors: P
authors: Soubeyran
authors: Carine
authors: C
authors: Bellera
authors: Muriel
authors: M
authors: Rainfray
authors: Simone
authors: S
authors: Mathoulin-Pélissier
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D013274:Stomach Neoplasms / Q000188:drug therapy*
chemical_list: D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin