title: FOLFIRI as a second-line therapy in patients with docetaxel-pretreated gastric cancer: a historical cohort.
abstract: BACKGROUND
  The role of second-line therapy in gastric cancer patients mostly stemmed from clinical trials with monochemotherapy carried out in Asian countries. Nevertheless, these results cannot be broadly generalized as molecular studies suggested the existence of different sets of deregulated gene networks correlated with ethnicity. In the present study, we investigated the activity and safety of FOLFIRI given as a second-line therapy in metastatic gastric or gastro-esophageal junction cancer patients who experienced disease progression on or after first-line docetaxel-containing chemotherapy.
  
  
  METHODS
  Patients with histologically confirmed metastatic gastric cancer who failed docetaxel-containing first-line therapy and who received FOLFIRI in second line were eligible for the study. Seventy patients treated at three Italian cancer centers between 2005 and 2012 entered the study. Patients received every 2 weeks irinotecan 180 mg/m2 as 1 h infusion on day 1, folinic acid 100 mg/m2 intravenously days 1-2, and fluorouracil as a 400 mg/m2 bolus and then 600 mg/m2 continuous infusion over 22 hours days 1-2.
  
  
  RESULTS
  We observed 1(1.4%) complete response, 15 (21.4%) partial response, for an overall response rate of 22.8% (95% confidence interval (CI): 13.4-32.3). Stable disease was recorded in 21 (30%) patients. Median progression-free survival and overall survival were 3.8 months (95% CI: 3.3-4.4) and 6.2 months (95% CI: 5.3-7.1), respectively. The treatment was well tolerated, as the most common G3-4 toxicities were neutropenia (28.5%) and diarrhea (14.5%).
  
  
  CONCLUSIONS
  FOLFIRI appears an effective and safe treatment option for pretreated metastatic gastric cancer patients, and deserves further investigation in randomized clinical trials.
authors: Marcello
authors: M
authors: Maugeri-Saccà
authors: Laura
authors: L
authors: Pizzuti
authors: Domenico
authors: D
authors: Sergi
authors: Maddalena
authors: M
authors: Barba
authors: Franca
authors: F
authors: Belli
authors: Silvia
authors: S
authors: Fattoruso
authors: Diana
authors: D
authors: Giannarelli
authors: Antonella
authors: A
authors: Amodio
authors: Sara
authors: S
authors: Boggia
authors: Patrizia
authors: P
authors: Vici
authors: Luigi
authors: L
authors: Di Lauro
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015331:Cohort Studies; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000627:therapeutic use*
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin