title: Phase II study of FOLFIRI regimen in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of FOLFIRI regimen in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.
  
  
  METHODS
  The FOLFIRI regimen consisted of intravenous infusion of irinotecan 180 mg/m(2) on day 1 plus leucovorin (LV) 400 mg/m(2) on day 1 plus 5-fluorouracil (5-FU) 400 mg/m(2) bolus on day 1 plus 46-hour intravenous infusion of 5-FU 2,400 mg/m(2), every 2 weeks as one cycle. The main selection criterion for this study was the advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.
  
  
  RESULTS
  Of the 57 evaluable patients for efficacy, 4 (7.5%) had a partial response, 36 (67.9%) had stable disease, and 13 (24.5%) had progressive disease. Median progression-free survival was 4.8 months (95% CI 3.9-5.7 months), and median overall survival was 7.8 months (95% CI 13.1-16.5 months). Safety analysis was based on the data of 57 evaluable patients. The most frequently observed grade 3 or 4 toxicities were neutropenia 16 (27.8%), nausea/vomiting 7 (12.3%), and diarrhea 1 (1.8%).
  
  
  CONCLUSIONS
  FOLFIRI regimen is effective and well tolerated in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin in Chinese population.
authors.affiliation: Department of Medical Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, 79 Qingchun Rd., 310003 Hangzhou, China.
authors.forename: Han Ying
authors.initials: HY
authors.lastname: Bao
authors.forename: Wei Jia
authors.initials: WJ
authors.lastname: Fang
authors.forename: Xiao Chen
authors.initials: XC
authors.lastname: Zhang
authors.forename: Gen Ming
authors.initials: GM
authors.lastname: Shi
authors.forename: Sui
authors.initials: S
authors.lastname: Huang
authors.forename: Lan Fang
authors.initials: LF
authors.lastname: Yu
authors.forename: Jin
authors.initials: J
authors.lastname: Chen
authors.forename: Hai Bo
authors.initials: HB
authors.lastname: Mou
authors.forename: Jing
authors.initials: J
authors.lastname: Deng
authors.forename: Peng
authors.initials: P
authors.lastname: Shen
authors.forename: Nong
authors.initials: N
authors.lastname: Xu
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D002681:China; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced / Q000453:epidemiology; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced* / Q000453:epidemiology; D009503:Neutropenia / Q000139:chemically induced* / Q000453:epidemiology; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011743:Pyrimidines / Q000008:administration & dosage; D013534:Survival; D014839:Vomiting / Q000139:chemically induced* / Q000453:epidemiology; D055815:Young Adult
chemical_list: D009944:Organoplatinum Compounds; D011743:Pyrimidines; D000077150:Oxaliplatin; C029269:5-fluoropyrimidine; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin