title: Combination of irinotecan (CPT-11) plus 5-fluorouracil and leucovorin (FOLFIRI regimen) as first line treatment for elderly patients with metastatic colorectal cancer: a phase II trial.
abstract: OBJECTIVE
  To evaluate the efficacy and tolerance of irinotecan (CPT-11) in combination with bolus and continuous infusion of 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFIRI regimen) as first-line treatment of elderly patients with metastatic colorectal cancer (MCC).
  
  
  METHODS
  Thirty consecutive, previously untreated patients with metastatic colorectal cancer, aged (median 76 years; range 70-84) were enrolled. The performance status (WHO) was 0 in 8, 1 in 16 and 2 in 6 patients; 19 (63%) patients had prior surgery and 8 (27%) adjuvant chemotherapy. CPT-11 (180 mg/m(2) as a 90 min i.v. infusion) was administered on day 1, LV (200 mg/m(2) as a 2-hour i.v. infusion), 5-FU (400 mg/m(2)/d i.v. bolus followed by 600 mg/m(2)/d as a 22-hour i.v. continuous infusion) were given on days 1 and 2 every 2 weeks.
  
  
  RESULTS
  Complete response was achieved in one (3.3%) patient and partial response in 10 (33.3%) (overall response rate: 36.6%; 95% C.I.: 26.6-48.4%); 11 (36.6%) patients had stable disease and, 8 (26.6%) disease progression. The median duration of response was 7.5 months and the median time to disease progression 7.0 months. After a median follow-up period of 17 months, the median overall survival was 14.5 months. Main toxicities were: grade 3-4 neutropenia (n = 6; 20%), grade 3 thrombocytopenia (n = 1; 3.3%), grade 2 anemia (n = 9; 30%), grade 3-4 diarrhea (n = 5; 17%) and grade 3 asthenia (n = 3; 10%). There was one treatment-related death due to neutropenic sepsis.
  
  
  CONCLUSIONS
  The FOLFIRI combination is an active regimen with manageable toxicity as front-line treatment in patients above 70 years of age.
authors.affiliation: Department of Medical Oncology, School of Medicine, University General Hospital of Heraklion, Crete, Greece.
authors.forename: J
authors.initials: J
authors.lastname: Souglakos
authors.forename: A
authors.initials: A
authors.lastname: Pallis
authors.forename: S
authors.initials: S
authors.lastname: Kakolyris
authors.forename: D
authors.initials: D
authors.lastname: Mavroudis
authors.forename: N
authors.initials: N
authors.lastname: Androulakis
authors.forename: C
authors.initials: C
authors.lastname: Kouroussis
authors.forename: S
authors.initials: S
authors.lastname: Agelaki
authors.forename: N
authors.initials: N
authors.lastname: Xenidis
authors.forename: G
authors.initials: G
authors.lastname: Milaki
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000627:therapeutic use; D008297:Male; D009362:Neoplasm Metastasis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin