title: Phase 2 study of modified irinotecan and bolus 5-fluorouracil/l-leucovorin in Japanese metastatic colorectal cancer patients.
abstract: BACKGROUND
  Using the recommended doses obtained from our previous phase 1 trial of a modified Saltz chemotherapy regimen for metastatic colorectal cancer (weekly irinotecan and bolus 5-fluorouracil/l-leucovorin for 3 weeks every 28 days), we performed the present phase 2 trial to evaluate efficacy and toxicity.
  
  
  METHODS
  A total of 29 patients with metastatic colorectal cancer were included. Our modified Saltz regimen was administered. The primary endpoint was overall response rate.
  
  
  RESULTS
  Of the 29 patients, 11 had previous chemotherapy. A partial response occurred in 11 patients, stable disease in 16 patients, and progressive disease in two patients. Disease control rate was 93.1%. Response rates with and without previous treatment were 18.2% and 50%, respectively. Median progression-free survival was 17.3 months. The main hematologic toxicities were leukopenia (22.6%) and neutropenia (45.2%). No treatment-related deaths occurred.
  
  
  CONCLUSIONS
  Our modified Saltz regimen exhibited sufficient efficacy, feasibility, and manageable toxicity as a therapeutic option for selected colorectal cancer patients.
authors.affiliation: Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan. e-baba@intmed1.med.kyushu-u.ac.jp
authors.forename: Eishi
authors.initials: E
authors.lastname: Baba
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Fujishima
authors.forename: Akitaka
authors.initials: A
authors.lastname: Makiyama
authors.forename: Keita
authors.initials: K
authors.lastname: Uchino
authors.forename: Risa
authors.initials: R
authors.lastname: Tanaka
authors.forename: Taito
authors.initials: T
authors.lastname: Esaki
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Kusaba
authors.forename: Kenji
authors.initials: K
authors.lastname: Mitsugi
authors.forename: Shuji
authors.initials: S
authors.lastname: Nakano
authors.forename: Koichi
authors.initials: K
authors.lastname: Akashi
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D007564:Japan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000008:administration & dosage
chemical_list: D014803:Vitamin B Complex; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin