title: A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as first-line treatment for advanced colorectal cancer: a Japanese experience.
abstract: OBJECTIVE
  This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin in combination with levofolinate and infusion 5-fluorouracil (FOLFOX4) as first-line therapy for Japanese patients with unresectable metastatic colorectal cancer.
  
  
  METHODS
  Sixty consecutive patients with histologically confirmed advanced or metastatic colorectal cancer were enrolled in the study. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred.
  
  
  RESULTS
  Two patients were ineligible. Toxicity was evaluated in 60 patients, who had received a part or all of the protocol therapy. A partial response was observed in 20 patients. The overall response rate was 34.5% (95% CI, 22.5%-48.1%) and the tumor control rate (partial response + stable disease) was 82.8%. The median progression-free survival was 6.9 months (95% CI, 5.1-9.8 months), and the median overall survival was 31.5 months (95% CI, 18.1-40.1 months). There were no toxicity-related deaths. Grade 3 or 4 neutropenia occurred in 48.3% of patients and often caused a delay in the subsequent treatment course. Mild to moderate cumulative peripheral sensory neuropathy affected 71.7% of patients.
  
  
  CONCLUSIONS
  The results showed good tolerability and efficacy for first-line FOLFOX4 in the treatment of patients with advanced colorectal cancer, indicating the promise of this regimen as first-line therapy for advanced colorectal cancer in the Japanese population.
authors.affiliation: Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Baba
authors.forename: Naoko
authors.initials: N
authors.lastname: Hayashi
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Emi
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kakeji
authors.forename: Akinori
authors.initials: A
authors.lastname: Egashira
authors.forename: Eiji
authors.initials: E
authors.lastname: Oki
authors.forename: Ken
authors.initials: K
authors.lastname: Shirabe
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Toyama
authors.forename: Takefumi
authors.initials: T
authors.lastname: Ohga
authors.forename: Manabu
authors.initials: M
authors.lastname: Yamamoto
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Hasegawa
authors.forename: Fumiko
authors.initials: F
authors.lastname: Kohakura
authors.forename: Hidefumi
authors.initials: H
authors.lastname: Higashi
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Niwa
authors.forename: Fumihiko
authors.initials: F
authors.lastname: Fujita
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ogata
authors.forename: Shunji
authors.initials: S
authors.lastname: Kohnoe
authors.forename: Masafumi
authors.initials: M
authors.lastname: Inomata
authors.forename: Hironori
authors.initials: H
authors.lastname: Samura
authors.forename: Shoji
authors.initials: S
authors.lastname: Tokunaga
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Maehara
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D007564:Japan; D002955:Leucovorin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D011446:Prospective Studies
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil