title: A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as second-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, levoforinate, and infusional 5-fluorouracil (FOLFOX4) as a second-line therapy for Japanese patients with unresectable advanced or metastatic colorectal cancer.
  
  
  METHODS
  A total of 53 patients with progressive disease after first-line chemotherapy were enrolled in the study. The treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred, or the patient chose to discontinue the treatment.
  
  
  RESULTS
  Four patients were ineligible and one did not receive the protocol therapy. Therefore, the response rate, overall survival (OS), and progression-free survival (PFS) were evaluated in 48 patients; toxicity was evaluated in 52 patients, excluding the patient who had not received the protocol therapy. A partial response was observed in 10 patients. The overall response rate was 20.8% (95% confidence interval [CI], 10.5%-35.0%). The median PFS was 5.6 months (95% CI, 4.1-7.0 months) and the median OS was 19.6 months (95% CI, 11.4-24.3 months). The most frequently encountered grade 3/4 hematological symptom was neutropenia (43.1%). The toxicity profile was generally predictable and manageable.
  
  
  CONCLUSIONS
  The results showed good tolerability and efficacy for second-line FOLFOX4 in patients with advanced colorectal cancer, thus indicating the promise of this regimen as an effective second-line therapy for advanced colorectal cancer in the Japanese population.
authors.affiliation: Department of Surgery, Kurume University School of Medicine, Kurume, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ogata
authors.forename: Shoji
authors.initials: S
authors.lastname: Tokunaga
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Emi
authors.forename: Eiji
authors.initials: E
authors.lastname: Oki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saeki
authors.forename: Ken
authors.initials: K
authors.lastname: Shirabe
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Hasegawa
authors.forename: Noriaki
authors.initials: N
authors.lastname: Sadanaga
authors.forename: Hironori
authors.initials: H
authors.lastname: Samura
authors.forename: Fumihiko
authors.initials: F
authors.lastname: Fujita
authors.forename: Takaho
authors.initials: T
authors.lastname: Tanaka
authors.forename: Masaki
authors.initials: M
authors.lastname: Kitazono
authors.forename: Manabu
authors.initials: M
authors.lastname: Yamamoto
authors.forename: Tatsuma
authors.initials: T
authors.lastname: Morikita
authors.forename: Masafumi
authors.initials: M
authors.lastname: Inomata
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kakeji
authors.forename: Kazuo
authors.initials: K
authors.lastname: Shirouzu
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Maehara
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D007564:Japan; D002955:Leucovorin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil