title: How do we apply adjuvant FOLFOX to Japanese patients with curatively resected colorectal cancer?
abstract: OBJECTIVE
  In Japan the combination of fluorouracil (5-FU), leucovorin and oxaliplatin (FOLFOX) was approved as adjuvant therapy for stage III or high-risk stage II colon cancer only in September 2009. In this study we evaluated the safety and efficacy of FOLFOX as adjuvant chemotherapy for stage IIIb or IV colorectal cancer (CRC) patients in a Japanese group at a single institute.
  
  
  METHODS
  A total of 45 consecutive patients received 12 cycles of adjuvant FOLFOX for stage IIIb (n = 31) or IV (n = 14) CRC. Toxicity and disease-free survival (DFS) were analyzed retrospectively.
  
  
  RESULTS
  The median dose intensities of oxaliplatin and 5-FU were 0.7 and 0.74, respectively. Oxaliplatin was discontinued in 10 (22%) patients due to an allergic reaction in five, neurotoxicity in four and gastrointestinal toxicity in one. No severe neurotoxicity occurred. The median duration from completion of treatment until complete recovery from peripheral neuropathy was 582 days (95% CI, 486-678). Two-year DFS for stages IIIb and IV was 56.9% and 56.3%, respectively (log-rank, P = 0.533). Univariate analysis revealed that severe vessel invasion, liver metastasis and higher baseline levels of CA19-9 were associated with shorter DFS in stage IV patients. Multivariate analysis including the selected biomarkers revealed none as a significant prognostic factor.
  
  
  CONCLUSIONS
  Adjuvant FOLFOX was well tolerated in a Japanese cohort of both stage IIIb and IV CRC patients.
authors.affiliation: Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. m.suenaga@jfcr.or.jp
authors.forename: Mitsukuni
authors.initials: M
authors.lastname: Suenaga
authors.forename: Satoshi
authors.initials: S
authors.lastname: Matsusaka
authors.forename: Toshiyasu
authors.initials: T
authors.lastname: Watanabe
authors.forename: Yasutoshi
authors.initials: Y
authors.lastname: Kuboki
authors.forename: Eiji
authors.initials: E
authors.lastname: Shinozaki
authors.forename: Keisho
authors.initials: K
authors.lastname: Chin
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Mizunuma
authors.forename: Masashi
authors.initials: M
authors.lastname: Ueno
authors.forename: Toshiharu
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Kiyohiko
authors.initials: K
authors.lastname: Hatake
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D044466:Asian People; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil