title: Clinical and economic evaluation of first-line therapy with FOLFIRI or modified FOLFOX6 for metastatic colorectal cancer.
abstract: OBJECTIVE
  Recently, significant progress in treatment of metastatic colorectal cancer has been achieved. Either FOLFIRI (fluorouracil, leucovorin and irinotecan) or modified FOLFOX6 (fluorouracil, leucovorin and oxaliplatin, oxaliplatin dose 85 mg/m(2)) is selected as first-line therapy in clinical practice in Japan. However, economic burden of colorectal cancer is considerable.
  
  
  METHODS
  Analysis was made for all patients who were treated with FOLFIRI or modified FOLFOX6 for metastatic colorectal cancer. Regimen of FOLFIRI was compared with modified FOLFOX6 under consideration from clinical and economic standpoints. Progression free survival, response, toxicity and cancer care cost in patients with metastatic colorectal cancer was analyzed. Direct costs based on the fee schedule of the Japanese national health insurance were calculated.
  
  
  RESULTS
  Median progression free survival was 7.7 months for FOLFIRI versus 8.4 months for modified FOLFOX6 (P = 0.48). Overall cost for first four cycles was yen756 284 for FOLFIRI and yen1 081 162 for modified FOLFOX6 (P < 0.0001). All grade alopecia was significantly more frequent with FOLFIRI than with modified FOLFOX6 (P = 0.04). All grade neuropathy was more observed with modified FOLFOX6 than FOLFIRI (P = 0.0002).
  
  
  CONCLUSIONS
  FOLFIRI is inexpensive in the initial stage of treatment which a number of patients can receive chemotherapy than modified FOLFOX6 as first-line therapy for metastatic colorectal cancer in Japanese national insurance system.
authors.affiliation: Graduate School of Pharmaceutical Sciences, Meiji Pharmaceutical University, Tokyo, Japan.
authors.forename: Hidetomo
authors.initials: H
authors.lastname: Ajima
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Ogata
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Fujita
authors.forename: Keisuke
authors.initials: K
authors.lastname: Miwa
authors.forename: Yu
authors.initials: Y
authors.lastname: Sunakawa
authors.forename: Keiko
authors.initials: K
authors.lastname: Mizuno
authors.forename: Hiroo
authors.initials: H
authors.lastname: Ishida
authors.forename: Keishi
authors.initials: K
authors.lastname: Yamashita
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Nakayama
authors.forename: Kaori
authors.initials: K
authors.lastname: Kawara
authors.forename: Harumi
authors.initials: H
authors.lastname: Takahashi
authors.forename: Yasutsuna
authors.initials: Y
authors.lastname: Sasaki
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000191:economics / Q000473:pathology; D003365:Costs and Cost Analysis; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005245:Fee Schedules; D005472:Fluorouracil / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D007564:Japan; D002955:Leucovorin / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin