title: Adjuvant modified FOLFOX-4 in patients with stage III rectum adenocarcinoma.
abstract: OBJECTIVE
  The aim of this study was to investigate efficacy and toxicity of a modified 5-fluorouracil (5-FU), folinic acid, oxaliplatin (mFOLFOX-4) regimen followed by infusional 5-FU concomitant with radiotherapy for curatively resected stage III rectum adenocarcinoma patients.
  
  
  METHODS
  Between April 2005 and July 2009, 55 operated stage III rectum cancer patients were evaluated retrospectively. mFOLFOX-4 regimen (oxaliplatin 85 mg/m2 1st day, folinic acid 200 mg/m2 1st day, 5-FU 400 mg/m2 iv bolus 1st day, 5-FU 1600 mg/m2 46 hours continuous infusion) was applied every 2 weeks. After four courses of mFOLFOX-4, 50.4 Gy (1.8 Gy in 28 fractions) radiotherapy with continuous 5-FU 200 mg/m(2)/day by infusion pump were given. On completion of chemoradiation four more mFOLFOX-4 courses were given.
  
  
  RESULTS
  Median age of the patients was 54 years (range 23-73 years). Low anterior resection was performed in 37 (67.3%) and abdominoperineal resection in 16 (29.1%) . Ten (18.2%) patients were at stage IIIA, 24 (43.6%) at stage IIIB and 21 (38.2%) at stage IIIC. Planned chemotherapy cycles were completed in 92.7% of patients. Grades 3-4 toxicity included neutropenia (9.1%), febrile neutropenia (3.6%), anemia (3.6%), diarrhea (21.8%), neuropathy (9.1%), renal toxicity (3.6%), hepatotoxicity (5.5%). Median follow-up time was 30 (9-57) months. Local recurrence and distant metastasis was observed in 3 (5.5%) and 10 (18.2%) patients, respectively. Ten (18.2%) patients died during follow-up. Three years disease free survival and overall survival were 67.5% and 77.3%, respectively.
  
  
  CONCLUSIONS
  mFOLFOX-4 following chemoradiotherapy with continuous 5- FU infusion is an effective and well tolerated adjuvant treatment for stage III rectal carcinoma patients.
authors.affiliation: Ankara Numune Education and Research Hospital, Department of Medical Oncology, Ankara, Turkey.
authors.forename: Şener
authors.initials: Ş
authors.lastname: Cihan
authors.forename: Doğan
authors.initials: D
authors.lastname: Uncu
authors.forename: Nalan Akgul
authors.initials: NA
authors.lastname: Babacan
authors.forename: Nuriye
authors.initials: N
authors.lastname: Özdemir
authors.forename: Hatice
authors.initials: H
authors.lastname: Odabaş
authors.forename: Sercan
authors.initials: S
authors.lastname: Aksoy
authors.forename: Berna
authors.initials: B
authors.lastname: Öksüzoğlu
authors.forename: Nurullah
authors.initials: N
authors.lastname: Zengin
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging / Q000379:methods; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil