title: Pilot study of modified FOLFOX6 adjuvant chemotherapy for high-risk rectal cancer treated with neoadjuvant chemoradiotherapy.
abstract: OBJECTIVE
  Neoadjuvant chemoradiotherapy (CRT) followed by total mesorectal excision is considered the standard of care for patients with locally advanced adenocarcinoma of the middle/low rectum. The present study evaluated the feasibility of using modified FOLFOX6 regimen as an adjuvant treatment for high-risk patients with locally advanced rectal cancer (LARC) treated with neoadjuvant CRT.
  
  
  METHODS
  Forty patients with LARC (ypT3-4 or N+) treated with neoadjuvant CRT were enrolled at Kyungpook National University Medical Center (Daegu, Korea) between December 2011 and December 2012. All the patients underwent rectal surgery with curative intent 8 weeks after the end of the neoadjuvant treatment. Adjuvant chemotherapy using modified FOLFOX6 regimen was then delivered for 3 months.
  
  
  RESULTS
  The treatments were generally well tolerated. Dose reduction was recorded in 11 of the 40 patients (27.5 %). The incidence of febrile neutropenia was 5 %, the incidence of grade 3 or 4 asthenia was 10 %, and the incidence of grade 3 gastrointestinal adverse events was 5 % during treatment. Treatment discontinuation caused by toxic effects or any other reasons was observed in six patients (15 %). The reasons for discontinuation were asthenia (n = 2, 5 %), diarrhea (n = 2, 5 %), acute renal failure (n = 1, 2.5 %), and relapse during chemotherapy (n = 1, 2.5 %). With a median follow-up duration of 18 months, six patients (15 %) relapsed and one patient (2.5 %) died of disease progression. The estimated 3-year disease-free survival and overall survival rates were 84.2 and 97.3 %, respectively.
  
  
  CONCLUSIONS
  Postoperative adjuvant modified FOLFOX6 regimen was found to be feasible for patients with LARC treated with neoadjuvant CRT.
authors.affiliation: Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, 807 Hogukno, Buk-gu, Daegu, 702-210, Korea.
authors.forename: Soo Jung
authors.initials: SJ
authors.lastname: Lee
authors.forename: Byung Woog
authors.initials: BW
authors.lastname: Kang
authors.forename: Yee Soo
authors.initials: YS
authors.lastname: Chae
authors.forename: Seung Hyun
authors.initials: SH
authors.lastname: Cho
authors.forename: Hye Jin
authors.initials: HJ
authors.lastname: Kim
authors.forename: Su Yeon
authors.initials: SY
authors.lastname: Park
authors.forename: Jun Seok
authors.initials: JS
authors.lastname: Park
authors.forename: Gyu Seog
authors.initials: GS
authors.lastname: Choi
authors.forename: Jong Gwang
authors.initials: JG
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D017024:Chemotherapy, Adjuvant; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D010865:Pilot Projects; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D012307:Risk Factors
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil