title: Concomitant administration of uracil-tegafur and leucovorin during adjuvant radiotherapy for locally advanced rectal cancer.
abstract: OBJECTIVE
  We report the feasibility and toxicity profile, and the impact on local control, disease-free survival and overall survival rates of our study which consisted of postoperative concurrent chemoradiotherapy, followed by adjuvant chemotherapy using uracil-tegafur (UFT)/leukovorin (LV) in locally advanced rectal cancer patients.
  
  
  METHODS
  Thirty-one patients operated for rectal adenocarcinoma (pT3/4 or N+) were enrolled onto the study. Twenty-three patients were males and 8 females with median age 62 years (range 21-85). Radiotherapy (RT) to the pelvis with conformal technique and individual blocks was delivered within 8 weeks following surgery. Total RT dose was 50.4 Gy and was given in a conventional single fraction of 1.8 Gy per day. Chemotherapy was administered concomitantly and consisted of UFT (300 mg/m(2)/day) and LV (30 mg/day) during RT-days. Following chemoradiotherapy, chemotherapy alone was administered for 4 cycles in the same dose for 28 days every 35 days.
  
  
  RESULTS
  No lethal toxicity occurred. All patients completed the scheduled RT. Concurrent chemotherapy continued in 22 (70.9%) patients until the end of RT. Seventeen (54.8%) patients completed the whole concurrent chemoradiotherapy and adjuvant chemotherapy as planned. No grade 3-4 stomatitis/mucositis or haematological toxicities were observed during the whole treatment period. During concomitant therapy grade 1-2 toxicities were: nausea/vomiting 60%, dyspepsia/gastric pain 39%, diarrhea 39% and dysuria 10%, whereas grade 3 nausea and diarrhea occurred in 6% and 19%, respectively. Median follow-up was 22 months. Two-year local control, disease-free survival and overall survival rates were 96.3%, 72.3% and 83.2%, respectively.
  
  
  CONCLUSIONS
  The acute toxicity profile of UFT/LV, local control, disease-free survival and overall survival in the concurrent chemoradiotherapy setting for operated, locally advanced rectal cancer seem comparable with the standard 5-fluorouracil (5-FU)-based therapies.
authors.affiliation: Department of Radiation Oncology, School of Medicine, Marmara University Hospital, Istanbul, Turkey. bmatasoy@yahoo.com
authors.forename: B M
authors.initials: BM
authors.lastname: Atasoy
authors.forename: U
authors.initials: U
authors.lastname: Abacioglu
authors.forename: F
authors.initials: F
authors.lastname: Dane
authors.forename: Z
authors.initials: Z
authors.lastname: Ozgen
authors.forename: P F
authors.initials: PF
authors.lastname: Yumuk
authors.forename: S
authors.initials: S
authors.lastname: Ozden
authors.forename: Z
authors.initials: Z
authors.lastname: Akgun
authors.forename: A
authors.initials: A
authors.lastname: Mayadagli
authors.forename: G
authors.initials: G
authors.lastname: Basaran
authors.forename: S
authors.initials: S
authors.lastname: Turhal
authors.forename: M
authors.initials: M
authors.lastname: Sengoz
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D018714:Radiotherapy, Adjuvant; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D005641:Tegafur; D002955:Leucovorin