A phase II study of oral UFT and leucovorin concurrently with pelvic irradiation as neoadjuvant chemoradiation for rectal cancer

Anticancer Res. 2007 Jul-Aug;27(4C):2877-80.

Abstract

Background: Neoadjuvant chemoradiation with continuous infusion (CI) of 5-fluorouracil (5FU) is widely used in rectal cancer. The aim of this study was to evaluate the use of oral tegafur-uracil (UFT) and leucovorin (LV) instead of CI 5FU.

Patients and methods: Patients had resectable T3-4 or low T2 rectal adenocarcinoma. Chemoradiation consisted of pelvic irradiation (45 Gy in fractions of 1.8 Gy) and oral UFT (240 mg/m2/day) and LV (30 mg/day) given during the first 28 days of radiotherapy.

Results: Thirty-two patients were treated; 81% had T3-4 tumors and 25% had N+ disease. Toxicity, predominantly gastrointestinal, was generally mild. Grade 3 toxicity occurred in only one patient. Pathological down-staging was noted in 13 patients (42%) and pathological complete response in 3 (10%). Sphincter preservation was possible in 71% of patients undergoing surgery.

Conclusion: Neoadjuvant chemoradiation with oral UFT/LV is well-tolerated and active against rectal cancer. Formal comparison with the current standard treatment is warranted.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Chemotherapy, Adjuvant
  • Female
  • Humans
  • Leucovorin / administration & dosage
  • Leucovorin / adverse effects
  • Male
  • Middle Aged
  • Neoadjuvant Therapy
  • Neoplasm Staging
  • Radiotherapy, Adjuvant
  • Rectal Neoplasms / drug therapy*
  • Rectal Neoplasms / pathology
  • Rectal Neoplasms / radiotherapy*
  • Rectal Neoplasms / surgery
  • Tegafur / administration & dosage
  • Tegafur / adverse effects
  • Uracil / administration & dosage
  • Uracil / adverse effects

Substances

  • Tegafur
  • Uracil
  • Leucovorin

Supplementary concepts

  • 1-UFT protocol