Surgical adjuvant therapy of rectal carcinoma: a controlled evaluation of leucovorin, 5-fluorouracil and radiation therapy with or without interferon-alpha 2b

Autor: Gennatas, C Dardoufas, C Mouratidou, D Tsavaris, N and Pouli, A Androulakis, G Philippakis, M Voros, D Batalis, T Besbeas, S Hatzistylianos, G Katsos, J Komporozos, V and Legakis, N Mallas, H Peros, G Photopoulos, A and Pisiotis, C Polymeneas, G Retalis, G Samanidis, L and Smyrniotis, V Stamatiadis, A Vasiliou, J Andreadis, H and Papadimitriou, J
Jazyk: angličtina
Rok vydání: 2003
Popis: Background: The aim of this study was to determine whether the efficacy of the combination of 5-fluorouracil (5-FU), leucovorin (LV) and radiation therapy (RT) could be improved by the addition of interferon-alpha2b (IFN-alpha) in patients who have had a ‘curative’ resection, for rectal adenocarcinorna (Dukes’ B-2/C; T3 N0, T4 N0, N1-3). Patients and methods: A total of 207 eligible patients with a performance status of 0 or 1 were randomized postoperatively between days 21 and 70 to one of the two treatment groups: group A, LV 20 mg/m(2) i.v. bolus and 5-FU 425 mg/m(2) i.v. days 1-5 and 29-33, LV 20 mg/m(2) and 5-FU 400 mg/m(2) days 57-60 and 85-88, LV 20 mg/m(2) and 5-FU 380 mg/m(2) days 1-5 and 29-33 with the second day 1 occurring 28 days after the completion of RT (45 Gy); group B, LV, 5-FU and RT as in group A, and IFN-alpha 5 x 10(6) IU s.c. three times during each week chemotherapy is given. Results: 104 patients were randomized into group A and 103 into group B. There was no statistically significant difference in either disease-free survival or overall survival between the two groups. Toxicity was also the same, except for the flu-like syndrome associated with the IFN-alpha administration. Conclusions: There was no difference in efficacy between the two combinations. Toxicity was greater with the LV + 5-FU + IFN-alpha regimen because of the flu-like syndrome.
Databáze: OpenAIRE