Surgical adjuvant therapy of rectal carcinoma: a controlled evaluation of leucovorin, 5-fluorouracil and radiation therapy with or without interferon-alpha2b.

Author(s): Gennatas C, Dardoufas C, Mouratidou D, Tsavaris N, Pouli A, Androulakis G, Philippakis M, Voros D, Batalis T, Besbeas S, Hatzistylianos G, Katsos J, Komporozos V, Legakis N, Mallas H, Peros G, Photopoulos A, Pisiotis C, Polymeneas G, Retalis G, Samanidis L, Smyrniotis V, Stamatiadis A, Vasiliou J, Andreadis H, Papadimitriou J

Affiliation(s): Second Department of Surgery, Areteion Hospital, University of Athens, Athens, Greece. gennatas@compulink.gr

Publication date & source: 2003-03, Ann Oncol., 14(3):378-82.

Publication type: Clinical Trial; Randomized Controlled Trial

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 adenocarcinoma (Dukes' B2/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/m2 i.v. bolus and 5-FU 425 mg/m2 i.v. days 1-5 and 29-33, LV 20 mg/m2 and 5-FU 400 mg/m2 days 57-60 and 85-88, LV 20 mg/m2 and 5-FU 380 mg/m2 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.