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Annals of Oncology 14:378-382, 2003
© 2003 European Society for Medical Oncology

Original Paper

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

C. Gennatas1,+, C. Dardoufas1, D. Mouratidou2, N. Tsavaris3, A. Pouli1, G. Androulakis4, M. Philippakis5, D. Voros1, T. Batalis5, S. Besbeas6, G. Hatzistylianos5, J. Katsos7, V. Komporozos8, N. Legakis4, H. Mallas1, G. Peros5, A. Photopoulos1, C. Pisiotis9, G. Polymeneas1, G. Retalis1, L. Samanidis1, V. Smyrniotis1, A. Stamatiadis5, J. Vasiliou1, H. Andreadis2 and J. Papadimitriou1

1 Second Department of Surgery, Areteion Hospital, University of Athens, Athens; 2 Third Department of Medical Oncology, Theagenion Cancer Hospital, Salonika; 3 Department of Medicine, Laikon Hospital, University of Athens, Athens; 4 Fourth Department of Surgery, Nikaia General Hospital, University of Athens, Athens; 5 Department of Surgery, Evgenidion Hospital, Athens; 6 Department of Surgery, Agios Savas Cancer Hospital, Athens; 7 Department of Gastrointestinal Medicine, Theagenion Cancer Hospital, Salonika; 8 Department of Surgery, Red Cross Hospital, Athens; 9 Department of Surgery, Evangelismos Hospital, Athens, Greece

Received 8 July 2002; revised 1 October 2002; accepted 22 October 2002

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-{alpha}2b (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 106 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.

Key words: adjuvant chemotherapy, adjuvant radiotherapy, randomized controlled trial, rectal neoplasm


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