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Annals of Oncology 14:1365-1372, 2003
© 2003 European Society for Medical Oncology

Original Paper

Adjuvant chemotherapy in the treatment of colon cancer: randomized multicenter trial of the Italian National Intergroup of Adjuvant Chemotherapy in Colon Cancer (INTACC)

F. Di Costanzo1,+, A. Sobrero2, S. Gasperoni1, L. Dogliotti3, L. Frassineti4, A. Falcone5, R. Lionetto6, P. Bruzzi6, G. Luppi1, L. Gallo2, P. Conte5, A. Comandone3, D. Turci4, M. Marzola1, U. Folco2, E. Pfanner5, M. Mestriner3, C. Boni1, C. Galli5, M. Tonato1 and R. Rosso2

1 Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Parma; 2 Gruppo Cooperativo Istituto Nazionale per la Ricerca sul Cancro (IST-Genova); 3 Gruppo Oncologico Piemontese Tumori Apparato Digerente (GOPTAD), Torino; 4 Istituto Oncologico Romagnolo (IOR), Forlì; 5 Gruppo Oncologico del Nord-Ovest (GONO), Pisa; 6 Servizio di Epidemiologia Clinica (IST)-Centro Trials (CBA), Genova, Italy

Received 12 November 2002; revised 18 March 2003; accepted 11 April 2003

Background:

To determine whether the addition of leucovorin to the combination 5-fluorouracil plus levamisole prolongs disease-free survival and overall survival in patients with radically resected colon cancer (Dukes’ B2–3 and C).

Patients and methods:

Patients (1703) were accrued between March 1992 and February 1995 in a large-scale clinical trial within five Italian cooperative groups. After stratification for center, patients were randomized as follows: arm A, 5-fluorouracil [450 mg/m2 intravenous (i.v.) bolus on days 1–5] and levamisole (150 mg orally for 3 days, every 14 days for 6 months) versus arm B, 6-S-leucovorin (100 mg/m2 i.v. bolus on days 1–5) followed by 5-fluorouracil (370 mg/m2 i.v. bolus on days 1–5), plus levamisole (as arm A), every 4 weeks for six cycles.

Results:

After a median follow-up of 6.4 years no significant difference was seen for either disease-free survival (58% versus 60%, not significant) or 5-year overall survival (68% versus 71%, not significant), respectively. Gastrointestinal toxicity (World Health Organization grade 3/4) was more frequent in arm B (8% versus 18%, not significant).

Conclusions:

In this trial the schedules used showed no statistically significant differences in terms of disease-free survival or overall survival in the treatment of colorectal cancer.

Key words: adjuvant chemotherapy, colon cancer


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