GIVIO: Adjuvant therapy of colon carcinoma: A re-opened question?

In January 1990, results of a trial testing adjuvant therapy with levamisole and 5-fluorouracil in patients with resected colon carcinoma were published in the New England Journal of Medicine. This study changed completely the therapeutic attitudes of US physicians in this disease. In Italy, the Interdiseiplinary Group for Cancer Care Evaluation (GIVIO) started, in January 1989, a large scale randomzed clinical trial in order to evaluate the efficacy of 5-fluorouracil and High Dose Folinic Acid in patients with resected colon cancer. The results of the US trial and the Consensus Conference (CC) that soon after took place lead the GIVIO group to an internal discussion about the opportunity of continuing its own trial, after the profound shift endorsed by the CC. The facts, questions and answers emerged from this debate can be considered a 'model-case' for diseussion besides the particular context where it took place and are presented here to a general audience. In the paper, the authors discuss main opinions about this topic, questions which GIVIO had to deal with and answers given at the present.