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Adjuvant therapy of poor prognosis colon cancer with levamisole: Results of an EORTC double‐blind randomized clinical trial

par Arnaud, Jean-Pierre;Buyse, Marc;Nordlinger, Bernard;Martin, François;Pector, Jean Claude ;Zeitoun, Paul;Adloff, A.;Duez, Nicole
Référence British journal of surgery, 76, 3, page (284-289)
Publication Publié, 1989

Article révisé par les pairs

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Résumé :

From 1978 to 1985, 297 patients were entered in a double‐blind randomized trial comparing levamisole to placebo as adjuvant therapy of Dukes' C carcinoma of the colon. Therapy consisted of from two to five tablets of 50 mg levamisole (or placebo) twice a week, depending on bodyweight for 1 year. Levamisole was generally well tolerated, with only four reversible cases of agranulocytosis reported among 129 patients. The trial failed to show a benefit of levamisole on disease‐free survival (P = 0·53) or on survival (P = 0·35). There was no difference between the two treatment groups in terms of number of disease relapses, sites of relapse, or time to relapse. The proportion of patients still alive at 5 years was 51 per cent (standard error, 5·5 per cent) in the levamisole group versus 39 per cent (standard error, 5·4 per cent) in the placebo group. Copyright © 1989 British Journal of Surgery Society Ltd.