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Journal of Clinical Oncology, Vol 16, 295-300, Copyright © 1998 by American Society of Clinical Oncology

ARTICLES

Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer

MJ O'Connell, JA Laurie, M Kahn, RJ Fitzgibbons Jr, C Erlichman, L Shepherd, CG Moertel, WI Kocha, R Pazdur, HS Wieand, J Rubin, AM Vukov, JH Donohue, JE Krook and A Figueredo
Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. oconnell.michael@mayo.edu

PURPOSE: This study had two major goals: (1) to assess the effectiveness of a regimen of fluorouracil (5-FU) plus levamisole plus leucovorin as postoperative surgical adjuvant therapy for patients with high-risk colon cancer, and (2) to evaluate 6 months versus 12 months of chemotherapy. PATIENTS AND METHODS: Patients with poor-prognosis stage II or III colon cancer were randomly assigned to receive adjuvant chemotherapy with either intensive-course 5-FU and leucovorin combined with levamisole, or a standard regimen of 5-FU plus levamisole. Patients were also randomly assigned to receive either 12 months or 6 months of chemotherapy, which resulted in four treatment groups. RESULTS: Eight hundred ninety-one of 915 patients entered (97.4%) were eligible. The median follow-up duration is 5.1 years for patients still alive. There was a difference among the four treatment groups with respect to patient survival, and a significant duration-by-regimen interaction was observed. Specifically, standard 5-FU plus levamisole was inferior to 5-FU plus leucovorin plus levamisole when treatment was given for 6 months (5-year survival rate, 60% v 70%; P < .01). CONCLUSION: There was no significant improvement in patient survival when chemotherapy was given for 12 months compared with 6 months. When chemotherapy was given for 6 months, standard 5-FU plus levamisole was associated with inferior patient survival compared with intensive- course 5-FU plus leucovorin plus levamisole. These data suggest that 5- FU plus levamisole for 6 months should not be used in clinical practice, whereas 6 months of treatment with 5-FU plus leucovorin plus levamisole is effective.
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