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

Michael J. O'Connell, John A. Laurie, Michael Kahn, Robert J. Fitzgibbons, Charles Erlichman, Lois Shepherd, Charles G. Moertel, Walter I. Kocha, Richard Pazdur, H. Sam Wieand, Joseph Rubin, Allen M. Vukov, John H. Donohue, James E. Krook, Alvaro Figueredo

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376 Scopus citations


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 re- spect 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.

Original languageEnglish (US)
Pages (from-to)295-300
Number of pages6
JournalJournal of Clinical Oncology
Issue number1
StatePublished - Jan 1998

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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