Postoperative adjuvant chemotherapy or BCG for colon cancer: Results from NSABP protocol C-01

Norman Wolmark, Bernard Fisher, Howard Rockette, Carol Redmond, D. Lawrence Wickerham, Edwin R. Fisher, Judith Jones, Andrew Glass, Harvey Lerner, Walter Lawrence, David Prager, Marvin Wexler, James Evans, Anatolio Cruz, Nikolay Dimitrov, Peter Jochimsen

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337 Scopus citations

Abstract

Data are presented from 1,166 patients with Dukes B and C carcinoma of the colon who were entered into the National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol C-01 between November 1977 and February 1983. Patients were randomized to one of three therapeutic categories: 1) no further treatment following curative resection (394 patients); 2) postoperative chemotherapy consisting of 5-fluorouracil, semustine, and vincristine (379 patients); or 3) postoperative BCG (393 patients). The average time on study was 77.3 months. A comparison between patients receiving postoperative adjuvant chemotherapy and those treated with surgery alone indicated that there was an overall improvement in disease-free survival (P=.02) and survival (P=.05) in favor of the chemotherapy-treated group. At 5 years of follow-up, patients treated with surgery alone were at 1.29 times the risk of developing a treatment failure and at 1.31 times the likelihood of dying as were similar patients treated with combination adjuvant chemotherapy. Comparison of the BCG-treated group with the group treated with surgery alone indicated that there was no statistically significant difference in disease-free survival (P=.09). There was, however, a survival advantage in favor of the BCG-treated group (P=.03). At 5 years of follow-up, patients randomized to the surgery-alone arm were at 1.28 times the risk of dying as were similar patients treated with BCG. Further investigation disclosed that this survival advantage in favor of BCG was a result of a diminution in deaths that were non-cancer related. When analyses were conducted on which events not related to cancer recurrence were eliminated, the survival difference between the BCG and control groups became nonsignificant (P=.40); the cumulative odds at 5 years decreased from 1.28 to 1.10. The findings from this study are the first from a randomized prospective clinical trial to demonstrate that a significant disease-free survival and survival benefit can be achieved with postoperative adjuvant chemotherapy in patients with Dukes B and C carcinoma of the colon who have undergone curative resection. [J Natl Cancer Inst 1988;80:30-36]

Original languageEnglish (US)
Pages (from-to)30-36
Number of pages7
JournalJournal of the National Cancer Institute
Volume80
Issue number1
DOIs
StatePublished - Mar 2 1988
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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