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In this issue, Smith et al. ( 1 ) present the 10-year results of the first National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol for colon cancer. The three-armed trial randomly assigned 1166 patients with Dukes’ stage B and C colon cancer to surgery alone; postoperative chemotherapy with eight 10-week cycles of semustine, 5-fluorouracil, and vincristine (MOF); or postoperative immunotherapy with bacillus Calmette-Guérin (BCG) given weekly for 12 weeks and then every other week for a total of 45 doses. When the initial results were published in 1988 ( 2 ) , adjuvant MOF therapy was associated with a statistically significant improvement in disease-free survival (58% versus 51%; P = .02) and overall survival (67% versus 59%; P = .05) at 5 years compared with those receiving surgery alone. Adjuvant BCG therapy was associated with a trend toward improvement in disease-free survival (56% versus 51%; P = .09) and a statistically significant survival advantage in overall survival (67% versus 59%; P = .03). When deaths with no evidence of tumor recurrence were eliminated, BCG therapy had no statistically significant benefit in either disease-free survival or overall survival, whereas benefit from chemotherapy was retained. These results led to the adoption of MOF as the reference arm in a subsequent trial (C-03). At 10 years, however, MOF therapy showed no benefit compared with surgery alone in terms of disease-free survival, relapse-free survival, or overall survival. Although BCG therapy did not prevent tumor relapse, it was associated with a statistically significant improvement in overall survival (approximately 53% versus 47%); of note, the survival curves diverged only after 4 years.

Issue Section:
Editorial
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