Journal of Clinical Oncology, Vol 11, 390-399, Copyright © 1993 by American Society of Clinical Oncology
Adjuvant active specific immunotherapy for human colorectal cancer: 6.5- year median follow-up of a phase III prospectively randomized trial
HC Hoover Jr, JS Brandhorst, LC Peters, MG Surdyke, Y Takeshita, J Madariaga, LR Muenz and MG Hanna Jr
Division of Surgical Oncology, Massachusetts General Hospital, Boston 02114.
PURPOSE: Patients with colon or rectal cancer were entered onto a
prospectively randomized, controlled clinical trial of active specific
immunotherapy (ASI) with an autologous tumor cell-bacillus Calmette- Guerin
(BCG) vaccine. We investigated whether ASI could improve disease- free
status and survival. PATIENTS AND METHODS: Ninety-eight patients with
Dukes' stage B2-C3 colon or rectal cancer were randomized into groups
treated by resection alone or resection plus ASI. Eighty patients met all
eligibility criteria. All patients with rectal cancer were to receive 50 Gy
of pelvic irradiation. Analysis of distribution of survival and
disease-free survival was made on all eligible patients until December 31,
1990. RESULTS: As a single study, no statistically significant differences
were detected in survival or disease-free survival for all 80 eligible
patients. However, since it was recognized at the outset that there were
treatment differences, in that rectal cancer patients were to receive
postimmunotherapy radiation, it was considered that a cohort analysis of
the colon and rectal cancer patients might be informative. With a median
follow-up of 93 months, there is a significant improvement in survival
(two-sided P = .02; hazards ratio, 3.97) and disease-free survival
(two-sided P = .039; hazards ratio, 2.67) in all eligible colon cancer
patients who received ASI. With a median follow-up of 58 months, no
benefits were seen in patients with rectal cancer who received ASI.
CONCLUSION: This study suggests that ASI may be beneficial to patients with
colon cancer.
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