Influence of regular aspirin use on survival for patients with stage III colon cancer: Findings from Intergroup trial CALGB 89803.
3530 Background: Regular aspirin use reduces the risk of colorectal neoplasia. In animals, aspirin and COX-2 inhibitors appear to inhibit tumor growth. The effect of aspirin use on outcome in patients with established colon cancer is unknown. METHODS: We prospectively studied aspirin use in 830 pts with stage III colon cancer enrolled in a randomized trial of post-operative adjuvant chemotherapy (5-fluorouracil/leucovorin +/- irinotecan). Patients completed a detailed survey of medication use and lifestyle midway through adjuvant therapy and then again 6 months after completion of therapy. We computed Cox proportional hazards for recurrence-free (RFS), disease-free (DFS) and overall survival (OS) according to aspirin use. Time intervals were measured from completion of the 2(nd) questionnaire to recurrence or death, excluding events within the 1(st) 60 days to avoid bias from analgesic use due to underlying disease. Median follow-up after the last questionnaire was 2.4 years. RESULTS: Among 830 patients who completed both questionnaires, 72 (8.7%) pts reported aspirin use both midway and 6 months after adjuvant therapy (consistent users). Compared to those who did not report consistent use, consistent aspirin users experienced a hazard ratio (HR) for disease recurrence (RFS) of 0.45 (95% CI, 0.21-0.97), after adjustment for age, gender, baseline performance status, N stage, T stage, preoperative CEA, bowel obstruction, perforation, tumor differentiation, and treatment arm. After identical adjustment, consistent aspirin use was associated with a HR for disease recurrence and/or death (DFS) of 0.48 (95% CI, 0.24-0.99) and a HR for death (OS) of 0.52 (95% CI, 0.19-1.46). Regular users of either celecoxib or rofecoxib (n=35; 4.3%) experienced a HR for recurrence of 0.56 (95% CI, 0.21-1.54). To assess whether these associations reflected a non-specific analgesic effect, we assessed regular acetaminophen use and found no recurrence or survival benefit. CONCLUSIONS: Consistent aspirin use may be associated with improved outcome in patients with stage III colon cancer. Ongoing randomized trials are assessing the addition of COX-2 inhibitors to chemotherapy in patients with advanced disease. [Table: see text].
Fuchs, C; Meyerhardt, JA; Heseltine, DL; Niedzwiecki, D; Hollis, D; Chan, AT; Saltz, LB; Schilsky, RL; Mayer, RJ
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