Response to preoperative multimodality therapy predicts survival in patients with carcinoma of the rectum

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Abstract
3505 Background:Chemoradiation is considered standard treatment for operable rectal cancer but the optimal time to deliver this therapy is unknown. NSABP R-03 trial compared preoperative neoadjuvant to postoperative adjuvant chemoradiation. Methods:Patients were randomized to preoperative therapy (1 cycle of 5-FU[FU] and leucovorin[LV], 2 cycles of FU/LV and concomitant radiation therapy[RT], surgery, 4 cycles FU/LV) or postoperative therapy (surgery, 1 cycle of FU/LV, 2 cycles of FU/LV and concomitant RTX, 4 cycles FU/LV). The endpoints were overall (OS), disease-free (DFS) and relapse-free (RFS) survival. OS, DFS, and RFS were estimated using Kaplan-Meier curves. P-values were calculated using Greenwood's variance estimator. Results:From June 1993 to June 1999, 123 patients in the preoperative and 130 patients in the postoperative group were eligible for evaluation. Among the 78 preoperative patients evaluable for response, 25.6% had a complete clinical response (CR), 48.7% had partial (PR), 23.1% stable (SD) and 2.6% progressive but operable disease (PD). In the CR group, OS was 100% as compared to 95% in the PR group and 83% in the SD group (p-value=0.02 for CR vs. other). Corresponding values were 95%, 78%, 66% (p=0.004) for DFS and 95%, 80%, 70% (p=0.01) for RFS. Conclusions:Compared with postoperative adjuvant, preoperative neoadjuvant appears to result in improved OS, DFS and RFS. Complete responders at surgery have a significant improvement in overall, disease-free and relapse-free survival. No significant financial relationships to disclose.

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