EFFICACY OF POSTOPERATIVE 5-FU, HIGH-DOSE LEUCOVORIN, AND SEQUENTIAL RADIATION-THERAPY FOR CLINICALLY RESECTABLE RECTAL-CANCER

We report the local control and survival in a previously reported phas e I dose escalation trial of combined postoperative 5-FU, high dose le ucovorin (LV), and sequential radiation therapy followed by maintenanc e LV/5-FU for the treatment of patients with clinically resectable rec tal cancer. Following surgery for stages T(3-4)N(0-2)M(0) primary (21) ol recurrent (4) rectal cancer, 25 patients received 5-FU/LV x 1 cycl e. Radiation therapy (5040 cGy) began on day 8. A second cycle of 5-FU /LV was given concurrent with the fourth week of radiation. Patients r eceived an additional 10 cycles of LV/5-FU. The median follow-up was 4 0 months (range 18-52). The incidence of grade 3 + acute toxicity in t he 9 patients who received the recommended dose of 5-FU was 44%. The l ocal failure rate was 28%. Abdominal and distant failure rates were 24 %. The 3-year actuarial disease-free survival was 74% and the overall survival was 80%. Our preliminary data reveal reasonable local control and survival rates, However, further follow-up is needed to assess ou r results at 5 years. Postoperative combined modality therapy with hig h-dose LV may be an option for the adjuvant treatment of patients with resectable rectal cancer.