PRELIMINARY-RESULTS OF PREOPERATIVE 5-FLUOROURACIL, LOW-DOSE LEUCOVORIN, AND CONCURRENT RADIATION-THERAPY FOR CLINICALLY RESECTABLE T3 RECTAL-CANCER

PURPOSE: We report the downstaging, sphincter preservation, acute toxi city, and preliminary local control and survival results of preoperati ve 5-fluorouracil (5-FU), low-dose leucovorin (ZN), and concurrent rad iation therapy followed by postoperative LV/S-FU for treatment of pati ents with clinically resectable T3 rectal cancer. MATERIALS AND METHOD S: A total of 32 patients received two monthly cycles of preoperative LV/5-FU (bolus daily X 5). Radiation therapy (5,040 cGy) began concurr ently on day 1. Postoperatively, patients received a median of two mon thly cycles of LV/S-FU (range, 0-10). RESULTS: The complete response r ate was 9 percent pathologic and 13 percent clinical, for a total of 2 2 percent. Total Grade 3+ acute toxicity during the preoperative combi ned modality segment was 25 percent (8/32). Of the 20 patients who wer e thought to initially require an abdominoperineal resection and for w hom the intent of treatment was sphincter preservation, 17 (85 percent ) were able to undergo sphincter-preserving surgery. With a median fol low-up of 22 (3-59) months, none have developed local failure, and the three-year actuarial disease-free survival rate was 60 percent. CONCL USION: Our data reveal encouraging downstaging, sphincter preservation , and acute toxicity with this regimen. Additional follow-up is needed to assess the long-term local control and survival rates.