Preoperative chemoradiation with oral tegafur within a multidisciplinary therapeutic approach in patients with T3-4 rectal cancer

Purpose: The aim of this study was to evaluate the activity in terms of downstaging histologic patterns of residual tumor and clinical tolerance of a neoadjuvant chemoradiation program with oral tegafur for rectal cancer. Methods and Materials: From May 1998 to May 2001, 62 consecutive patients with cT3-4 or cN+ rectal cancer, or both, were treated with 45-50 Gy (1.8 Gy/day; 25 fractions) and oral tegafur 1200 mg/day. Surgery was performed 6 weeks after the completion of chemoradiation. All patients received a boost with intraoperative electron beam radiotherapy (IOERT) over the presacral space. Results: Grade 3-4 hematologic toxicity consisted on Grade 3 anemia in 1 patient. Nonhematologic toxicity was mild. Fifteen patients (23%) had Grade 3 dermatitis, 16 (25%) had Grade 3, and 2 (3%) had Grade 4 proctitis. The median dose of radiotherapy was 50.4 Gy. Surgery consisted on anterior resection in 38 patients (61%) and abdominoperineal amputation in 24 (39%). Five complete pathologic responses were observed (8%), and 29 patients (47%) had a minimal microscopic residual tumor (mic category). The total downstaging rate was 68%. With a median follow-up of 46 months, the pelvic control rate was 95%, disease-free survival 74.1%, and overall survival 76.5%. Conclusions: Neoadjuvant chemoradiation with oral tegafur is feasible, well tolerated, and active, with the additional advantage of offering the convenience of oral chemotherapy