Concurrent Oral UFT and Pelvic Irradiation as Neoadjuvant Chemoradiation for Operable Rectal Cancer: A Phase II Study

Abstract

Introduction: Preoperative radiotherapy is one of the standard treatment modalities for rectal cancer and is often combined with 5-fluorouracil-based chemotherapy. UFT, an oral 5FU derivative, given daily during a course of radiotherapy mimics the effect of continuous- infusion 5FU. Methods: Twenty- five patients with potentially resectable low to mid rectal tumors, aged 21-75 years, males/females: 16/9, clinical stages T3 (n = 20), T4 (n = 5) were treated with UFT (400 mg/m 2 /d, 5 days a week for 6 weeks) and concomitant RT to the pelvis (45 Gy; 1.8 Gy/d over 5 weeks plus 5.4 Gy boost). Twenty-two patients underwent surgery 5 to 6 weeks later followed by four cycles of FU/LV. Patients were followed up for 33 months with median follow up of 14 months. Results: All patients received the neoadjuvant chemoradiotherapy treatment. Three patients (12%) received less than full dose of UFT. Preoperative G3+ toxicities included diarrhea (8%), urinary tract infection (UTI) (16%), and wet desquamation (24%). Surgery consisted of low anterior resection in 11 patients, abdominoperineal resection in 10 patients and proctectomy in 1 patient. The down staging rate was 59.1%, pathologic complete response (pCR) was 9.1% and the sphincter preservation rate was 33.3%. Postoperative chemotherapy was administered to 20 patients (90.9%). At median follow up of 14 months, relapse free survival rate was 70% with estimated median relapse free survival of 25 months (95% CI, 20.7-29.3). OS was 60.5% with estimated median survival time of 26 months (95% CI, 22.8-29.2). Conclusion: UFT combined with RT is well-tolerated and effective as neoadjuvant treatment of resectable rectal cancer as regarding down staging and sphincter preservation