Originally published as JCO Early Release 10.1200/JCO.2004.11.124 on June 21 2004

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Preoperative Uracil, Tegafur, and Concomitant Radiotherapy in Operable Rectal Cancer: A Phase II Multicenter Study With 3 Years' Follow-Up

From the Departments of Medical Oncology, Radiation Oncology, and Surgery, Fundación Instituto Valenciano de Oncología; Hospital Universiatrio La Fe; Hospital Peset Aleixandre; Hospital Arnau de Vilanova, Valencia; Hospital Luis Alcañiz, Xativa-Valencia; Hospital de la Ribera, Alcira-Valencia; Hospital General Universitario; and Hospital Virgen de los Lirios, Alcoy-Alicante, Spain

Address reprint requests to Carlos Fernández-Martos, MD, Department of Medical Oncology, Fundación Instituto Valenciano de Oncología, c/o Professor Beltrán Báguena 8 y 19, 46009 Valencia, Spain; e-mail: carlosfmartos{at}mx2.redestb.es

PURPOSE: To assess tolerance and efficacy of preoperative treatment with uracil/tegafur and radiotherapy (RT) followed by surgery and postoperative flurouracil (FU)/leucovorin (LV) in patients with rectal cancer.

PATIENTS AND METHODS: Patients (n = 94) with potentially resectable tumors, ultrasound at stages T2N+ (n = 4), T3 (n = 77), T4 (n = 13) were treated with UFT (400 mg/m²/d, 5 days a week for 5 weeks) and concomitant RT to the pelvis (45 Gy; 1.8 Gy/d over 5 weeks). Patients underwent surgery 5 to 6 weeks later followed by four cycles of FU/LV. Primary end points included downstaging, pathologic responses, and sphincter-preserving surgery. Secondary end points were recurrence-free survival and overall survival.

RESULTS: All patients received the full RT dose. Fifteen patients (16%) needed UFT dose reduction. Preoperative G3+ toxicities included diarrhea (14%), leukopenia (1%), thrombocytopenia (1%), and nausea (4%). The downstaging rate was 54%, pathologic complete response (pCR) was 9% and, in an additional 23%, there were only residual microscopic foci. When cellular viability criteria were taken into account, the pCR was 15%. From 43 patients with abdominoperineal resection indication, 11 (25%) had sphincter-preserving surgery performed. Postoperative scheduled chemotherapy dose was not administered to 24% of patients because of G3+ toxicity (diarrhea, 8%; mucositis, 9%; and leukopenia, 7%). Patients with downstaging had significantly higher survival and recurrence-free survival rates than those without. At 3 years, actuarial patterns of failure were pelvic, 5% and distant, 11%. OS was 75%.

CONCLUSION: UFT combined with RT is safe and effective. In resectable rectal cancer, if preoperative treatment is considered, this approach can be an option.

Presented in part at the 37th American Society of Clinical Oncology meeting, San Francisco, CA, May 2001.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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