• Alejandro de la Torre, Maria Isabel García-Berrocal, Fernando Arias, Alfonso Mariño, Francisco Valcárcel, Rosa Magallón, Carlos A Regueiro, Jesús Romero, Irma Zapata, Cristina de la Fuente, Eva Fernández-Lizarbe, Gloria Vergara, Belén Belinchón, Maria Veiras, Rafael Molerón, and Isabel Millán.
• Department of Radiation Oncology, Hospital Universitario Puerta de Hierro, Madrid, Spain. oncrtcph@saludalia.com
• Int. J. Radiat. Oncol. Biol. Phys. 2008 Jan 1; 70 (1): 102-10.

PurposeTo compare, in a randomized trial, 5-fluorouracil (FU) plus leucovorin (LV) (FU+LV) vs. oral uracil and tegafur (UFT) plus LV (UFT+LV) given concomitantly with preoperative irradiation in patients with cT3-4 or N+ rectal cancer.Methods And MaterialsA total of 155 patients were entered onto the trial. Patients received pelvic radiotherapy (4500-5,040 cGy in 5 to 6 weeks) and chemotherapy consisting of two 5-day courses of 20 mg/m(2)/d LV and 350 mg/m(2)/d FU in the first and fifth weeks of radiotherapy (77 patients) or one course of 25 mg/d oral LV and 300 mg/m(2)/d UFT for 4 weeks beginning in the second week of radiotherapy (78 patients). The primary endpoints were pathologic complete response (pCR) and resectability rate. Secondary endpoints included downstaging rate, toxicity, and survival.ResultsGrade 3-5 acute hematologic toxicity occurred only with FU+LV (leukopenia 9%; p = 0.02). There were no differences in resectability rates (92.1% vs. 93.4%; p = 0.82). The pCR rate was 13.2% in both arms. Tumor downstaging was more frequent with UFT+LV (59.2% vs. 43.3%; p = 0.04). Three-year overall survival was 87% with FU+LV and 74% with UFT+LV (p = 0.37). The 3-year cumulative incidences of local recurrence were 7.5% and 8.9%, respectively (p = 0.619; relative risk, 1.46; 95% confidence interval 0.32-6.55).ConclusionAlthough this study lacked statistical power to exclude clinically significant differences between both groups, the outcome of patients treated with UFT+LV did not differ significantly from that of patients treated with FU+LV, and hematologic toxicity was significantly lower in the experimental arm.

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