Comparison of the efficacy of oral capecitabine versus bolus 5-FU in preoperative radiotherapy of locally advanced rectal cancer.

The effects of treatment with oral capecitabine vs. bolus 5-FU, administered concurrently with preoperative radiotherapy, were compared in the treatment of locally advanced rectal cancer (LARC). One hundred and twenty-seven patients with LARC received concurrent preoperative chemoradiation using two cycles bolus 5-FU (500 mg/m2/day) plus leucovorin (LV, 20 mg/m2/day) (Group I). Another LARC group received concurrent chemoradiation using two cycles 1,650 mg/m2/day of oral capecitabine and 20 mg/m2/day of LV (Group II, 97 patients). Radiation was delivered to the primary tumor at 50.4 Gy in both groups. Definitive surgery was performed 6 weeks after the completion of chemoradiation. A pathologic complete remission was achieved in 11.4% of patients in Group I and in 22.2% of patients in Group II (p= 0.042). The down-staging rates of the primary tumor and lymph nodes were 39.0/ 68.7% in Group I and 61.1/87.5% in Group II (p=0.002/0.005). Sphincter-preserving surgery was possible in 42.1% of patients in Group I and 66.7% of those in Group II (p=0.021). Grade 3 or 4 leucopenia, diarrhea, and radiation dermatitis were statistically more prevalent in Group I than in Group II, while the opposite was true for grade 3 hand-foot syndrome. Preoperative chemoradiation using oral capecitabine was better tolerated than bolus 5-FU and was more effective in the promotion of both down-staging and sphincter preservation in patients with LARC.