Capecitabine-based Neoadjuvant Chemoradiation Therapy in Locally-advanced Rectal Cancer

Choi, Hong Jo; Park, Ki Jae; Lee, Tae Moo; Ha, Sang Sik; Lee, Ho Young; Lee, Hyung Sik

Abstract

PURPOSE
The aim of the study was to evaluate the efficacy and the toxicity of preoperative treatment with capecitabine in combination with radiation therapy (RT) in patients with locally-advanced, resectable rectal cancer.
METHODS
Thirty-five patients with locally-advanced rectal cancer (cT3/4, N-/+) were treated with capecitabine (825 mg/m2, twice daily for 7 days/wk) and concomitant RT (50.4 Gy/28 fractions). Surgery was performed 6-8 wk after completion of the chemoradiation followed by 4-6 cycles of adjuvant capecitabine monotherapy (1,250 mg/m2, twice daily for 14 days every 3 wk).
RESULTS
The chemoradiation program was completed in all but 2 patients, for whom both capecitabine and RT were interrupted for 2 wk because of grade-3 diarrhea. A R0 resection under the principle of total mesorectal excision (low anterior resection, 26; intersphincteric resection, 6; abdominoperineal resection, 2) was performed in all but one patient with a low anterior resection with positive circumferential margin (R1). Primary tumor and node downstaging occurred in 57% and 60% of patients, respectively. The overall rate of downstaging, including both the primary tumor and node, was 77% (27 patients). A pathological complete response of the primary tumor was achieved in 4 patients (11%). No patient had grade-4 toxicity, and the only grade-3 toxicity developed was diarrhea in 2 patients (6%) during chemoradiation. During a median follow-up of 38 mo, distant metastases developed in 4 patients (multiple lung metastases, 2; aortocaval nodal metastases, 2), and another 2 patients showed local recurrence. The three-year disease-free survival was 83%.
CONCLUSION
This study suggests that preoperative capecitabine-based chemoradiation therapy is an effective and safe treatment modality for the tratment of locally-advanced, resectable rectal cancer.