Preoperative radiotherapy combined with capecitabine chemotherapy in Chinese patients with locally advanced rectal cancer.

BACKGROUND

This phase II study is performed to evaluate the efficacy and safety of capecitabine combined with preoperative radiotherapy (RT) in Chinese patients with locally advanced rectal cancer (LARC).

METHODS

Between February 2007 and December 2008, 62 patients with LARC were treated with capecitabine (825 mg/m(2), twice daily) and concurrent RT (50.4 Gy/28 fractions). Patients underwent surgery after 6-8 weeks of combined therapy, followed by 4 cycles of adjuvant capecitabine (1,250 mg/m(2), twice daily on days 1-14, every 3 weeks). The primary endpoint was the rate of pathologic complete response (pCR).

RESULTS

Fifty-eight patients (93.5%) completed the preoperative chemoradiation course as initially planned. The most severe hematologic adverse event was leucopenia, which occurred with grade 2 intensity in 12 (19.7%) patients and grade 3 in 2 (3.3%) patients. Grade 3 diarrhea and hand-foot syndrome (HFS) were observed in one (1.6%) and two (3.3%) patients, respectively. However, no grade 4 toxicity was observed. There were no treatment-related deaths during this study. Of the 59 patients treated with surgery, all had radial margins (R0 resections). Among the 29 patients with the primary tumor ≤5 cm from the anal verge, 18 (62.1%) underwent sphincter-preserving surgical resections. pCR was found in eight patients (13.6%). The pathologic stage was lower than the initial clinical stage in 57.6% (34/59), 63.4% (26/41), and 81.4% (48/59) of the resected tumors for the primary tumor (T), lymph node (N), and combined TN categories, respectively. The estimate of disease-free survival and overall survival at 24 months were 80.6% (95% CI, 70.8-90.4%) and 92.5% (95% CI, 85.9-99.1%), respectively.

CONCLUSION

Preoperative chemoradiotherapy with capecitabine and RT appears to be a safe, well-tolerated, and effective neoadjuvant treatment modality for LARC.