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.