Preoperative Radiotherapy Combined with Capecitabine Chemotherapy in Chinese Patients with Locally Advanced Rectal Cancer

Abstract

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. © 2011 The Society for Surgery of the Alimentary Tract.