Abstract
Purpose: The aim of the study was to evaluate the efficacy and tolerance of pre-operative chemoradiotherapy with oral capecitabine in Greek patients with locally advanced, resectable rectal cancer. Materials and Methods: Thirty patients, 16 men and 14 women with a median age of 58 years (range, 21-75 years), with potentially resectable T3N0 (30%), T3N1 (53%) and T4N0-1 (17%) rectal cancer, were treated with capecitabine (825 mg/m2, twice daily for 7 days/week) and concomitant radiotherapy (50.4 Gy/28 fractions) for 5.5 weeks. Patients underwent surgery with total mesorectal excision 4-6 weeks later followed by 4-months of post-operative treatment with capecitabine. The primary end-point was to determine the clinical and pathological response, safety profile, preservation of the sphincter mechanism and rate of peri-operative complications. Results: The median distance of rectal tumors from the anal verge was 7 cm. All patients had curative resection. Downstaging rate was 84% (25/30) on endorectal ultrasonography and 75% (22/30) on pathology findings. Pathological complete response rate was 23% (7/30). No patient had grade 4 toxicity. Grade 3 toxicity occurred in 3 patients (10%) and consisted mainly of leucopenia (6%) and hand-foot syndrome (4%). Mild or moderate toxicity was frequent, but always reversible. Twenty-four patients (80%) received sphincter-preserving surgical procedures. Peri-operative complications were seen in 6 (20%) patients and included mechanical ileus (3%), delayed wound healing (7%), wound infection (7%) and anastomotic leakage (3%). Conclusion: Pre-operative chemoradiotherapy with oral capecitabine in locally advanced, resectable rectal cancer achieves significant rates of tumor downstaging and sphincter preservation with a favorable safety profile.
Footnotes
- Received October 5, 2006.
- Revision received November 16, 2006.
- Accepted November 20, 2006.
- Copyright© 2007 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved