Phase II study of capecitabine (Xeloda (registered) ) and concomitant boost radiotherapy in patients with locally advanced rectal cancer
- Department of Radiation Oncology, University of Texas, M.D. Anderson Cancer Center, Houston, TX (United States)
- Deparment of Surgical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)
- Department of Gastrointestinal Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)
- Department of Biostatistics and Applied Mathematics, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)
- Department of Cytokine Therapy and Supportive Care, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)
- Department of Pathology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)
Purpose: The aim of this study was to determine the efficacy of capecitabine (Xeloda (registered) ), an oral fluoropyrimidine, as a radiosensitizer in the neoadjuvant treatment of locally advanced rectal cancer (LARC). Methods and Materials: We conducted a phase II study of capecitabine (825 mg/m{sup 2} orally, twice daily continuous) with radiotherapy (52.5 Gy/30 fractions to the primary tumor and perirectal nodes) in 54 patients with LARC (node-negative {>=}T3 or any node-positive tumor) staged by endoscopic ultrasound (EUS). The primary endpoint was pathologic response rate; secondary endpoints included toxicity profiles and survival parameters. Results: Of the 54 patients (median age, 56.7 years; range, 21.3-78.7 years; male:female ratio, 1.7; Eastern Cooperative Oncology Group performance status 0-1: 100%), 51 patients (94%) had T3N0 or T3N1 disease by EUS. Surgery was not performed in 3 patients; 2 of these patients had metastatic disease, and the third patient refused after a complete clinical response. Of the 51 patients evaluable for pathologic response, 9 patients (18%) achieved complete response, and 12 patients (24%) had microscopic residual disease (<10% viable cells). In addition, 26 patients of all 54 patients (51%) achieved T-downstaging, and 15 patients of 29 patients (52%) achieved N-downstaging. Grade 3/4 toxicities were radiation dermatitis (9%) and diarrhea (2%). Sphincter preservation rate for tumor {<=}5 cm from the anal verge was 67% (18/27). Conclusion: This regimen of radiotherapy plus capecitabine is well tolerated and is more convenient than protracted venous infusion of 5-FU. The pathologic response rate is comparable to our previous experience using protracted venous infusion 5-FU for LARC.
- OSTI ID:
- 20850161
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 66, Issue 3; Conference: 48. annual meeting of the American Society for Therapeutic Radiology and Oncology, Pennsylvania, PA (United States), 5-9 Nov 2006; Other Information: DOI: 10.1016/j.ijrobp.2006.05.063; PII: S0360-3016(06)00984-9; Copyright (c) 2006 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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