Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 4271
© 2005 American Society of Clinical Oncology

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Abstract

A phase II study of capecitabine plus oxaliplatin and radiation therpy, XELOX-XRT, in squamous cell carcinoma (SCCA) of the anal canal: A preliminary analysis

Univ of Texas M. D. Anderson Cancer Ctr, Houston, TX

4271

Background: The limitations of chemoradiation for SCCA of the anal canal include significant acute toxicity and high rates of relapse in locally advanced disease. The aim of this study is to assess the rate of treatment-related toxicities, time to treatment failure, and response rate in patients with locally advanced SCCA (AJCC stage II-IIIB) of the anal canal treated with XELOX-XRT. Methods: Patients received capecitabine (825 mg/m² orally BID, M-F), weekly oxaliplatin (50 mg/m², intravenously), and radiation therapy (45 Gy for T₁, 55 Gy for T₂, or 59 Gy for T_3–4 lesions). Chemotherapy is delivered on the days of radiation therapy only, M-F, weeks 1–6. The estimated accrual rate is 2–3 patients per month for a total of 60 patients. Interim safety monitoring is to be completed after every 10 patients. A multidisciplinary team is involved during all aspects of the patient’s treatment. Results: Patient accrual was initiated in June 2004. Thus far, 3 patients have enrolled and completed therapy. Two patients are currently evaluable for response; both patients have had a clinical complete response. Predominant grade 3 toxicities encountered include diarrhea, radiation dermatitis, pain, and dehydration. No incidences of Grade 4 toxicity were noted. Conclusions: Patient accrual is ongoing. Updated preliminary toxicities and response will be reported.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Sanofi