부산대학교 도서관

4116 Background: Definitive therapy for squamous cell carcinoma (SCC) of the anal canal consists of external beam radiotherapy with concurrent 5-fluorouracil and mitomycin C or cisplatin. This regimen can be toxic but curative in 80-85% of cases with remaining patients requiring salvage surgical resection. The purpose of this study was to evaluate the tolerability and efficacy of XELOX-XRT as definitive treatment for anal cancer. Primary objectives were time to treatment failure and occurrence of treatment-related toxicity.Methods: Patients with histologically proven SCC of the anal canal, AJCC Stage II-IIIB (T2-4 or N+M0), ECOG PS 0-1, HIV-, and no prior therapy were eligible for XELOX-based chemoradiotherapy. Chemotherapy initially consisted of capecitabine (825 mg/m2) BID, M-F and weekly oxaliplatin (50 mg/m2) (Group 1) with subsequent modification to omission of chemotherapy during weeks 3 and 6 (Group 2). Radiation therapy was provided in the following manner: T1 (45 Gy in 25 fractions), T2 (55 Gy in 30 fractions), and T3-4 (59 Gy in 32 fractions). Intensity-modulated radiation therapy (IMRT) was allowed. Interim safety analysis was conducted 3 months after the 10th pt. Patients were followed in a multidisciplinary manner. Response was determined by CT/MRI, digital rectal examination, and proctoscopy. A biopsy was performed for clinical suspicion of residual or progressive disease.Results: Twenty patients were evaluable for toxicity; 17 for response. Five of 11 (45%) patients developed grade 3 treatment-related diarrhea (Group 1). Therefore, the chemotherapy schedule was modified and only 1 of 9 patients in Group 2 developed grade 3 diarrhea. Complete response rates were 90% in Group 1 and 100% in Group 2. One patient in Group 1 developed distant failure. After a median follow-up of 19 months, no patient has developed local recurrence or required salvage resection with colostomy for a colostomy-free rate of 100%.Conclusions: The combination of capecitabine, oxaliplatin, and radiation therapy (XELOX-XRT) is effective for locally advanced squamous cell carcinoma of the anal canal. This trial continues accrual and updated results will be provided. [Table: see text].