Cathy Eng1, Alexandre A Jácome2, Prajnan Das3, George J Chang4, Miguel Rodriguez-Bigas4, John M Skibber4, Robert A Wolff2, Wei Qiao5, Yan Xing5, Salil Sethi2, Aki Ohinata2, Christopher H Crane3. 1. Department of Gastrointestinal Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX. Electronic address: cathy.eng@vumc.org. 2. Department of Gastrointestinal Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX. 3. Department of Radiation Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX. 4. Department of Surgical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX. 5. Department of Biostatistics, The University of Texas M.D. Anderson Cancer Center, Houston, TX.
Abstract
INTRODUCTION: Squamous cell carcinoma of the anal canal (SCCA) presents a rising incidence in the United States. Standard of care for locally advanced disease is comprised of infusional 5-fluorouracil with mitomycin C or cisplatin concurrent with radiation therapy (RT). We designed this trial to evaluate the efficacy and safety of a more convenient regimen composed of capecitabine and oxaliplatin. PATIENTS AND METHODS: This was a single-arm, phase II trial, with treatment-naive stage II to IIIB (TX,1-4NxM0) SCCA patients. The regimen was composed of capecitabine (825 mg/m2 twice per day for 5 days) and oxaliplatin (50 mg/m2 weekly) during weeks 1 through 6, concurrent with RT (XELOX-XRT; group 1). After the first 11 patients, the study was amended to omit chemotherapy during the third and sixth weeks (group 2). The primary objective was 3-year time to treatment failure (TTF) and safety. Secondary objectives were complete response (CR) rate, locoregional control, colostomy-free survival (CFS), and overall survival (OS). RESULTS: Twenty patients were enrolled. Seven patients of group 1 (63%) developed Grade 3 toxicity, which reduced to 22% in Group 2. No Grade 4 toxicities were noted. The median RT dose was 55 Gy. CR occurred in 100% of the 19 patients evaluable for response at 12 to 14 weeks. After a median follow-up of 47.6 months, 2 patients had local recurrence and 1 had distant recurrence. Three-year TTF was 90.0%, with similar rates between groups 1 and 2 (respectively, 90.9% vs. 88.8%, P = .984). Three-year CFS was 90.0%. The median OS has not been reached. CONCLUSION: The XELOX-XRT regimen is safe, with promising efficacy, and should be explored in larger trials for the treatment of locally advanced SCCA.
INTRODUCTION:Squamous cell carcinoma of the anal canal (SCCA) presents a rising incidence in the United States. Standard of care for locally advanced disease is comprised of infusional 5-fluorouracil with mitomycin C or cisplatin concurrent with radiation therapy (RT). We designed this trial to evaluate the efficacy and safety of a more convenient regimen composed of capecitabine and oxaliplatin. PATIENTS AND METHODS: This was a single-arm, phase II trial, with treatment-naive stage II to IIIB (TX,1-4NxM0) SCCA patients. The regimen was composed of capecitabine (825 mg/m2 twice per day for 5 days) and oxaliplatin (50 mg/m2 weekly) during weeks 1 through 6, concurrent with RT (XELOX-XRT; group 1). After the first 11 patients, the study was amended to omit chemotherapy during the third and sixth weeks (group 2). The primary objective was 3-year time to treatment failure (TTF) and safety. Secondary objectives were complete response (CR) rate, locoregional control, colostomy-free survival (CFS), and overall survival (OS). RESULTS: Twenty patients were enrolled. Seven patients of group 1 (63%) developed Grade 3 toxicity, which reduced to 22% in Group 2. No Grade 4 toxicities were noted. The median RT dose was 55 Gy. CR occurred in 100% of the 19 patients evaluable for response at 12 to 14 weeks. After a median follow-up of 47.6 months, 2 patients had local recurrence and 1 had distant recurrence. Three-year TTF was 90.0%, with similar rates between groups 1 and 2 (respectively, 90.9% vs. 88.8%, P = .984). Three-year CFS was 90.0%. The median OS has not been reached. CONCLUSION: The XELOX-XRT regimen is safe, with promising efficacy, and should be explored in larger trials for the treatment of locally advanced SCCA.