THE USE OF PACLITAXEL IN CHEMORADIOTHERAPY OF PATIENTS WITH SQUAMOUS CELL CARCINOMA OF THE ANAL CANAL: A PILOT STUDY

Objectives : to assess the feasibility of a combination of the intensity-modulated radiation therapy (IMRT) with a triplet chemotherapy with paclitaxel, capecitabine, and mitomycin C in the treatment of patients with anal cancer, and to evaluate the toxicity of the proposed treatment regimen. Materials and methods . All patients included in the study had stage I–IIIB anal cancer. All patients underwent IMRT radiotherapy 52–58 Gy (the dosage is calculated according T symbol) by 1.8 to 2.2 Gy fractions daily. The proposed chemotherapy scheme includes mitomycin C 10 mg/m2 on day 1, paclitaxel 45 mg/m2 on days 3, 10, 17, 24, 31, capecitabine 625 mg/m2 during radiotherapy. A complete response to treatment after 26 weeks, and the compliance to the study protocol were the primary end points of the study. Results . The study included 38 patients. Among patients stage I anal cancer occurred in 1 (2.6 %) case, II – in 5 (13.2 %), IIIA – 15 (39.5 %) and IIIB – in 17 (44.7 %). A significant deviation from the protocol reported in 6 (15.8 %) patients, in 11 (28.9 %) patients a slight alteration from the treatment was documented, and 21 (55.3 %) patients completed the treatment of chemoradiotherapy with full compliance to the study protocol. The high profile of toxicity (grade III–IV) was recorded in 23 (60.5 %) patients. An incomplete clinical response at 26 weeks after treatment was reported in 5 (13.2 %) patients, one whom continued watchful waiting and achieved complete response at 9 months posttreatment. Median followup was 27 months. 1 patient developed a local recurrence 1 year posttreatment. Conclusions . The proposed triplet chemotherapy regimen using IMRT is feasible and has acceptable toxicity. For further assess the continuous research is needed.