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

Abstract

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.

Keywords

• anal carcinoma
• squamous-cell cancer
• chemoradiotherapy
• paclitaxel