Concurrent paclitaxel, capecitabine, mitomycin C and pelvic radiation therapy for patients with squamous cell anal carcinoma.
PURPOSE
The goals of this study were to assess safety and efficacy of triplet chemoradiotherapy (CRT) with paclitaxel for squamous cell anal carcinoma (SCAC).


METHODS
Patients with stage I-IIIB SCAC were enrolled and received 52-58 Gy intensity-modulated radiotherapy (IMRT) (with dose based on the T stage) in consecutive daily 1.8-2.2 Gy fractions. The concurrent chemotherapy consisted of paclitaxel 45 mg/m2 days 3, 10, 17, 24, 31, capecitabine 625 mg/m2 bid on treatment days and mitomycin C 10 g/m2 on day 1. Primary endpoints were complete clinical response at 26 weeks and protocol compliance; secondary endpoints included toxicity, overall survival (OS) and progression-free survival (PFS).


RESULTS
Thirty-eight patients were enrolled. The percentage of patients with stage I, II, IIIA, and IIIB disease were 1 (2.6%), 5 (13.2%), 15 (39.5%), and 17 (44.7%), respectively. 32 patients (84.2%) completed CRT without significant alterations. Grade 3-4 toxicity occurred in 23 (60.5%) patients. 33 (86.8%) patients had complete clinical response at 26 weeks. Median follow-up was 25.6 months. Seven (18.4%) patients experienced disease progression: four patients had residual tumor after CRT, 2 patients developed distant metastases and 1 patient developed a local recurrence 12 months after CRT. Two-year OS was 93.6%, 2-year PFS was 83.9%.


CONCLUSIONS
Investigated treatment scheme is feasible despite high toxicity profile, and may be beneficial for patients with advanced SCAC. Further research is warranted.
['Gordeyev|Sergey S|SS|http://orcid.org/0000-0002-9303-8379', 'Rasulov|Arsen O|AO|', 'Gorbounova|Vera A|VA|', 'Tkachev|Sergey I|SI|', 'Glebovskaya|Valeriya V|VV|', 'Fedyanin|Mikhail Yu|MY|http://orcid.org/0000-0001-5615-7806', 'Besova|Nataliya S|NS|', 'Surayeva|Yulia E|YE|']
D000328:Adult D000368:Aged D000971:Antineoplastic Combined Chemotherapy Protocols D001005:Anus Neoplasms D000069287:Capecitabine D002294:Carcinoma, Squamous Cell D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D016685:Mitomycin D017239:Paclitaxel D050397:Radiotherapy, Intensity-Modulated
Paclitaxel Chemoradiotherapy Intensity-modulated radiotherapy Squamous cell anal cancer