Phase II Study of Capecitabine in Substitution of 5-FU in the Chemoradiotherapy Regimen for Patients with Localized Squamous Cell Carcinoma of the Anal Canal
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This was a phase II study of capecitabine in substitution of 5-fluorouracil (5-FU) in the chemoradiotherapy regimen for patients with localized squamous cell carcinoma of the anal canal.
Combined chemoradiation with infusional 5-FU and mitomycin is the standard treatment for localized squamous cell carcinoma (SCC) of the anal canal. Capecitabine is an oral fluoropirimidine that has been shown to be equally effective to 5-FU in many solid tumors. However, the efficacy of the substitution of 5-FU for capecitabine in anal SCC needs confirmation.
Patients with SCC of anal cancer T2-4N0M0 or T (any) N1-3M0, with good performance status and normal blood and renal function, were treated with capecitabine 825 mg/m2 bid during radiotherapy associated with a single dose of mitomycin 15 mg/m2 on day 1. The primary objective was local control rate at 6 months determined by clinical examination and radiological assessment. Sample size was calculated using the Fleming single-stage design.
From November 2010 to February 2014, N = 51 patients were initially included; however, 43 patients were assessed. Seventeen patients (39.5 %) were stage II, 11 patients (25.6 %) stage IIIA, and 15 patients (34.9 %) stage IIIB. Four patients (9.3 %) were HIV positive. With a median follow-up of 23.1 months (range 4 to 44.4 months), 3 patients (7 %) presented partial response, 37 (86 %) had complete response, and 3 patients developed progression of the disease (7 %) at 6 months. The colostomy rate was 18.6 %. It was observed a locoregional control of 86 % in 6 months (CI 95 % 0.72–0.94). The main grade 3–4 toxicities were grade 3 radiodermitis in 10 patients (23.2 %), grade 3 lymphopenia in 5 patients (11.6 %), and grade 3 neutropenia in 2 patients (6.9 %). One HIV-positive patient had septic shock, pneumonia, herpetic encephalitis, atrial fibrillation, and macrophage activation syndrome.
Capecitabine can safely substitute infusional 5-FU in the standard chemoradiation regimen for SCC of the anal cancer, with a locoregional control of 86 % in 6 months (CI 95 % 0.72–0.94).
KeywordsSquamous cell carcinoma Anus neoplasms/drug therapy Anus neoplasms/radiotherapy Mitomycin Capecitabine
Conflict of Interest
The authors declare that they have no competing interests.
The study was conducted in accordance with local ethical and regulatory requirements. It followed the recommendations to conduct clinical trials of the International Conference on Harmonization Good Clinical Practices. Informed consent was applied to all patients before inclusion in the study.
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