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

被引：42

作者：

Oliveira S.C.R. ^{[1
]}

Moniz C.M.V. ^{[1
]}

Riechelmann R. ^{[1
]}

Alex A.K. ^{[1
]}

Braghirolli M.I. ^{[1
]}

Bariani G. ^{[1
]}

Nahas C. ^{[1
]}

Hoff P.M.G. ^{[1
]}

机构：

[1] Universidade de Sao Paulo, Sao Paulo, Sao Paulo

来源：

Journal of Gastrointestinal Cancer | 2016年 / 47卷 / 1期

关键词：

Anus neoplasms/drug therapy; Anus neoplasms/radiotherapy; Capecitabine; Mitomycin; Squamous cell carcinoma;

D O I：

10.1007/s12029-015-9790-4

中图分类号：

学科分类号：

摘要：

Summary: 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. Background: 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. Methods: 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. Results: 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. Conclusions: 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). © 2015, Springer Science+Business Media New York.

引用

页码：75 / 81

页数：6

共 19 条

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