title: 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.
abstract: 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/m(2) bid during radiotherapy associated with a single dose of mitomycin 15 mg/m(2) 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).
authors.affiliation: Universidade de Sao Paulo, Sao Paulo, Sao Paulo, Brazil. suilanecr@yahoo.com.br.
authors.forename: Suilane Coelho Ribeiro
authors.initials: SC
authors.lastname: Oliveira
authors.affiliation: Universidade de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.
authors.forename: Camila Motta Venchiarutti
authors.initials: CM
authors.lastname: Moniz
authors.affiliation: Universidade de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.
authors.forename: Rachel
authors.initials: R
authors.lastname: Riechelmann
authors.affiliation: Universidade de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.
authors.forename: Alexandra Kichfy
authors.initials: AK
authors.lastname: Alex
authors.affiliation: Universidade de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.
authors.forename: Maria Ignez
authors.initials: MI
authors.lastname: Braghirolli
authors.affiliation: Universidade de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Bariani
authors.affiliation: Universidade de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.
authors.forename: Caio
authors.initials: C
authors.lastname: Nahas
authors.affiliation: Universidade de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.
authors.forename: Paulo Marcelo Gehm
authors.initials: PM
authors.lastname: Hoff
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001005:Anus Neoplasms / Q000473:pathology / Q000628:therapy*; D000069287:Capecitabine / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D011379:Prognosis; D012074:Remission Induction; D015996:Survival Rate
chemical_list: D016685:Mitomycin; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil
keywords: Anus neoplasms/drug therapy; Anus neoplasms/radiotherapy; Capecitabine; Mitomycin; Squamous cell carcinoma