UNLABELLED: 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).
UNLABELLED: 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).
Entities:
Keywords:
Anus neoplasms/drug therapy; Anus neoplasms/radiotherapy; Capecitabine; Mitomycin; Squamous cell carcinoma
Authors: J A Martenson; S R Lipsitz; H Wagner; E H Kaplan; L A Otteman; L M Schuchter; E G Mansour; M S Talamonti; A B Benson Journal: Int J Radiat Oncol Biol Phys Date: 1996-07-01 Impact factor: 7.038
Authors: Heena Patel; Guadalupe Polanco-Echeverry; Stefania Segditsas; Emmanouil Volikos; Amy McCart; Cecilia Lai; Thomas Guenther; Abed Zaitoun; Oliver Sieber; Mohammed Ilyas; John Northover; Andrew Silver Journal: Int J Cancer Date: 2007-12-15 Impact factor: 7.396
Authors: Carmen J Allegra; Greg Yothers; Michael J O'Connell; Robert W Beart; Timothy F Wozniak; Henry C Pitot; Anthony F Shields; Jerome C Landry; David P Ryan; Amit Arora; Lisa S Evans; Nathan Bahary; Gamini Soori; Janice F Eakle; John M Robertson; Dennis F Moore; Michael R Mullane; Benjamin T Marchello; Patrick J Ward; Saima Sharif; Mark S Roh; Norman Wolmark Journal: J Natl Cancer Inst Date: 2015-09-14 Impact factor: 13.506
Authors: H Bartelink; F Roelofsen; F Eschwege; P Rougier; J F Bosset; D G Gonzalez; D Peiffert; M van Glabbeke; M Pierart Journal: J Clin Oncol Date: 1997-05 Impact factor: 44.544
Authors: Jaffer A Ajani; Kathryn A Winter; Leonard L Gunderson; John Pedersen; Al B Benson; Charles R Thomas; Robert J Mayer; Michael G Haddock; Tyvin A Rich; Christopher Willett Journal: JAMA Date: 2008-04-23 Impact factor: 56.272
Authors: J F Bosset; F Roelofsen; D A L Morgan; V Budach; P Coucke; J J Jager; E Van der Steen-Banasik; N Trivière; G Stüben; M Puyraveau; M Mercier Journal: Eur J Cancer Date: 2003-01 Impact factor: 9.162
Authors: D Meulendijks; L Dewit; N B Tomasoa; H van Tinteren; J H Beijnen; J H M Schellens; A Cats Journal: Br J Cancer Date: 2014-08-28 Impact factor: 7.640
Authors: Yoanna Pumpalova; Margaret M Kozak; Rie von Eyben; Pamela Kunz; George Fisher; Daniel T Chang; Sigurdis Haraldsdottir Journal: J Gastrointest Oncol Date: 2019-08
Authors: Karla T Souza; Allan Al Pereira; Raphael L Araujo; Suilane Coelho Ribeiro Oliveira; Paulo M Hoff; Rachel P Riechelmann Journal: Ecancermedicalscience Date: 2016-12-01