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| |  Docetaxel Plus Capecitabine Shows More Benefit as First-Line Therapy for Metastatic Breast Cancer Than Docetaxel Plus Epirubicin: Presented at SABCS By Jennifer Reising SAN ANTONIO, Tex -- December 12, 2009 -- The combination of docetaxel and capecitabine is associated with an increased nonprogression rate at 6 months and a longer progression-free survival (PFS) and overall survival (OS) than docetaxel plus epirubicin as a first-line treatment for metastatic breast cancer, according to the final results of a study presented here on December 11 at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). “Our study shows that docetaxel and capecitabine is superior to docetaxel plus epirubicin in the first-line of treatment for women with metastatic breast cancer,” said Thomas Bachelot, MD, PhD, Centre Léon Bérard, Lyon, France. “There appears to be no gain in including anthracyclines, such as epirubicin, in the first line of treatment for this group of patients.” Nonprogression at 6 months after randomisation was the primary endpoint of the Etude de phase III comparant l’efficacité de 2 stratégies thérapeutiques de chimiothérapie chez des patientes atteintes d’un cancer du sein métastatique (ERASME-4). The main secondary endpoints were PFS and OS. Between June 2004 and April 2006, 68 patients with metastatic breast cancer who were previously untreated with chemotherapy were randomised to receive either DC (docetaxel 75 mg/m2 intravenously on day 1 and oral capecitabine 1,000 mg/m2 twice daily on days 1 to 14 every 3 weeks) or DE (docetaxel 75 mg/m2 intravenously and epirubicin 75 mg/m2 intravenously on day 1 every 3 weeks). Study results demonstrated that 6 months after treatment, 75.8% (95% confidence interval [CI], 57.7%-88.9%) of patients who were treated in the DC arm were progression free, compared with 65.7% (95% CI, 47.8%-80.9%) in the DE arm. After a medium follow-up of 42 months (95% CI, 32.5-21.1), the median progression-free survival was 12.4 months in the DC group, compared with 6.8 months in the DE group (P = .04). The median OS was 37 months for the DC arm versus 27 months for the DE arm (P = .49). “The combination of docetaxel and capecitabine may be a valid alternative to adding epirubicin to docetaxel -- especially for those patients who have been previously exposed to an anthracycline therapy in the adjuvant setting and for those who are unable to be treated with bevacizumab,” said Dr. Bachelot. Funding for this study was provided by Roche France and sanofi-aventis France. [Presentation title: Superiority of Docetaxel + Capecitabine Compared to Docetaxel + Epirubicin as First-Line Therapy for Metastatic Breast Cancer - Final Results of the ERASME-4 Study. Abstract 2099]
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