To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Docetaxel Plus Anthracycline Regimen Effective in All Patient Subgroups With Early-Stage Breast Cancer: Presented at ASCO-Breast URL: http://www.pslgroup.com/dg/22B6E2.htm Doctor's Guide September 8, 2008
By Lisa M. Cockrell, PhD WASHINGTON, DC -- September 8, 2008 -- The addition of docetaxel to a traditional anthracycline-based regimen confers significant benefit for women with node-positive, early-stage breast cancer regardless of patient subgroup, according to an updated analysis of the Taxit126 study results presented here at the American Society of Clinical Oncology's Annual Breast Cancer Symposium (ASCO-Breast). The patient subgroups analysed were age (>50 years vs <=50 years), menopausal status, oestrogen receptor (ER) status, and extent of lymph-node involvement (1-3 vs 4 nodes). Angelo Raffaele Bianco, Department of Molecular and Clinical Endocrinology and Oncology, Universitą Federico II, Napoli, Italy, presented the results in a poster session on September 5. Prior to this study, improvements in treatment efficacy conferred by the addition of a taxane to an anthracycline among specific patient subgroups were regarded as controversial, Dr. Bianco said. The Taxit216 study was designed to evaluate if the addition of docetaxel could improve the efficacy of the standard anthracycline-based regimen of epirubicin plus cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) for adjuvant treatment of node-positive, early-stage breast cancer. In their exploratory analysis of the Taxit216 data, Dr. Bianco and colleagues sought to determine patient outcomes by specific subgroup analysis. Efficacy and safety results at a median follow-up of 4.5 years were reported previously.(1) Median follow-up in this updated analysis was 62 months. Between July 1998 and July 2002, 972 patients with node-positive, early-stage breast cancer were randomised to either epirubicin/CMF alone or combined with docetaxel. Patients were stratified according to investigational site, number of positive nodes, menopausal status, and ER status. Patient's baseline characteristics were similar between treatment arms. Nearly half of all patients were postmenopausal and the majority were diagnosed with ductal carcinoma. Most patients were ER-positive. The primary study endpoint was disease-free survival and the secondary endpoints were recurrence-free survival and overall survival. All endpoints were found to be superior in the docetaxel treatment arm, indicated by a hazard ratio (HR) of <1. Although the HR for 5-year disease-free survival (HR = 0.82) did not reach statistical significance, HR for 5-year recurrence-free survival (HR = 0.75, P = .0394) and 5-year overall survival (HR = 0.67, P = .0168) were significant. According to the researchers, the improved efficacy resulting from the addition of docetaxel was not significantly influenced by patient subgroup. According to Dr. Bianco, the results of the Taxit216 study are expected to be published shortly. 1. Bianco AR et al. American Society of Clinical Oncology 2006. Abstract LBA520. [Presentation title: Sequential Epirubicin-Docetaxel-CMF as Adjuvant Therapy for Node-Positive Early-Stage Breast Cancer: Subgroup Analysis of the TAXit216 Randomized Trial. Abstract 187] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.