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Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment

 Eva S. Thomas  ;  Henry L. Gomez  ;  Henri H. Roché  ;  Linda T. Vahdat  ;  Pralay Mukhopadhyay  ;  Ronald A. Peck  ;  Guillermo L. Lerzo  ;  Mario Campone  ;  Binghe Xu  ;  Fernando Hurtado de Mendoza  ;  Judith V. Klimovsky  ;  Xavier B. Pivot  ;  Jacek Jassem  ;  Valorie F. Chan  ;  Luis E. Fein  ;  Hyun-Cheol Chung  ;  Rubi K. Li 
 JOURNAL OF CLINICAL ONCOLOGY, Vol.25(33) : 5210-5217, 2007 
Journal Title
Issue Date
Adult ; Aged ; Anthracyclines/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Breast Neoplasms/drug therapy* ; Breast Neoplasms/mortality ; Bridged-Ring Compounds/therapeutic use ; Capecitabine ; Deoxycytidine/administration & dosage ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives* ; Disease Progression ; Epothilones/administration & dosage* ; Epothilones/adverse effects ; Female ; Fluorouracil/administration & dosage ; Fluorouracil/adverse effects ; Fluorouracil/analogs & derivatives* ; Humans ; Middle Aged ; Neoplasm Metastasis ; Taxoids/therapeutic use
PURPOSE: Effective treatment options for patients with metastatic breast cancer resistant to anthracyclines and taxanes are limited. Ixabepilone has single-agent activity in these patients and has demonstrated synergy with capecitabine in this setting. This study was designed to compare ixabepilone plus capecitabine versus capecitabine alone in anthracycline-pretreated or -resistant and taxane-resistant locally advanced or metastatic breast cancer. PATIENTS AND METHODS: Seven hundred fifty-two patients were randomly assigned to ixabepilone 40 mg/m(2) intravenously on day 1 of a 21-day cycle plus capecitabine 2,000 mg/m(2) orally on days 1 through 14 of a 21-day cycle, or capecitabine alone 2,500 mg/m(2) on the same schedule, in this international phase III study. The primary end point was progression-free survival evaluated by blinded independent review. RESULTS: Ixabepilone plus capecitabine prolonged progression-free survival relative to capecitabine (median, 5.8 v 4.2 months), with a 25% reduction in the estimated risk of disease progression (hazard ratio, 0.75; 95% CI, 0.64 to 0.88; P = .0003). Objective response rate was also increased (35% v 14%; P < .0001). Grade 3/4 treatment-related sensory neuropathy (21% v 0%), fatigue (9% v 3%), and neutropenia (68% v 11%) were more frequent with combination therapy, as was the rate of death as a result of toxicity (3% v 1%, with patients with liver dysfunction [>/= grade 2 liver function tests] at greater risk). Capecitabine-related toxicities were similar for both treatment groups. CONCLUSION: Ixabepilone plus capecitabine demonstrates superior efficacy to capecitabine alone in patients with metastatic breast cancer pretreated or resistant to anthracyclines and resistant to taxanes.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
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