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Thomas, Eva S.,Gomez, Henry L.,Li, Rubi K.,Chung, Hyun-Cheol,Fein, Luis E.,Chan, Valorie F.,Jassem, Jacek,Pivot, Xavier B.,Klimovsky, Judith V.,de Mendoza, Fernando Hurtado,Xu, Binghe,Campone, Mario,L Grune & Stratton 2007 Journal of clinical oncology Vol.25 No.33
<B>Purpose</B><P>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.</P><B>Patients and Methods</B><P>Seven hundred fifty-two patients were randomly assigned to ixabepilone 40 mg/m<SUP>2</SUP>intravenously on day 1 of a 21-day cycle plus capecitabine 2,000 mg/m<SUP>2</SUP>orally on days 1 through 14 of a 21-day cycle, or capecitabine alone 2,500 mg/m<SUP>2</SUP>on the same schedule, in this international phase III study. The primary end point was progression-free survival evaluated by blinded independent review.</P><B>Results</B><P>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.</P><B>Conclusion</B><P>Ixabepilone plus capecitabine demonstrates superior efficacy to capecitabine alone in patients with metastatic breast cancer pretreated or resistant to anthracyclines and resistant to taxanes.</P>