Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies

Jacek Jassem; Luis Fein; Mark Karwal; Mario Campone; Ronald Peck; Valerie Poulart; Linda Vahdat

doi:10.1016/j.breast.2011.09.003

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Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies

Journal article

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Peer reviewed

Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies

Jacek Jassem, Luis Fein, Mark Karwal, Mario Campone, Ronald Peck, Valerie Poulart and Linda Vahdat

Breast (Edinburgh), Vol.21(1), pp.89-94

02/2012

DOI: 10.1016/j.breast.2011.09.003

PMID: 21937232

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Abstract

Metastatic breast cancer (MBC) patients with rapid disease relapse after neo/adjuvant chemotherapy including anthracyclines and taxanes have limited treatment options and their efficacy is marginal. Two phase III studies compared ixabepilone plus capecitabine vs. capecitabine alone as first-line treatment in MBC patients pretreated with anthracyclines and taxanes in the neo/adjuvant setting. Here we report the efficacy and safety of these treatments in a prespecified subset of patients whose disease relapsed within 12 months. Of 1973 patients across two studies, 293 relapsed within 12 months of neo/adjuvant treatment and received ixabepilone plus capecitabine (n = 149) or capecitabine alone (n = 144) as first-line chemotherapy for MBC. Analysis included progression-free survival (PFS), overall survival (OS), objective response rate (ORR) and toxicity. In 293 patients, ixabepilone plus capecitabine, as compared to capecitabine alone, increased PFS (median: 5.6 months vs. 2.8 months; hazard ratio, 0.58; p < 0.0001), ORR (46% vs. 24%) and OS (median: 15.1 months vs. 12.5 months; hazard ratio, 0.84; p = 0.208). Major toxicities of this regimen included neuropathy, neutropenia and hand-foot syndrome, but were manageable. Patients with breast cancer with early relapse following neo/adjuvant treatment with anthracyclines and taxanes may benefit from ixabepilone plus capecitabine. (ClinicalTrials.gov identifiers: NCT00080301 and NCT00082433.).

Adult

Aged

Aged, 80 and over

Anthracyclines - administration & dosage

Antineoplastic Combined Chemotherapy Protocols - therapeutic use

Breast Neoplasms - drug therapy

Breast Neoplasms - pathology

Capecitabine

Chemotherapy, Adjuvant

Deoxycytidine - administration & dosage

Deoxycytidine - analogs & derivatives

Epothilones - administration & dosage

Female

Fluorouracil - administration & dosage

Fluorouracil - analogs & derivatives

Humans

Middle Aged

Taxoids - administration & dosage

Young Adult

Details

Title: Subtitle: Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies
Creators: Jacek Jassem - Gdańsk Medical University
Luis Fein - Instituto de Oncología de Rosario
Mark Karwal - University of Iowa
Mario Campone - Department of Medical Oncology, Centre Regional Rene Gauducheau, Nantes-Saint-Herblain, France
Ronald Peck - Bristol-Myers Squibb (Germany)
Valerie Poulart - Bristol-Myers Squibb (Germany)
Linda Vahdat - Breast Center
Resource Type: Journal article
Publication Details: Breast (Edinburgh), Vol.21(1), pp.89-94
DOI: 10.1016/j.breast.2011.09.003
PMID: 21937232
NLM abbreviation: Breast
ISSN: 0960-9776
eISSN: 1532-3080
Grant note: DOI: 10.13039/100002491, name: Bristol-Myers Squibb
Language: English
Date published: 02/2012
Academic Unit: Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
Record Identifier: 9984359915802771

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