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Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment
Open accessAbstract
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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Metadata
- Authors
- Thomas, E. S., Gomez, H. L., Li, R. K., Chung, H.-C., Fein, L. E., Chan, V. F., Jassem, J., Pivot, X. B., Klimovsky, J. V., de Mendoza, F. H., Xu, B., Campone, M., Lerzo, G. L., Peck, R. A., Mukhopadhyay, P., Vahdat, L. T., & Roché, H. H.
- Venue
- Journal of Clinical Oncology
- Published
- 2007-11-20
- Volume
- 25
- Issue
- 33
- Pages
- 5210-5217
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2127340468
- Cited by
- 481
- References
- 18
- FWCI
- 29.13
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Thomas, E. S., Gomez, H. L., Li, R. K., Chung, H.-C., Fein, L. E., Chan, V. F., Jassem, J., Pivot, X. B., Klimovsky, J. V., de Mendoza, F. H., Xu, B., Campone, M., Lerzo, G. L., Peck, R. A., Mukhopadhyay, P., Vahdat, L. T., & Roché, H. H. (2007). Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2007.12.6557
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