Advertisement
Journal of Clinical Oncology  
Search for:
Limit by:
  Browse by Subject or Issue
Home Search or Browse JCO Subscriptions PDA Services My JCO Customer Service

Originally published as JCO Early Release 10.1200/JCO.2007.12.6557 on October 29 2007

Journal of Clinical Oncology, Vol 25, No 33 (November 20), 2007: pp. 5210-5217
© 2007 American Society of Clinical Oncology.

This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Purchase Article
Right arrow View Shopping Cart
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a colleague
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Save to my personal folders
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Thomas, E. S.
Right arrow Articles by Roché, H. H.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Thomas, E. S.
Right arrow Articles by Roché, H. H.
Related Articles
Right arrowRelated Correspondence

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

Eva S. Thomas, Henry L. Gomez, Rubi K. Li, Hyun-Cheol Chung, Luis E. Fein, Valorie F. Chan, Jacek Jassem, Xavier B. Pivot, Judith V. Klimovsky, Fernando Hurtado de Mendoza, Binghe Xu, Mario Campone, Guillermo L. Lerzo, Ronald A. Peck, Pralay Mukhopadhyay, Linda T. Vahdat, Henri H. Roché

From the M.D. Anderson Cancer Center, Houston, TX; Instituto Nacional de Enfermedades Neoplasicas; Hospital Nacional Edgardo Rebagliati Martins, Lima, Peru; St Luke's Medical Center; Veterans Memorial Medical Center, Quezon City, Philippines; Yonsei Cancer Center, Seoul, Republic of Korea; Centro de Oncologia Rosario, Sante Fe; Hospital de Oncologia ‘Maria Curie,’ Buenos Aires, Argentina; Medical University of Gdansk, Gdansk, Poland; C.H.U. Jean Minjoz, Besançon; Centre Rene Gauducheau, Nantes; Institut Claudius Regaud, Toulouse, France; Bristol-Myers Squibb, Research and Development, Wallingford, CT; Cancer Hospital –Chinese Academy of Medical Sciences, Beijing, China; and Weill Medical College of Cornell University, New York, NY

Address reprint requests to Eva S. Thomas, MD, 280 West MacArthur Blvd, Oakland, CA 94611; e-mail: eva.s.thomas{at}kp.org

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/m2 intravenously on day 1 of a 21-day cycle plus capecitabine 2,000 mg/m2 orally on days 1 through 14 of a 21-day cycle, or capecitabine alone 2,500 mg/m2 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.

published online ahead of print at www.jco.org on October 29, 2007.

Supported by Bristol-Myers Squibb. Interim efficacy and safety analyses were supervised by an independent data-monitoring committee. The authors vouch for the completeness and accuracy of results presented.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 3, 2007, Chicago, IL.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.


Related Correspondence

  • Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment
    Eva S. Thomas
    JCO 2008 26: 2223 [Full Text]


This article has been cited by other articles:


Home page
Am J Health Syst PharmHome page
S. Goodin
Novel cytotoxic agents: Epothilones
Am. J. Health Syst. Pharm., May 15, 2008; 65(10_Supplement_3): S10 - S15.
[Abstract] [Full Text] [PDF]


Home page
Am J Health Syst PharmHome page
S. Y. Barbour
Caring for the treatment-experienced breast cancer patient: The pharmacist's role
Am. J. Health Syst. Pharm., May 15, 2008; 65(10_Supplement_3): S16 - S22.
[Abstract] [Full Text] [PDF]


Home page
JCOHome page
E. S. Thomas
Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment
J. Clin. Oncol., May 1, 2008; 26(13): 2223 - 2223.
[Full Text] [PDF]


Home page
Journal of Pharmacy PracticeHome page
J. R. Murillo Jr, J. E. Cox, and M. S. Oholendt
An Overview of Chemotherapy-Induced Peripheral Neuropathy
Journal of Pharmacy Practice, April 1, 2008; 21(2): 138 - 145.
[Abstract] [PDF]


Home page
Clin. Cancer Res.Home page
J. J. Lee and S. M. Swain
The Epothilones: Translating from the Laboratory to the Clinic
Clin. Cancer Res., March 15, 2008; 14(6): 1618 - 1624.
[Abstract] [Full Text] [PDF]


Home page
The OncologistHome page
L. Vahdat
Ixabepilone: A Novel Antineoplastic Agent with Low Susceptibility to Multiple Tumor Resistance Mechanisms
Oncologist, March 1, 2008; 13(3): 214 - 221.
[Abstract] [Full Text] [PDF]


Home page
Am Soc Clin Oncol Ed BookHome page
E. J. Wasserman and A. R. Tan
Evolving Strategies for the Treatment of "Triple-Negative" Breast Cancer
ASCO Educational Book, January 1, 2008; 2008(1): 120 - 126.
[Abstract] [Full Text] [PDF]



About
JCO
 Editorial
Roster
 Advertising
Information
 Librarians &
Institutions
 Rights &
Permissions
 Site Map

Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
Terms and Conditions of Use
  HighWire Press HighWire Press™ assists in the publication of JCO Online