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

Journal of Clinical Oncology, Vol 25, No 31 (November 1), 2007: pp. 4967-4973
© 2007 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2006.09.5992

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 Google Scholar
Google Scholar
Right arrow Articles by Deshmane, V.
Right arrow Articles by Buzdar, A. U.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Deshmane, V.
Right arrow Articles by Buzdar, A. U.

Phase III Double-Blind Trial of Arzoxifene Compared With Tamoxifen for Locally Advanced or Metastatic Breast Cancer

VijayaLaxmi Deshmane, S. Krishnamurthy, Allen S. Melemed, Patrick Peterson, Aman U. Buzdar

From the Kidwai Memorial Institute of Oncology, Karnataka, Bangalore, India; Eli Lilly and Co, Indianapolis, IN; and The University of Texas M.D. Anderson Cancer Center, Houston, TX

Address reprint requests to VijayaLaxmi Deshmane, Masters of Surgery, Department of Surgical Oncology, Kidwai Memorial Institute of Oncology, Hosur Rd, Bangalore 560029 India; e-mail: vldeshmane{at}hotmail.com

Purpose: To compare the efficacy of arzoxifene with tamoxifen for the treatment of locally advanced or metastatic breast cancer.

Patients and Methods: Women with estrogen- or progesterone-receptor–positive breast cancer who had not received prior systemic therapy, or who had relapsed more than 12 months after stopping adjuvant hormonal therapy, were randomly assigned to receive 20 mg arzoxifene or 20 mg tamoxifen daily. Each treatment arm was to have 240 patients enrolled. The primary end point was progression-free survival. Secondary end points included other measures of tumor response, overall survival, and safety.

Results: Enrollment was stopped when a planned interim analysis of the first 200 patients suggested arzoxifene to be significantly inferior to tamoxifen. The median progression-free survival for the 352 patients who had been randomly assigned when enrollment was stopped was 4.0 months (95% CI, 3.4 to 5.6 months) for the arzoxifene group and 7.5 months (95% CI, 5.9 to 8.8 months) for the tamoxifen group. On-study progression-free survival (P = .011) and time to treatment failure (P = .029) also favored tamoxifen. Overall tumor response rate and median response duration were comparable between the groups. Adverse events were similar between the treatments, except for nausea (more frequent with arzoxifene) and vaginal discharge (more frequent with tamoxifen).

Conclusion: Tamoxifen produced significantly longer progression-free survival and time to treatment failure compared with arzoxifene in the treatment of locally advanced and metastatic breast cancer. There were no significant differences between tumor response rate, clinical benefit rate, or median response duration.

Supported by Eli Lilly and Company, Indianapolis, IN.

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






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