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Title: Zoledronic Acid Cuts Relapse Rate in Premenopausal Women With Early-Stage Breast Cancer: Presented at ESMO
URL: http://www.pslgroup.com/dg/22C9EA.htm
Doctor's Guide
September 17, 2008

By Jill Stein

STOCKHOLM, Sweden -- September 17, 2008 -- Adding the bisphosphonate agent zoledronic acid to adjuvant endocrine therapy reduces the risk of a relapse in premenopausal women with early breast cancer who are undergoing ovarian suppression and who are being treated with tamoxifen or anastrozole.

The results are from the phase 3 Austrian Breast & Colorectal Cancer Study Group 12 (ABCSG-12) trial, which was presented here on September 16 at the 33rd European Society for Medical Oncology Congress (ESMO).

Michael Gnant, MD, Medical University of Vienna, Vienna, Austria, and associates randomised 1,803 women to receive 3 years of treatment with either goserelin plus tamoxifen with or without zoledronic acid or with goserelin plus anastrozole with or without zoledronic acid.

All participants in the trial were premenopausal and had oestrogen receptor-positive stage I or II breast cancer with fewer than 10 positive nodes.

Before the trial, patients underwent surgery and radiotherapy.

The primary endpoint in the analysis was disease-free survival (DFS) events at 5 years in the tamoxifen versus anastrozole group and the zoledronic acid versus no-zoledronic acid groups.

Results showed that zoledronic acid plus endocrine therapy yielded a 36% reduction in the risk of DFS events versus endocrine therapy alone (P = .012).

Zoledronic acid also decreased the risk of recurrence-free survival events by 35% (P = .014).

In addition, zoledronic acid produced a trend towards improved survival (P = .10) and a trend towards a reduction in bone metastases (P = .224).

Zoledronic acid was generally well tolerated, with no reported cases of osteonecrosis of the jaw or renal toxicity.

Dr. Gnant urged oncologists to consider the use of adjuvant treatment with zoledronic acid to improve the standard of care in premenopausal patients with breast cancer and added that roughly half of all breast cancer patients under 55 years of age could benefit from zoledronic acid treatment.

Funding for this trial was provided by Novartis Pharma AG and AstraZeneca Pharmaceuticals LP.


[Presentation Title: Zoledronic Acid (ZOL) Improves Disease-Free (DFS) and Recurrence-Free Survival (RFS) in Premenopausal Women With Early Breast Cancer (ERB) Receiving Adjuvant Endocrine Therapy: Multivariate Analysis of Efficacy Data From the Austrian Breast and Colorectal Cancer Study Group (ABCSG-12). Presentation Number 690]

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