December 25, 2011
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Zoledronic acid improved DFS, OS in premenopausal women with breast cancer

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San Antonio Breast Cancer Symposium

SAN ANTONIO — Adjuvant zoledronic acid improved DFS and OS in premenopausal women with ER-positive, early-stage breast cancer, according to researchers from Austria and Germany.

According to study researcher Michael Gnant, MD, professor of surgery at the Medical University of Vienna, Austria, previous data from the ABCSG-12 trial demonstrated an improved DFS when zoledronic acid was added to goserelin (Zoladex, AstraZeneca) with tamoxifen or anastrozole, as have other trials.

The researchers randomly assigned 1,803 women to goserelin with tamoxifen or anastrozole, with or without zoledronic acid. At a median follow-up of 76 months, patients who received zoledronic acid had a 27% reduction in the risk for DFS events (P=.022). The patients also had a 41% reduction in the risk for death (P=.027).

Multivariate analyses demonstrated a strong interaction between zoledronic acid and patient age. Among patients aged older than 40 years, zoledronic acid reduced the risk for DFS events by 34% (P=.014) and a 49% reduction in the risk for death (P=.020). There were no significant DFS or OS benefits for women aged younger than 40 years.

After 3 years of zoledronic acid, there have been no reported cases of osteonecrosis of the jaw or renal failure.

"These results are consistent with the significant DFS and OS improvements seen in the postmenopausal cohort of the AZURE trial and suggest that both estrogen deprivation and reduction of bone turnover-deprived growth factors in the bone marrow microenvironment are needed for sufficient suppression of dormant metastases," Gnant said. "Taken together with the previously demonstrated bone protective effects of zoledronic acid, these DFS and OS benefits strongly suggest that adding zoledronic acid to adjuvant endocrine therapy should be considered for premenopausal women with ER-positive, early-stage breast cancer."

For more information:

  • Gnant M. #S1-2. Presented at: 2011 CTRC-AACR San Antonio Breast Cancer Symposium; Dec. 6-10, 2011; San Antonio.

Disclosure: Dr. Gnant has received research funding from AstraZeneca, Novartis and Pfizer. He is also a consultant for AstraZeneca, Novartis and Pfizer, and he has received other financial or material support from AstraZeneca, Novartis, Sanofi-Aventis, Roche, Schering, Amgen and Pfizer.

Earn CME this spring at the HemOnc Today Breast Cancer Review & Perspective meeting to be held March 23-24, 2012 at the Hilton San Diego Bayfront. See details at HemOncTodayBreastCancer.com.

PERSPECTIVE

Adam Brufsky, MD
Adam M.
Brufsky

The problem with studies of this nature is that people do so well for so long with the standard of care. You need to wait a long time, beyond 5 years, to actually see a difference in relapse rate. Actually, these curves started to grow apart, so the data are nothing new. But what is surprising to everybody, is that only with 3 years of therapy, there is now a survival benefit. This has been shown in many trials. I have a hard time understanding why people don't accept the fact that bisphosphonates have an antitumor effect. The problem is that they can't explain it, so they don't want to believe it. There are several trials going in this direction. There are more data to support this than there are to support dose-dense chemotherapy, which is commonly used. If there is as much data to support this treatment, which is not as toxic, we ought to be using it in postmenopausal women.

- Adam M. Brufsky, MD, PhD
HemOnc Today Editorial Board member

Disclosure: Dr. Brufsky received consulting fees and speaking honoraria from Novartis and Amgen.

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