Healio
Healio
July 02, 2008
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Zoledronic acid prevented bone loss in women with ovarian failure

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According to the first results from CALGB trial 79809, zoledronic acid added minimal toxicity and prevented the accelerated bone loss common in women who develop ovarian failure.

Charles Shapiro, MD, director of breast cancer oncology at the Ohio State University Comprehensive Cancer Center, presented the results at the 2008 ASCO Annual Meeting in Chicago.

Women eligible for the study were aged 40 years or older, were diagnosed with stage I, II or III breast cancer and had a menstrual period within six months of entering the study.

The women were randomly assigned into a control group (n=85) or an experimental group (n=81). The women in the experimental group were assigned to 4 mg IV zoledronic acid (Reclast, Zometa) every three months. The doses were to start within three months of the patient receiving adjuvant chemotherapy.

All women were assigned to receive 1,000 mg of calcium and 400 IU of vitamin D. Compliance and toxicity were assessed every three months.

Shapiro and colleagues found that in the experimental group, lumbar spine BMD increased by 2.2% from baseline. Lumbar spine BMD decreased by 6.6% in the control group.

The researchers determined that most toxicities related to zoledronic acid were either grade 1 or grade 2. The grade-3 toxicities observed were fever (3%), pain (3%) and fatigue (2%). No patients developed osteonecrosis or serious renal toxicity. – by Jason Harris

PERSPECTIVE

The endpoints we see are that these drugs can protect BMD. If one feels fair about making the extrapolation to fracture from an osteoporosis setting, it is also probably true that these drugs can prevent fracture in patients with breast cancer as well. I believe there are also substantial data that suggest that these drugs prevent bone recurrence. I see enough data from even before the National Surgical Adjuvant Breast and Bowel Project study. That is a point of view that might be controversial. The question regarding general recurrences and overall survival remains unanswered.

– Kathleen Pritchard, MD

Head of Clinical Trials and Epidemiology, Toronto-Sunnybrook Regional Cancer Centre

For more information:

  • Shapiro C. #512. Presented at: 2008 ASCO Annual Meeting; May 30-June 2, 2008; Chicago.

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