August 2014, Vol 3, No 5

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Less May Be More With Zoledronic Acid

Uncategorized

In breast cancer patients with bone metastasis, less frequent infusion of zoledronic acid was as effective as the standard monthly dose, the randomized OPTIMIZE-2 study showed.

“We found that less frequent treatment may reduce the risk of serious side effects, with the additional benefits of reduced inconvenience to the patient and less cost,” said Gabriel N. Hortobagyi, MD, professor of medicine at The University of Texas MD Anderson Cancer Center, Houston, at ASCO 2014.

Zoledronic acid 4 mg given every 3 months was as effective as infusions given every 3 to 4 weeks, which is the FDA-approved schedule.

OPTIMIZE-2 compared the schedules in 403 women with breast cancer and bone metastases who had received at least 9 doses of an IV bisphosphonate (either zoledronic acid or pamidronate) before enrolling in the study.

The rate of skeletal-related events was 22% in the monthly group and 23.2% in the every-12-week group, indicating that less frequent dosing is not inferior. Other efficacy measures, such as time to first skeletal-related event and bone turnover markers, were also similar between the arms, and safety profiles were similar as well.

ASCO press briefing moderator Patricia Ganz, MD, a supportive care specialist from the University of California, Los Angeles, commented, “It’s not necessary for women to come in every 4 weeks.”

The data are important because there are no evidence-based guidelines for the optimal treatment schedule after 1 year of treatment.

Importantly, less frequent dosing seemed to ameliorate some of the safety concerns for bisphosphonates as a class. As with all agents in the class, “zoledronic acid has some safety concerns,” said Hortobagyi, indicating osteonecrosis of the jaw (ONJ), long-bone fractures (ie, atypical femoral fractures), and chronic kidney function impairment.

The less frequent dosing in this study was associated with fewer cases of ONJ (0 vs 2), and lower rates of renal impairment (7.9% vs 9.6%). No patients experienced long-bone fractures.

Since the study size was, in Hortobagyi’s terms, “relatively modest,” and there were some “design limitations,” he said the findings should be “interpreted with caution.”

Interview with the Innovators - August 15, 2014

Personalized Medicine and Value:

An Interview with Faculty at the Fourth Annual Conference of the Association for Value-Based Cancer Care

C. Daniel Mullins, PhD, is a professor and former department chair of the Pharmaceutical Health Services Research Department at the University of Maryland School of Pharmacy. Linda Bosserman, MD, is a community medical oncologist at Wilshire Oncology. Andrew Stainthorpe, PhD, is associate director of the National Institute of Health and [ Read More ]

Uncategorized - August 18, 2014

PSA Trend Analysis May Help Avoid Unnecessary Biopsies

Delaying a prostate-specific antigen (PSA)-triggered prostate biopsy to allow for additional PSA assessments might have avoided more than 70% of subsequent biopsies, according to a study of negative biopsies for 28,000 men. An analysis based on deceleration of PSA growth rate suggested that 80% of negative biopsies might have been [ Read More ]