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.”

Uncategorized - August 18, 2014

Anti–PD-1 Antibodies in NSCLC and Renal Cell Carcinoma

Attendees at ASCO got a look at maturing data for the anti–PD-1 monoclonal antibody nivolumab in non–small cell lung cancer (NSCLC) and at early results for this drug in other tumor types. They also heard early results for pembrolizumab. In phase 1 and 2 trials, these immunotherapies made a strong [ Read More ]

Uncategorized - August 18, 2014

Federal Spending on Cancer Research and Access to Care Called Woefully Inadequate by ASCO President

Sequester Threatens Progress Made in Cancer The impact of federal budget cuts on cancer research is threatening progress against cancer and access to increasing demand for cancer services, said ASCO President Clifford Hudis, MD, in his presidential address. He called for achievement of “social justice in cancer care” by loosening [ Read More ]