Abstract
e19615 Background: Recent papers by Stopeck et al (J Clin Oncol, 2010), and by Fizazi et al (Lancet, 2011) evaluated rates of pathologic fractures (PF) in breast cancer (BC) and prostate cancer (PC) patients with bone metastases, and concluded that 23% and 15% of the patients on zoledronic acid (ZOL) respectively had a PF. Since these results were obtained within a randomized controlled trial environment, it is very important to compare these rates to those observed in actual practice. The objective of this study was therefore to determine the rate of PF among both BC and PC patients with bone metastases treated with ZOL in clinical practice. Methods: A patient chart review was conducted in two institutions, Florida Cancer Specialists (FCS) and Georgia Cancer Specialists (GCS) to determine the rate of PF in BC and PC patients with bone metastases initiating ZOL. BC and PC patients with confirmed diagnoses who initiated ZOL treatment from 2005 thru 2007 were included in the study. The patients were required to have been on ZOL for a minimum of 18 months following initiation of treatment. Demographic information, baseline clinical characteristics, and outcomes related to the treatment of bone metastases were assessed. Results: A total of 207 BC patients and 178 PC patients were included in the sample. Median age in the BC group was 65, and in the PC group was 74. In the BC cohort, of the 207 patients, only 17 (8.2%) patients had a PF. In the PC cohort, of the 178 patients, only 8 (4.5%) patients had a pathological fracture. When evaluated by institution, only 5 (4.7%) BC patients, and 4 (4%) PC patients from FCS had a pathological fracture; and only 12 (12%) BC and 4 (5.2%) PC patients from GCS had a pathological fracture. Conclusions: The findings from this study indicate that the rate of pathological fractures associated with ZOL treatment in clinical practice is very different from that observed in a randomized controlled trial setting. Physicians, payers and policy makers should carefully consider these findings in both clinical pathway decisions and formulary inclusion.
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