Abstract
BackgroundBisphosphonate therapy has been readily accepted as standard of care for individuals with bone metastases from breast cancer. In this study we determined whether the proportion of patients experiencing a skeletal related event (SRE) in a clinical practice population was similar to that observed in phase III randomized controlled studies.MethodsA retrospective chart review was conducted of 110 patients receiving intravenous bisphosphonates for advanced breast cancer. The proportion of patients experiencing at least one SRE after 12 months of therapy was determined. SRE included vertebral or non-vertebral fracture, cord compression, surgery and/or radiotherapy to bone.ResultsThe proportion of patients who had an SRE was 30% (28 individuals) and the median time to first event was greater than 350 days. Non-vertebral events and radiotherapy were the most frequent type of SRE, while cord compression and hypercalcaemia were rare (1%). Most patients in the study had bone-only disease (58.2%) and most had multiple bone lesions. In the first 12 months the mean duration of exposure to intravenous bisphosphonates was 261 days and most patients remained on treatment until just before death (median 27 days).ConclusionThis study suggests that the rate of clinically relevant SREs is substantially lower than the event rate observed in phase III clinical trials. We attribute this lower rate to observational bias. In the clinical trial setting it is possible that over-detection of skeletal events occurs due to the utilisation of regular skeletal survey or radionucleotide bone scan, whereas these procedures are not routine in clinical practice. Phase IV observational studies need to be conducted to determine the true benefits of bisphosphonate therapy in order to implement rationale use of bisphosphonates.
Highlights
Bisphosphonate therapy has been readily accepted as standard of care for individuals with bone metastases from breast cancer
Randomised controlled studies have consistently demonstrated that the skeletal complications of metastatic breast cancer can be reduced by the regular administration of intravenous bisphosphonates [1,2,3,4,5,6,7]
We propose that prescribing habits are unlikely to change without evidence of the efficacy, impact on quality of life, and cost-effectiveness of bisphosphonates in routine clinical practice
Summary
Bisphosphonate therapy has been readily accepted as standard of care for individuals with bone metastases from breast cancer. Given the potential impact of a pathological fracture, it is not surprising that bisphosphonate therapy has been readily accepted as standard of care for metastatic bone disease [8,9,10]. This therapy is expensive, and since bisphosphonates have no impact on survival, their cost-effectiveness is primarily justified by the avoidance of radiotherapy or surgery [11,12]. Patients are treated on a three to four weekly basis for an indefinite period Until their death, individuals with advanced cancer are exposed to the risk of infusion-related adverse events, the possibility of nephrotoxicity, and the inconvenience of intravenous treatment. We propose that prescribing habits are unlikely to change without evidence of the efficacy, impact on quality of life, and cost-effectiveness of bisphosphonates in routine clinical practice
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