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Comparing The Results Of Bisphosphonate Use In Clinical Trials With Actual Practice:
Abstract
Multiple randomized clinical trials have confirmed the ability of bisphosphonates to reduce or delay skeletal related events (SREs) when given in combination with either hormonal or chemotherapy to breast cancer patients with bone metastases. The use of bisphosphonates has therefore become a standard of care for the secondary prevention of skeletal complications in these patients.
While the hazard ratios of benefit are impressive for the reduction and delay of SREs it is however important to appreciate that the patients enrolled onto these trials were restricted to those with a life expectancy of at least six months and were frequently over represented with patients with bone only disease. These patient populations are those who were most likely to derive maximum benefit from treatment. Patients treated in actual clinical practice are a more heterogeneous population with often an inherently poorer prognosis. It is likely that they do not derive the same degree of benefit.
This paper reviews the use and outcomes of treatment with bisphosphonates in a cohort of 190 breast cancer patients with bone metastases treated at three Canadian centers. It highlights the differences between clinical practice and trial populations and discusses why we cannot estimate the true order of magnitude of benefit for treatment with bisphosphonates in an off trial setting. This can have important implications for individual patient care and also for pharmacoeconomic evaluation of these agents.
While the hazard ratios of benefit are impressive for the reduction and delay of SREs it is however important to appreciate that the patients enrolled onto these trials were restricted to those with a life expectancy of at least six months and were frequently over represented with patients with bone only disease. These patient populations are those who were most likely to derive maximum benefit from treatment. Patients treated in actual clinical practice are a more heterogeneous population with often an inherently poorer prognosis. It is likely that they do not derive the same degree of benefit.
This paper reviews the use and outcomes of treatment with bisphosphonates in a cohort of 190 breast cancer patients with bone metastases treated at three Canadian centers. It highlights the differences between clinical practice and trial populations and discusses why we cannot estimate the true order of magnitude of benefit for treatment with bisphosphonates in an off trial setting. This can have important implications for individual patient care and also for pharmacoeconomic evaluation of these agents.