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  • Apart from their association with severe pain and reduced

    2019-06-29

    Apart from their association with severe pain and reduced quality of life, SREs require substantial healthcare resource utilization (HRU) in their treatment and management. Previous retrospective studies have attempted to quantify various aspects of the burden of SREs across specific tumor types/countries, with studies in the United States of America (USA), France, Portugal and Spain all reporting high costs associated with SREs [9–14]. However, these studies did not address the overall HRU burden. With the current cost restraints across European healthcare systems influencing resource reimbursement, this information is important when planning future healthcare requirements and evaluating new treatment options to prevent skeletal complications. Thus, our observational, multinational study was designed to estimate HRU related to each of the defined SRE types in patients with breast, lung or prostate cancer, or multiple myeloma. Owing to the high incidence of these malignancies [15] and the frequency of associated bone metastases [1,2] these cancers can be considered to be responsible for the majority of the burden associated with bone metastases and their related complications in clinical practice. The study was carried out in Canada, Germany, Italy, Spain, the United Kingdom (UK) and the USA. Herein we report data for a cohort from 4 European countries.
    Materials and methods
    Results
    Discussion One of the limitations with the study was that the duration of follow-up was shorter than planned (up to a median of 8.1 months in this European cohort). Slow recruitment (study Fmoc-Thr(tBu)-OH was defined as 30 months following enrollment of the first patient) and early withdrawal from the study due to patient death may have been the main contributing factors. Withdrawal from the study was slightly higher than predicted, with death the primary reason for early discontinuation despite the inclusion criteria stating patients should have a life expectancy of at least 6 months. This could reflect the challenges associated with physicians׳ estimation of patients׳ life expectancies [16]. Slow recruitment also contributed to small sample size per SRE in some countries, which limits interpretation of some of the results. This may in part be due to difficulties with engaging patients and their physicians in observational research when no active therapies/interventions are offered as part of the study and participation in a concurrent investigational study is not permitted. However, the data show a generally consistent approach to patient management across countries, which suggests that the outcomes are valid, even though small sample numbers may prevent detailed interpretation. Another potential limitation was that we did not use an independent, blinded review for attributing HRU to SREs; however, there were no external influences on the local investigators, therefore their attribution of HRU should be reflective of clinical practice on a local level. Despite the robust approach of this study, the HRU observed may underestimate the overall resource burden associated with SREs for patients with bone metastases due to advanced cancer. Patients with low performance status and limited life expectancy (ECOG performance status 3 or 4 or a life expectancy of <6 months) were excluded from this study, although temperate forest biome may arguably utilize substantial healthcare resources during the late stage of their disease. Some data were not accessible to the investigators at all study sites, i.e. information relating to home health visits and/or long-term care facility stays were often not recorded in the hospital patient charts. Emergency room visits were often not reported or required; in case of an emergency, a patient may have contacted the treating specialist department directly for admission or treatment. Furthermore, in case of an emergency, patients may have attended an emergency room in a different center to that of the participating institute and this information may therefore not be transferred to the patient chart. In addition, indirect costs (i.e. transport to and from treatment units and the costs to employers as a result of patients and their care givers taking time off work) that are incurred as a result of SREs were not available to the investigators and not included in the study, Finally, bone pain requiring analgesic use or changes in anticancer therapy to manage tumor burden in the bone are frequent in patients with advanced cancer and bone metastases. These events were not defined as SREs, although they may require additional inpatient stays and/or outpatient visits.