Off-trial evaluation of bisphosphonates in patients with metastatic breast cancer

Abstract

Background: Bisphosphonate 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.

Skeletal-related events (SREs) in breast cancer patients with bone metastases treated in the nontrial setting

“…Firstly, the percentage of patients with bone only metastases at the time of BP initiation was 35%, which is congruent with another offtrial evaluation of bisphosphonate use in metastatic BC patients [21]. This contrasts with the majority of randomized clinical trials evaluating the benefit of BP treatment, which includes approximately 60% of patients with bone only disease [11].…”

Incidence, consequences and treatment of bone metastases in breast cancer patients—Experience from a single cancer centre

“…In order to assess the proportion of patients with first SRE prior to and after initiation of a BTA, SREs were considered to have occurred before BTA treatment if the therapy was administered as a consequence of the development of an SRE or if the SRE had occurred within 1 month of starting the BTA [11] , [14] . Treatment data collected included time of initiation of BTA treatment from the time of diagnosis of bone metastases, type of BTA, reasons for discontinuation of BTA treatment, and, when applicable, why BTAs were not commenced.…”

“…With the widespread use of BTAs there is a growing body of data that suggests that their benefits in routine clinical practice are more modest than that observed in randomised trials [10] , [11] , [12] , [13] , [14] ( Table 2 ). We therefore decided to evaluate the incidence, consequences, and management of bone metastases in an unselected cohort of breast cancer patients at a large Canadian cancer centre.…”

Concurrent administration of zoledronic acid and irradiation leads to improved bone density, biomechanical strength, and microarchitecture in a mouse model of tumor‐induced osteolysis

“…Patients with bone metastases often suffer from debilitating bone pain, pathological fracture, spinal cord compression, and hypercalcemia [1]. Currently there is no cure for bone metastases, and patients are typically treated with radiation therapy to palliate bone pain and bisphosphonates (BPs) to inhibit osteoclastic bone resorption [2]. The efficacy of these drugs has been established through numerous clinical trials [1,[3][4][5] that have shown that patients treated with BPs had fewer skeletal complications then patients treated with placebo.…”