Abstract
Pre-clinical and clinical evidence suggest that bisphosphonates inhibit both bone resorption and cancer progression. New and updated analyses from several large, controlled studies in pre- and post-menopausal women with early stage breast cancer (BC) suggest that addition of bisphosphonates improves cancer-related outcomes, particularly in patients with a ‘low-estrogen environment’. Further, preliminary clinical data suggest that bisphosphonate therapy may reduce circulating tumour cell numbers (a negative prognostic indicator of disease-free and overall survival) in patients with advanced/metastatic disease. These new findings warrant reconsideration of the therapeutic role of bisphosphonates in BC.
Highlights
Bisphosphonates are the most common pharmaceutical intervention for prevention of skeletal-related events (SREs) in patients with malignant skeletal involvement
In patients with multiple myeloma, wherein the majority of the cancer resides within the bone marrow, post-hoc analyses of phase III trial data in patients with malignant bone disease showed that, patients with solid tumours had similar cancer-related outcomes, denosumab was associated with an increased risk of death versus zoledronic acid (ZOL) in this subset of patients (HR = 2.26; 95% CI = 1.13–4.50; n = 180) [10, 11]
These data are consistent with known prognostic significance of circulating tumour cells (CTCs) level in metastatic breast cancer (BC) [17, 18], and emerging evidence showing that ZOL decreases median CTC basal value from 20 to 10 cells in BC patients with bone metastases [19]
Summary
Bisphosphonates are the most common pharmaceutical intervention for prevention of skeletal-related events (SREs) in patients with malignant skeletal involvement. Anticancer benefits were more marked in the subset of patients >50 years of age (recurrence-free interval: HR = 0.76, P = 0.05; bone metastases-free interval [BMFI]: HR = 0.61, P = 0.024; non-BMFI: HR = 0.63, P = 0.015; OS: HR = 0.80, P = 0.1) [3] Consistent with these data, Coleman et al reported that adjuvant ZOL had no effect on survival in the overall study population of BC patients in the AZURE trial, ZOL was associated with survival benefit in the subset of patients with a low-estrogen environment (>5 years post-menopause at study entry) [6]. These studies show that treatment with adjuvant bisphosphonates is safe and may provide sustained anticancer benefit—desirable treatment characteristics for this patient population with good prognosis and prone to recurrent disease
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