Abstract
PurposeIn the integrated analysis of phase III head-to-head trials in patients with advanced solid tumors, denosumab demonstrated superiority over zoledronic acid in preventing skeletal-related events (SREs). Regular and continued drug use (persistence) is a precondition of clinical efficacy; persistence in real-life is yet undetermined for denosumab.MethodsThis was a single-arm, prospective, observational, non-interventional study in 598 patients with bone metastases from breast, prostate, lung, or other solid tumors treated with denosumab every four weeks in real-world clinical practice in Austria, Czech Republic, Hungary, Slovakia, and Bulgaria. Persistence was defined as denosumab administration at ≤ 35-day intervals over 24 or 48 weeks, respectively.ResultsPrevious SREs were found in 10.9% of patients. 62.6% were persistent over 24 weeks and 40.1% over 48 weeks. The Kaplan-Meier median (95% CI) time to non-persistence was 274.0 days (232.0, 316.0). The most frequent reason for non-persistence was delayed administration. There was a trend towards weaker analgesics over time, with approximately 60% of patients not requiring any analgesics. Serum calcium remained within the normal range throughout the study. Adjudicated osteonecrosis of the jaw was documented in three patients with an incidence per patient-year (95% CI) of 0.012 (0.004, 0.029).ConclusionsMost patients received denosumab regularly once every four weeks over 24 weeks of treatment. Non-persistence was mainly due to delayed administration. The incidence of adverse drug reactions, especially of osteonecrosis of the jaw, was in line with expectations from previous studies.
Highlights
MethodsBone metastases represent a frequent complication of cancer, with more than 1.5 million affected patients worldwide [1]
Written informed consent was obtained from the patient or legally acceptable representative
National ethics committee approval of the protocol and informed consent form was obtained before recruitment of patients or any data collection
Summary
MethodsBone metastases represent a frequent complication of cancer, with more than 1.5 million affected patients worldwide [1]. Important skeletal complications are the result of osteoclast-mediated bone destruction [2, 3] often leading to severe pain, decreased quality of life, instability, and neurologic compromise [4]. In its oncological formulation, denosumab is indicated in Europe for the prevention of skeletal-related events (SREs; pathological fracture, radiation to bone, spinal cord compression, or surgery to bone) in adults with advanced malignancies involving the bone and for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [5]. Medication persistence refers to the act of conforming to a recommendation of continuing treatment for the prescribed length of time (= days medication was taken without exceeding permissible intervals) [7]
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