PURPOSE: In 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. METHODS: This 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. RESULTS: Previous 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). CONCLUSIONS: Most 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.

Abteilung für Innere Medizin Salzkammergut Klinikum Vöcklabruck Dr Wilhelm Bock Straße 1 A 4840 Vöcklabruck Austria

Complex Oncology Center Plovdiv EOOD Plovdiv Bulgaria

Global Medical Affairs Amgen GmbH Europe HQ Rotkreuz Switzerland

Medical Affairs Amgen GmbH Vienna Austria

Medical Affairs Amgen Rotkreuz Switzerland

Nemocnice Na Homolce Prague Czech Republic

Onkologicky ustav Sv Alzbety Bratislava Slovak Republic

Ordensklinikum Linz Barmherzige Schwestern Elisabethinen Linz Austria

Paracelsus Medizinische Privatuniversität Salzburger Landeskliniken Universitätsklinikum Salzburg Salzburg Cancer Research Institute Salzburg Austria

Quartesian Kharkov Ukraine

University of Szeged Szeged Hungary

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