Prospective observational study to evaluate the persistence of treatment with denosumab in patients with bone metastases from solid tumors in routine clinical practice: final analysis

Autor: Katja Björklöf, Daniela Niepel, Richard Greil, Antoaneta Tomova, Miriam Porubska, Martin Safanda, Andreas L. Petzer, Christine Jaeger, Zoltán Bajory, Dmitry Kalinin, Ferdinand Haslbauer
Rok vydání: 2019
Předmět:
Zdroj: Supportive Care in Cancer
ISSN: 1433-7339
0941-4355
DOI: 10.1007/s00520-019-04988-7
Popis: 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. Electronic supplementary material The online version of this article (10.1007/s00520-019-04988-7) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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