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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

F. Haslbauer, A. Petzer, M. Safanda, A. Tomova, M. Porubska, Z. Bajory, D. Niepel, C. Jaeger, K. Bjorklof, D. Kalinin, R. Greil,

. 2020 ; 28 (4) : 1855-1865. [pub] 20190726

Language English Country Germany

Document type Journal Article, Multicenter Study, Observational Study

Persistent link   https://www.medvik.cz/link/bmc20023090

Grant support
Not applicable Amgen (Europe North East)

E-resources Online Full text

NLK ProQuest Central from 1997-01-01 to 1 year ago
CINAHL Plus with Full Text (EBSCOhost) from 2008-01-11 to 1 year ago
Medline Complete (EBSCOhost) from 2007-01-01 to 1 year ago
Nursing & Allied Health Database (ProQuest) from 1997-01-01 to 1 year ago
Health & Medicine (ProQuest) from 1997-01-01 to 1 year ago

Links

PubMed 31350601
DOI 10.1007/s00520-019-04988-7
Knihovny.cz E-resources

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.

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$a Petzer, Andreas $u Ordensklinikum Linz Barmherzige Schwestern/Elisabethinen, Linz, Austria.
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