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
Open Access
- 1 April 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Supportive Care in Cancer
- Vol. 28 (4), 1855-1865
- https://doi.org/10.1007/s00520-019-04988-7
Abstract
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.Keywords
Funding Information
- Amgen (Not applicable)
This publication has 10 references indexed in Scilit:
- Cost of skeletal complications from bone metastases in six European countriesJournal of Medical Economics, 2016
- Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trialsEuropean Journal Of Cancer, 2012
- Randomized, Double-Blind Study of Denosumab Versus Zoledronic Acid in the Treatment of Bone Metastases in Patients With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple MyelomaJournal of Clinical Oncology, 2011
- Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind studyThe Lancet, 2011
- Denosumab Compared With Zoledronic Acid for the Treatment of Bone Metastases in Patients With Advanced Breast Cancer: A Randomized, Double-Blind StudyJournal of Clinical Oncology, 2010
- Medication Compliance and Persistence: Terminology and DefinitionsValue in Health, 2008
- The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancerAnnals of Oncology, 2005
- Monitoring Response to Treatment—the Role of Biochemical MarkersPublished by Wiley ,2005
- Safety and Pain Palliation of Zoledronic Acid in Patients with Breast Cancer, Prostate Cancer, or Multiple Myeloma Who Previously Received Bisphosphonate TherapyThe Oncologist, 2004
- Bisphosphonates: Clinical ExperienceThe Oncologist, 2004