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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

1371 - Prospective observational study to evaluate the persistence of treatment with denosumab (dmab) in patients (pts) with bone metastases (BM) from solid tumors (ST) in routine clinical practice: final analysis

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Presenters

Ferdinand Haslbauer

Citation

Annals of Oncology (2018) 29 (suppl_8): viii603-viii640. 10.1093/annonc/mdy300

Authors

F. Haslbauer1, A.L. Petzer2, M. Safanda3, A. Tomova4, M. Porubska5, Z. Bajory6, D. Niepel7, C. Jäger8, D. Kalinin9, R. Greil10

Author affiliations

  • 1 Oncology, Krankenhaus Voecklabruck, 4840 - Voecklabruck/AT
  • 2 Department Of Internal Medicine I - Oncology, Hematology And Gastroenterology, Ordensklinikum Linz Barmherzige Schwestern/Elisabethinen, 4040 - Linz/AT
  • 3 Department Of Clinical Oncology, Nemocnice Na Homolce, 150 30 - Prague/CZ
  • 4 Ist Internal Dept, Complex Cancer Center, 4004 - Plovdiv/BG
  • 5 Department Of Internal Medicine, St. Elisabeth Cancer Institute, 81250 - Bratislava/SK
  • 6 Department Of Urology, University of Szeged, Szeged/HU
  • 7 Global Medical Affairs, Amgen (Europe) GmbH, 6301 - Zug/CH
  • 8 Medical Affairs, AMGEN - Austria, 1010 - Vienna/AT
  • 9 Biostatistics, Quartesian, Kharkov/UA
  • 10 Department Of Internal Medicine Iii, Salzburger Landeskliniken - Universitätsklinikum Salzburg, Paracelsus Medizinische Privatuniversität, Salzburg Cancer Research Institute, 5020 - Salzburg/AT
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Resources

Abstract 1371

Background

Persistence with dmab therapy may impact clinical efficacy in preventing skeletal-related events (SREs), but is undetermined in real-world.

Methods

Single-arm, prospective, observational, non-interventional study in pts with BM from ST (breast, prostate, lung, other) treated with dmab in real-world in Austria, Czech Republic, Hungary, Slovakia, and Bulgaria between 10/2012 and 05/2017. Primary objective: persistence at 24 weeks (wks) (=6 dmab subcutaneous injections; permissible intervals: 4±1 wks). Secondary objectives: persistence at 48 wks, time to non-persistence, calcium (Ca) / vitamin D supplementation, (serious) adverse drug reactions ([S]ADRs) incl. non-adjudicated osteonecrosis of the jaw (ONJ) rate.

Results

598 patients were included, 451 completed 24 wks, 387 completed 48 wks of study, 211 discontinued before 48 wks due to death (n = 80), loss to follow-up (n = 35), informed consent withdrawal (n = 7), dmab discontinuation (n = 56, [S]ADRs [n = 5]), other reasons (n = 28). 10.9% (n = 65) had previous SREs. Persistence with dmab and safety are shown in the table. Persistence at 24/48 wks was 62.6/40.1% overall, 69.5/45.5% for breast, 69.3/46.6% for prostate, 26.1/10.9% for lung, and 40.7/21.1% for other cancers. Median (IQR) duration of dmab exposure was 309 days (168.0, 319.0) and 11 doses (6.0, 12.0). The most frequent reason for non-persistence was the violation of one time window. Overall, analgesics use trended towards weaker analgesics over time, with ∼60% of pts not requiring any analgesics. Serum Ca remained within the normal range of 2.2 to 2.7 mmol/L throughout the study. ∼70% of pts received Ca and vitamin D supplements at baseline, increasing to ∼80% at dose 2 and steadily decreasing thereafter.Table: 1787P

N = 598
Persistence, % (95% CI)
At 24 wks62.6 (58.4, 66.7)
At 48 wks40.1 (35.9, 44.4)
KM-median (95% CI) time to non-persistence, days274.0 (232.0, 316.0)
ADRs, n (%)61 (10.2)
SADRs, n (%)8 (1.3)
ONJ3 (0.7)
Incidence of ONJ per pt-year (95% CI)0.012 (0.004, 0.029)

Conclusions

Persistence (Diel, ESMO 2015) and ONJ rate (Stopeck, JCO 2010, Fizazi, Lancet 2011, Henry, JCO 2011) were comparable with previous reports.

Clinical trial identification

Legal entity responsible for the study

Amgen.

Funding

Amgen.

Editorial Acknowledgement

Margit Hemetsberger, Hemetsberger Medical Services, Vienna, Austria.

Disclosure

A.L. Petzer: Speakers honoraria, advisory board: Amgen. D. Niepel, C. Jäger: Employee, stocks: Amgen. R. Greil: Research grants: Celgene, Roche, Merck, Takeda, AstraZeneca, Novartis, Amgen, BMS; Consulting fees: Celgene, Roche, BMS, Takeda, Abbie, AstraZeneca, Novartis. All other authors have declared no conflicts of interest.

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