Everolimus as treatment for breast cancer patients with bone metastases only: Results of the phase II RADAR study

Maass N, Harbeck N, Mundhenke C, Lerchenmueller C, Barinoff J, Lueck HJ, Ettl J, Aktas B, Kuemmel S, Roesel S, Wagner S, Mueller L, Bischoff J, Luebbe K, Schwedler K, Schmidt M, Bauerschlag D, Nekljudova V, Von Minckwitz G, Loibl S (2013)

Publication Type: Journal article

Publication year: 2013

Journal

Journal of Cancer Research and Clinical Oncology Springer Verlag (Germany)

Book Volume: 139

Pages Range: 2047-2056

Journal Issue: 12

DOI: 10.1007/s00432-013-1518-x

Abstract

Purpose: Everolimus has shown to stop formation and activity of osteoclasts. Breast cancer patients with bone metastases only are candidates for effective but low toxic treatment. Patients and methods: We evaluated everolimus in a double-blind, placebo-controlled, phase II, randomized discontinuation study in breast cancer patients with HER2 negative breast cancer patients with bone metastases only. After being stable on 8 weeks of everolimus 10 mg/day, patients were randomized to everolimus-continuation or placebo. Primary outcome was time (from randomization) to progression (TTP). Seventy-six patients would have had to be randomized to show a hazard ration (HR) of 0.5 for everolimus-continuation. Results: Eighty-nine patients were enrolled in 4 years. Thirty-nine patients with SD after 8 weeks on everolimus were randomized to everolimus-continuation or placebo. TTP in patients with everolimus- continuation was 37.0 (95 % CI 16.7-40.3) versus 12.6 weeks (95 % CI 7.1-17.9) with placebo [HR 0.554 (95 % CI 0.282-1.09) p = 0.0818], adjusted for endocrine therapy [HR 0.464 (95 % CI 0.226-0.954) p = 0.037]. TTP in everolimus responders (n = 6) was 86 weeks. Conclusion: The RADAR study is mainly hypothesis generating. It suggests that everolimus has single-agent activity, and patients with bone metastases only may retrieve long-term benefit from everolimus if they do not progress within 8 weeks of treatment. © 2013 Springer-Verlag Berlin Heidelberg.

Authors with CRIS profile

Christoph Mundhenke

Involved external institutions

Horst-Schmidt-Kliniken DE Germany (DE) Klinikum rechts der Isar DE Germany (DE) Universitätsklinikum Essen DE Germany (DE) Kliniken Essen-Mitte DE Germany (DE) Universitätsklinikum Magdeburg A.ö.R. DE Germany (DE) Universitätsklinikum Aachen (UKA) DE Germany (DE) Ludwig-Maximilians-Universität (LMU) DE Germany (DE) Diakoniekrankenhaus Henriettenstiftung DE Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) DE Germany (DE) Universitätsmedizin der Johannes Gutenberg-Universität Mainz DE Germany (DE) GBG Forschungs GmbH (German Breast Group) DE Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) DE Germany (DE)

How to cite

APA:

Maass, N., Harbeck, N., Mundhenke, C., Lerchenmueller, C., Barinoff, J., Lueck, H.-J.,... Loibl, S. (2013). Everolimus as treatment for breast cancer patients with bone metastases only: Results of the phase II RADAR study. Journal of Cancer Research and Clinical Oncology, 139(12), 2047-2056. https://doi.org/10.1007/s00432-013-1518-x

MLA:

Maass, Nicolai, et al. "Everolimus as treatment for breast cancer patients with bone metastases only: Results of the phase II RADAR study." Journal of Cancer Research and Clinical Oncology 139.12 (2013): 2047-2056.

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