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- Title
Everolimus as treatment for breast cancer patients with bone metastases only: results of the phase II RADAR study.
- Authors
Maass, Nicolai; Harbeck, Nadia; Mundhenke, Christoph; Lerchenmüller, Christian; Barinoff, Jana; Lück, Hans-Joachim; Ettl, Johannes; Aktas, Bahriye; Kümmel, Sherko; Rösel, Siegfried; Wagner, Steffen; Müller, Lothar; Bischoff, Joachim; Lübbe, Kristina; Schwedler, Kathrin; Schmidt, Marcus; Bauerschlag, Dirk; Nekljudova, Valentina; von Minckwitz, Gunter; Loibl, Sibylle
- 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.
- Subjects
EVEROLIMUS; BREAST cancer patients; BREAST cancer treatment; BONE metastasis; OSTEOCLASTS; PLACEBOS; HEALTH outcome assessment
- Publication
Journal of Cancer Research & Clinical Oncology, 2013, Vol 139, Issue 12, p2047
- ISSN
0171-5216
- Publication type
Article
- DOI
10.1007/s00432-013-1518-x