Everolimus as treatment for breast cancer patients with bone metastases only: results of the phase II RADAR study.
J Cancer Res Clin Oncol
; 139(12): 2047-56, 2013 Dec.
Article
en En
| MEDLINE
| ID: mdl-24072232
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 ANDMETHODS:
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.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
6_ODS3_enfermedades_notrasmisibles
Problema de salud:
6_breast_cancer
/
6_other_malignant_neoplasms
Asunto principal:
Neoplasias Óseas
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Neoplasias de la Mama
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Sirolimus
/
Antineoplásicos
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Aged
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Female
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Humans
/
Middle aged
Idioma:
En
Revista:
J Cancer Res Clin Oncol
Año:
2013
Tipo del documento:
Article
País de afiliación:
Alemania