The tubulin binding taxane Cabazitaxel in combination with prednisone significantly extended overall survival in men with hormone refractory prostate cancer previously with docetaxel containing treated and provides also for disease control, researchers said on the 26th anniversary of European Association of Urology (EAU) Congress.
Bertrand Tombal, MD, presented the results of its analysis of effect of Cabazitaxel with prednisone on disease control, pain and performance status (PS) measures which in men enrolled in the 755-patient Belgium, and colleagues with Cliniques Universitaires Saint-Luc in Brussels, phase III cancer previously treated treatment of metastatic hormone refractory prostate cancer with TAXOTERE (TROPIC)-study.
Cabazitaxel's recent approval by the European Union for the treatment of men with metastatic hormone refractory prostate cancer previously containing treated with Docetaxel is based on the results of the study of TROPIC. The novel taxane, which therefore significantly extend the first approved agent to survive in this population of men with advanced prostate cancer, was approved Administration (FDA) U.S. food and drug in the last year by the.
Study participants had histologically or cytologically with both disease progression documented during or within six months prior to hormone therapy, as well as progression of the disease during or after the administration of a previous treatment with docetaxel containing prostate cancer diagnosed. They had also measurable disease response evaluation criteria in solid tumors (RECIST) or non-measurable disease of rising prostate specific antigen (PSA) level or the appearance of a new lesion. All men had a European Cooperative Oncology Group (ECOG) carried out performance status (PS) from 0 to 2 and a life expectancy > 2 months.
All men were assigned to prednisone daily and 12 mg / m2 Mitoxantrone or 25 mg / m2 Cabazitaxel all 3 weeks at random 10 mg oral.
A first analysis of the results showed a median overall survival 15.1 months in the Cabazitaxel arm compared to the Mitoxantrone 12, 7 months = arm, HR 0.70, p ?0. 0001. A similar survival benefit seen long-pass filters years in patients ?65 of age and patients.
Results show also disease control rates with Cabazitaxel with prednisone compared to 47.5% with mitoxantrone plus prednisone 61.7% (p = 0.004) in 405 men evaluable tumor response.
The mean number of treatment cycles was in the Cabazitaxel with prednisone Group (6 compared to 4).
Also, the analysis revealed that PS during the treatment in most men (79% of the Cabazitaxel with prednisone patients and 78% of patients of mitoxantrone plus prednisone) remained stable. The deterioration in PS (20% compared to 20%) or improved PS (1% compared to 2%) were similar.
The study also documented similar changes in intensity and analgesic use in the treatment of two cohorts.
Amit Bahl, MD, with Bristol & Hematology Oncology Centre in Bristol, UK, said that with high risk and advanced or metastatic disease several systemic therapies, ideally within the managed multidisciplinary team approach requires. Multidisciplinary teams a urologist should nurse, radiologist, pathologist, specialist Oncology and palliative care specialist include.
Written by Jill stone Jill Stein is Paris-based freelance medical writer.
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