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Cabazitaxel plus prednisone for metastatic castration-resistant prostate cancer progressing after docetaxel: results from the German compassionate-use programme.
- Source :
-
European urology [Eur Urol] 2013 Jun; Vol. 63 (6), pp. 977-82. Date of Electronic Publication: 2012 Sep 03. - Publication Year :
- 2013
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Abstract
- Background: Cabazitaxel (Cbz) is an approved second-line treatment in metastatic castration-resistant prostate cancer (mCRPC) following docetaxel therapy with a significant survival benefit compared with mitoxantrone. However, grade 3/4 toxicities were reported in 82% of patients.<br />Objective: To report on the safety results of mCRPC patients treated within a compassionate-use programme in Germany.<br />Design, Setting, and Participants: A total of 111 patients with a mean age of 67.9 yr (range: 49-81 yr) and progressive mCRPC were included. Patients had received a mean number of 12.7 ± 10.8 cycles (range: 6-69 cycles) of docetaxel with a mean cumulative dose of 970.9 mg/m(2); mean time from last docetaxel application to progression was 6.95 mo (range: 2-54 mo). Of the patients, 31.5% progressed by prostate-specific antigen (PSA) increase only; the remainder had a combination of PSA increase and clinical progression.<br />Intervention: Cbz at a dosage of 25mg/m(2) intravenously every 3 wk combined with 5mg of oral prednisone twice a day.<br />Outcome Measurements and Statistical Analysis: Treatment-associated toxicity was the primary study end point; progression-free and overall survival were secondary end points. A descriptive statistical analysis was performed.<br />Results and Limitations: Patients received a mean number of 6.5 ± 2.2 cycles of Cbz and a mean cumulative dose of 160.3 ± 51.5mg/m(2). Grade 3 and 4 treatment-emergent adverse events were recorded in 34 patients (30.6%) and 18 patients (16.2%), respectively. Grade 3/4 anaemia, neutropenia, and thrombocytopenia were reported in 4.5%, 7.2%, and 0.9% of the patients, respectively. Neutropenic fever was reported in 1.8% of the patients. Grade 3/4 gastrointestinal toxicity was identified in 4.5% of the patients. Three patients died because of Cbz-related toxicity. Granulocyte colony-stimulating growth factors were used in 17.1% of patients. The limitations are due to the nonrandomised nature of the trial.<br />Conclusions: Treatment with Cbz is tolerable and is associated with a low incidence of serious adverse events in a real-world patient population with CRPC. The outcome of serious adverse events can be minimised with proactive treatment management and conscientious monitoring.<br /> (Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
- Subjects :
- Aged
Aged, 80 and over
Anemia chemically induced
Compassionate Use Trials
Disease-Free Survival
Docetaxel
Fever chemically induced
Fever complications
Germany
Humans
Kallikreins
Male
Middle Aged
Neutropenia chemically induced
Neutropenia complications
Prednisone administration & dosage
Prostate-Specific Antigen
Prostatic Neoplasms mortality
Prostatic Neoplasms pathology
Taxoids administration & dosage
Thrombocytopenia chemically induced
Treatment Failure
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols adverse effects
Prostatic Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1873-7560
- Volume :
- 63
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- European urology
- Publication Type :
- Academic Journal
- Accession number :
- 23116658
- Full Text :
- https://doi.org/10.1016/j.eururo.2012.08.058