Abstract | Background: Patients and methods: The primary objectives were to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of cabazitaxel plus abiraterone (phase I), and the prostate-specific antigen (PSA) response defined as a ≥ 50% decrease confirmed ≥3 weeks later with this combination (phase II). Results: Ten patients were enrolled in the phase I component; nine were evaluable. No DLTs were identified. The MTD was established as the approved doses for both drugs ( cabazitaxel 25 mg/m2 every 3 weeks and abiraterone 1000 mg once daily). Daily abiraterone treatment did not impact on cabazitaxel clearance. Twenty-seven patients received cabazitaxel plus abiraterone plus prednisone (5 mg twice daily) in phase II. The median number of cycles administered ( cabazitaxel) was seven (range: 1-28). Grade 3-4 treatment-emergent adverse events included asthenia (in 5 patients; 14%), neutropenia (in 5 patients; 14%) and diarrhea (in 3 patients; 8%). Nine patients (24%) required dose reductions of cabazitaxel. Of 26 evaluable patients, 12 achieved a PSA response [46%; 95% confidence interval (CI): 26.6-66.6%]. Median PSA-progression-free survival was 6.9 months (95% CI: 4.1-10.3 months). Of 14 patients with measurable disease at baseline, 3 (21%) achieved a partial response per response evaluation criteria in solid tumors. Conclusions:
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Authors | C Massard, J Mateo, Y Loriot, C Pezaro, L Albiges, N Mehra, A Varga, D Bianchini, C J Ryan, D P Petrylak, G Attard, L Shen, K Fizazi, J de Bono |
Journal | Annals of oncology : official journal of the European Society for Medical Oncology
(Ann Oncol)
Vol. 28
Issue 1
Pg. 90-95
(01 01 2017)
ISSN: 1569-8041 [Electronic] England |
PMID | 28039155
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article)
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Copyright | © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. |
Chemical References |
- Androstenes
- Taxoids
- Docetaxel
- cabazitaxel
- Prostate-Specific Antigen
- abiraterone
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Topics |
- Aged
- Androstenes
(administration & dosage, adverse effects, pharmacokinetics)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Disease Progression
- Disease-Free Survival
- Docetaxel
- Humans
- Kaplan-Meier Estimate
- Male
- Maximum Tolerated Dose
- Middle Aged
- Neoplasm Metastasis
- Neoplasm Recurrence, Local
(drug therapy)
- Prostate-Specific Antigen
(blood)
- Prostatic Neoplasms, Castration-Resistant
(drug therapy, mortality, pathology)
- Taxoids
(administration & dosage, adverse effects)
- Treatment Outcome
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