Safety of cabazitaxel in senior adults with metastatic castration-resistant prostate cancer: results of the European compassionate-use programme.

Abstract

BACKGROUND:

Cabazitaxel/prednisone has been shown to prolong survival versus mitoxantrone/prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or after docetaxel. Subsequently, compassionate-use programmes (CUPs) and expanded-access programmes (EAPs) were established worldwide, allowing access to cabazitaxel before its commercial availability. Preliminary results of the European CUP/EAP, focusing on the elderly population (aged > or =70 years), are reported.

PATIENTS AND METHODS:

Enrolled patients with progressive mCRPC received cabazitaxel (25 mg/m2) plus 10mg oral prednisone/prednisolone every 3 weeks until disease progression, death, unacceptable toxicity or physician/patient decision. Safety was analysed by age group (<70, 70-74 and > or =75 years). The influence of selected variables on grade > or =3 neutropenia and/or neutropenic complications was analysed in multivariate analysis.

RESULTS:

746 men were enrolled (<70 years, n=421; 70-74, n=180, > or =75 years, n=145). Number of cabazitaxel cycles, dose reductions for any cause, dose delays possibly related to cabazitaxel adverse events, and tolerability were similar in the three age groups. Prophylactic granulocyte colony-stimulating factor (G-CSF) use was more common in men aged > or =0 years. In multivariate analysis, age > or =75 years, treatment cycle 1, and neutrophil count <4000/mm3 before cabazitaxel injection were associated with increased risk of developing grade > or =3 neutropenia and/or neutropenic complications. Prophylactic use of G-CSF at a given cycle significantly reduced this risk by 30% (odds ratio 0.70, p=0.04).

CONCLUSION:

The results suggest that cabazitaxel has a manageable safety profile in everyday clinical practice. Prophylactic use of G-CSF, especially at cycle 1 and in men aged > or =75 years, is important and improves tolerability in senior adults treated with cabazitaxel.

• Authors: Axel Heidenreich, Sergio Bracarda, Malcolm Mason, Haluk Ozen, Lisa Sengelov, Inge Van Oort, Christos Papandreou, Sophie Fossa, Simon Hitier, Miguel Angel Climent, European investigators
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 50 Issue 6 Pg. 1090-9 (Apr 2014) ISSN: 1879-0852 [Electronic] England
• PMID: 24485664 (Publication Type: Journal Article)
• Copyright: Copyright © 2014 Elsevier Ltd. All rights reserved.

Chemical References

• Taxoids
• cabazitaxel
• Prednisolone
• Prednisone

Topics

• Aged
• Aged, 80 and over
• Anemia (chemically induced)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Compassionate Use Trials
• Diarrhea (chemically induced)
• Disease Progression
• Drug Administration Schedule
• Europe
• Humans
• Male
• Middle Aged
• Multivariate Analysis
• Nausea (chemically induced)
• Neoplasm Metastasis
• Neutropenia (chemically induced)
• Prednisolone (administration & dosage, adverse effects)
• Prednisone (administration & dosage, adverse effects)
• Prostatic Neoplasms, Castration-Resistant (drug therapy, pathology)
• Taxoids (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome