1 Oncology, Herlev and Gentofte Hospital, The Capital Region of Denmark2 RWTH Aachen University, Department of Urology, Aachen, Germany. Electronic address: firstname.lastname@example.org Ospedaliero San Donato, Department of Oncology, Arezzo, Italy.4 Cardiff University, Department of Oncology, Wales, UK.5 Hacettepe University, Department of Urology, Ankara, Turkey.6 Radboud University Nijmegen Medical Centre, Department of Urology, Nijmegen, Netherlands.7 Larissa University Hospital, Department of Oncology, Larissa, Greece.8 Oslo University Hospital, Department of Oncology, Oslo, Norway.9 Sanofi, Statistics, Paris, France.10 Fundación Instituto Valenciano De Oncología, Department of Oncology, Valencia, Spain.11 unknown
results of the European compassionate-use programme
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.
European Journal of Cancer (oxford, England : 1990), 2014, Vol 50, Issue 6, p. 1090-9