955 - Safety Data of Cabazitaxel (JEVTANA®) in Patients Treated for Metastatic Castration Resistant Prostate Cancer after Docetaxel Treatment: Results of a Cohort of Patients During the Temporary Authorization for Use in France (ATU)

Abstract

ABSTRACT Background The TROPIC1 study demonstrated that cabazitaxel (a novel tubulin-binding taxane drug) improves overall survival of patients (pts) with metastatic castration resistant prostate cancer (mCRPC) who progressed during or after docetaxel-based chemotherapy, with a median survival of 15.1 months. Based on this result, a compassionate-use program has been established to provide pts with mCRPC with the opportunity to receive treatment with cabazitaxel, before licensing of the drug. Methodology Temporary Authorization for Use (ATU) of cabazitaxel in France has been granted before its marketing authorization; all safety data from pts treated during this period were collected following a specific therapeutic use protocol. All participating physicians were instructed about the molecule and its administration by a company physician and contacted before the first treatment, on day 15 and at the end of treatment of each patient to make sure that all G3/4 and serious adverse events were collected. Results We report baseline characteristics and safety data from the 184 pts treated in 92 French centers. The median age was 67.2 years (46 - 92), ECOG performance status was 0-1 for 85% of pts, 88% had bone metastases and 21% had visceral metastases. All the pts had received prior docetaxel, 55% had discontinued for disease progression; 85% of the patients received 1-2 lines of chemotherapy before cabazitaxel. Patients received a median of 3 cycles of cabazitaxel (1-6). Rates of grade 3-4 hematological toxicities were: neutropenia grade≥ 3 (4%), febrile neutropenia (3%), all resolved. All grade non-hematological toxicities were: nausea (0.5%), diarrhea (2.7%) and fatigue (0.5%). No treatment-related death was reported. Conclusion The ATU program provides additional safety information on cabazitaxel in the real-life setting; they are consistent with the TROPIC study safety results. The incidence of neutropenia grade≥ 3 (4%) and febrile neutropenia (3%) appears to be lower than expected from the TROPIC trial. Therapeutic use protocols such as these can be helpful for physicians and pharmacists when new therapies become available. Proactive education of healthcare givers on AEs management could be considered when new treatments are introduced. 1Johann Sebastien de Bono et al; Lancet Vol 376 October 2, 2010. Disclosure T. Zoubir: Medical Director of Sanofi France. All other authors have declared no conflicts of interest.