Cabazitaxel in patients with advanced CRPC after docetaxel failure: Results of expanded program access (EAP) in Spain: Safety and efficacy.

Abstract

e15149 Background: Cabazitaxel is the new chemotherapy standard as second line in castrate resistant prostate cancer (CPRC) [Tropic Trial, Lancet 2010]. The aim of this study was to analyze the baseline characteristics and outcomes in a different cohort of patients (pts) from six hospitals in Spain within to EAP. Methods: We report a cohort of 65 pts including in EAP trial, who have progressed on or after docetaxel-based chemotherapy. Cabazitaxel was administered a standard dose of 25 mg/m2 IV q3wks. All pts had proven histology confirmation of prostate adenocarcinoma and progressive disease (radiologic and/or rising PSA) at the beginning of the treatment. Results: We collected data of 65 pts between 3-2011 to 12-2012. Median age was 63 years (range 45-83) and ECOG 0-1-2 in 26%-58%-16% respectively. Median basal PSA was 864 and Gleason grade was 7. Seventy-eight percent had bone metastases, 33% ganglionar metastases and 14% visceral metastases. Previous therapy was: hormonal, median 2 lines and chemotherapy was median of 1.6 lines. Thirty percent (20 pts) had received ketoconazole. Median of previous docetaxel dose was 1029 mg/m2(50-3750). Seventy percent of pts received G-CSF as primary prophylaxis in any cycle, 24% (16pts) had grade >3 neutropenia and 6 pts (9%) had febrile neutropenia. Other toxicities were: g3 anemia 3pts (4,6%), g3 asthenia 5pts (7,7%), g3 diarrhea 1 pt (1,5%). No toxic death was reported. The PSA response rate to cabazitaxel was 64% (31pts) and the median of cabazitaxel cycles administered was 6 at last follow-up. Median progression free survival was 4.4 months (2.7-6.1). Conclusions: These results confirm the efficacy and safety of cabazitaxel in this setting. Similar baselines parameters to Tropic trial were observed. This data reflex that Cabazitaxel in CRPC pts after docetaxel failure require the use of G-CSF in daily clinical practice.