Cabazitaxel in Patients with Advanced CRPC after Docetaxel-Failure. Results of Expanded Program Access (EAP) in Spain: Safety and Efficacy

Background Cabazitaxel is the new chemotherapy standard in second line treatment of metastatic castrate resistant prostate cancer (CPRC) [TROPIC Trial, Lancet 2010]. The aim of this study was to analyze the baseline characteristics and outcomes of a cohort of patients from six Spanish hospitals enrolled in a EAP. (total no of pts: 138) Methods Between 3-2011 and 12-2012, 65 mCRPC pts who have progressed on or after docetaxel-based chemotherapy were treated with Cabazitaxel (25 mg/m2 IV q3wks plus oral prednisone 10mg daily. All pts had proven histology confirmation of prostate adenocarcinoma and progressive disease (radiologic and/or rising PSA) at the beginning of the treatment. Results Median age was 63 years (range 45-83) and ECOG 0-1 in 25%-68% respectively. Median PSA at baseline was 864 ng/ml. Seventy-eight percent had bone metastases, 33% lymph nodes metastases and 14% visceral metastases. Previous therapy was: hormonal, (median 2 lines) and chemotherapy (median 1.6 lines). Thirty percent (20 pts) had received ketoconazole. Median 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 9% (6 pts) had febrile neutropenia. Other grade 3 toxicities were: anemia 3pts (4,6%), asthenia 5pts (7,7%), diarrhea 1 pt (1,5%). No toxic death was reported. The PSA decrease ≥50% was observed in 64% (31pts) and the median number of cycles administered was 6 at last check. Median progression free survival was 4.4 months (2.7-6.1). Conclusions Results of this Spanish EAP confirm the efficacy and manageable safety of Cabazitaxel in daily practice. (CGR I would not comment on GCSF as many countries do not use prophylactic GCSF) Disclosure All authors have declared no conflicts of interest.