953 - Cabazitaxel in patients with advanced CRPC after docetaxel-failure. Results of Expanded Program Access (EAP) in Spain: safety and efficacy

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anti-Cancer Agents & Biologic Therapy
Prostate Cancer
Presenter Daniel E. Castellano
Authors D.E. Castellano1, L.M. Anton Aparicio2, E. Esteban3, G. Velasco1, Q. Perez4, A. Sanchez5, B. Pérez-Valderrama6, N. Batista7
  • 1Medical Oncology Department, University Hospital 12 de Octubre, Madrid/ES
  • 2Medical Oncology Department, Complejo Hospitalario A Coruña, A Coruña/ES
  • 3Hospital Universitario Central de Asturias, Oviedo/ES
  • 4Hospital Universitario Central de Asturias, 33006 - Oviedo/ES
  • 5Medical Oncology Department, Hospital Provincial de Castellon, Castellon/ES
  • 6Medical Oncology, Hospital Virgen del Rocío, Seville/ES
  • 7Medical Oncology Department, Hospital Universitario de Canarias, Las Palmas/ES



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)


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.


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).


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)


All authors have declared no conflicts of interest.