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 Cytotoxic agents
Prostate Cancer
Therapy
Biological therapy
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

Abstract

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.