783P - Preliminary results of a phase II study of weekly cabazitaxel in "unfit" metastatic castration-resistant prostate cancer (mCRPC) patients progressi...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Prostate Cancer
Cancer in Special Situations
Biological Therapy
Presenter Begoña Pérez-Valderrama
Citation Annals of Oncology (2014) 25 (suppl_4): iv255-iv279. 10.1093/annonc/mdu336
Authors B. Pérez-Valderrama1, B. Mellado2, M.J. Juan3, O. Fernandez4, E. Fernández-Parra5, M. Ochoa de Olza6, D.E. Castellano7, U. Anido8, M. Domenech9, S. Hernando10, J. Arranz Arija11, C. Caballero12, I. Duran1, M. Campayo13, M. Chilet3, M. Climent14
  • 1Departamento De Oncologia, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 2Oncology Department, Hospital Clínic de Barcelona, Barcelona/ES
  • 3Oncología Médica, Instituto Valenciano de Oncología, Valencia/ES
  • 4Medical Oncology, Complexo Hospitario de Ourense, 32005 - Ourense/ES
  • 5Medical Oncology, Hospital Nuestra Señora de Valme, Seville/ES
  • 6Medical Oncology, Institut Catala d'Oncologia L'Hospitalet, 08908 - L'Hospitalet de Llobregat/ES
  • 7Medical Oncology, Hospital Universitario 12 de Octubre, Madrid/ES
  • 8Oncology Department, Complexo Hospitalario Universitario de Santiago de Compostela, A Coruña/ES
  • 9Oncology, ALthaia, Xarxa Assistencial de Manresa, 08243 - Manresa/ES
  • 10Medical Oncology, Hospital Universitario Fundación Alcorcón, Alcorcón/ES
  • 11Servicio De Oncologia Medica, Hospital General Universitario Gregorio Marañon, Madrid/ES
  • 12Oncología Médica, Hospital General Universitario de Valencia, Valencia/ES
  • 13Oncologia Medica, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 14Medical Oncology Department, Instituto Valenciano de Oncologia, 46009 - Valencia/ES



Cabazitaxel (C), a novel taxane developed to overcome docetaxel (D) resistance, showed an overall survival improvement after D in mCRPC in a three-weekly dose schedule. We aimed to evaluate efficacy and safety of a weekly C/prednisone (P) schedule in "unfit" mCRPC patients previously treated with D.


Unfit pts (ECOG 2, dose reduction due to febrile neutropenia during treatment with D or radiation therapy affecting more than 25% of bone marrow reserve) with mCRPC progressing after D treatment with adequate bone marrow, liver and kidney functions were included. C 10 mg/m2 was administered on days 1, 8, 15 and 22 of 5-week cycles with P (5 mg b.i.d.). Radiological and PSA responses were evaluated according to the PCWG2 (Scher H, 2008) criteria and toxicity according NCI-CTC AE.


To date 69 pts have been enrolled and data are available for 54. Median age was 73 y (range 54-83); 59% pts had ECOG 2, 83% had bone, 19% liver and 9% lung metastases. 50% had Gleason > 7. Twenty three pts (43%) achieved ≥50% PSA response and 19 (35.2%) ≥80% PSA response. Response was evaluable in 28 pts. PR was observed in 1 pt (3.6%) and SD in 18 pts (64.3%). Median PSA PFS was 5.9 months. Median overall survival was 8.3 months. Most frequent toxicities of all grades as percentage of pts were: anemia (44.4%), asthenia (22.2%), thrombocytopenia (27.8%), leukopenia (18.5%), diarrhea (11.1%), nauseas (11.1%), neutropenia (5.6%), peripheral neuropathy (5.6%), and anorexia (3.7%). Grade 3-4: thrombocytopenia (20.4%), anemia (7.5%), leucopenia (3.8%), neutropenia (1.9%), asthenia (1.9%), diarrhea (1.9%), anorexia (1.9%), and peripheral neuropathy (1.9%). No grade IV diarrhea nor febrile neutropenia was observed.


Administration of weekly C (10 mg/m2) plus P to unfit pts seems efficacious and safe with no grade 4 neutropenia, diarrhea or febrile neutropenia reported.

Funding: Sanofi


All authors have declared no conflicts of interest.