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 Anti-Cancer Agents & Biologic Therapy
Prostate Cancer
Cancer in Special Situations
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.