782P - Safety of cabazitaxel + prednisone (Cbz + P) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Prostate Cancer
Biological Therapy
Presenter Axel Heidenreich
Citation Annals of Oncology (2014) 25 (suppl_4): iv255-iv279. 10.1093/annonc/mdu336
Authors A. Heidenreich1, H. Scholz2, H. Ozen3, C. Pripatnanont4, I.M. van Oort5, W.R. Gerritsen6, E. Efstathiou7, J.A. Rinck Jr8, J. Lee9, A. Boumessous10, Z. Su11, S. Hitier12, A. Ardavanis13
  • 1Department Of Urology, Uniklinik RWTH Aachen, 52074 - Aachen/DE
  • 2Department Of Urology, Asklepios Klinik Weissenfels-Hohenmölsen, Weissenfels/DE
  • 3Department Of Urology, Hacettepe University Medical Faculty, 06100 - Ankara/TR
  • 4Department Of Surgery, Faculty Of Medicine, Prince of Songkla University, Songkla/TH
  • 5Urology, Radboud University Medical Centre, Nijmegen/NL
  • 6Medical Oncology, Radboud University Medical Centre, Nijmegen/NL
  • 7Department Of Clinical Therapeutics, Alexandra Hospital, The University of Athens, 11528 - Athens/GR
  • 8Department Of Clinical Oncology, A. C. Camargo Cancer Center, BR-01509-010 - Sao Paulo/BR
  • 9Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KP
  • 10Oncology, Sanofi, Vitry/FR
  • 11Oncology, Sanofi, Cambridge/US
  • 12Biostatistcs & Programming, Sanofi, Chilly-Mazarin/FR
  • 131st Department Of Medical Oncology, St. Savvas Hospital, 15773 - Athens/GR



In the Phase III TROPIC trial, Cbz + P improved survival vs. mitoxantrone + P in pts with mCRPC previously treated with DOC (P < 0.0001). A CUP was initiated to provide pre-licensing access to Cbz + P and assess real-world safety.


Cbz 25 mg/m2 Q3W + P 10 mg QD were given until disease progression, death, unacceptable toxicity or physician/pt decision. Pts were followed for ≥30 days after last dose. Granulocyte colony-stimulating factor (G-CSF) was recommended in pts at risk of neutropenic complications.


In total, 451 pts were enrolled in 12 countries (∼70 sites) worldwide. Median age was 68 years (range 43–84), median time from last DOC to first Cbz + P dose was 4.4 months, and median cumulative last DOC dose was 675 mg/m2. A total of 24.3% of pts progressed during last-line DOC. Most pts (90.0%) had ECOG performance status ≤1 and 59.9% had ≥2 metastatic sites. Median number of Cbz + P cycles was 5 (range 1–34). Treatment was discontinued due to progression in 40.8% and adverse event (AE) in 21.7%. Dose reductions (17.3%) and delays (36.4%) were due to related AEs in 15.3% and 15.7%, respectively. During the study, 248 pts (55.0%) received G-CSF, 214 (47.5%) at Cycle 1. In pts with prophylactic G-CSF use at Cycle 1 (n = 137, 30.4%), neutropenia and febrile neutropenia occurred in 4.4% and 0.7%, respectively; in pts without G-CSF at Cycle 1, respective rates were 7.6% and 1.7%. Treatment-emergent AEs (TEAEs) occurred in 83.4% (Grade 3/4 51.0%) and TEAEs related to treatment in 72.9% (Grade 3/4 41.2%). Most frequent Grade 3/4 TEAEs related to Cbz + P were neutropenia (16.9%), febrile neutropenia (8.9%), anaemia (6.0%), leukopenia (5.1%) and fatigue (4.0%). 30 deaths (6.7%) occurred, due to progression, AE or other reasons during the on-treatment period (first dose – 30 days after last dose), or due to possibly related AEs during follow up.


In pts with prior taxane exposure, Cbz + P had a predictable, manageable safety profile consistent with the TROPIC trial. A low rate of neutropenic complications in pts with prophylactic G-CSF at Cycle 1 supports use of G-CSF to prevent haematological AEs in pts at risk.


A. Heidenreich: has provided a consultancy role and been a member of advisory boards for Astellas, Bayer, Janssen-Cilag, Sanofi Aventis, TEVA, and Dendreon, and has received research funding from Astellas and Sanofi Aventis;H. Ozen: has been a member of advisory boards for Sanofi, Janssen and Astellas;

I.M. van Oort: has been a member of advisory boards for Sanofi, Astellas, Janssen and Bayer;

W.R. Gerritsen: D has been a member of advisory boards for Sanofi;

E. Efstathiou: has provided a consultancy role, received honoraria and been a member of advisory boards for Johnson and Johnson, Sanofi, Millennium/Takeda and Bayer; J. Lee: has received research funding from Bayer; A. Boumessous: is an employee of Sanofi; Z. Su: is an employee and stock holder of Sanofi.

S. Hitier: is an employee and stock holder of Sanofi. All other authors have declared no conflicts of interest.