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 Anti-Cancer Agents & Biologic Therapy
Prostate Cancer
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.