932P - Tolerability of cabazitaxel in senior adults with metastatic castration-resistant prostate cancer (mCRPC) in Europe

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anticancer agents
Geriatric Oncology
Prostate Cancer
Therapy
Biological Therapy
Presenter Axel Heidenreich
Authors A. Heidenreich1, S. Bracarda2, M. Mason3, H. Ozen4, L. Sengelov5, W.R. Gerritsen6, C. Papandreou7, S. Fossa8, S. Hitier9, M. Climent10
  • 1Urology, RWTH Aachen University, 50274 - Aachen/DE
  • 2Department Of Oncology, Medical Oncology Arezzo, 52100 - Arezzo/IT
  • 3Institute Of Cancer & Genetics, Cardiff University, CF142TL - Cardiff/UK
  • 4Urology, Hacettepe University Medical Faculty, 06100 - Ankara/TR
  • 5Oncology Department R, Herlev University Hospital, DK-2730 - Herlev/DK
  • 6Medical Oncology, University Medical Center Nijmegen, 6525 GA - Nijmegen/NL
  • 7Medical Oncology, Larissa University Hospital, 41110 - Larissa/GR
  • 8Medical Oncology, Oslo University Hospital, Oslo/NO
  • 9Statistics, Sanofi, 75008 - Paris/FR
  • 10Medical Oncology, Instituto Valenciano de Oncologia, 46009 - Valencia/ES

Abstract

Background

Cabazitaxel (CBZ), a novel taxane developed to overcome docetaxel resistance, has been shown to prolong overall survival compared with mitoxantrone in mCRPC patients (pts) who progressed during or after a docetaxel (D)-based therapy. Compassionate Use (CUP) and Early-Access (EAP) Programs are allowing access to the drug before its commercial availability. This interim analysis of the European part of the CUP/EAP focuses on the safety profile of CBZ in elderly population.

Methods

As of September 1st 2011, 746 pts (range 44-86 years; ≥70 years, n = 325; <70 years, n = 421) were enrolled. They received CBZ (25mg/m every 3 weeks + 10 mg oral prednisone/prednisolone daily throughout the cycle) until disease progression, death, unacceptable toxicity or physician/pt decision.

Results

Baseline clinical characteristics of pts aged ≥70 years (group A) or <70 years (group B) were comparable. Most had a good performance status (ECOG 0-1, 89.5%) and ≥2 metastatic sites (59.5%), mainly located in bone (91.7%), regional (31.6%) or distant (30.1%) lymph nodes, lung (11.7%) and liver (11.2%). Pts received a median of 8 cycles (range 1–69) of D. Overall, 16.4% of pts progressed during D and 83.6% after D (within a median of 4.2 months). Median number of administered CBZ cycles was 4 (range 1-16) with a median relative dose intensity of 99%. Dose delay due to CBZ treatment emergent adverse event (TEAE) was needed in 12.9% of pts (A = 10.6%; B = 14.7%), dose reduction in 17.4% of pts (A = 16%; B = 18.5%) and 15.8% of pts discontinued CBZ due TEAE (A = 19.1%; B = 13.3%). Main grade ≥3 toxicities were neutropenia (A = 19.7%; B = 15.0%), leukopenia (A = 8.9%; B = 6.2%), febrile neutropenia (A = 5.5%; B = 5.2%), anaemia (A = 4.3%; B = 5.0%), asthenia (A = 4.9%; B = 1.4%), fatigue (A = 4.3%; B = 4.0%) and diarrhoea (A = 2.2%; B = 3.3%). Grade ≥3 peripheral neuropathy was uncommon (A = 0.3%; B = 0%). At cycle 1, G-CSF was used in 52% of pts (A = 58.5%; B = 47.0%), mainly prophylactically (A = 48%; B = 39.2%). In all, 2.0% of pts experienced AEs leading to death and possibly related to CBZ (A = 2.2%; B = 1.9%), in most cases in a context of neutropenic infection.

Conclusions

This interim analysis of European CUP/EAP suggests that Cabazitaxel-related side effects are manageable in elderly population with mCRPC.

de Bono et al. Lancet 2010; 376:1147–54

Disclosure

A. Heidenreich: Advisory relationship with Astellas, Jansen Cilag, Sanofi, Ipsen, Takeda Honoraria received from Amgen, Astellas, Glaxo, Ipsen, Jansen Cilag, Pfizer, Sanofi, Takeda,

S. Bracarda: Advisory relationship with Sanofi and Janssen and honoraria from Sanofi,

M. Mason: Honoraria and lecture fees from Sanofi, Ferring,BMS, Takeda, Janssen Chair and member of advisory boards for Sanofi,

L. Sengelov: Investigator in Sanofi clinical trial,

W. Gerritsen: Member of advisory board for Sanofi,

C. Papandreou: I participated to 2 advisory boards for Sanofi,

S. Fossa: Honoraria from Janssen and Sanofi,

S. Hitier: Sanofi employee,

M. Climent: Advisory relationship and honoraria from Sanofi.

All other authors have declared no conflicts of interest.