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 Anti-Cancer Agents & Biologic Therapy
Geriatric Oncology
Prostate Cancer
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.