Real-world experience with cabazitaxel in patients with metastatic castration-resistant prostate cancer: a final, pooled analysis of the compassionate use programme and early access programme
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Zafar Malik1, Axel Heidenreich1,2, Sergio Bracarda3, Alexandros Ardavanis4, Philip Parente5, Hans-Joerg Scholz6, Ayse Ozatilgan7, Evelyne Ecstein-Fraisse8, Simon Hitier9 and Giuseppe Di Lorenzo10
1 The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, UK
2 Department of Urology, Uro-Oncology, Robot-Assisted and Specialized Urologic Surgery, University Hospital Cologne, Cologne, Germany
3 Azienda USL Toscana Sud-Est, Istituto Toscana Tumori (ITT), Ospedale San Donato, Arezzo, Italy
4 Oncology Hospital AGIOS SAVVAS Oncology Clinic, Athens, Greece
5 ECRU-Oncology, Victoria, Australia
6 Asklepios Klink GmbH Weissenfels, Weissenfels, Germany
7 Sanofi, Cambridge, Massachusetts, USA
8 Sanofi, Paris, France
9 Sanofi, Chilly-Mazarin, France
10 Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy
|Zafar Malik,||email:||[email protected]|
Keywords: mCRPC; cabazitaxel; CUP; EAP; real-world
Received: January 08, 2019 Accepted: April 29, 2019 Published: June 25, 2019
Cabazitaxel is a second-generation taxane approved for use in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel. Early access programmes were established to allow eligible patients with mCRPC access to cabazitaxel before regulatory approval.
Materials and Methods
The primary objective was to allow access to cabazitaxel before commercial availability for patients with mCRPC whose disease had progressed during or after chemotherapy with docetaxel; the secondary objective was overall safety. Patients received cabazitaxel 25 mg/m2 on Day 1 of a 21-day cycle, with daily oral 10 mg prednisone/prednisolone. G-CSF was administered per ASCO guidelines.
In total, 1432 patients received cabazitaxel across 41 countries between 2010 and 2014 (median 6.0 treatment cycles [range 1–49]). The most frequently occurring treatment-emergent adverse events (TEAEs) possibly related to treatment were diarrhoea (33.3%), fatigue (25.4%) and anaemia (23.7%); the most frequently occurring possibly related Grade 3/4 TEAEs were neutropenia (18.7%) and febrile neutropenia (6.9%). G-CSF was administered in ≥ 1 cycle in 64% of patients (10.1% therapeutic use; 57.8% prophylactic use; 9.7% both uses).
The safety profile of cabazitaxel in this pooled analysis of two cabazitaxel early access programmes was manageable and consistent with previous Phase III trials (TROPIC, PROSELICA).
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