Regional analysis of a cohort compassionate-use program (CUP) and early access program (EAP) with cabazitaxel (Cbz) plus prednisone (P; Cbz + P) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel (D).

Authors

null

Zafar Malik

Clatterbridge Cancer Centre, Bebington, United Kingdom

Zafar Malik , Giuseppe di Lorenzo , Sergio Bracarda , Alexandros Ardavanis , Mert Basaran , Phillip Parente , Wito de Schultz , Fred Saad , Inge van Oort , Winald R. Gerritsen , Luis M. Antón Aparicio , Geoffrey Matus , Simon Hitier , Axel Heidenreich , Amit Bahl

Organizations

Clatterbridge Cancer Centre, Bebington, United Kingdom, Medical Oncology, GU Cancer Section, University Federico II, Napoli, Italy, Medical Oncology, Ospedale San Donato USL8, Istituto Toscano Tumori (ITT), Arezzo, Italy, St. Savas Anticancer Hospital, Athens, Greece, Institute of Oncology, Istanbul University, Istanbul, Turkey, Eastern Health Clinical School, Box Hill Hospital, Monash University, Melbourne, Australia, Klinik für Urologie, Asklepios Klinik, Weissenfels, Germany, University of Montreal Hospital Center, CRCHUM, Montreal, QC, Canada, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands, Oncology Department, Hospital Juan Canalejo, A Coruña, Spain, Centre Hospitalier Chrétien-Liège, Clinique Saint-Joseph, Liège, Belgium, Sanofi, Chilly-Mazarin, France, University Hospital Aachen, Aachen, Germany, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom

Research Funding

Pharmaceutical/Biotech Company

Background: Cbz is an established second-line treatment for pts with mCRPC, having demonstrated an overall survival benefit (with P) vs mitoxantrone with P in the Phase III TROPIC trial. The global CUP (CABAZ_C_05005) and EAP (NCT01254279) (both funded by Sanofi) aimed to provide access to Cbz + P before commercial availability and to document safety in a real-world population. We present a regional analysis of interim data from the CUP and EAP. Methods: Expected total enrolment is 1,450 pts. Pts received Cbz 25 mg/m2 IV Q3W + P 10 mg QD until disease progression (PD), death, unacceptable toxicity or physician/pt decision. Granulocyte colony-stimulating factor (G-CSF) was administered per ASCO guidelines. The cut-off date for this analysis was 30 May 2012. Results: Globally, 1,301 pts have been included from eight regions (Eastern Europe [EE], Western Europe [WE], Northern Europe [NE] and Southern Europe [SE]; Asia [As]; Canada [Ca]; Latin America [LA]; and Australia [Aus]). Key data by region are shown in the Table. Median age varied from 65 years (Ca) to 70 years (Aus, LA, SE). In pts who progressed after last D line, time from last D dose to last PD ranged from 2.3 months (EE, LA) to 6.6 months (Ca). G-CSF use (therapeutic or prophylactic) at Cycle 1 varied widely between regions, from 23% (WE) to 79% (As). Between 11% (LA) and 30% (NE) of patients received ≥10 cycles of Cbz. Conclusions: In this extensive, real-world CUP/EAP cohort of mCRPC pts, substantial regional variation was observed for baseline and on-treatment parameters, including time from last D dose to last PD and G-CSF use. The low proportion of patients receiving ≥10 cycles in LA, Ca and WE may result from a limit of 10 cycles of therapy in some centers. Clinical trial information: NCT01254279.

Region Pts,
n
Age,
years,
median
Time from last
D dose to last PD,
months, median
(patients who
progressed after
last D line only)
Patients
progressing
during last D
line, %
≥10 cycles
of cabazitaxel,
%
G-CSF at
Cycle 1,
%
As 172 68 2.8 21 20 79
Aus 104 70 4.1 16 23 48
Ca 61 65 6.6 13 12 33
EE 46 67 2.3 15 24 44
LA 40 70 2.3 25 11 35
NE 197 67 5.3 12 30 70
SE 458 70 5.0 13 18 61
WE 223 68 3.7 25 13 23

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Abstract Details

Meeting

2014 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session B: Prostate, Penile, Urethral, and Testicular Cancers, and Urothelial Carcinoma

Track

Urothelial Carcinoma,Prostate Cancer,Penile, Urethral, and Testicular Cancers

Sub Track

Prostate Cancer

Clinical Trial Registration Number

NCT01254279

Citation

J Clin Oncol 32, 2014 (suppl 4; abstr 242)

DOI

10.1200/jco.2014.32.4_suppl.242

Abstract #

242

Poster Bd #

D10

Abstract Disclosures