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
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 Disclosures
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First Author: Zafar I. Malik
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