Abstract 627P
Background
CARD demonstrated superiority of CBZ over abiraterone (ABI) or enzalutamide (ENZ) in pts with mCRPC who had previously received docetaxel (DOC) and progressed ≤ 12 months on the alternative androgen receptor-targeted agent (ARTA; de Wit et al, N Engl J Med 2019). We evaluated a large real-world dataset comparing characteristics of pts receiving CBZ after DOC and one ARTA with the CARD-eligible population.
Methods
Medimix LiveTrackerTM, a retrospective, global oncology database of healthcare professional-reported electronic pt medical forms, was used to identify pts with mCRPC who received CBZ and prior DOC and ABI or ENZ (in any order), between 2001 and 2019. Only pts with available CBZ treatment duration were included.
Results
In total, 452 pts were included in the RWE cohort. Median age was similar to CARD (73 vs 70 years); Eastern Cooperative Oncology Group performance status score ≥ 2 was greater in the RWE cohort (45% vs 4.7%). More pts in the RWE cohort vs CARD received prior ARTA before DOC (48% vs 39%; ABI 57% vs 43%; ENZ 43% vs 56%) and had prior ARTA treatment duration > 12 months (30% vs 17%; Table). Pts in the RWE cohort had more aggressive disease features vs CARD: M1 at diagnosis (46% vs 38%) and Gleason 8–10 (65% vs 57%), although the proportion of pts with visceral metastases (12% vs 16%) was comparable with CARD. Despite more pts in the RWE cohort vs CARD receiving the lower CBZ dose (20 mg/m2 dose; 55% vs 21%), CBZ treatment duration in the RWE cohort was comparable with CARD (21.9 vs 22.0 weeks).
Conclusions
The RWE cohort demonstrates that for most pts receiving ARTA and DOC followed by CBZ, the ARTA was received for ≤ 12 months. Despite having a poorer performance status and more aggressive disease features, duration of CBZ was similar to the CARD study. These results may imply that the CARD study is reflective of the real-world setting.
Clinical trial identification
Editorial acknowledgement
Editorial assistance was provided by Danielle Walsh of MediTech Media, funded by Sanofi.
Legal entity responsible for the study
Sanofi Genzyme.
Funding
Sanofi.
Disclosure
R. de Wit: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Sanofi; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Merck Sharp & Dohme; Advisory/Consultancy: Roche/Genetech; Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bayer; Advisory/Consultancy: Clovis Oncology; Travel/Accommodation/Expenses: Lilly. S. Freedland: Research grant/Funding (self), Personal fee: Pfizer; Advisory/Consultancy, Personal fee: Astellas; Advisory/Consultancy, Personal fee: Janssen; Advisory/Consultancy, Personal fee: Bayer; Advisory/Consultancy, Personal fee: Myovant; Advisory/Consultancy, Personal fee: AstraZeneca; Advisory/Consultancy, Personal fee: Merck; Advisory/Consultancy, Personal fee: Dendreon; Advisory/Consultancy, Personal fee: Sanofi. S. Oudard: Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Travel/Accommodation/Expenses: Bayer; Honoraria (self), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Travel/Accommodation/Expenses: Merck; Honoraria (self), Travel/Accommodation/Expenses: Janssen; Honoraria (self), Travel/Accommodation/Expenses: Astellas; Travel/Accommodation/Expenses: Sanofi. G. Marinov: Advisory/Consultancy, Personal fee (contracted by Sanofi): Sanofi. P. Capart: Full/Part-time employment: Medimix; Advisory/Consultancy, Personal fees (contracted by Sanofi): Sanofi. A. Combest: Full/Part-time employment: Medimix; Advisory/Consultancy, Personal fees (contracted by Sanofi): Sanofi. R. Peterson: Full/Part-time employment: Sanofi. A. Ozatilgan: Shareholder/Stockholder/Stock options, Full/Part-time employment: Sanofi. A. Morgans: Advisory/Consultancy, Personal fees: Janssen; Advisory/Consultancy, Personal fees: Astellas; Advisory/Consultancy, Personal fees: Seattle Genetics; Advisory/Consultancy, Personal fees: Genentech; Advisory/Consultancy, Research grant/Funding (self), Personal fees: Bayer.