3228 - Treatment outcomes of 3rd treatment in a real-world metastatic castration resistant prostate cancer (mCRPC) population: results from the Dutch CAPRI-registry

Background

Data on outcomes of a 3^rd line life prolonging drug (LPD) in patients with metastatic castration resistant prostate cancer (mCRPC) is lacking. Aim of this study was to evaluate outcomes of a 3^rd LPD in a real-world cohort of mCRPC patients.

Methods

mCRPC patients with a 3^rd LPD before July 1^st 2017 were retrospectively identified from the Dutch Castration-resistant Prostate Cancer Registry (CAPRI) and followed to December 31^st 2017. Outcomes were overall survival (OS), treatment duration (TD) and PSA response. The association of potential risk factors with death was tested by Cox proportional-hazard models after multiple imputation of missing baseline characteristics.

Results

We identified 602 patients treated with a 3^rd LPD. Baseline characteristics are listed in the table. Median OS was 7.8 mo (IQR 4.4-14.0), median TD was 3.2 mo (IQR 1.9-4.7) and PSA response (≥ 50% decline) was observed in 131 patients (22%). ECOG PS of 1 and >1 (HR 1.48, p < 0.01 and HR 1.75, p < 0.01, respectively), opioid use (HR 1.51, p < 0.01), symptoms (HR 1.50, p = 0.04), visceral metastases (HR 2.11, p < 0.01), PSA ≥170 ug/l (HR 1.32, p < 0.01), alkaline phosphatase ≥150 U/l (HR 1.66, p < 0.01) and time from CRPC to start 3^rd LPD <24 mo (HR 1.56, p < 0.01) were related to shorter survival in multivariable analysis. Patients were categorized into low (0-1 point, n = 81), low-intermediate (2-3 points, n = 262), high-intermediate (4-5 points, n = 208) and high risk (6-7 points, n = 51) prognosis groups based on the number of prognostic factors and their regressions coefficients. These groups had a median OS of 20.4, 11.0, 6.6 and 3.9 mo, with a median TD of 4.6, 3.4, 2.6 and 1.9 mo, respectively (p < 0.01).Table:

865P Baseline characteristics at start of a 3rd line line prolonging drug (LPD) treatment

Note: Data are defined as ^amean ± SD, ^bmedian (IQR) or ^cnumber of patients (%). Abbreviations: CRPC; Castration-resistant prostate Cancer, ECOG PS;

Eastern Cooperative Oncology Group Performance Score.

Conclusions

Our results show that the efficacy of a 3^rd LPD in mCRPC patients was limited compared to pivotal trials of 1^st and 2^nd line. We used a simple prognostic model to identify mCRPC patients that can benefit from a 3^rd LPD.

Clinical trial identification

NL3440 (NTR3591).

Editorial acknowledgement

Legal entity responsible for the study

Institute for Medical Technology Assessment, Erasmus University Rotterdam.

Funding

Sanofi-Aventis Netherlands B.V., Janssen-Cilag B.V., Astellas Pharma B.V., Bayer B.V.

Disclosure

M.C.P. Kuppen: Travel / Accommodation / Expenses: Ipsen. H.M. Westgeest: Travel / Accommodation / Expenses: Ipsen; Honoraria (self): Roche. A.J.M. van den Eertwegh: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Oncology; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: Ipsen; Honoraria (institution), Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Amgen; Advisory / Consultancy: Novartis; Advisory / Consultancy: Merck. J. Van Moorselaar: Honoraria (institution), Advisory / Consultancy: Amgen; Honoraria (institution), Advisory / Consultancy: Astellas; Honoraria (institution), Advisory / Consultancy: AstraZeneca; Honoraria (institution), Advisory / Consultancy: Bayer; Honoraria (institution), Advisory / Consultancy: Janssen; Honoraria (institution), Advisory / Consultancy: Sanofi-Genzyme. N. Mehra: Research grant / Funding (institution): Astellas; Honoraria (self), Research grant / Funding (institution): Janssen; Research grant / Funding (institution): Pfizer; Honoraria (self), Research grant / Funding (institution): Sanofi; Honoraria (self), Research grant / Funding (institution): Roche; Honoraria (self): Merck; Honoraria (self): Bayer; Honoraria (self): BMS; Honoraria (self): MSD. J.L. Coenen: Advisory / Consultancy: Sanofi. I. van Oort: Advisory / Consultancy, Research grant / Funding (institution): Astellas; Advisory / Consultancy, Research grant / Funding (institution): Janssen; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy: Roche; Advisory / Consultancy: Mdx Health; Advisory / Consultancy: Astellas. D.M. Somford: Research grant / Funding (institution): Astellas. R. de Wit: Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Sanofi; Honoraria (institution), Advisory / Consultancy: Merck; Honoraria (institution), Advisory / Consultancy: Sharp&Dohme; Advisory / Consultancy: Roche/ Genentech; Advisory / Consultancy: Janssen; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy: Clivis; Travel / Accommodation / Expenses: Lilly. A.M. Bergman: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Speaker Bureau / Expert testimony: Janssen. C. Uyl-de Groot: Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Astellas; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Sanofi; Research grant / Funding (institution): Janssen-Cilag; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Genzyme; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Glycostem Therapeutics; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Merck. W.R. Gerritsen: Advisory / Consultancy, Speaker Bureau / Expert testimony: Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Speaker Bureau / Expert testimony: Bavarian Nordic; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Speaker Bureau / Expert testimony: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: Janssen-Cilag; Advisory / Consultancy: Amgen; Advisory / Consultancy: Merck; Advisory / Consultancy: Morphosys; Advisory / Consultancy: Sanofi; Advisory / Consultancy, Ad hoc Consultancy: Aglaia Biomedical Ventures; Advisory / Consultancy, Ad hoc Consultancy: Psioxus Therapeutics; Advisory / Consultancy: Curvevac; Advisory / Consultancy: Dendreon. All other authors have declared no conflicts of interest.