Abstract 3816
Background
Radium-223 dichloride (Ra-223) is a targeted alpha-emitter that selectively binds to areas of increased bone turnover in bone metastases. In the ALSYMPCA trial an increased overall survival over placebo in both docetaxel pretreated (14.4 mo) and docetaxel untreated (16.1 mo) patients was shown. With multiple life-prolonging agents (LPD), data on treatment sequencing and outcomes in real-world practice are needed. The aim of this study was to investigate the use of Ra-223 and outcomes in daily practice in the Netherlands.
Methods
Patients treated with Ra-223 in the CAPRI registry were included and followed until 01-01-2018. Subgroups were based on prior use of docetaxel (docetaxel naive, DOC-naïve; post-docetaxel, post-DOC). Outcomes were treatment sequence and overall survival from 1st Ra-223 injection.
Results
288 patients treated with Ra-223 were included in this analysis. 90% were pretreated with one or more lines of LPD (38% 1 line, 52% ≥1 line). 33% of DOC-naïve patients were treated with Ra-223 as line 1. Baseline characteristics are shown in the table. DOC-naïve patients had prognostic favorable baseline characteristics compared to post-DOC patients, namely higher hemoglobin (7.9 vs 7.4 mmol/L, p < 0.01), lower PSA (85 vs 147 µg/L, p < 0.01) and longer period from castration to mCRPC (16.8 vs 13.1 months, p < 0.01). 47% completed all 6 cycles. 43% were alive or lost-to-follow-up at database cutoff. Median overall survival was 12.2 months (IQR 7-24 months), with longer median overall survival in DOC-naïve compared to post-DOC patients (17.0 vs 11.2 months, p < 0.01).Table:
869P
Radium-223 N = 288 | Doc-naïve N = 120 | Post-doc N = 168 | p-value | |
---|---|---|---|---|
Age ≥75 years (%) | 46 | 63 | 33 | <0.01 |
Extent of disease (%) N0 / N1 / Nx M0 / M1 / Mx (visceral) | 54 / 20 / 26 71 / 4 / 26 | 57 / 23 / 21 76 / 3 / 21 | 52 / 18 / 30 67 / 4 / 29 | 0.62 0.78 |
Charlson score (%) 6 7-8 9-10 >10 | 64 30 6 1 | 64 30 5 1 | 63 30 6 1 | 0.98 |
ECOG (%) 0 1 >1 Missing | 19 48 13 20 | 24 43 13 19 | 16 51 13 20 | 0.21 |
Hb, mmol/L Median (IQR) Missing (%) | 7.7 (6.8-8.3) 10 | 7.9 (7.1-8.4) 10 | 7.4 (6.6-8.1) 10 | <0.01 |
LDH, U/L Median (IQR) Missing (%) | 243 (201-310) 33 | 240 (205-288) 31 | 248 (197-332) 34 | 0.60 |
ALP, U/L Median (IQR) Missing (%) | 153 (91-267) 14 | 139 (87-227) 14 | 167 (94-274) 14 | 0.11 |
PSA, µg/L Median (IQR) Missing (%) | 124 (48-344) 13 | 85 (44-205) 14 | 147 (55-444) 13 | <0.01 |
Period from castration to mCRPC, months Median (IQR) | 14.3 (8-27) | 16.8 (9-28) | 13.1 (8-23) | <0.01 |
Previous ART use, % Yes No | 80 20 | 76 24 | 83 17 | 0.12 |
ART, androgen-receptor targeting drugs (i.e. abiraterone acetate or enzalutamide)
Conclusions
Although Ra-223 was positioned as a later line of mCRPC in this Dutch real-world practice than in the ALSYMPCA trial, overall survival was comparable. This is probably explained by adequate patient selection. Further research on the best timing of Ra-223 in the treatment of mCRPC is awaited.
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., and 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 (institution), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Oncology; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Amgen; Advisory / Consultancy: Novartis; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Merck. J. Van Moorselaar: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Astellas; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), 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 (self): Astellas; Advisory / Consultancy, Research grant / Funding (self): Janssen; Advisory / Consultancy, Research grant / Funding (self): Bayer; Advisory / Consultancy: Roche; Advisory / Consultancy: Mdx health. D.M. Somford: Research grant / Funding (institution): Astellas. R. de Wit: Travel / Accommodation / Expenses: Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Sanofi; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Honoraria (self), Advisory / Consultancy: Merck Sharp Dohme; Advisory / Consultancy: Roche/Genentech; Advisory / Consultancy: Janssen; Advisory / Consultancy: Clovis. A.M. Bergman: 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; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi; 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): Roche; Research grant / Funding (institution): AstraZeneca. 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: CureVac; Advisory / Consultancy: Dendreon; Advisory / Consultancy: Merck (MSD); Advisory / Consultancy: Morphosys; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Aglaia Biomedical Ventures; Advisory / Consultancy: PsiOxus Therapeutics. All other authors have declared no conflicts of interest.
Resources from the same session
2344 - Lung Cancer in Europe: strengthening policy responses to address unmet needs
Presenter: Mary Bussell
Session: Poster Display session 3
Resources:
Abstract
1359 - Curative treatment timelines for breast, colorectal, lung and prostate cancer: Implications for medical leave coverage
Presenter: Selina Wong
Session: Poster Display session 3
Resources:
Abstract
4433 - Acute Diagnostic Oncology Clinic: A Unique Primary Care-Oncology Service
Presenter: Abhijit Gill
Session: Poster Display session 3
Resources:
Abstract
3506 - THE NEW MUTATIONAL MODEL IN ONCOLOGY. What changes in welfare, clinical practice, research, and regulatory procedures
Presenter: Nicola Normanno
Session: Poster Display session 3
Resources:
Abstract
3350 - Selection of a set of quality indicators (QI) for oncological clinical pathway
Presenter: Aude Fourcade
Session: Poster Display session 3
Resources:
Abstract
4400 - Sustainable drug prices at market launch: policy proposals and their empirical evidence
Presenter: Nora Fanzen
Session: Poster Display session 3
Resources:
Abstract
4118 - Impact of financial considerations on French physicians’ prescription choices for advanced non-small cell lung cancer (NSCLC)
Presenter: Nathalie Olympios
Session: Poster Display session 3
Resources:
Abstract
1340 - The direct medical cost of breast cancer in a Belgian hospital
Presenter: Hannan Lemhouer
Session: Poster Display session 3
Resources:
Abstract
1863 - Does the healthcare system approaches cancer patients for using private services during diagnostic process?
Presenter: Karolina Osowiecka
Session: Poster Display session 3
Resources:
Abstract
2637 - Measuring financial toxicity of cancer in the Italian health care system: initial results of the patient reported outcome for Fighting Financial Toxicity of cancer project (proFFiT).
Presenter: Silvia Riva
Session: Poster Display session 3
Resources:
Abstract