593P - Pain efficacy with radium-223 (Ra-223) in the REASSURE global, prospective, observational study of men with metastatic castration-resistant prostate cancer (mCRPC)

Background

Ra-223, a first-in-class alpha emitter, is approved for patients (pts) with mCRPC and symptomatic bone metastases. In a phase III trial, Ra-223 significantly prolonged overall survival (OS), delayed opioid and external beam radiotherapy (EBRT) (post hoc), and improved pain-related quality of life (QoL). Here we assessed pain efficacy with Ra-223 treatment in pts with baseline (BL) pain in real-world clinical settings.

Methods

REASSURE (NCT02141438) is an ongoing, global, noninterventional study of Ra-223 in pts with mCRPC and bone metastases. We analyzed pain response (≥2 point improvement in Brief Pain Inventory–Short Form [BPI-SF] worst pain score), other pain outcomes, and OS in pts with BL BPI-SF worst pain score ≥2 without concomitant opioid or EBRT to bone during Ra-223 therapy.

Results

Of 1465 pts who received Ra-223, 1027 (70%) had BL worst pain ≥2; 394/1027 (38%) received no concomitant opioid or EBRT to bone. During Ra-223 treatment, 566/1027 pts (55%) overall and 228/394 pts (58%) with no concomitant opioid/EBRT achieved a pain response. Pain response by extent of disease (EOD) at BL is presented in the table. Pain severity (BPI-SF score) and interference summary scores (mean of the scores for how pain interfered with 7 daily activities) decreased with each Ra-223 cycle and remained below BL during follow-up (Table). By the last follow up, 18% of pts overall and 23% with no concomitant opioid/EBRT reported complete pain relief. Median OS was 14.7 months (95% confidence interval 13.4, 15.9) overall and 17.6 months (16.5, 19.3) in pts with no concomitant opioid/EBRT.

Conclusions

In real-world settings, pts with BL pain treated with Ra-223 experienced incremental reduction in pain with each cycle, regardless of baseline EOD or concomitant opioid/EBRT use. Benefits were sustained following completion of Ra-223 and complement clinical trial evidence of improved pain-related QoL. Table: 593P

Pain efficacy with Ra-223 in pts with BL BPI-SF worst pain score ≥2

*Data are not available from all pts at every cycle. C, cycle.

Clinical trial identification

NCT02141438.

Editorial acknowledgement

Sara Black, ISMPP CMPP™, from OPEN Health, London, UK provided medical writing support.

Legal entity responsible for the study

Bayer AG, Berlin, Germany.

Funding

Bayer AG, Berlin, Germany.

Disclosure

C.S. Higano: Financial Interests, Personal, Research Grant: Aptevo; Financial Interests, Personal, Research Grant: Asana Aragon Pharma; Financial Interests, Personal, Research Grant: Astellas; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Research Grant: Bayer; Financial Interests, Personal, Research Grant: Blue Earth Diagnostics; Financial Interests, Personal, Research Grant: Churchill Pharma; Financial Interests, Personal, Research Grant: Clovis; Financial Interests, Personal, Research Grant: Dendreon; Financial Interests, Personal, Research Grant: eFFECTOR Therapeutics; Financial Interests, Personal, Research Grant: Endocyte; Financial Interests, Personal, Research Grant: Emergent BioSolutions; Financial Interests, Personal, Research Grant: Ferring; Financial Interests, Personal, Research Grant: Genentech; Financial Interests, Personal, Research Grant: Hinova; Financial Interests, Personal, Research Grant: Hoffman-La Roche; Financial Interests, Personal, Research Grant: Janssen; Financial Interests, Personal, Research Grant: Medivation; Financial Interests, Personal, Research Grant: Myriad; Financial Interests, Personal, Research Grant: Orion; Financial Interests, Research Grant: Pfizer. N. Agarwal: Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Aveo; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Calithera; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: EMD Serono; Financial Interests, Personal, Advisory Board: Exelixis; Financial Interests, Personal, Advisory Board: Foundation Medicine; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: MEI Pharma; Financial Interests, Personal, Advisory Board: Nektar; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Pharmacyclics; Financial Interests, Personal, Advisory Board: Seattle Genetics. M. Essler: Financial Interests, Personal and Institutional, Research Grant: Novartis; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Sponsor/Funding: Ipsen; Financial Interests, Personal, Sponsor/Funding: Sirtex. D. Song: Financial Interests, Personal and Institutional, Funding: Bayer; Financial Interests, Personal and Institutional, Funding: Advantagene; Financial Interests, Personal and Institutional, Funding: Bristol Myers Squibb; Financial Interests, Personal and Institutional, Funding: BioProtect; Financial Interests, Personal, Advisory Board: BioProtect. S. George: Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Exelixis; Financial Interests, Personal, Advisory Board: Corvus; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: EMD Serono. N.D. Shore: Financial Interests, Personal, Advisory Board: AbbVie; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Janssen Scientific Affairs; Financial Interests, Personal, Advisory Board: Dendreon; Financial Interests, Personal, Advisory Board: Tolmar; Financial Interests, Personal, Advisory Board: Ferring; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Myovant Sciences; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Sanofi-Genzyme; Financial Interests, Personal, Advisory Board: Invitae; Financial Interests, Personal, Advisory Board: Myriad; Financial Interests, Personal, Advisory Board: Phosphorous; Financial Interests, Personal, Advisory Board: Sema4; Financial Interests, Personal, Advisory Board: Foundation Medicine; Financial Interests, Personal, Advisory Board: Guardant; Financial Interests, Personal, Speaker’s Bureau: Janssen; Financial Interests, Personal, Speaker’s Bureau: Bayer; Financial Interests, Personal, Speaker’s Bureau: Dendreon. M. Kurtinecz: Financial Interests, Personal, Full or part-time Employment: Bayer. F. Verholen: Financial Interests, Personal, Full or part-time Employment: Bayer. P. Sandström: Financial Interests, Personal, Full or part-time Employment: Bayer. O. Sartor: Financial Interests, Personal, Other, Grants and/or fees: Advanced Accelerator Applications; Financial Interests, Personal, Other, Grants and/or fees: Astellas; Financial Interests, Personal, Other, Grants and/or fees: AstraZeneca; Financial Interests, Personal, Other, Grants and/or fees: Bayer; Financial Interests, Personal, Other, Grants and/or fees: Bellicum; Financial Interests, Personal, Other, Grants and/or fees: Blue Earth Diagnostics; Financial Interests, Personal, Other, Grants and/or fees: Bristol Myers Squibb; Financial Interests, Personal, Other, Grants and/or fees: Celgene; Financial Interests, Personal, Other, Grants and/or fees: Constellation; Financial Interests, Personal, Other, Grants and/or fees: Dendreon; Financial Interests, Personal, Other, Grants and/or fees: EMD Serono; Financial Interests, Personal, Other, Grants and/or fees: Innocrin; Financial Interests, Personal, Other, Grants and/or fees: Invitae; Financial Interests, Personal, Other, Grants and/or fees: Johnson & Johnson; Financial Interests, Personal, Other, Grants and/or fees: Merck; Financial Interests, Personal, Other, Grants and/or fees: Myovant; Financial Interests, Personal, Other, Grants and/or fees: Pfizer; Financial Interests, Personal, Other, Grants and/or fees: Sanofi; Financial Interests, Personal, Other, Grants and/or fees: SOTIO. D.J. George: Financial Interests, Personal, Other, Grants and/or fees: Acerta Pharma; Financial Interests, Personal, Other, Grants and/or fees: American Association for Cancer Research; Financial Interests, Personal, Other, Grants and/or fees: Astellas; Financial Interests, Personal, Other, Grants and/or fees: AstraZeneca; Financial Interests, Personal, Other, Grants and/or fees: Axess Oncology; Financial Interests, Personal, Other, Grants and/or fees: Bayer; Financial Interests, Personal, Other, Grants and/or fees: Bristol Myers Squibb; Financial Interests, Personal, Other, Grants and/or fees: Calithera; Financial Interests, Personal, Other, Grants and/or fees: Capio Biosciences; Financial Interests, Personal, Other, Grants and/or fees: EMD Serono; Financial Interests, Personal, Other, Grants and/or fees: Exelixis; Financial Interests, Personal, Other, Grants and/or fees: Flatiron; Financial Interests, Personal, Other, Grants and/or fees: Ipsen; Financial Interests, Personal, Other, Grants and/or fees: UroGPO; Financial Interests, Personal, Other, Grants and/or fees: Janssen; Financial Interests, Personal, Other, Grants and/or fees: Leidos Biomedical Research; Financial Interests, Personal, Other, Grants and/or fees: Merck Sharp & Dohme; Financial Interests, Personal, Other, Grants and/or fees: Michael J Hennessey Associates; Financial Interests, Personal, Other, Grants and/or fees: Millennium Med Publishing; Financial Interests, Personal, Other, Grants and/or fees: Modra Pharmaceuticals; Financial Interests, Personal, Other, Grants and/or fees: Myovant Sciences; Financial Interests, Personal, Other, Grants and/or fees: NCI; Financial Interests, Personal, Other, Grants and/or fees: Nektar Therapeutics; Financial Interests, Personal, Other, Grants and/or fees: Novartis; Financial Interests, Personal, Other, Grants and/or fees: Pfizer; Financial Interests, Personal, Other, Grants and/or fees: Physician Education Resource; Financial Interests, Personal, Other, Grants and/or fees: Sanofi; Financial Interests, Personal, Other, Grants and/or fees: UroToday; Financial Interests, Personal, Other, Grants and/or fees: Vizuri Health Sciences. All other authors have declared no conflicts of interest.