Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

2891 - Use of bone health agents (BHAs) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223) after abiraterone (Abi): An interim review of REASSURE


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care


Supportive Care and Symptom Management;  Radiation Oncology

Tumour Site

Prostate Cancer


Cora Sternberg


Annals of Oncology (2018) 29 (suppl_8): viii271-viii302. 10.1093/annonc/mdy284


C.N. Sternberg1, B. Tombal2, K. Miller3, F. Saad4, O. Sartor5, J.P. Sade6, C. Logothetis7, J. Bellmunt8, S. Dizdarevic9, L.C. Harshman8, J. Logue10, S. Baldari11, T. Richardson12, D. Bottomley13, M. Schostak14, I. Bayh15, J. Kalinovsky16, C. Higano17

Author affiliations

  • 1 Medical Oncology, San Camillo Forlanini Hospital, 00152 - Rome/IT
  • 2 Dept. Of Urology, Cliniques Universitaires St. Luc, 1200 - Brussels/BE
  • 3 Medical Oncology, Charité Berlin, Berlin/DE
  • 4 Urology, Hospital St. Luc du CHUM, H2X 3J4 - Montreal/CA
  • 5 Tulane Cancer Center, Tulane Medical School, New Orleans/US
  • 6 Dept. Of Genitourinary Tumors, Instututo Alexander Fleming, Buenos Aires/AR
  • 7 Medical Oncology, 7MD Anderson Cancer Center, Houston/US
  • 8 Lank Center For Genitourinary Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 9 Dept. Of Imaging And Nuclear Medicine, Brighton and Sussex University Hospitals NHS Trust, Brighton/GB
  • 10 Medical Oncology, 10The Christie NHS Foundation Trust, Manchester/GB
  • 11 Nuclear Medicine Unit, University of Messina, Messina/IT
  • 12 Medical Oncology, Wichita Urology, Wichita/US
  • 13 Dept. Of Clinical Oncology, St. James's Institute of Oncology, Leeds/GB
  • 14 Clinic Of Urology, Dkg-certified Prostate Cancer Center, University Hospital Magdeburg, Magdeburg/DE
  • 15 Bayer Ag, SBU Oncology, Pharmaceuticals, Wuppertal/DE
  • 16 Medical Oncology, Bayer Consumer Care AG, Basel/CH
  • 17 Medical Oncology, University of Washington, Seattle/US


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 2891


When the Ra-223 phase 3 clinical trial (ALSYMPCA) was conducted, Abi was not available; REASSURE is a prospective, observational clinical study of Ra-223 in pts with mCRPC with a 7-year follow-up (NCT02141438). Pts could have had anti-hormonal agents, such as Abi, prior to receiving Ra-223. The objective of this interim review was to evaluate the fractures and skeletal-related events (SREs) based on prior Abi and the use of BHAs, denosumab and bisphosphonates.


Descriptive statistics were generated for baseline characteristics, fractures, SREs and overall survival (OS) by BHA use in pts who had completed Abi treatment prior to receiving Ra-223 (prior Abi) or who had no prior Abi (Abi-naïve). An SRE was defined as any skeletal-related adverse event or any radiotherapy to bone.


As of Nov 2017, 1439 pts were enrolled, with a median follow-up time of 9.1 months. 708 (49%) pts had received BHAs at baseline, and BHAs were given concomitantly with Ra-223 in 553 (38%) pts. 430 (30%) pts received prior Abi, and Ra-223 was given as second line in 37% (157/430) of those pts; 705 (49%) pts were considered Abi-naïve. For the prior Abi group, median time of exposure to Abi was 11 months. In the prior Abi group SREs occurred in 17% and 22% of pts, with and without BHAs, respectively. In the Abi-naïve group, 16% of pts had SREs regardless of BHA use. Fractures were reported in 7/430 pts (1.6%) in the prior Abi group. In the Abi-naïve group fractures were reported in 2/311 (1%) and 8/394 (2%) pts with and without BHAs, respectively (Table).Table: 826P

Abi-naïve pts (n = 705)Prior Abi pts (n = 430)Overall cohort (n = 1439)
With BHAs (n = 311)Without BHAs (n = 394)With BHAs (n = 216)Without BHAs (n = 214)With BHAs (n = 708)Without BHAs (n = 731)
Time from CRPC to Ra-223 initiation, median months (range)6 (0–134)10 (0–109)23 (0–80)23 (0–117)12 (0–147)13 (0–117)
PSA, median ng/mL (Q1, Q3)49 (11, 160)46 (15, 161)114 (31, 331)121 (30, 311)60 (14, 212)59 (19, 201)
Prior docetaxel,n (%)95 (31)106 (27)122 (57)120 (56)273 (39)269 (37)
Patient outcomes
≥1 SRE, n (%)49 (16)62 (16)36 (17)46 (22)116 (16)129 (18)
≥1 fracture, n (%)2 (1)8 (2)2 (1)5 (2)7 (1)17 (2)
5–6 Ra-223 injections, n (%)199 (64)252 (64)128 (59)128 (60)480 (68)465 (64)
OS from initiation of Ra-223, median months (95% CI)15.5 (13.1, 16.6)11.1 (10.2, 11.8)14.8 (13.5, 16.0)


BHAs were under-utilised in this study despite several guidelines and recommendations. The rate of fracture was the same in those who were Abi-naïve compared with those who received Abi prior to Ra-223. Pts with prior Abi had a shorter OS; these pts received Ra-223 at a later time during their disease course, as reflected by a longer time from CRPC to Ra-223 initiation.

Clinical trial identification


Legal entity responsible for the study




Editorial Acknowledgement

Medical writing support was provided by Michael Sheldon of Scion, London UK, funded by Bayer.


C.N. Sternberg: Honoraria or consulting fees: Bayer, Sanofi, Pfizer, Janssen, Astellas, Clovis, Novartis. B. Tombal: Investigator, paid advisor: Bayer, Astellas, Janssen, Sanofi. K. Miller: Honoraria, consultation fees: Amgen, Bayer, BMS, Ferring, Janssen, MSD, Novartis, Pfizer, Roche, Sotio, Takeda, Tolmar. F. Saad: Consultant, research grants: Bayer, Amgen, Astellas, Jansssen, Sanofi, AstraZeneca. O. Sartor: Consultant, investigator: Bayer. J. Bellmunt: Advisory role: Genentech, MSD, Pfizer, GSK, BMS, Pierre-Fabre, Sanofi Aventis, Astellas, OncoGenx, Janssen; Lecture fees: Pfizer, MSD, GSK, Novartis, Pierre-Fabre, Astellas; Research funding: Takeda, Pfizer, Novartis, Sanofi Aventis. S. Dizdarevic: Support, travel expenses, registration costs for occasional conference, advisory role: Bayer. L.C. Harshman: Advisory: Bayer, Genentech, Dendreon, Pfizer, Medivation/Astellas, Kew Group, Theragene, Corvus, Merck, Exelixis, Novartis; Research to institution: Bayer, Sotio, Bristol-Myers Squib, Merck, Takeda, Dendreon/Valient and Janssen. J. Logue: Honoraria: Bayer. T. Richardson: Speaker, peer advisor: Bayer (Xofigo); Speaker: Janssen (Erleada), Astellas (Myrbetriq). D. Bottomley: Honoraria, travel/subsistence grants: Bayer, Janssen, AccelyonBT. M. Schostak: Advisor: Bayer. I. Bayh: Employee, consultant: Fresenius Medical Care; Stocks: Fresenius Medical Care Deutschland GmBH. J. Kalinovsky: Employee: Bayer. C. Higano: Advisory boards: Astellas, Bayer, Blue Earth Diagnostics, Ferring, Janssen, Myriad, Tolmar; Sponsored research: Aragon, Astellas, AstraZeneca, Dendreon, Genentech, Medivation, Emergent, Bayer, Pfizer, Hoffman La Roche: Employment: Spouse employed in leadership position: CTI Biopharma. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.