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Poster display session

3073 - First Interim Results of the Radium-223 (Ra-223) REASSURE Observational Study: Analysis of Patient (Pt) Characteristics and Safety by Use of Abiraterone and/or Enzalutamide (Abi/Enza)


10 Sep 2017


Poster display session


Cytotoxic Therapy;  Prostate Cancer


Lauren Harshman


Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370


L.C. Harshman1, J. Logue2, C.N. Sternberg3, S. Sundar4, D. Schrijvers5, M. Schostak6, J. Sylvester7, S. George8, M. Tucci9, C. Mantz10, P. Borrega11, P. Ziem12, R. Concepcion13, K. Miller14, O. Sartor15, J. Kalinovsky16, Y. De Sanctis17, B. Tombal18

Author affiliations

  • 1 Lank Center For Genitourinary Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 2 Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 3 Department Of Oncology, San Camillo and Forlanini Hospitals, 156 - Roma/IT
  • 4 Oncology, Nottingham University Hospitals NHS Trust-City Hospital Campus, NG5 1PB - Nottingham/GB
  • 5 Department Of Medical Oncology, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp/BE
  • 6 Department Of Urology, Universitätsklinik für Urologie und Kinderurologie, 39120 - Magdeburg/DE
  • 7 Oncology, 21st Century Oncology, Lakewood Ranch/US
  • 8 Dept Of Medicine, Roswell Park Cancer Institute, NY - Buffalo/US
  • 9 Oncology, Azienda Ospedaliera Universitaria San Luigi Gonzaga, 10043 - Orbassano/IT
  • 10 Oncology, 21st Century Oncology, Fort Myers/US
  • 11 Oncology, San Pedro de Alcántara Hospital, Cáceres/ES
  • 12 Klinik Für Urologie, Dietrich-Bonhoeffer-Klinikum Neubrandenburg, 17022 - Neubrandenburg/DE
  • 13 Oncology, Urology Associates, Nashville/US
  • 14 Oncology, Benjamin Franklin Medical Center, Berlin/DE
  • 15 Oncology, Tulane University, 70112 - New Orleans/US
  • 16 Oncology, Bayer, Bratislava/SK
  • 17 Oncology, Bayer, Whippany/US
  • 18 Urology, Cliniques Universitaires St. Luc, 1200 - Brussels/BE


Abstract 3073


Ra-223 prolongs survival with a favorable safety profile in metastatic castration-resistant prostate cancer (mCRPC). The pivotal phase 3 ALSYMPCA trial had a relatively short 3-year follow-up and was conducted before availability of 2nd generation hormonal agents. The REASSURE study was designed to assess long-term safety (7 years follow-up) and conducted in an era when pts had access to other effective 1st line agents such as abi/enza.


REASSURE is a global, prospective, single-arm, observational study that enrolled pts with mCRPC with bone metastases planned to start Ra-223. Treatment decision was made independently before enrollment. We undertook a planned interim descriptive analysis of safety and drug completion based on prior or concomitant abi/enza use.


REASSURE enrolled 1106 pts in N. America and Europe from Sep 2014 to Sep 2016. The interim analysis included 583 pts who received ≥1 Ra-223 dose (Table; median 7 months observation). Prior abi/enza use was reported in 168 (29%) and concomitant in 153 (26%) pts. Treatment-related adverse events (TRAEs) occurred in 37%: prior abi/enza 45%, no prior abi/enza 34%; concomitant abi/enza 29%, no concomitant abi/enza 40%. TRAEs were most often gastrointestinal or hematological, with permanent discontinuation of Ra-223 in 6%: prior abi/enza 8%, no prior abi/enza 5%; concomitant abi/enza 5%, no concomitant abi/enza 7%. Serious TRAEs (mostly hematologic) occurred in 4.5% leading to permanent Ra-223 discontinuation in 1.5%.Table:

807P Baseline characteristics and treatment completion by prior or concomitant* abi/enza

Prior – Yes (n = 168)Prior – No (n = 415)Concomitant – Yes (n = 153)Concomitant – No (n = 430)
ECOG 0–1, n (%)122 (73)329 (79)121 (79)330 (77)
No. of metastases**, n (%)
2039 (24)67 (17)27 (19)79 (20)
Superscan14 (9)21 (5)5 (3)30 (8)
ALP (U/L), median155115114134


Ra-223 has a good short-term safety profile when used in the routine clinical practice setting. Prior or concomitant abi/enza does not appear to increase TRAE incidence. Pts who had prior abi/enza had a lower rate of completing full Ra-223 dosing, perhaps reflecting poorer prognosis or more advanced disease as suggested by higher median PSA and LDH levels.

Clinical trial identification


Legal entity responsible for the study

Bayer Healthcare


Bayer Healthcare


L.C. Harshman: Advisory Board for Genentech, Dendron, Pfizer, Medivation/Astellas; Kew Research to the institution: Bayer, Sotio, BMS, Merck, Takeda, Dendrion/Valient, Janssen. C.N. Sternberg: Honoraria: Janssen, Sanofi, Astellas, Clovis, Bayer, Ferring. Research funding to institution: Roche/Genentech, Bayer, Sanofi, Janssen, Medivation, Sanofi Genzyme. S. Sundar: Advisory board of Bayer UK. D. Schrijvers: Studies in prostate cancer sponsored by Cougar, Janssen and Bayer. Advisory board of Janssen and Bayer. Speaker: Janssen and Bayer. M. Schostak: Advisory boards: Bayer, Sanofi, Janssen, Amgen and Astellas. Honorarium for scientific talks about mCRPC-Management from Bayer, Sanofi, Janssen, Amgen and Astellas. J. Sylvester: QLRAD, Royalties Theragenics, Consultant Augmenix, stock options Isoray, research grant. S. George: Grants and personal fees from BMS, Novartis, Pfizer, Bayer. Personal fees from Exelixis and AstraZeneca. Grants from Celldex, Agensys, and Merck. M. Tucci: Advisory Board for Bayer, Sanofi, Astellas, Janssen. P. Borrega: Head of Medical Oncology Service at Universitary Hospital San Pedro De Alcantara. (Cáceres, Spain), and IP on reassure study. Advisory board of Janssen, Bayer and Astellas Pharmaceutical Companies. K. Miller: Advisor to: Amgen, Astellas, AstraZeneca, Bayer, BMS, Ferring, Janssen, Merck, MSD, Novartis, Pfizer, Roche, Sotio, Takeda. All other authors have declared no conflicts of interest.

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