Speaker
Dr
Joe M. O'Sullivan
(Center for Cancer Research and Cell Biology, Queen’s University Belfast, Northern Ireland Cancer Center, Belfast City Hospital, Belfast, Northern Ireland)
Description
Background
When the radium-223 Phase III clinical trial (ALSYMPCA) was conducted, abiraterone was an investigational agent that was only available through clinical trials. REASSURE is a prospective, observational clinical study of radium-223 in patients with mCRPC with a 7-year follow-up (NCT02141438). Patients could have had anti-hormonal agents, such as abiraterone, prior to receiving radium-223. The objective of this interim review was to evaluate the fractures and symptomatic skeletal events (SSEs) based on prior abiraterone use and the use of BHAs, denosumab and bisphosphonates.
Methods
Descriptive statistics were generated for baseline characteristics, fractures, SSEs, and overall survival (OS) by BHA use in patients who had completed abiraterone treatment prior to receiving radium-223 (prior abiraterone) or who had no prior abiraterone (abiraterone-naïve). SSEs consisted of events reported as “musculoskeletal” adverse events (fracture, spinal cord compression, radiotherapy to bone, surgery, and SSE documented as a type of progression).
Results
As of November 2017, 1439 patients were enrolled, with a median follow-up time of 9.1 months. 720 (50%) patients had received BHAs prior to, concomitantly with, or after radium-223. 431 (30%) patients received prior abiraterone; 675 (47%) patients were considered abiraterone-naïve. For the prior-abiraterone group, median time of exposure to abiraterone was 11 months. The median time from diagnosis of CRPC to initiation of radium-223 was 9 months in abiraterone-naïve patients and 23 months in prior-abiraterone patients. In the prior-abiraterone group, SSEs occurred in 18% and 25% of patients with and without BHAs, respectively. In the abiraterone-naïve group, 19% of patients with BHAs and 20% of those without BHAs had SSEs. Fractures were reported in 10/431 patients (2%) in the prior-abiraterone group. In the abiraterone-naïve group, fractures were reported in 5/302 (2%) and 11/373 (3%) patients with and without BHAs, respectively. OS from the initiation of radium-223 initiation was 15.5 months in the abiraterone-naïve group and 11.3 months in the prior-abiraterone group.
Conclusion
Similar rates of fractures were observed in abiraterone-naïve patients and those who received abiraterone prior to radium-223. Patients with prior abiraterone treatment had a shorter OS, and these patients received radium-223 at a later time during their disease course, as reflected by a longer time from CRPC to radium-223 initiation.
| Funding Agency | Bayer |
|---|---|
| Email Address | joe.osullivan@qub.ac.uk |
| Presentation Type | Poster |
Primary author
Dr
Joe M. O'Sullivan
(Center for Cancer Research and Cell Biology, Queen’s University Belfast, Northern Ireland Cancer Center, Belfast City Hospital, Belfast, Northern Ireland)
Co-authors
Dr
Bertrand Tombal
(Cliniques Universitaires Saint-Luc, Brussels, Belgium)
Dr
Celestia Higano
(University of Washington, Seattle, WA, USA)
Dr
Christopher Logothetis
(MD Anderson Cancer Center, Houston, TX, USA)
Dr
Cora N. Sternberg
(Englander Institute for Precision Medicine, Weill Cornell, New York, New York, USA)
Dr
David Bottomley
(St. James’s University Hospital, Leeds, UK)
Dr
Fred Saad
(University of Montreal Hospital Center, Montreal, Quebec, Canada)
Dr
Inga Bayh
(Bayer AG, Wuppertal, Germany)
Dr
Jan Kalinovsky
(Bayer Consumer Care AG, Basel, Switzerland)
Dr
Joaquim Bellmunt
(Dana-Farber Cancer Institute, Boston, MA, USA)
Dr
John Logue
(The Christie NHS Foundation Trust, Manchester, UK)
Dr
Juan P. Sade
(Instituto Alexander Fleming, Buenos Aires, Argentina)
Dr
Kurt Miller
(Charité Berlin, Berlin, Germany)
Dr
Lauren Harshman
(Dana-Farber Cancer Institute, Boston, MA, USA)
Dr
Martin Schostak
(Department of Urology, University of Magdeburg, Magdeburg, Germany)
Dr
Oliver Sartor
(Tulane University School of Medicine, New Orleans, LA, USA)
Dr
Sabina Dizdarevic
(Brighton & Sussex University Hospitals NHS Trust, Brighton, UK)
Sergio Baldari
(Nuclear Medicine Unit, University of Messina, Messina, Italy)
Timothy Richardson
(Wichita Urology, Wichita, KS, USA)
