ESMO 2021: Pain Efficacy With Radium-223 in the REASSURE Global, Prospective, Observational Study of Men With Metastatic Castration-Resistant Prostate Cancer

( In the on-demand poster session of the European Society for Medical Oncology (ESMO) Annual Congress, Dr. Higano presented a real-world analysis of pain efficacy of radium-223 treatment among patients with metastatic castration-resistant prostate cancer (mCRPC) and symptomatic bone metastases. Radium-223 is a first-in-class alpha emitter which, based on the ALSYMPCA trial, is approved for patients with mCRPC and symptomatic bone metastases which demonstrated significantly prolonged overall survival (OS), delayed opioid and external beam radiotherapy (EBRT), and improved pain-related quality of life (QoL).


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


Among 1465 patients who received Radium-223 and were included in the cohort, 1027 (70%) had BL worst pain ≥2 and 394 or 1027 (38%) received no concomitant opioid or EBRT to bone. During the course of Radium-223 treatment, 566 of 1027 pts (55%) overall and 228 of 394 patients (58%) with no concomitant opioid/EBRT achieved a pain response.


Pain severity (BPI-SF score) and interference summary scores (mean of the scores for how pain interfered with 7 daily activities) decreased with each cycle of Radium-223 and remained below BL during follow-up. At the time of last follow up, 18% of patients overall and 23% with no concomitant opioid/EBRT reported complete pain relief. 

Median OS was somewhat longer (17.6 months, 95% confidence interval 16.5, 19.3) among patients with no concomitant opioid/EBRT than the overall cohort (14.7 months, 95% confidence interval 13.4, 15.9).

The authors, therefore, concluded that using these real-world data, patients with pain at baseline who received treatment with Radium-223 experienced an incremental reduction in pain with each cycle, regardless of baseline EOD or concomitant opioid/EBRT use.

Presented by: Celestia S. Higano, MD, FACP, Professor, Division of Medical Oncology, The University of Washington School of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington