San Francisco, CA USA (UroToday.com) Hiroji Uemura and colleagues presented their single-arm, open-label, multicenter, phase II study on the use of Radium 223 in a cohort of Japanese prostate cancer patients with symptomatic bony metastases. Patients in the study had at least 2 sites of osseous metastases on nuclear scan with no evidence of visceral disease, and included patients with or without prior docetaxel treatment.
Patients received Radium 223 injections every for weeks for 6 doses. Primary outcome of interest was ALP at 12 weeks vs baseline, while secondary outcomes included overall survival (OS), time to skeletal related event (SRE), % change in ALP and PSA, and safety.
49 of the 67 enrolled patients proceeded to receive at least one treatment with Radium 223. Mean % change in ALP was -19.3% (CI -28-10.7%). Median time to total ALP progression was not reached, and progression free rate at 1 year was 59%. There were no deaths during treatment or up to 30 days following the last injection, and there was only one grade 4 adverse event (neutropenia). Median OS was 381 days, and OS at 1 year was 78%. Five patients (10.2%) had SREs, and median time to SRE was not reached. SRE-free rate at 1 year was 89%.
The investigators concluded that the reduction in ALP seen in this cohort of patients is consistent with that of the ALSYMPCA trial. Radium 223 was well tolerated.
Reported By:
Nikhil Waingankar, MD at the 2016 Genitourinary Cancers Symposium - January 7 - 9, 2016 – San Francisco, CA
Fox Chase Cancer Center, Philadelphia, PA