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• W3094582020 abstract "Radium-223 (Ra-223) improved overall survival (OS) and demonstrated a favorable safety profile in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 ALSYMPCA trial. REASSURE (NCT02141438) is a global, prospective, single-arm, observational study investigating the safety of Ra-223 in routine clinical practice in pts with mCRPC over 7 years. The objective of this investigation, using data from the second prespecified interim analysis, was to assess safety and clinical outcomes in pts from REASSURE, including the subgroups who received radiotherapy concomitant with Ra-223, or investigational 177Lu-PSMA subsequent to Ra-223. Results of this analysis may help to inform future treatment decisions in pts with mCRPC. This analysis (data cut-off: March 20, 2019) was conducted for the entire cohort and two subsets of pts treated with either concomitant radiotherapy or with subsequent 177Lu-PSMA. Incidence of second primary malignancy (SPM), pain response, incidence of adverse events (AEs), and OS are described. In total, 1465 pts with mCRPC were included. Median follow-up was 11.5 months, and a median of 6 Ra-223 injections was received. Overall, 14 pts (1%) developed a SPM. At Cycle 6, 222/657 pts (34%) had a clinically meaningful pain response (decrease ≥2 points from baseline) in the Brief Pain Inventory worst pain item. Overall, median OS was 15.6 months (95% CI 14.6, 16.5). The most frequent treatment-emergent serious AEs (any grade; ≤30 days after Ra-223) were anemia (n = 27; 2%), physical health deterioration (n = 14; 1%), and pneumonia (n = 13; 1%). Grade 3–4 hematologic AEs occurred in 214 pts (15%); 70 pts (5%) had fractures. 160/1465 pts (11%) had concomitant radiotherapy, mainly external beam radiation therapy (n = 117; 73%), brachytherapy (n = 14; 9%), and gamma knife or stereotactic therapy (n = 8; 5% for each). Of these 160 pts, 1 (<1%) developed a SPM. Safety, including hematologic toxicity fracture rate, and pain response in this pt group was acceptable and will be presented. 26/1465 pts (2%) received 177Lu-PSMA treatment after Ra-223. Median duration of 177Lu-PSMA was 3.5 months. 3/26 pts (12%) had drug-related serious AEs; 9/26 pts (35%) had grade 3–4 hematologic AEs. 2/26 pts (8%) had fractures. Median OS was 28.0 months (95% CI 19.5, 32.7) from start of Ra-223 and 13.2 months (8.4, 16.2) from start of 177Lu-PSMA. There was a low incidence of SPM, low rate of grade 3–4 hematologic AEs, and low incidence of fractures in this second interim analysis of REASSURE, in a real-life clinical practice setting. A pain response was observed in about one-third of pts. Treatment with 177Lu-PSMA in pts who had prior Ra-223 may be feasible in selected pts based on the subset analyzed." @default.
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• W3094582020 date "2020-11-01" @default.
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• W3094582020 title "Safety And Clinical Outcomes Of Radium-223 With Concomitant Radiotherapy Or Subsequent Treatment With The Investigational Agent 177Lu-PSMA In Patients With Metastatic Castration-Resistant Prostate Cancer: An Interim Analysis Of The REASSURE Study" @default.
• W3094582020 doi "https://doi.org/10.1016/j.ijrobp.2020.07.415" @default.
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