Radium-223 (Ra-223) re-treatment (Re-tx): First experience from an international, multicenter, prospective study in patients (Pts) with castration-resistant prostate cancer and bone metastases (mCRPC).

Abstract

197 Background: Ra-223 tx for up to 6 injections (inj) is indicated for pts with symptomatic bone metastases. Ra-223 tx beyond 6 inj has not been previously reported. Herein we report the first safety and efficacy findings of Ra-223 re-tx from an international prospective trial in mCRPC pts. Methods: Pts with CRPC with ≥ 2 bone mets who completed 6 initial Ra-223 inj with no disease progression in bone and progressed after initial tx were potentially eligible for Ra-223 re-tx, provided that hematologic (heme) parameters were adequate. No concomitant cytotoxic agents were allowed; other agents were allowed at investigator discretion. Primary objective was safety. Exploratory objectives were time to radiographic bone progression, time to ALP progression, and radiographic progression-free survival (rPFS) based on MRI/CT and bone scans performed q 3 mo. Results: 44 pts had Ra-223 re-tx, 29 (66%) completed tx with all 6 inj; median (med) number inj = 6. Med time from initial Ra-223 tx = 6 mo. Besides prior Ra-223, all pts had ≥ 2 hormonal regimens; 45% had ≥ 1 chemotherapy regimen. 32 (73%) failed novel hormonal agents, eg, abiraterone and enzalutamide. Baseline characteristics were comparable to ALSYMPCA (Table). No new safety concerns were noted; incidence of tx-emergent adverse events (TEAEs) in re-tx pts was comparable to or lower than ALSYMPCA (Table). Only 2 re-tx pts had grade 3 heme TEAEs. Only 1 pt had radiographic bone progression; med time to ALP progression was not reached. Med rPFS = 9.9 mo. Conclusions: Ra-223 re-tx was well tolerated in this highly selected population, with minimal heme toxicity, and provided continued control of disease progression in bone. Clinical trial information: NCT01934790. [Table: see text] [Table: see text]

No evidence of association between psychological distress and pain relief in patients with bone metastases from castration‐resistant prostate cancer treated with 223Radium

“…Since its introduction, 223Radium treatment is gaining widespread use in clinical practice. During recent years, many clinical trials conducted in expanded access setting confirmed the safety and efficacy of this treatment Sartor et al, 2016;Vogelzang et al, 2015).…”

“…During recent years, many clinical trials conducted in expanded access setting confirmed the safety and efficacy of this treatment Sartor et al, 2016;Vogelzang et al, 2015). During recent years, many clinical trials conducted in expanded access setting confirmed the safety and efficacy of this treatment Sartor et al, 2016;Vogelzang et al, 2015).…”

Possibilities of Radium-223 Application in Therapy of Prostate Gland Cancer

“…По нашему мнению, потенциальным кан-дидатом на радий-223 может быть пациент с симптомати-ческим метастазом в кости, ограниченной тяжестью забо-левания и длительным периодом удвоения ПСА (напри-мер, 6 месяцев) или сопутствующими заболеваниями, при которых противопоказано использование химиотерапии, либо при отказе от химиотерапии. Следует отметить, что использование радия-223 не ухудшало комплаентность пациента в отношении последующей терапии доцетаксе-лом, которую можно безопасно сочетать с использовани-ем радия-223 [25].…”

Radioisotopes in management of metastatic prostate cancer

“…Furthermore, in a recent international study investigating retreatment with Ra-223, investigators found that retreatment was well tolerated with minimal morbidity while mitigating bone disease progression. [ 21 ]…”