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. 2019 Feb;17(2):1467-1476.
doi: 10.3892/ol.2018.9785. Epub 2018 Nov 30.

Radium-223 in patients with metastatic castration-resistant prostate cancer: Efficacy and safety in clinical practice

Arsela Prelaj  1 , Sara Elena Rebuzzi  2 , Federica Buzzacchino  1 , Chiara Pozzi  1 , Carla Ferrara  3 , Viviana Frantellizzi  1 , Giulia Anna Follacchio  1 , Liana Civitelli  1 , Giuseppe De Vincentis  1 , Silverio Tomao  1 , Vincenzo Bianco  1
Affiliations

Radium-223 in patients with metastatic castration-resistant prostate cancer: Efficacy and safety in clinical practice

Arsela Prelaj et al. Oncol Lett. 2019 Feb.

Abstract

Radium-223 has improved overall survival (OS) and reduced symptomatic skeletal events (SSE) in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases (ALSYMPCA trial). Our aim was to assess clinical and biochemical factors related to survival, safety and survival outcomes of Radium-223 in a clinical practice setting. We retrospectively analysed 32 mCRPC patients treated with Radium-223, assessing bone scan, pain reduction, alkaline phosphatase (ALP) and prostate-specific antigen (PSA) response (≥30% reduction). At scintigraphic assessment, 41% had partial response with a disease control rate of 91%; 56% had ALP response and 25% had PSA response; 41% had pain reduction with pain control of 72%. Scintigraphic response and stability were correlated with longer median progression-free survival (mPFS) (13 and 12 vs. 6 months; P=0.002) and mOS (16 and 12 vs. 6 months; P=0.003). ALP response was associated with longer mPFS (13 vs. 12 months; P=0.2) and mOS (16 vs. 12 months; P=0.2). PSA response was associated with longer mPFS (13 vs. 12 months; P=0.02), whereas mOS could not be computed. Pain response and stability were associated with survival benefit according to mPFS (13 and 12 vs. 9 months) and mOS (both 16 vs. 12 months) without statistical significance. Baseline ALP <220 UI/l, Eastern Cooperative Oncology Group (ECOG) performance status 0 and absence of previous chemotherapy correlated with statistically significantly longer survival outcomes. Skeletal-related events (SRE) occurred in three patients and median time to first SRE was 9.5 months, mPFS was 12 months and mOS 14 months. G3-G4 toxicities developed in 16% of patients. Our results are in line with those reported in the pivotal trial and in other retrospective studies. In conclusion, Radium-223 was associated with high scintigraphic, biochemical and pain response rates and was tolerated well by most patients. Response to Radium-223 and better baseline factors correlated to longer survival in clinical practice experience as in the clinical trial setting.

Keywords: alkaline phosphatase; bone scan; metastatic castration-resistant prostate cancer; pain; prostate-specific antigen; radium-223.

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Figures

Figure 1.
Figure 1.
Waterfall plots of the percentage change in the (A) ALP and (B) PSA level from baseline to the end of Radium-223 treatment. The dotted line indicates a 30% decrease from baseline. *PSA value clipped. ALP, alkaline phosphatase; PSA, prostate-specific antigen.
Figure 2.
Figure 2.
Kaplan-Meier curves of PFS and OS according to response. (A and B) Scintigraphic response, (C and D) PSA response. PFS, progression-free survival; OS, overall survival; PSA, prostate-specific antigen.
Figure 3.
Figure 3.
Kaplan-Meier curves of PFS and OS according to (A and B) ALP response and (C and D) baseline ALP. PFS, progression-free survival; OS, overall survival; ALP, alkaline phosphatase.
Figure 4.
Figure 4.
Kaplan-Meier curves of PFS and OS according to (A and B) performance status and (C and D) previous chemotherapy. PFS, progression-free survival; OS, overall survival.
See this image and copyright information in PMC

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