Real-world patient characteristics associated with survival of 2 years or more after radium-223 treatment for metastatic castration-resistant prostate cancer (EPIX study).

George, Daniel J;Agarwal, Neeraj;Sartor, Oliver;Sternberg, Cora N;Shore, Neal;et.al.
(2022) Prostate Cancer and Prostatic Diseases — Vol. 25, n° 2, p. 306-313 (2022)

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Authors
  • George, Daniel Jorcid-logo
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  • Agarwal, Neerajorcid-logo
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  • Sartor, Oliverorcid-logo
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  • Sternberg, Cora N
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  • Tombal, Bertrandorcid-logoUCLouvain
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  • Shore, Neal
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Abstract
(en) BACKGROUND: The real-world EPIX study was conducted to gather information about the characteristics of patients with metastatic castration-resistant prostate cancer (mCRPC) who survived ≥2 years after treatment with the alpha-emitter radium-223. METHODS: This retrospective study of electronic health records in the US Flatiron database (NCT04516161) included patients with mCRPC treated with radium-223 between January 2013 and June 2019. Median overall survival (OS) and prostate-specific antigen (PSA) response (≥50% reduction) from start of radium-223 treatment were the primary and secondary endpoints, respectively. Patient characteristics were compared between those who survived ≥2 years versus <2 years, including a subgroup who survived <6 months. RESULTS: In the 1180 patients identified, median OS was 12.9 months (95% CI: 12.1-13.7), and 13% of patients with data at 6 months had a PSA response. The survival groups included 775 patients (65.7%) who survived <2 years (including 264 (22.4%) who survived <6 months) and 185 patients (15.7%) who survived ≥2 years; 220 patients (18.6%) had incomplete follow-up data and were censored. On multivariate analysis, age >75 years, Eastern Cooperative Oncology Group performance status (ECOG PS) 2-4, visceral metastases, prior symptomatic skeletal events (SSEs), and prior chemotherapy were independently prognostic of reduced OS. For patients with survival ≥2 years versus <2 years, median age was 71 versus 75 years, 4% versus 14% had ECOG PS 2-4, 4% versus 10% had visceral metastases, 38% versus 44% had prior SSEs, and 16% versus 32% had prior chemotherapy. CONCLUSIONS: In this study of men with mCRPC treated in real-world clinical practice, median OS was consistent with that seen in the phase 3 ALSYMPCA trial. Patients who survived ≥2 years after the start of radium-223 were younger and had better ECOG PS, lower disease burden, and less use of prior chemotherapy than those who survived <2 years.
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George, D. J., Agarwal, N., Sartor, O., Sternberg, C. N., Tombal, B., Saad, F., Miller, K., Constantinovici, N., Guo, H., Reeves, J., Jiao, X., Sandström, P., Verholen, F., Higano, C. S., & Shore, N. (2022). Real-world patient characteristics associated with survival of 2 years or more after radium-223 treatment for metastatic castration-resistant prostate cancer (EPIX study). Prostate Cancer and Prostatic Diseases, 25(2), 306-313. https://doi.org/10.1038/s41391-021-00488-0 (Original work published 2022)