Real-world survival analysis in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223) in Slovenia

180 Background: Radium-223 (RA-223) is the first FDA approved targeted alpha therapy that significantly improves overall survival (OS) in patients (pts) with metastatic castration resistant prostate cancer (mCRPC) with symptomatic bone metastases. There is limited real world data describing RA-223 current use. Methods: A retrospective patient chart review was done of men who received at least 1 cycle of Ra-223 for mCRPC in 10 centers throughout the US (4 academic, 6 private practices). All pts had a minimum follow-up of 4 months, or placed in hospice or death. Descriptive analyses for clinical characteristics and treatment outcomes were performed. Results: Among the 200 pts (mean age-73.6 years, mean Charlson comorbidity index-6.9) RA-223 was initiated on average 1.6 years from mCRPC diagnosis (first line use (1L)=38.5%, 2L=31.5% and ≥3L=30%). 78% completed 5-6 cycles of RA-223 with mean therapy duration of 4.2 months. Among all pts, 43% received RA-223 as monotherapy (no overlap with other mCRPC therapies) while 57% had combination therapy with either abiraterone or enzalutamide. Median OS following RA-223 initiation was 21.2 months (95% CI 19.6- 29.2). Table provides the RA-223 utilization by type of clinical practice. Conclusions: Utilization of RA-223 in this real world data set was distinct from clinical trial data. Most patients received RA-223 in combination with abiraterone or enzalutamide, therapies that were unavailable when the pilot trial was conducted. Median survival was 21.2 months. Real world use of RA-223 has evolved as newer agents have become FDA approved in bone-metastatic CRPC. Academic and community patterns of practice were more similar than distinct. [Table: see text]

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Optimising Radium 223 Therapy for Metastatic Castration-Resistant Prostate Cancer –5-year Real-World Outcome: Focusing on Treatment Sequence and Quality of Life

Clinical Oncology ◽

10.1016/j.clon.2020.05.002 ◽

2020 ◽

Vol 32 (10) ◽

pp. e177-e187 ◽

Cited By ~ 1

Author(s):

X.Y. Jiang ◽

S. Atkinson ◽

R. Pearson ◽

D. Leaning ◽

S. Cumming ◽

...

Keyword(s):

Quality Of Life ◽

Prostate Cancer ◽

Real World ◽

Treatment Sequence ◽

Castration Resistant Prostate Cancer ◽

Castration Resistant ◽

Radium 223

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Clinical outcome with radium-223 (Ra-223) in patients (pts) previously treated with abiraterone (Abi) or enzalutamide (Enza): A retrospective study of real-world (RW) data from pts with metastatic castration-resistant prostate cancer (mCRPC)

Annals of Oncology ◽

10.1093/annonc/mdy284.036 ◽

2018 ◽

Vol 29 ◽

pp. viii288-viii289 ◽

Cited By ~ 1

Author(s):

C.S. Higano ◽

B. Tombal ◽

K. Miller ◽

F. Saad ◽

O. Sartor ◽

...

Keyword(s):

Prostate Cancer ◽

Retrospective Study ◽

Clinical Outcome ◽

Real World ◽

Castration Resistant Prostate Cancer ◽

Castration Resistant ◽

Radium 223 ◽

Previously Treated

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Safety and activity of radium-223 in metastatic castration-resistant prostate cancer: the experience of Istituto Nazionale dei Tumori

Tumori Journal ◽

10.1177/0300891620905646 ◽

2020 ◽

Vol 106 (5) ◽

pp. 406-412

Author(s):

Alessandra Raimondi ◽

Pierangela Sepe ◽

Melanie Claps ◽

Marco Maccauro ◽

Gianluca Aliberti ◽

...

Keyword(s):

Prostate Cancer ◽

Real World ◽

Group Performance ◽

Interquartile Range ◽

World Population ◽

Treatment Schedule ◽

Castration Resistant Prostate Cancer ◽

Castration Resistant ◽

Radium 223 ◽

Ecog Ps

Introduction: Therapeutic decision-making in metastatic castration-resistant prostate cancer (mCRPC) represents an open challenge. Radium-223 is approved for patients with symptomatic bone metastases, no visceral involvement, progressing after at least 2 lines of systemic therapy, or ineligible for any other systemic treatment. Methods: We performed a retrospective, observational study on patients with mCRPC treated with radium-223 at our institution outside of clinical trials, to assess the safety and activity in a real-world population. Data regarding baseline patient/disease characteristics and treatment outcomes (number of cycles, treatment-related adverse events [AEs], cause of discontinuation, and best response) were collected. Results: Overall, 41 patients were treated from September 2015 to September 2018. Median age was 73 years; baseline Eastern Cooperative Oncology Group Performance Status (ECOG PS) was 0, 1, or 2 in 15%, 80%, and 5% of cases, respectively; and 3%, 41%, 44%, and 12% of patients had <6, 6–20, >20, and superscan bone lesions, respectively. A median number of 5 cycles (interquartile range 3–6) with median dose 19.52 MBq (interquartile range 12.87–24.83) was received. Treatment schedule was completed in 49% of cases; discontinuations due to AEs, disease-related death, or disease progression occurred in 24%, 33%, and 43% of patients, respectively. Any-grade AEs occurred in 73% and grade 3/4 treatment-related AEs occurred in 29% of patients, mainly anemia, decreased platelet count, and fatigue. No skeletal-related events or treatment-related deaths were recorded. After treatment, 66%, 2%, and 32% of patients had a stable, improved, or deteriorated ECOG PS versus baseline, respectively, and 24%, 61%, and 15% reported a stable, improved, or worsened pain symptom control. Post-treatment versus baseline alkaline phosphatase was reduced or stable in 46% and increased in 54% of patients, whereas prostate-specific antigen was decreased or stable in 83% and increased in 17% of patients. Conclusions: Our study provides clinically useful real-world data on radium-223, highlighting the importance of multidisciplinary patient management to guarantee the best continuum of care for patients with mCRPC.

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Real world lessons for optimal selection of patients with bone metastatic castration-resistant prostate cancer for radium-223 therapy

European Urology Supplements ◽

10.1016/s1569-9056(17)31837-7 ◽

2017 ◽

Vol 16 (10) ◽

pp. e2691-e2692

Author(s):

M.J. Van Der Doelen ◽

M.C.P. Kuppen ◽

M.A. Jonker ◽

M.J.R. Janssen ◽

N. Mehra ◽

...

Keyword(s):

Prostate Cancer ◽

Real World ◽

Optimal Selection ◽

Castration Resistant Prostate Cancer ◽

Castration Resistant ◽

Radium 223 ◽

Selection Of Patients ◽

Selection Of

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Concurrent or layered treatment with radium-223 and enzalutamide or abiraterone/prednisone: real-world clinical outcomes in patients with metastatic castration-resistant prostate cancer

Prostate Cancer and Prostatic Diseases ◽

10.1038/s41391-020-0236-0 ◽

2020 ◽

Vol 23 (4) ◽

pp. 680-688

Author(s):

Neal Shore ◽

Celestia S. Higano ◽

Daniel J. George ◽

Cora N. Sternberg ◽

Fred Saad ◽

...

Keyword(s):

Prostate Cancer ◽

Real World ◽

Incidence Rates ◽

Castration Resistant Prostate Cancer ◽

Real World Data ◽

Combination Treatments ◽

Castration Resistant ◽

Radium 223 ◽

Pathologic Fractures ◽

Health Database

Abstract Background In this study, we evaluated real-world data on radium-223 plus abiraterone/prednisone or enzalutamide. Previously, the ERA 223 trial (NCT02043678) demonstrated increased fracture risk with concurrent treatment with radium-223 and abiraterone plus prednisone/prednisolone in patients with metastatic castration-resistant prostate cancer (mCRPC). Methods We used the Flatiron Health database to perform a retrospective study of patients with mCRPC treated with radium-223. Treatment with radium-223 plus abiraterone/prednisone or enzalutamide was defined as concurrent if both drugs started within 30 days of one another, or layered when the second drug started ≥30 days after the first. The index date was defined as the day of the first radium-223 dose. Outcome measures included symptomatic skeletal events (SSEs), overall survival (OS), and patterns of treatments received. Results Of the 625 patients treated with radium-223, 22% received it together with abiraterone/prednisone and 27% with enzalutamide. When these agents were combined, they were often initiated in a layered fashion (73% layered, 23% concurrent). Prior or concomitant bone health agents (BHAs) were received by 67% and 55% of patients, respectively. Median follow-up was 9 months. Overall, incidence rates for SSEs and pathologic fractures were 0.35 and 0.11 patients per person-year, respectively. Median OS from mCRPC diagnosis was 28.1 months. Conclusions In this real-world setting, combination treatments with radium-223 and abiraterone/prednisone or enzalutamide were common. These agents were more commonly given in a layered than a concurrent fashion. Incidence rates for SSEs were reduced when BHAs were used; however, BHAs were underutilized.

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