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

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.

scholarly journals The prognostic power of inflammatory indices and clinical factors in metastatic castration-resistant prostate cancer patients treated with radium-223 (BIO-Ra study)

2021 ◽  
Author(s):  
Matteo Bauckneht ◽  
Sara Elena Rebuzzi ◽  
Alessio Signori ◽  
Viviana Frantellizzi ◽  
Veronica Murianni ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Bone Metastases ◽  
Group Performance ◽  
Prognostic Score ◽  
Castration Resistant Prostate Cancer ◽  
Clinical Factors ◽  
Lymphocyte Ratio ◽  
Castration Resistant ◽  
Radium 223 ◽  
Ecog Ps

Abstract Purpose To combine peripheral blood indices and clinical factors in a prognostic score for metastatic castration-resistant prostate cancer (mCRPC) patients treated with radium-223 dichloride ([223Ra]RaCl2). Patients and methods Baseline neutrophil-to-lymphocyte ratio (NLR), derived NLR (donor), lymphocyte-to-monocyte ratio (LMR), platelet-to-lymphocyte ratio (PLR), systemic inflammation index (SII), Eastern Cooperative Oncology Group performance status (ECOG PS), Gleason score (GS) group, number of bone metastases, prostate-specific antigen (PSA), alkaline phosphatase (ALP), line of therapy, previous chemotherapy, and the presence of lymphadenopathies were collected from seven Italian centers between 2013 and 2020. Lab and clinical data were assessed in correlation with the overall survival (OS). Inflammatory indices were then included separately in the multivariable analyses with the prognostic clinical factors. The model with the highest discriminative ability (c-index) was chosen to develop the BIO-Ra score. Results Five hundred and nineteen mCRPC patients (median OS: 19.9 months) were enrolled. Higher NLR, dNLR, PLR, and SII and lower LMR predicted worse OS (all with a p < 0.001). The multivariable model including NLR, ECOG PS, number of bone metastases, ALP, and PSA (c-index: 0.724) was chosen to develop the BIO-Ra score. Using the Schneeweiss scoring system, the BIO-Ra score identified three prognostic groups (36%, 27.3%, and 36.6% patients, respectively) with distinct median OS (31, 26.6, and 9.6 months, respectively; hazard ratio: 1.62, p = 0.008 for group 2 vs. 1 and 5.77, p < 0.001 for group 3 vs. 1). Conclusions The BIO-Ra score represents an easy and widely applicable tool for the prognostic stratification of mCRPC patients treated with [223Ra]RaCl2 with no additional costs.

scholarly journals Real-world use of radium-223 for treatment of metastatic castration resistant-prostate cancer (mCRPC): Results from the Dutch CAPRI registry

2019 ◽  
Vol 30 ◽  
pp. v340
Author(s):  
M.C.P. Kuppen ◽  
H.M. Westgeest ◽  
A.J.M. van den Eertwegh ◽  
J. Van Moorselaar ◽  
N. Mehra ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Radium 223

Racial disparities in radium-223 treatment in a large real-world population.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 268-268
Author(s):  
Hanson Hanqing Zhao ◽  
Lauren Howard ◽  
Amanda de Hoedt ◽  
Martha K Terris ◽  
Christopher L. Amling ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Black Men ◽  
Real World ◽  
Multivariable Analysis ◽  
Treatment Patterns ◽  
World Population ◽  
Castration Resistant Prostate Cancer ◽  
Cox Models ◽  
Radium 223 ◽  
To Receive

268 Background: Black men with prostate cancer are more likely to have unfavorable tumor characteristics and are at greater risk of prostate cancer mortality. Radium-223 is a FDA approved treatment for metastatic castration-resistant prostate cancer (mCRPC) that showed a survival benefit in the ALSYMPCA trial, where 94% of the participants were Caucasian. We aim to examine treatment patterns and outcomes of radium-223 in a large, heterogeneous population in the real world. Methods: We reviewed charts of all men with diagnosed with mCRPC in the entire Veterans Affairs (VA) system alive as of January 1st, 2013 who received radium-223. We compared common treatment patterns and characteristics between black and nonblack men. We analyzed predictors of time from radium-223 start to overall survival and time to skeletal related event (SRE) with Cox models. Results: 318 patients with bone mCRPC who received radium-223 were identified. 27% (87/318) were black. Black men were younger (67 vs 70 years, p = 0.001) and had higher PSA and alkaline phosphatase (ALP) levels at radium start (p = 0.014 and 0.017, respectively). There were no significant differences in biopsy Gleason, number of bone metastasis, primary localized treatment (yes/no), PSA doubling time, bone pain, or number of radium injections. Black men had lower mortality risk (HR 0.75; 95% CI 0.57 to 0.98; P = 0.038) on multivariable analysis. Comparison of common treatment patterns between black and nonblack men revealed that black men were more likely to receive other therapies prior to radium, including chemotherapy. Conclusions: Using a large, heterogeneous, real world cohort, we describe differences in treatment patterns and outcomes with radium-223 between black and nonblack men with mCRPC. While black men had a lower risk of mortality in this cohort, they had higher PSA and ALP levels when receiving radium-223. They were also more likely to receive other therapies prior to radium-223, indicating a possible delay in radium use in black men.

A retrospective analysis of treatment patterns in metastatic castration-resistant prostate cancer patients treated with radium-223.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 180-180 ◽  
Author(s):  
A. Oliver Sartor ◽  
Sreevalsa Appukkuttan ◽  
Ronald E. Aubert ◽  
Jeffrey Weiss ◽  
Joy Wang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Pilot Trial ◽  
Clinical Trial Data ◽  
Castration Resistant Prostate Cancer ◽  
Real World Data ◽  
Data Set ◽  
World Data ◽  
Castration Resistant ◽  
Radium 223

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]

The National Radium-223 Dichloride Audit Group: Data from patients in United Kingdom oncology centers with metastatic castration-resistant prostate cancer treated with radium-223 dichloride.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 59-59
Author(s):  
Manreet Randhawa ◽  
Irene Stratton ◽  
Robert J. Jones ◽  
Keyword(s):  
Prostate Cancer ◽  
Final Analysis ◽  
Outcome Data ◽  
Treatment Patterns ◽  
Quality Data ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Radium 223 ◽  
The Uk ◽  
Ecog Ps

59 Background: Clinicians in 20 UK oncology centres comprise the National Radium-223 Dichloride Audit group which is evaluating treatment patterns and outcomes in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with Radium-223 dichloride (Xofigo). Methods: Pts first treated with Xofigo from September 2017 were included and demographics, treatment, clinical, biochemical and outcome data collected prospectively. Analysis was carried out using frequency tables, univariate and survival analysis. Results: We report the outcomes on the first 100 pts in 4 centres with good quality data. Median values of each characteristic including 25th and 75th percentiles are as follows: Age at diagnosis = 67 years (62-72), weight = 83.5kgs (73.6-92.8), Hb = 139g/L (118 – 136), WCC = 7.3X109/L (5.7 – 8.7), plt count = 252x109/L (208 – 290), ALP = 128U/L (96-263) and PSA = 42.1ug/L (21.5 – 125.7). A majority of pts had an ECOG PS of 0-1. The number of pts having Xofigo as 1st, 2nd, 3rd and 4th line treatment was 15, 64, 20 and 1 respectively. There was a statistically significant decline in median weight, Hb, WCC, plt count and ALP and a rise in PSA between cycle 1 and cycle 6. Thirty eight pts did not complete 6 cycles with 31 of these (82%) discontinuing due to disease progression. The prevalence of adverse events was 5% (20/100). Twenty nine pts had a skeletal event by 12 months. There was no change in the WHO analgesic score, QOL scores or ECOG PS between treatment 1 and 6. Thirty nine pts had subsequent lines of treatment with 31 of these having only 1 line of treatment. Median overall survival was 363 days (95% CI 312-426 days). Conclusions: The ongoing National Radium-223 Dichloride Audit records data from approximately 600 mCRPC pts treated across the UK in routine clinical NHS care. To our knowledge, it is the first prospective analysis of such pts and the largest in assessing treatment patterns, outcomes and quality of life data in addition to standard biochemical and clinical parameters. Further multivariate analysis will be presented and the implications of the licensing change of Xofigo will be illustrated in the final analysis.

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