Age influence on adverse events in patients treated with abiraterone plus prednisone, enzalutamide and radium-223 for metastatic castration resistant prostate cancer: Analysis of real life data from Eudra Vigilance database.

2019 ◽  
Vol 18 (1) ◽  
pp. e1221-e1222
Author(s):  
C. De Nunzio ◽  
G. Tema ◽  
R. Lombardo ◽  
O. Voglino ◽  
A. Sica ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Real Life ◽  
Castration Resistant Prostate Cancer ◽  
Life Data ◽  
Castration Resistant ◽  
Radium 223 ◽  
Real Life Data

scholarly journals Real-life data of Cabazitaxel-Prednisone second-line scheme in metastatic castration-resistant prostate cancer

2020 ◽  
Vol 21 ◽  
pp. S151
Author(s):  
L.F. Sánchez-Cousido ◽  
Á. Rodríguez Sánchez ◽  
M. López Flores ◽  
A. López González ◽  
B. Castañón González ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real Life ◽  
Second Line ◽  
Castration Resistant Prostate Cancer ◽  
Life Data ◽  
Castration Resistant ◽  
Real Life Data

scholarly journals Abiraterone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: a systematic review of ‘real-life’ studies

2018 ◽  
Vol 10 (10) ◽  
pp. 305-315 ◽  
Author(s):  
Michele Marchioni ◽  
Petros Sountoulides ◽  
Maida Bada ◽  
Sebastiano Rapisarda ◽  
Cosimo De Nunzio ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Meta Analysis ◽  
Real Life ◽  
Castration Resistant Prostate Cancer ◽  
The Real ◽  
Castration Resistant ◽  
Real Life Setting ◽  
Grade 3 ◽  
Baseline Psa

Background: To assess the efficacy and safety of treatment with abiraterone acetate (AA) in chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC) in the ‘real-life’ setting. Methods: Data acquisition on the outcomes of the use of AA in chemotherapy-naive patients with mCRPC was performed by a MEDLINE comprehensive systematic literature search using combinations of the following key words: ‘prostate cancer’, ‘metastatic’, ‘castration resistant’, ‘abiraterone’, ‘real life’, and excluding controlled clinical trials (phase II and III studies). Identification and selection of the studies was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) criteria. Outcomes of interest were overall survival (OS), progression-free survival (PFS), 12-week 50% reduction in prostate-specific antigen (PSA), and grade 3 and higher adverse events. Data were narratively synthesized in light of methodological and clinical heterogeneity. Results: Within the eight identified studies that fulfilled the criteria, a total of 801 patients were included in the meta-analysis. Baseline PSA ranged between 9.5 and 212.0 ng/ml. Most of the patients had bone metastases. Duration of treatment with AA was longer in the studies with lower baseline PSA levels. The median OS ranged between 14 and 36.4 months. The PFS, assessed according to different definitions, ranged from 3.9 to 18.5 months. A 50% PSA reduction at 12 weeks was reached by a variable percentage of patients ranging from 36.0% to 62.1%. Finally, the rate of grade 3 and higher adverse events was reported in three studies and ranged from 4.4% to 15.5%. Conclusions: Despite the high grade of heterogeneity among studies, treatment with AA seems to ensure good survival outcomes in the ‘real-life’ setting. However, prospective studies based on patients’ characteristics being more similar to ‘real-life’ patients are necessary.

scholarly journals Radium-223 in metastatic castration-resistant prostate cancer (mCRPC): efficacy and safety in real-life experience

2017 ◽  
Vol 28 ◽  
pp. vi23-vi24
Author(s):  
S.E. Rebuzzi ◽  
A. Prelaj ◽  
C. Pozzi ◽  
C. Ferrara ◽  
V. Frantellizzi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Life Experience ◽  
Real Life ◽  
Efficacy And Safety ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Radium 223

Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database

2021 ◽  
Vol 73 (3) ◽  
Author(s):  
Giorgia TEMA ◽  
Riccardo LOMBARDO ◽  
Olivia VOGLINO ◽  
Angela SICA ◽  
Valeria BALDASSARRI ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real Life ◽  
Life Data ◽  
Radium 223 ◽  
Real Life Data

scholarly journals Overall and progression-free survival with cabazitaxel in metastatic castration-resistant prostate cancer in routine clinical practice: the FUJI cohort

2019 ◽  
Vol 121 (12) ◽  
pp. 1001-1008 ◽  
Author(s):  
Magali Rouyer ◽  
◽  
Stéphane Oudard ◽  
Florence Joly ◽  
Karim Fizazi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Real Life ◽  
Progression Free Survival ◽  
European Medicines Agency ◽  
Castration Resistant Prostate Cancer ◽  
Free Survival ◽  
Castration Resistant ◽  
Grade 3 ◽  
Metastatic Sites

Abstract Background Cabazitaxel is a treatment of metastatic castration-resistant prostate cancer (mCRPC) after docetaxel failure. The FUJI cohort aimed to confirm the real-life overall and progression-free survival (OS, PFS) and safety of cabazitaxel. Methods Multicentre, non-interventional cohort of French mCRPC patients initiating cabazitaxel between 2013 and 2015, followed 18 months. Results Four hundred one patients were recruited in 42 centres. At inclusion, median age was 70, main metastatic sites were bones (87%), lymph nodes (42%) and visceral (20%). 18% had cabazitaxel in 2nd-line treatment, 39% in 3rd-line and 43% in 4th-line or beyond. All had prior docetaxel, and 82% prior abiraterone, enzalutamide or both. Median duration of cabazitaxel treatment was 3.4 months. Median OS from cabazitaxel initiation was 11.9 months [95% CI: 10.1–12.9]. In multivariate analyses, grade ≥ 3 adverse events, visceral metastases, polymedication, and >5 bone metastases were associated with a shorter OS. Main grade ≥ 3 adverse events were haematological with 8% febrile neutropenia. Conclusion Real-life survival with cabazitaxel in FUJI was shorter than in TROPIC (pivotal trial, median OS 15.1 months) or PROSELICA (clinical trial 20 vs 25 mg/m2, median OS, respectively, 13.4 and 14.5 months). There was no effect of treatment-line on survival. No unexpected adverse concerns were identified. Study registration It was registered with the European Medicines Agency EUPASS registry, available at www.encepp.eu, as EUPAS10391. It has been approved as an ENCEPP SEAL study.

scholarly journals A real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0253021
Author(s):  
Stephanie I. Kim ◽  
Andy H. Szeto ◽  
Katherine P. Morgan ◽  
Blaine Brower ◽  
Mary W. Dunn ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Adverse Events ◽  
Progression Free Survival ◽  
Castration Resistant Prostate Cancer ◽  
Serious Adverse Events ◽  
Free Survival ◽  
Castration Resistant ◽  
Radium 223 ◽  
Skeletal Event

Introduction Radium-223, abiraterone, and enzalutamide have each been shown to significantly improve survival as monotherapy in patients with metastatic castration-resistant prostate cancer. However, effects of combination radium-223 plus abiraterone or enzalutamide on survival and safety remain unclear. Patients and methods This single-center retrospective cohort study used electronic health record data of patients with metastatic castration-resistant prostate cancer and bone metastases who were treated with radium-223 between April 1, 2014 and February 19, 2019. Patients who received radium-223 monotherapy were compared to patients who received a combination of radium-223 plus either abiraterone or enzalutamide. The primary endpoint was overall survival. Secondary endpoints included progression-free survival, time to symptomatic skeletal event, symptomatic skeletal event-free survival, and incidence of drug-related adverse events. Time-to-event analyses were estimated by log rank tests using Kaplan-Meier curves. Hazard ratios and 95% confidence intervals were derived from Cox proportional hazards models. Chi-square tests evaluated difference in serious adverse events between the two arms. Results A total of 60 patients met inclusion criteria (n = 41 in the monotherapy arm, n = 19 in the combination arm). Differences in median overall survival were not observed (12.7 vs. 12.8 months; HR 1.15, 95% CI 0.59–2.23; P = 0.68), but median progression-free survival was significantly longer in the combination arm (7.6 vs. 4.9 months; HR 1.94, 95% CI 1.11–3.40; P = 0.02). Significant differences were not observed in time to first SSE (P = 0.97), SSE-free survival (P = 0.16), or in the overall incidence of serious adverse events (P = 0.45). Conclusion Combination radium-223 plus abiraterone or enzalutamide did not improve overall survival, but prolonged progression-free survival without increasing the incidence of serious adverse events in metastatic castration-resistant prostate cancer patients with bone metastases. However, these results are limited by small numbers and patient selection inherent in retrospective analysis.

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