scholarly journals Radionuclide Therapies in Prostate Cancer: Integrating Radium-223 in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

2016 ◽  
Vol 18 (2) ◽  
Author(s):  
Sten Nilsson
Keyword(s):  
Prostate Cancer ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Radium 223

scholarly journals Early alkaline phosphatase dynamics as biomarker of survival in metastatic castration-resistant prostate cancer patients treated with radium-223

2021 ◽  
Author(s):  
Maarten J. van der Doelen ◽  
Agnes Stockhaus ◽  
Yuanjun Ma ◽  
Niven Mehra ◽  
Jeffrey Yachnin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Alkaline Phosphatase ◽  
Confidence Interval ◽  
Surrogate Marker ◽  
Response Monitoring ◽  
Castration Resistant Prostate Cancer ◽  
Related Event ◽  
Castration Resistant ◽  
Radium 223 ◽  
Skeletal Related Event

Abstract Purpose Radium-223 is a life-prolonging therapy for castration-resistant prostate cancer (CRPC) patients with symptomatic bone metastases. However, validated biomarkers for response monitoring are lacking. The study aim was to investigate whether early alkaline phosphatase (ALP) dynamics after the first radium-223 injection can act as surrogate marker for overall survival (OS). Methods This retrospective multicenter study included consecutive CRPC patients treated with radium-223. Patients were divided into four subgroups based on baseline ALP level (normal/elevated) and early ALP response, defined as ≥10% ALP decrease after the first radium-223 injection. Primary endpoint was OS among the subgroups. Secondary endpoints included time to first skeletal-related event, time to ALP progression, and treatment completion rate. Results A total of 180 patients were included for analysis. Median OS was 13.5 months (95% confidence interval 11.5–15.5). Patients with elevated baseline ALP without ALP response after the first injection had significantly worse OS when compared to all other patients (median OS 7.9 months versus 15.7 months, hazard ratio 2.56, 95% confidence interval 1.73–3.80, P < 0.001). Multivariate analysis demonstrated that elevated baseline ALP without ALP response after the first injection, the number of prior systemic therapies, baseline LDH level, and baseline ECOG performance status were prognostic factors of OS. Patients with elevated baseline ALP without ALP response after the first injection had significantly shorter times to ALP progression and first skeletal-related event, and more frequently discontinued radium-223 therapy when compared to other patients. Conclusion Early treatment–induced changes in ALP after one radium-223 injection were associated with OS in metastatic CRPC patients.

Decreased fracture rate by mandating bone protecting agents in the EORTC 1333/PEACEIII trial combining Ra223 with enzalutamide versus enzalutamide alone: An updated safety analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5002-5002
Author(s):  
Silke Gillessen ◽  
Ananya Choudhury ◽  
Alejo Rodriguez-Vida ◽  
Franco Nole ◽  
Enrique Gallardo Diaz ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Safety Analysis ◽  
Phase Iii ◽  
Fracture Rate ◽  
Castration Resistant Prostate Cancer ◽  
Continuous Administration ◽  
Castration Resistant ◽  
Radium 223 ◽  
Safety Population

5002 Background: The randomized phase III EORTC-1333-GUCG (NCT02194842) trial compares enzalutamide vs. a combination of Radium 223 and enzalutamide in asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) patients. The premature unblinding of ERA223 (NCT02043678) in Nov 2017 due to a significant increase in the rate of fractures in the combination of abiraterone and Ra223 arm led to the implementation of the mandatory use of bone protecting agents (BPA) in the EORTC-1333-GUCG trial. Skeletal fractures, pathological or not, are a frequent and underestimated adverse event of systemic treatment of advanced prostate cancer. Whether this mandated use of BPA (zoledronic acid or denosumab) would mitigate the risk of fractures in this patient population was unclear. An early safety analysis (Tombal, ASCO, 2019) suggested that the risk of fractures was well controlled in both arms when patients receive BPA. We present here an updated analysis of fracture incidence with longer follow-up. Methods: As of 28/01/2021, a total of 253 patients (134 after making BPA mandatory) were randomized between enzalutamide/Ra223 and enzalutamide. The fracture rate was estimated with the cumulative incidence method in the safety population of 237 (122 after making BPA mandatory) treated patients. Death in absence of fracture was analyzed as competing risk and censoring was applied at last follow-up. Results: Overall, 69.5% of enzalutamide/Ra223 patients (95.2% after making BPA mandatory) and 73.1% of enzalutamide patients (95% after making BPA mandatory) received BPA on treatment: 13.6% in the enzalutamide/Ra223 arm and 21.8% in the enzalutamide arm did not use BPA at registration, but started during protocol treatment and 55.9% and 51.3% respectively, received BPA since entry. At 36.7 months median follow-up in patients without BPA and 23.1 months median follow-up in patients receiving BPA, a total of 39 patients reported a fracture. Among them, 30 patients (20 in enzalutamide/Ra223 arm) did not receive BPA and 9 (4 in the enzalutamide/Ra223 arm) received BPA (see table). Conclusions: The updated safety analysis confirms the early fracture rate results. In the absence of BPA, the risk of fracture is increased when RA223 is added to enzalutamide. Strikingly, in both arms, the risk remains almost abolished by a preventive continuous administration of BPA, thus stressing the importance of complying to international recommendations in terms of giving BPA to mCRPC patients. This study is sponsored by EORTC and supported by Bayer and Astellas. Clinical trial information: NCT02194842. [Table: see text]

scholarly journals Economic Evaluations of Cabazitaxel for Treatment of Post-docetaxel Metastatic Castration-resistant Prostate Cancer: Evidence from a Systematic Review

2019 ◽  
pp. 1-8
Author(s):  
Nikinaz Ashrafi Shahmirzadi ◽  
Pardis Zaboli ◽  
Monireh Afzali ◽  
Bereket Molla Tigabu ◽  
Mirhamed Hajimiri ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Systematic Review ◽  
Cost Effective ◽  
Bibliographic Databases ◽  
Economic Evaluations ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Radium 223 ◽  
Number Of Patients ◽  
Effective Option

Background and Objectives: Prostate cancer is an ever-increasing global incidence and has become the fifth leading cause of cancer-related mortality in men. A significant number of patients with prostate cancer develop metastatic castration-resistant prostate cancer (mCRPC). There are a few second-line treatment options for patients with post-docetaxel mCRPC. This systematic review aimed to assess the cost-effectiveness of cabazitaxel for the treatment of mCRPC. Materials and Methods: Electronic bibliographic databases including: PubMed/Medline, NICE, CRD, and Scopus were searched in January 2018 for identifying full economic evaluations published in English and Persian. The risk of assessment bias and descriptive analyses of individual studies’ findings were presented. Results: Three articles that fulfilled the inclusion criteria were included in the current study. All the included records had a reasonable quality. Cabazitaxel was not recommended as the most cost-effective option for the treatment of docetaxel-refractory mCRPC. Abiraterone acetate and radium-223 were the recommended cost-effective treatments for mCRPC treatment. Conclusion: We found that, in general, while cabazitaxel had equal or slightly higher improvement in Quality-adjusted Life Year (QALY) as compared to the alternatives, it incurred a high cost. Despite the inclusion of a few studies in this review, cabazitaxel was not found to be a cost-effective option. Therefore, we recommend full economic evaluations to be conducted in this area.

scholarly journals Correction to: Dutch Economic Value of Radium-223 in Metastatic Castration-Resistant Prostate Cancer

2018 ◽  
Vol 16 (1) ◽  
pp. 145-145
Author(s):  
Michel L. Peters ◽  
Claudine de Meijer ◽  
Dirk Wyndaele ◽  
Walter Noordzij ◽  
Annemarie M. Leliveld-Kors ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Economic Value ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Radium 223
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