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Introduction Advanced prostate cancer has always been a difficult point in the diagnosis and treatment of urinary tumors, and new therapeutic drugs have been emerging in endlessly.
New endocrine therapy drugs represented by enzalutamide have become a new choice for urological oncologists.
From February 11th to 13th, 2021, major urinary oncology experts from all over the world will gather in the American Society of Clinical Oncology-Genitourinary System Oncology Symposium (ASCO-GU) through online connection to participate in the grand event.
The editor compiled the efficacy of enzalutamide and apatamide, dalotamide and bicalutamide for non-metastatic castration-resistant prostate cancer (nmCRPC), as well as metastatic castration-resistant prostate cancer ( mCRPC) Comparison of cardiovascular toxicity between Enzalutamide and Abiraterone in patients, for readers.
01Abstract 101: The efficacy of enzalutamide compared with apatamide, dalotamide and bicalutamide for nmCRPC delays the progression of nmCRPC to mCRPC and prolongs patient survival, which is the main goal of nmCRPC therapy.
In recent years, the efficacy of the second-generation anti-androgen drugs enzalutamide, apatamide and dalotamide for nmCRPC has been well known to everyone.
The first-generation anti-androgen is more common in clinical medicine than carutamide.
At present, these drugs lack head-to-head comparisons.
In order to compare the relative efficacy of enzalutamide with apatamide, dalotamide and bicalutamide, the authors conducted a study based on the published phase III clinical trial data of these drugs.
Network meta-analysis (NMA).
Study Introduction This meta-analysis uses a systematic literature review (SLR) to compare PROSPER (enzalutamide vs.
placebo), SPARTAN (apartamide vs.
placebo), ARAMIS (dalotamide vs.
placebo) and STRIVE (Enzalutamide vs.
Bicalutamide, only nmCRPC patients) study data.Primary endpoints include metastasis-free survival (MFS), overall survival (OS), time to prostate-specific antigen progression (TTPP), and time to first use of cytotoxic chemotherapy (TTCH).
Study results MFS enzalutamide and placebo (HR 0.
29; 95% CI: 0.
24-0.
35), dalotamide (HR 0.
71; 95% CI: 0.
54-0.
93) and bicalutamide (HR 0.
24; 95%) CI: 0.
10-0.
57) Compared with MFS, MFS was longer, and no significant difference was observed compared with apatamide.
Sensitivity analysis showed that in the included studies, the definition of MFS was different, but the results were not different.
Figure 1 MFS results OS enzalutamide compared with placebo, OS was significantly prolonged (HR 0.
73; 95% CI: 0.
61-0.
89), and no significant difference was observed compared with apatamide and dalotamide.
Figure 2 OS results TTCH enzalutamide compared with placebo, TTCH was significantly prolonged (HR 0.
54; 95% CI: 0.
44-0.
67), and it also has advantages compared with apatamide and dalotamide.
Figure 3 TTCH results TTPP and placebo (HR 0.
07; 95% CI: 0.
05-0.
08), bicalutamide (HR 0.
18; 95% CI: 0.
10-0.
34) and dalotamide (HR 0.
51; 95% CI: 0.
38-0.
67) Compared with enzalutamide, the TTPP is significantly prolonged.
Figure 4 TTPP results study conclusions The study showed that enzalutamide benefited significantly.
Compared with placebo, enzalutamide's MFS, OS, TTCH and TTPP are all prolonged; compared with dalotamide and bicalutamide, enzalutamide's MFS and TTPP benefits are more obvious; enzalut No statistically significant difference was observed between amine and apatamide.
02Abstract 62: Comparison of enzalutamide and abiraterone for cardiovascular toxicity in mCRPC patients.
The new endocrine therapy drugs enzalutamide and abiraterone have shown benefits in mCRPC patients, but currently, there is no information about these two Head-to-head research on drugs. The safety and tolerability of the two drugs are good, but both have adverse effects of cardiovascular events.
This study aims to compare the cardiovascular toxicity of enzalutamide and abiraterone in the real world.
Study Introduction This study is a population-based retrospective cohort real-world data (RWD) conducted using the Quebec Public Health Management Database.
The purpose is to test the cardiovascular safety of enzalutamide and abiraterone in mCRPC patients.
The primary endpoint of the study is cardiovascular (CVD)-related hospitalization rate (/100-patient-year), which is a composite endpoint of acute coronary artery disease, cerebrovascular disease, heart failure, arrhythmia and other cardiac diseases.
The secondary endpoints are each of the composite endpoints.
Single item.
The propensity score is generated by a logistic regression model using baseline characteristics, and the inverse probability weighting method (IPTW) is derived from the propensity score, and then the weight of IPTW is applied to the Cox risk regression model to calculate the hazard ratio HR and 95% CI.
Research results The study included 2183 patients, of which 1773 (81%) were treated with abiraterone and 410 (19%) were treated with enzalutamide.
Before IPTW, the average age of the enzalutamide group was higher than that of the abiraterone group (78 vs.
76 years), and the enzalutamide group had both arrhythmias (15.
1% vs.
10.
7%) and diabetes (25.
1% vs.
21.
5%) more patients.
The CVD-related hospitalization rates in the enzalutamide group and abiraterone group were 10 cases/100-patient-years (PYs) and 7 cases/100-patient-years, respectively.
After the application of IPTW, the standardized difference between the two groups was <0.
05, and the abiraterone group had a higher risk of CVD-related hospitalization than the enzalutamide group (IPTW-HR: 1.
79, 95% CI: 1.
04-3.
09).
At the same time, the abiraterone group had a higher risk of hospitalization due to heart failure (IPTW-HR: 3.
02, 95% CI: 1.
17-7.
78). Figure 5 Crude and IPTW cumulative incidence curve of cardiovascular-related hospitalization.
Conclusions The study found that compared with enzalutamide, patients who used abiraterone had a higher risk of CVD-related hospitalization, especially the risk of hospitalization due to heart failure.
.
Due to the lack of head-to-head studies, the results of this study can provide references for clinicians to treat mCRPC patients in the real world, and further studies are needed to demonstrate this result.
References: 1.
Tomasz M.
Beer,Fred Saad,Cora N.
Sternberg,et al.
Network meta-analysis (NMA) comparing the efficacy of enzalutamide versus apalutamide,darolutamide, and bicalutamide for treatment of nonmetastatic (nm) castration-resistant prostate cancer (CRPC).
2021 ASCO-GU.
Abstract 101.
2.
Jason Hu,Armen G.
Aprikian,Marie Vanhuyse,et al.
Comparative cardiotoxicity of the novel hormonal agents abiraterone and enzalutamide in metastatic castration-resistant prostate cancer using real-world data .
2021 ASCO-GU.
Abstract 62.
New endocrine therapy drugs represented by enzalutamide have become a new choice for urological oncologists.
From February 11th to 13th, 2021, major urinary oncology experts from all over the world will gather in the American Society of Clinical Oncology-Genitourinary System Oncology Symposium (ASCO-GU) through online connection to participate in the grand event.
The editor compiled the efficacy of enzalutamide and apatamide, dalotamide and bicalutamide for non-metastatic castration-resistant prostate cancer (nmCRPC), as well as metastatic castration-resistant prostate cancer ( mCRPC) Comparison of cardiovascular toxicity between Enzalutamide and Abiraterone in patients, for readers.
01Abstract 101: The efficacy of enzalutamide compared with apatamide, dalotamide and bicalutamide for nmCRPC delays the progression of nmCRPC to mCRPC and prolongs patient survival, which is the main goal of nmCRPC therapy.
In recent years, the efficacy of the second-generation anti-androgen drugs enzalutamide, apatamide and dalotamide for nmCRPC has been well known to everyone.
The first-generation anti-androgen is more common in clinical medicine than carutamide.
At present, these drugs lack head-to-head comparisons.
In order to compare the relative efficacy of enzalutamide with apatamide, dalotamide and bicalutamide, the authors conducted a study based on the published phase III clinical trial data of these drugs.
Network meta-analysis (NMA).
Study Introduction This meta-analysis uses a systematic literature review (SLR) to compare PROSPER (enzalutamide vs.
placebo), SPARTAN (apartamide vs.
placebo), ARAMIS (dalotamide vs.
placebo) and STRIVE (Enzalutamide vs.
Bicalutamide, only nmCRPC patients) study data.Primary endpoints include metastasis-free survival (MFS), overall survival (OS), time to prostate-specific antigen progression (TTPP), and time to first use of cytotoxic chemotherapy (TTCH).
Study results MFS enzalutamide and placebo (HR 0.
29; 95% CI: 0.
24-0.
35), dalotamide (HR 0.
71; 95% CI: 0.
54-0.
93) and bicalutamide (HR 0.
24; 95%) CI: 0.
10-0.
57) Compared with MFS, MFS was longer, and no significant difference was observed compared with apatamide.
Sensitivity analysis showed that in the included studies, the definition of MFS was different, but the results were not different.
Figure 1 MFS results OS enzalutamide compared with placebo, OS was significantly prolonged (HR 0.
73; 95% CI: 0.
61-0.
89), and no significant difference was observed compared with apatamide and dalotamide.
Figure 2 OS results TTCH enzalutamide compared with placebo, TTCH was significantly prolonged (HR 0.
54; 95% CI: 0.
44-0.
67), and it also has advantages compared with apatamide and dalotamide.
Figure 3 TTCH results TTPP and placebo (HR 0.
07; 95% CI: 0.
05-0.
08), bicalutamide (HR 0.
18; 95% CI: 0.
10-0.
34) and dalotamide (HR 0.
51; 95% CI: 0.
38-0.
67) Compared with enzalutamide, the TTPP is significantly prolonged.
Figure 4 TTPP results study conclusions The study showed that enzalutamide benefited significantly.
Compared with placebo, enzalutamide's MFS, OS, TTCH and TTPP are all prolonged; compared with dalotamide and bicalutamide, enzalutamide's MFS and TTPP benefits are more obvious; enzalut No statistically significant difference was observed between amine and apatamide.
02Abstract 62: Comparison of enzalutamide and abiraterone for cardiovascular toxicity in mCRPC patients.
The new endocrine therapy drugs enzalutamide and abiraterone have shown benefits in mCRPC patients, but currently, there is no information about these two Head-to-head research on drugs. The safety and tolerability of the two drugs are good, but both have adverse effects of cardiovascular events.
This study aims to compare the cardiovascular toxicity of enzalutamide and abiraterone in the real world.
Study Introduction This study is a population-based retrospective cohort real-world data (RWD) conducted using the Quebec Public Health Management Database.
The purpose is to test the cardiovascular safety of enzalutamide and abiraterone in mCRPC patients.
The primary endpoint of the study is cardiovascular (CVD)-related hospitalization rate (/100-patient-year), which is a composite endpoint of acute coronary artery disease, cerebrovascular disease, heart failure, arrhythmia and other cardiac diseases.
The secondary endpoints are each of the composite endpoints.
Single item.
The propensity score is generated by a logistic regression model using baseline characteristics, and the inverse probability weighting method (IPTW) is derived from the propensity score, and then the weight of IPTW is applied to the Cox risk regression model to calculate the hazard ratio HR and 95% CI.
Research results The study included 2183 patients, of which 1773 (81%) were treated with abiraterone and 410 (19%) were treated with enzalutamide.
Before IPTW, the average age of the enzalutamide group was higher than that of the abiraterone group (78 vs.
76 years), and the enzalutamide group had both arrhythmias (15.
1% vs.
10.
7%) and diabetes (25.
1% vs.
21.
5%) more patients.
The CVD-related hospitalization rates in the enzalutamide group and abiraterone group were 10 cases/100-patient-years (PYs) and 7 cases/100-patient-years, respectively.
After the application of IPTW, the standardized difference between the two groups was <0.
05, and the abiraterone group had a higher risk of CVD-related hospitalization than the enzalutamide group (IPTW-HR: 1.
79, 95% CI: 1.
04-3.
09).
At the same time, the abiraterone group had a higher risk of hospitalization due to heart failure (IPTW-HR: 3.
02, 95% CI: 1.
17-7.
78). Figure 5 Crude and IPTW cumulative incidence curve of cardiovascular-related hospitalization.
Conclusions The study found that compared with enzalutamide, patients who used abiraterone had a higher risk of CVD-related hospitalization, especially the risk of hospitalization due to heart failure.
.
Due to the lack of head-to-head studies, the results of this study can provide references for clinicians to treat mCRPC patients in the real world, and further studies are needed to demonstrate this result.
References: 1.
Tomasz M.
Beer,Fred Saad,Cora N.
Sternberg,et al.
Network meta-analysis (NMA) comparing the efficacy of enzalutamide versus apalutamide,darolutamide, and bicalutamide for treatment of nonmetastatic (nm) castration-resistant prostate cancer (CRPC).
2021 ASCO-GU.
Abstract 101.
2.
Jason Hu,Armen G.
Aprikian,Marie Vanhuyse,et al.
Comparative cardiotoxicity of the novel hormonal agents abiraterone and enzalutamide in metastatic castration-resistant prostate cancer using real-world data .
2021 ASCO-GU.
Abstract 62.
