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The final analysis of PROSPER showed that compared with only receiving androgen deprivation therapy (ADT), enzalutamide + ADT significantly improved the overall survival of patients with rapidly rising prostate-specific antigen (PSA) and non-metastatic castration-resistant prostate cancer (nmCRPC) Period (OS)
.
Among patients of different regions and ages, the diagnosis, management and treatment of prostate cancer are quite different, which may affect the recurrence of the disease and the survival of patients
.
PROSPER post-hoc analysis mainly assessed the overall survival (OS) and safety results of enzalutamide in subgroups of patients of different ages (≥70 years, <70 years) and regions (North America, Europe, Asia and other regions)
.
The results of the study were recently published online in the European Journal of Cancer (impact factor: 9.
162)
.
Research background When the prostate-specific antigen doubling time (PSADT) ≤ 10 months, non-metastatic castration-resistant prostate cancer (nmCRPC) has an increased risk of developing metastatic disease
.
The median OS for metastatic castration-resistant prostate cancer (mCRPC) is about 3 years
.
Delaying the time of metastasis may delay cancer-related incidence, delay the use of anti-tumor therapies, and prolong OS
.
Past results of the PROSPER study show that, compared with placebo, enzalutamide can significantly improve the metastasis-free survival (MFS) of patients with nmCRPC
.
The STRIVE study also showed that compared with bicalutamide, enzalutamide can also significantly improve the radiological progression-free survival (rPFS) of patients with nmCRPC
.
The results of PROSPER's previous analysis suggest that more information on the efficacy and safety of new endocrine treatments in different subgroups of patients is needed in order to make better treatment decisions
.
Research methods The study included patients with serum testosterone levels ≤50 ng/dL and elevated PSA pathologically confirmed as prostate adenocarcinoma, with PSA ≥ 2 ng/ml at baseline and PSADT ≤ 10 months
.
The enrolled patients were randomly assigned to the enzalutamide (160 mg/day) + ADT group and the placebo + ADT group at a 2:1 ratio until radiological progress, death, or unacceptable toxicity occurred
.
The primary end point was MFS, and the secondary end point was OS
.
Main outcome baseline characteristics From November 26, 2013 to June 28, 2017, 1401 nmCRPC patients were randomly assigned to receive enzalutamide + ADT (n=933) or placebo + ADT (n= 468), the median age was 74 years, 425 patients were younger than 70 years old, and 970 patients were older than 70 years old
.
Six patients who did not receive treatment were not included in the post-event multivariate analysis
.
The baseline characteristics such as age and ECOG status of patients in the two treatment groups and regions are balanced and comparable (Table 1)
.
Table 1 Baseline characteristics of patients in each region.
Multivariate analysis of OS in each subgroup.
Multivariate analysis was used to analyze the effects of age, region, and other characteristics on OS
.
The results showed that there was no significant difference in the benefits of OS between ≥70 years old and <70 years old group (P=0.
063).
Compared with the placebo group (66.
2%), patients in the enzalutamide group received less follow-up treatment (34.
2%)
.
Compared with patients who did not receive follow-up treatment, patients who received follow-up treatment had a reduced OS benefit (P<0.
0001), which may be due to more aggressive disease patients who need to receive more treatment
.
Similarly, the reduction in OS benefit was associated with a higher ECOG PS score (P<0.
0001) and log (PSA) value (P<0.
0001)
.
However, previous use of bicalutamide, age, PSADT, and region had no effect on OS (Table 2)
.
Table 2 Multivariate analysis results Follow-up treatment The follow-up treatment is analyzed in the safety population (n=606).
Compared with elderly patients (≥70 years old) (57%), younger patients (<70 years old) are more common Use more than one follow-up treatment (77.
8%)
.
The most commonly used treatment options for younger and elderly patients are a new generation of androgen receptor inhibitors (54.
9% vs 43.
2%) and chemotherapy (63.
6% vs 32%)
.
Compared with North America (27%) and Europe (28%), more patients in the subgroup (38.
4%) and other regions (43.
6%) received a single follow-up treatment
.
The safety of patients of different ages and regions is the same, and the adverse events of any level of treatment are similar
.
Research conclusions Enzalutamide can benefit patients of different ages and regions with rapid PSA rise in nmCRPC subgroups, and the safety is also consistent.
Factors affecting OS benefit include ECOG PS score, log (PSA) and follow-up treatment
.
References: De Giorgi U, Hussain M, Shore N, et al.
Consistent survival benefit of enzalutamide plus androgen deprivation therapy in men with nonmetastatic castration-resistant prostate cancer: PROSPER subgroup analysis by age and region.
Eur J Cancer.
2021 Nov 13 ;159:237-246.
doi: 10.
1016/j.
ejca.
2021.
10.
015.
Epub ahead of print.
PMID: 34784577.
.
Among patients of different regions and ages, the diagnosis, management and treatment of prostate cancer are quite different, which may affect the recurrence of the disease and the survival of patients
.
PROSPER post-hoc analysis mainly assessed the overall survival (OS) and safety results of enzalutamide in subgroups of patients of different ages (≥70 years, <70 years) and regions (North America, Europe, Asia and other regions)
.
The results of the study were recently published online in the European Journal of Cancer (impact factor: 9.
162)
.
Research background When the prostate-specific antigen doubling time (PSADT) ≤ 10 months, non-metastatic castration-resistant prostate cancer (nmCRPC) has an increased risk of developing metastatic disease
.
The median OS for metastatic castration-resistant prostate cancer (mCRPC) is about 3 years
.
Delaying the time of metastasis may delay cancer-related incidence, delay the use of anti-tumor therapies, and prolong OS
.
Past results of the PROSPER study show that, compared with placebo, enzalutamide can significantly improve the metastasis-free survival (MFS) of patients with nmCRPC
.
The STRIVE study also showed that compared with bicalutamide, enzalutamide can also significantly improve the radiological progression-free survival (rPFS) of patients with nmCRPC
.
The results of PROSPER's previous analysis suggest that more information on the efficacy and safety of new endocrine treatments in different subgroups of patients is needed in order to make better treatment decisions
.
Research methods The study included patients with serum testosterone levels ≤50 ng/dL and elevated PSA pathologically confirmed as prostate adenocarcinoma, with PSA ≥ 2 ng/ml at baseline and PSADT ≤ 10 months
.
The enrolled patients were randomly assigned to the enzalutamide (160 mg/day) + ADT group and the placebo + ADT group at a 2:1 ratio until radiological progress, death, or unacceptable toxicity occurred
.
The primary end point was MFS, and the secondary end point was OS
.
Main outcome baseline characteristics From November 26, 2013 to June 28, 2017, 1401 nmCRPC patients were randomly assigned to receive enzalutamide + ADT (n=933) or placebo + ADT (n= 468), the median age was 74 years, 425 patients were younger than 70 years old, and 970 patients were older than 70 years old
.
Six patients who did not receive treatment were not included in the post-event multivariate analysis
.
The baseline characteristics such as age and ECOG status of patients in the two treatment groups and regions are balanced and comparable (Table 1)
.
Table 1 Baseline characteristics of patients in each region.
Multivariate analysis of OS in each subgroup.
Multivariate analysis was used to analyze the effects of age, region, and other characteristics on OS
.
The results showed that there was no significant difference in the benefits of OS between ≥70 years old and <70 years old group (P=0.
063).
Compared with the placebo group (66.
2%), patients in the enzalutamide group received less follow-up treatment (34.
2%)
.
Compared with patients who did not receive follow-up treatment, patients who received follow-up treatment had a reduced OS benefit (P<0.
0001), which may be due to more aggressive disease patients who need to receive more treatment
.
Similarly, the reduction in OS benefit was associated with a higher ECOG PS score (P<0.
0001) and log (PSA) value (P<0.
0001)
.
However, previous use of bicalutamide, age, PSADT, and region had no effect on OS (Table 2)
.
Table 2 Multivariate analysis results Follow-up treatment The follow-up treatment is analyzed in the safety population (n=606).
Compared with elderly patients (≥70 years old) (57%), younger patients (<70 years old) are more common Use more than one follow-up treatment (77.
8%)
.
The most commonly used treatment options for younger and elderly patients are a new generation of androgen receptor inhibitors (54.
9% vs 43.
2%) and chemotherapy (63.
6% vs 32%)
.
Compared with North America (27%) and Europe (28%), more patients in the subgroup (38.
4%) and other regions (43.
6%) received a single follow-up treatment
.
The safety of patients of different ages and regions is the same, and the adverse events of any level of treatment are similar
.
Research conclusions Enzalutamide can benefit patients of different ages and regions with rapid PSA rise in nmCRPC subgroups, and the safety is also consistent.
Factors affecting OS benefit include ECOG PS score, log (PSA) and follow-up treatment
.
References: De Giorgi U, Hussain M, Shore N, et al.
Consistent survival benefit of enzalutamide plus androgen deprivation therapy in men with nonmetastatic castration-resistant prostate cancer: PROSPER subgroup analysis by age and region.
Eur J Cancer.
2021 Nov 13 ;159:237-246.
doi: 10.
1016/j.
ejca.
2021.
10.
015.
Epub ahead of print.
PMID: 34784577.
