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Introduction Combined androgen blockade (CAB)-bicalutamide + androgen deprivation therapy (ADT)-has been widely used in Japan for metastatic or non-metastatic prostate cancer, and some patients will develop prostate-specific antigen ( PSA) relapsed and progressed to castration-resistant prostate cancer (CRPC).
Flutamide + ADT is commonly used in Japan for CRPC patients who have progressed after bicalutamide + ADT treatment; based on ARCHES and ENZAMET studies, enzalutamide + ADT is also approved for the treatment of CRPC in Japan, enzalutamide + ADT has become the first-line treatment option for patients with advanced CRPC after treatment with bicalutamide + ADT.
The study compared enzalutamide + ADT and flutamide + ADT in the treatment of bicalutamide + ADT in patients with advanced CRPC, the efficacy, safety and treatment sequence.
Research introduction The AFTERCAB study is an open phase IV study conducted in Japan from November 2016 to March 2020.
A total of 206 cases of asymptomatic or mild symptoms (ECOG PS 0-1) aged 20 years or older were enrolled in Bica.
Patients with metastatic or non-metastatic CRPC who progressed after Lutamide+ADT were randomly assigned to enzalutamide (160mg/day)+ADT group (enzalutamide first-line group) and flutamide (375mg/day)+ The ADT group (flutamide first-line group) switched to second-line treatment after PSA progressed, other disease progressed, or treatment stopped due to adverse events (AE).
Figure 1 AFTERCAB study design The primary endpoint of the study is the time from first-line treatment to PSA progression (TTPP1), and the secondary endpoints include TTPP2 (the duration of TTPP1 + the time from second-line treatment to PSA progression), and the PSA response rate for first-line treatment (minimum PSA ≥ 3 weeks later, Decrease ≥50% or ≥90% from baseline), PSA response rate on the 13th week of line treatment (reduced by ≥50% or ≥90% from baseline), time from first-line treatment to a 50% decrease in PSA from baseline, and imaging progression-free survival Period (rPFS) and so on.
The results of the study were similar in baseline and disease characteristics between the two groups; the median treatment exposure time was 14.
3 months (0.
8-35.
9 months) in the first-line enzalutamide group and 5.
6 months (0.
3-37.
7 months) in the first-line flutamide group.
The primary endpoint TTPP1 and secondary endpoint TTPP2 studies showed that TTPP1 in the first-line enzalutamide group was significantly higher than that in the first-line flutamide group, with a median TTPP1 of 21.
4 months and 5.
8 months, respectively (HR 0.
42; 95% CI 0.
29-0.
61 ).
Compared with the flutamide first-line group, enzalutamide first-line group can significantly prolong the time of PSA progression and reduce the risk of PSA progression by 58%.
Figure 2 Results of TTPP1 Both the first-line enzalutamide group and the first-line flutamide group have a numerical TTPP2 benefit.
Among them, the median TTPP2 of the first-line flutamide group is 21.
2 months, and the first-line enzalutamide group is 35.
9 months long.
TTPP2 was not reached within the monthly observation period.
Figure 3 TTPP2 results and other secondary endpoints PSA response rate of first-line treatment and 13th week of PSA response rate: enzalutamide first-line group was significantly higher than flutamide first-line group; first-line treatment to PSA decreased by 50% time: Enza The first-line group of lutamide is shorter than the first-line group of flutamide; rPFS (only statistics of distant metastatic CRPC population): There is no statistical difference between the two groups, but due to the small number of cases and events, the data should be interpreted with caution.
Figure 4 Secondary Endpoint Results Safety The overall tolerability of the two treatments is better, and the AEs are consistent with previously known safety.
Research conclusions The study showed that compared with flutamide first-line treatment, enzalutamide + ADT first-line treatment significantly improved the time to PSA progression and other PSA-related clinical outcomes in CRPC patients who progressed on bicalutamide + ADT treatment.
The two treatments were well tolerated, and the AEs were consistent with known safety.
Enzalutamide+ADT may become the first-line androgen treatment option for patients with metastatic or non-metastatic CRPC who have progressed in the treatment of bicalutamide+ADT in Japan.
References Hiroji Uemura, Kazuki Kobayashi, Akira Yokomizo, et al.
Enzalutamide plus androgen deprivation therapy (ADT) versus flutamide plus ADT in men with castration-resistant prostate cancer (CRPC): AFTERCAB.
2021 ASCO-GU.
Abstract 81.
Flutamide + ADT is commonly used in Japan for CRPC patients who have progressed after bicalutamide + ADT treatment; based on ARCHES and ENZAMET studies, enzalutamide + ADT is also approved for the treatment of CRPC in Japan, enzalutamide + ADT has become the first-line treatment option for patients with advanced CRPC after treatment with bicalutamide + ADT.
The study compared enzalutamide + ADT and flutamide + ADT in the treatment of bicalutamide + ADT in patients with advanced CRPC, the efficacy, safety and treatment sequence.
Research introduction The AFTERCAB study is an open phase IV study conducted in Japan from November 2016 to March 2020.
A total of 206 cases of asymptomatic or mild symptoms (ECOG PS 0-1) aged 20 years or older were enrolled in Bica.
Patients with metastatic or non-metastatic CRPC who progressed after Lutamide+ADT were randomly assigned to enzalutamide (160mg/day)+ADT group (enzalutamide first-line group) and flutamide (375mg/day)+ The ADT group (flutamide first-line group) switched to second-line treatment after PSA progressed, other disease progressed, or treatment stopped due to adverse events (AE).
Figure 1 AFTERCAB study design The primary endpoint of the study is the time from first-line treatment to PSA progression (TTPP1), and the secondary endpoints include TTPP2 (the duration of TTPP1 + the time from second-line treatment to PSA progression), and the PSA response rate for first-line treatment (minimum PSA ≥ 3 weeks later, Decrease ≥50% or ≥90% from baseline), PSA response rate on the 13th week of line treatment (reduced by ≥50% or ≥90% from baseline), time from first-line treatment to a 50% decrease in PSA from baseline, and imaging progression-free survival Period (rPFS) and so on.
The results of the study were similar in baseline and disease characteristics between the two groups; the median treatment exposure time was 14.
3 months (0.
8-35.
9 months) in the first-line enzalutamide group and 5.
6 months (0.
3-37.
7 months) in the first-line flutamide group.
The primary endpoint TTPP1 and secondary endpoint TTPP2 studies showed that TTPP1 in the first-line enzalutamide group was significantly higher than that in the first-line flutamide group, with a median TTPP1 of 21.
4 months and 5.
8 months, respectively (HR 0.
42; 95% CI 0.
29-0.
61 ).
Compared with the flutamide first-line group, enzalutamide first-line group can significantly prolong the time of PSA progression and reduce the risk of PSA progression by 58%.
Figure 2 Results of TTPP1 Both the first-line enzalutamide group and the first-line flutamide group have a numerical TTPP2 benefit.
Among them, the median TTPP2 of the first-line flutamide group is 21.
2 months, and the first-line enzalutamide group is 35.
9 months long.
TTPP2 was not reached within the monthly observation period.
Figure 3 TTPP2 results and other secondary endpoints PSA response rate of first-line treatment and 13th week of PSA response rate: enzalutamide first-line group was significantly higher than flutamide first-line group; first-line treatment to PSA decreased by 50% time: Enza The first-line group of lutamide is shorter than the first-line group of flutamide; rPFS (only statistics of distant metastatic CRPC population): There is no statistical difference between the two groups, but due to the small number of cases and events, the data should be interpreted with caution.
Figure 4 Secondary Endpoint Results Safety The overall tolerability of the two treatments is better, and the AEs are consistent with previously known safety.
Research conclusions The study showed that compared with flutamide first-line treatment, enzalutamide + ADT first-line treatment significantly improved the time to PSA progression and other PSA-related clinical outcomes in CRPC patients who progressed on bicalutamide + ADT treatment.
The two treatments were well tolerated, and the AEs were consistent with known safety.
Enzalutamide+ADT may become the first-line androgen treatment option for patients with metastatic or non-metastatic CRPC who have progressed in the treatment of bicalutamide+ADT in Japan.
References Hiroji Uemura, Kazuki Kobayashi, Akira Yokomizo, et al.
Enzalutamide plus androgen deprivation therapy (ADT) versus flutamide plus ADT in men with castration-resistant prostate cancer (CRPC): AFTERCAB.
2021 ASCO-GU.
Abstract 81.
