A randomized
experimental results show that receiving androgen receptor signaling
inhibitor enzalutamide treated castration resistant prostate cancer patients,
prolonged survival by nearly five months. Enzalutamide (formerly:
MDV3100) experimental group, the median overall survival was 18.4
months, the use of placebo-treated control group was 13.6 months. In the
United States Society of Clinical Oncology meeting, Johann Sebastian de
Bono, MD, reported that the survival advantage persisted in all
subgroups were pre-determined.
As the Royal Marsden Hospital in Sutton, England one, deBono Dr. said: "I think this is the best we have ever seen after chemotherapy survival data." Most of the patients receiving enzalutamide treat prostate specific antigens greater than 50% of baseline, which also includes a considerable part of the baseline PSA values declined by more than 90% of patients.
Dr. de Bono said: "To be honest I never thought of these patients will decline in PSA in 25% 至 90%." Enzalutamide is an androgen receptor signaling antagonists, the first clinical models, there is no evidence that having agonist activity. Dr. de Bono explains the destruction of androgen receptor signaling for the entire signal transduction pathways are present influence.
In phase I / II experiment, whether it is for not receiving chemotherapy or disease progression after chemotherapy CRPC patients, the drug's anti-tumor activity were confirmed. A large part of two groups of patients decrease in PSA values are greater than or equal to 50%. Contributed to the positive results of early treatment of CRPC patients enzalutamide Phase III, multi-center, randomized clinical trials carried out. From 15 countries, 156 Research Center survey will those Duoxitaisuo (Taxotere) no response to treatment of cancer patients as subjects. These patients were randomized in a 2:1 ratio into enzalutamide treated daily with the same dose experimental group and the control group treated with placebo. And overall survival as the primary endpoint.
de Bono pointed out that steroids are not essential, but the doctors they can be used in conjunction with the study drug. Secondary endpoints included response indicators and progression-free survival (PFS). Preliminary analysis included 1199 patients, and their median age was 69 years old. More than half of the patients had previously received three or more of the hormone therapy, more than a quarter of the patients had received two or more courses of chemotherapy. All patients received Duoxitaisuo treatment, with a median of eight treatment cycles. In the planned interim analysis showed enzalutamide survival of the experimental group was significantly higher after the early termination of the study. The entire sample population, the median follow-up period was 14.4 months. 4.9 months of survival differences mean enzalutamide experimental group relative to the control group, it was 37 percent lower risk of death. Experimental group and the control group, the median duration of treatment was 8.3 months and 3 months.
As the Royal Marsden Hospital in Sutton, England one, deBono Dr. said: "I think this is the best we have ever seen after chemotherapy survival data." Most of the patients receiving enzalutamide treat prostate specific antigens greater than 50% of baseline, which also includes a considerable part of the baseline PSA values declined by more than 90% of patients.
Dr. de Bono said: "To be honest I never thought of these patients will decline in PSA in 25% 至 90%." Enzalutamide is an androgen receptor signaling antagonists, the first clinical models, there is no evidence that having agonist activity. Dr. de Bono explains the destruction of androgen receptor signaling for the entire signal transduction pathways are present influence.
In phase I / II experiment, whether it is for not receiving chemotherapy or disease progression after chemotherapy CRPC patients, the drug's anti-tumor activity were confirmed. A large part of two groups of patients decrease in PSA values are greater than or equal to 50%. Contributed to the positive results of early treatment of CRPC patients enzalutamide Phase III, multi-center, randomized clinical trials carried out. From 15 countries, 156 Research Center survey will those Duoxitaisuo (Taxotere) no response to treatment of cancer patients as subjects. These patients were randomized in a 2:1 ratio into enzalutamide treated daily with the same dose experimental group and the control group treated with placebo. And overall survival as the primary endpoint.
de Bono pointed out that steroids are not essential, but the doctors they can be used in conjunction with the study drug. Secondary endpoints included response indicators and progression-free survival (PFS). Preliminary analysis included 1199 patients, and their median age was 69 years old. More than half of the patients had previously received three or more of the hormone therapy, more than a quarter of the patients had received two or more courses of chemotherapy. All patients received Duoxitaisuo treatment, with a median of eight treatment cycles. In the planned interim analysis showed enzalutamide survival of the experimental group was significantly higher after the early termination of the study. The entire sample population, the median follow-up period was 14.4 months. 4.9 months of survival differences mean enzalutamide experimental group relative to the control group, it was 37 percent lower risk of death. Experimental group and the control group, the median duration of treatment was 8.3 months and 3 months.
Experimental
group and the control group objective response rates were 28.9% and 3.8%
(P <0.0001). According to Dr. de Bono reported that in enzalutamide
the experimental group and 54% of patients PSA value decreased by at
least 50%, while the control group only 2% (P <0.0001). Meanwhile, in
enzalutamide experimental group, 25% of patients PSA dropped by more
than 90%, while the control group only 1%. (P <0.0001)
The median progression-free survival in enzalutamide experimental group and the control group were 8.3 months and three months, which means a reduced risk of biochemical progression by 75%. Median radiotherapy of progression-free survival in enzalutamide experimental group and the control group were 8.3 months and 2.9 months target drug treatment also greatly improves the bone-related events starting time (experimental and control groups, respectively was 16.7 months and 13.3 months, P <0.0001). In the overall and individual range of enzalutamide experimental group patients quality of life evaluation ratings also showed a clear advantage. Experimental group and the control group is basically the same incidence of side effects, serious side effects, discontinuation of therapy due to side reactions and fatal incidence of side effects is almost the same.
Experimental group and the control group of patients with cardiac events are basically the same proportion. Five cases of patients treated with enzalutamide appeared seizures. Two patients suffering from intracranial disease, one patient multiple central nervous system involvement. Another one patient accidentally injected with lidocaine, and one patient with severe drinking history, and in the course of the experiment has not interrupted.
de Bono said: "I think some patients noticed the presence of interference experiments factors are very important, however, was not one case of the control group patients had seizures as invited discussant, MD WilliamKevin Kelly recorded enzalutamide and abiraterone (Zytiga) in clinical similarities between the experimental results and in 2011 for the treatment of metastatic CRPC Duoxitaisuo treatment has been recognized.
From Thomas Jefferson University in Philadelphia, Kelly said Dr.: a parallel and a control shows enzalutamide abiraterone (Zytiga) and radiation therapy in relapsing forms of significant progress similarity, which means that although the two drugs has different mechanisms of action, and finally for the androgen receptor axis has a similar effect. kelly considered acceptable enzalutamide treated patients observed seizures further study is needed, because in preclinical models in the study found that androgen receptor antagonist associated with the occurrence of tremor.
The median progression-free survival in enzalutamide experimental group and the control group were 8.3 months and three months, which means a reduced risk of biochemical progression by 75%. Median radiotherapy of progression-free survival in enzalutamide experimental group and the control group were 8.3 months and 2.9 months target drug treatment also greatly improves the bone-related events starting time (experimental and control groups, respectively was 16.7 months and 13.3 months, P <0.0001). In the overall and individual range of enzalutamide experimental group patients quality of life evaluation ratings also showed a clear advantage. Experimental group and the control group is basically the same incidence of side effects, serious side effects, discontinuation of therapy due to side reactions and fatal incidence of side effects is almost the same.
Experimental group and the control group of patients with cardiac events are basically the same proportion. Five cases of patients treated with enzalutamide appeared seizures. Two patients suffering from intracranial disease, one patient multiple central nervous system involvement. Another one patient accidentally injected with lidocaine, and one patient with severe drinking history, and in the course of the experiment has not interrupted.
de Bono said: "I think some patients noticed the presence of interference experiments factors are very important, however, was not one case of the control group patients had seizures as invited discussant, MD WilliamKevin Kelly recorded enzalutamide and abiraterone (Zytiga) in clinical similarities between the experimental results and in 2011 for the treatment of metastatic CRPC Duoxitaisuo treatment has been recognized.
From Thomas Jefferson University in Philadelphia, Kelly said Dr.: a parallel and a control shows enzalutamide abiraterone (Zytiga) and radiation therapy in relapsing forms of significant progress similarity, which means that although the two drugs has different mechanisms of action, and finally for the androgen receptor axis has a similar effect. kelly considered acceptable enzalutamide treated patients observed seizures further study is needed, because in preclinical models in the study found that androgen receptor antagonist associated with the occurrence of tremor.
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