06-23-2012, 12:46 PM
Chicago - A randomized trial showed that patients with ITGAM castration resistant prostate cancer receiving androgen receptor signaling the inhibitor enzalutamide treatment, survival extension of nearly five months. Enzalutamide (formerly known as: MDV3100) experimental group, the median overall survival was 18.4 months, the placebo-treated control group was 13.6 months. American Society of Clinical Oncology meeting, the report says Johann Sebastian de Bono, MD, the survival of ITK advantages continue to exist in which all pre-determined sub-group.As one of the Royal Marsden Hospital in England Sutton, Dr. deBono said: "I think this is we've seen the best chemotherapy and survival data. Most accept enzalutamide treatment of patients with prostate specific antigen response are greater than 50% of the baseline, which also includes a considerable portion of the PSA value ITLN1 decreased more than 90% of the baseline patients.Dr. de Bono said: "To be honest I never thought that this group of patients with PSA decline of 25% to 90%." Enzalutamide is an androgen receptor signaling antagonist, the first clinical model, there is no evidence that its agonist activity. Dr. de Bono explained that the destruction of the androgen receptor signaling for the entire signal ITPA transduction pathway.In the phase I / II experiments CRPC patients who did not receive chemotherapy or chemotherapy after disease progression, the anti-tumor activity of the drug have been confirmed. The two groups of patients in a large part of the decline of PSA values greater than or equal to 50%. The early positive results led to the enzalutamide treatment of CRPC patients with stage III, multicenter, randomized clinical IVD trials carried out. From 156 study centers in 15 countries surveyed cancer patients who respond to treatment Duoxitaisuo (Taxotere) as experimental subjects. These patients were randomly assigned in a 2:1 ratio daily enzalutamide treatment of the experimental group and to the same dose of placebo-treated control group. And overall survival as 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 of 1199 patients, their median age was 69 years old. More than half of patients had previously received three or more of hormone therapy, more than a quarter of the patients had received two or more course of chemotherapy. All patients received treatment of Duoxitaisuo, median treatment of 8 cycles. In a planned interim analysis showed enzalutamide experimental group, survival was significantly increased after the study ended prematurely. The entire sample group, the median follow-up period of 14.4 months. Survival of 4.9 months of difference means enzalutamide experimental group relative to the control group for the lower risk of death by 37%. Experimental group and control group, the median duration of treatment were 8.3 months and 3 months.Objective response rate of the experimental and control groups were 28.9% and 3.8% (P <0.0001). Reported by Dr de Bono in enzalutamide experimental group and 54% of patients with PSA levels dropped by at least 50%, while the control group only 2% (P <0.0001). At the same time, 25% of patients with PSA declined by more than 90% in enzalutamide experimental group, while the control group only 1%. (P <0.0001)The median progression-free survival of 8.3 months and three months in enzalutamide experimental and control groups, respectively, decreased by 75% which means that the risk of biochemical progression. Radiation resistance of the median progression-free survival of in enzalutamide experimental group and control group were 8.3 and 2.9 target pharmaceutical treatment to a large extent of bone-related events starting time (experimental and control groups, respectively 16.7 months and 13.3 months, P <0.0001). Range of overall and individual ratings of enzalutamide experimental group patients quality of life assessment showed a clear advantage. Basically the same experimental group and control group the incidence of side effects, serious side effects, and interruption of treatment due to side effects and the incidence of fatal adverse reactions is almost the same.
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 of 1199 patients, their median age was 69 years old. More than half of patients had previously received three or more of hormone therapy, more than a quarter of the patients had received two or more course of chemotherapy. All patients received treatment of Duoxitaisuo, median treatment of 8 cycles. In a planned interim analysis showed enzalutamide experimental group, survival was significantly increased after the study ended prematurely. The entire sample group, the median follow-up period of 14.4 months. Survival of 4.9 months of difference means enzalutamide experimental group relative to the control group for the lower risk of death by 37%. Experimental group and control group, the median duration of treatment were 8.3 months and 3 months.Objective response rate of the experimental and control groups were 28.9% and 3.8% (P <0.0001). Reported by Dr de Bono in enzalutamide experimental group and 54% of patients with PSA levels dropped by at least 50%, while the control group only 2% (P <0.0001). At the same time, 25% of patients with PSA declined by more than 90% in enzalutamide experimental group, while the control group only 1%. (P <0.0001)The median progression-free survival of 8.3 months and three months in enzalutamide experimental and control groups, respectively, decreased by 75% which means that the risk of biochemical progression. Radiation resistance of the median progression-free survival of in enzalutamide experimental group and control group were 8.3 and 2.9 target pharmaceutical treatment to a large extent of bone-related events starting time (experimental and control groups, respectively 16.7 months and 13.3 months, P <0.0001). Range of overall and individual ratings of enzalutamide experimental group patients quality of life assessment showed a clear advantage. Basically the same experimental group and control group the incidence of side effects, serious side effects, and interruption of treatment due to side effects and the incidence of fatal adverse reactions is almost the same.