The New England Journal of Medicine has updated the ULTIMATE OS results of the PROSPER study.
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Last Update: 2020-07-18
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Source: Internet
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Author: User
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During this year's ASCO conference, Professor Cora n. Sternberg of the wil Cornell School of Medicine published the final analysis of the prosper study, which was published in the New England Journal of medicine.background at present, androgen deprivation therapy (ADT) is still the main treatment for patients with advanced prostate cancer. After about 12 months of endocrine therapy, almost all patients will progress to castration resistant prostate cancer. Br / >most patients with prostate cancer have a non metastatic stage.before 2018, there was no standard treatment recommendation in the guidelines. Most patients were recommended to continue to observe or participate in clinical trials. Once nm CRPC metastasis occurs, the patient's condition will accelerate or even worsen. Therefore, delaying metastasis is of great significance to delay the progression of the disease.according to statistics, 1 / 3 nm CRPC patients will have bone metastasis within 2 years after diagnosis.because metastatic castration resistant prostate cancer is associated with decreased overall survival rate, deterioration of quality of life and increased medical costs, delaying metastasis time is one of the clinical related goals.prosper is a double-blind, placebo-controlled phase III randomized study in which patients with nm CRPC continued to receive ADT and were randomly assigned to receive nzalumide or placebo in a 2:1 ratio.previous results of prosper showed that the overall survival (OS) data was not mature at 23 months follow-up, and the median OS of both groups was not reached (HR = 0.80, P = 0.15).based on the prosper study, nzalumide combined with ADT significantly reduced the risk of metastasis or death compared with ADT (HR = 0.29, P < 0.001), which was approved by FDA in 2018 for the treatment of nm CRPC.the study also showed that nzalutamide was associated with better health-related quality of life and a significantly reduced risk of prostate-specific antigen (PSA) progression (HR = 0.07, P < 0.001) and longer duration of follow-up anti-tumor therapy (HR = 0.21, P < 0.001).during this year's ASCO conference, Professor Cora n. Sternberg of wil Cornell School of Medicine published the results of the third interim analysis (final analysis) of the prosper study, which was published in the New England Journal of medicine.main results between 2013 and 2017, a total of 1401 patients were included and randomly assigned to receive treatment. There were 933 patients and 468 patients in the nzalutamide and placebo groups, respectively. The baseline characteristics of the two groups were balanced, and the median PSA doubling time of the two groups was 3.8 months and 3.6 months, respectively.at the end of the initial analysis, the placebo group could be cross treated to the nzalumide group, and 59% (288 / 552) of the nzalumide group and 20% (17 / 87) of the cross treatment group stopped treatment at the end of the initial analysis.the results showed that the median OS was 67 months and 56.3 months in the nzalutamide and placebo groups, respectively (Fig. 1a). The risk of death was reduced by 27% (HR = 0.73, P = 0.001) in nzalumide + ADT group. The efficacy of nzalumide was generally consistent in the pre-set subgroup, except for patients receiving bone targeted drugs at baseline (Figure 1b).follow up treatment was associated with delayed use of follow-up anti-tumor therapy (HR = 0.29). The median time to first use of new treatment was 66.7 months and 19.1 months in both groups, with 33% and 65% of patients receiving at least one follow-up anti-tumor treatment, respectively.conclusion the final analysis of prosper study shows that nzalutamide can reduce the risk of death in nm CRPC patients by 27%, and nzalumide can significantly prolong the OS of patients with nm CRPC, and the safety is similar to that of previous studies.References: Sternberg CN, fizazi K, Saad F, et al. Enzalutamide and survival in nonmetastic, castration resistant prostate cancer. N Engl J Med. 2020; 382 (23): 2197-2206 doi:10.1056/NEJMoa2003892
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