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Treatment options for patients with non-metastatic descending resistance prostate cancer (nmCRPC) have increased rapidly since spring 2018.
until the SPARTAN and PROSPER trials were proposed, it was reported that the use of aparumide and enserruamine GU ASCO in the 2007 nmCRPC did not have specially approved treatment options for these patients in February 2018.
drugs as well as dalorumide (according to ARAMIS data) and were subsequently approved based on an improvement in non-transferable survival rate (MFS).
follow-up to SPARTAN, PROSPER and ARAMIS also showed significant improvements in overall survival.
previous post-mortem analysis of PROSPER showed that PSA declined more and shifted risk increased in patients with PSA deterioration.
In order to provide guidance on expected results and further explore the impact of PSA dynamics, Dr Hussain and colleagues analyzed the depth of overall survival and metastasis at the poster highlights of the 2021 ASCO GU Cancer Symposium: Prostate Cancer Conference, based on the depth of the PSA response and the non-survival of patients in the PROSPER trial.
methods used in the PROSPER trial have previously been reported and published.
In short, in addition to continuing androgen deprivation therapy, men with nmCRPC, PSA times the time ≤10 months and PSA≥2 ng / mL are randomly assigned to enzalutide 160 mg or placebo at screening.
given the previously reported primary results of non-transferable survival, the overall survival assessment was evaluated as a key secondary result using a grouping sequence test program with O'Brien-Fleming alpha consumption.
In this post-mortem analysis, the authors divided the patients into four groups based on the level of PSA decline at the lowest point: slt;50% (reference value), 50-90%, 90% or higher (lowest point≥0.2 ng / mL, 90% or higher, lowest point , 0.2 ng / mL.
authors used an unstateted Cox scale risk analysis model to evaluate the overall survival rate and MFS between the four groups.
of the 1,401 men registered with PROSPER and 933 men treated with ENZA, 905 men had PSA data available.
the lowest point, 38% of male PSA decreased by ≥90% (actual nadir slt;0.2 ng / mL), and 27% of male PSA decreased by ≥90% (actual nadir ≥0.2 ng / mL).
men in the PROSPER placebo group, only 3/457 had a 90 percent ≥ PSA.
shown below, the depth of PSA reaction at the lowest point is closely related to overall survival and non-transferable survival, and has a dose response relationship.
, the authors concluded that the degree of decline in PSA was closely related to survival outcomes in patients treated with ensyruamine.
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