ASCO GU 2021: Analysis of the efficacy of the treatment of non-metastatic despotable prostate cancer

Since the spring of 2018, treatment options for patients with non-metastatic desopathic prostate cancer (NM-CRPC) have developed rapidly.
SPARTAN and PROSPER trials, reported in February 2018 at GU ASCO, reported the use of aparumamide and erythramine in NM-CRPC patients.
July 30, 2019, the U.S. FDA approved dalorumamine for the treatment of NM-CRPC based on ARAMIS trial data.
is (Darolutamide, product name: Nubeqa) is an androgen-inhibitor.
ARAMIS test results showed that dalorumamine had no metastasis lifetime (PFS) improvement in NM-CRPC patients.
, further follow-up of SPARTAN, PROSPER and ARAMIS test participants also demonstrated significant improvements in total lifetime (OS).
patients were eventually treated with non-blind methods, as evidenced in the main analysis of PFS that the treatment of dalorumide benefited.
, 170 patients experienced cross-overs from placebos to lorumam.
an analysis by Dr. Shore and colleagues at the 2021 American Society of Clinical Oncology Reproductive Urology (ASCO GU) Conference on Prostate Cancer-Local Diseases looked at the effects of cross-treatment on OS benefits for patients seen in ARAMIS.
ARAMIS trial, the researchers analyzed a total of 1,509 NM-CRPC patients and then randomly assigned 600 mg of lorumam twice a day (n-955) or PBO (n-554) at a 2:1 scale.
all patients continue to use ADT.
the main outcome of the trial was the PFS results in NM-CRPC patients.
other secondary endpoints include pain progress time, first chemotherapy, first bone symptom event time, and safety.
survival analysis was conducted after approximately 240 deaths and was graded.
to illustrate the therapeutic effect of cross-entry from placebo to lorumam, the researchers took an iterative parameter estimation (IPE) and a hierarchical protection structure failure time (RPSFT) analysis.
resulted in the Kaplan-Meier curve of the PBO arm, which predicted the survival of patients without the above crossovers.
As mentioned earlier, 170 patients experienced cross-treatment from placebo to loluamine (30.7 percent of patients who received PBO at random);
the combined double-blind period and the open label period was conducted after 254 deaths.
the above-mentioned deaths occurred in 15.5 percent of patients who received dalorumamine and 19.1 percent of patients who received a placebo at random.
analysis shows that the OS benefits of dalorumamine are statistically significant (HR s 0.69; 95% CI 0.53-0.88).
cross-treatment effects, the results of the IPE (HR=0.66;95% CI 0.51-0.84) and RPSFT (HR=0.68; 95% CI 0.51-0.90) analysis are consistent with the original intent therapy analysis.
the study found no side effects of the new daloroline treatment.
, the researchers believe that early use of daloroline in NM-CRPC patients significantly improved overall survival, regardless of cross-effects.
: ASCO GU 2021: Analysis of The Effect of Crossover from Placebo to Darolutamide on Overall Survival Benefit in The ARAMIS Trial.MedSci Original Source: MedSci Original Copyright Notice: All noted on this website Source: Metz Medicine or Source: MedSci Originals Text, images and audio and video materials, copyrighted by Metz Medical, are not authorized, and may not be reproduced by any media, website or individual, and shall be reproduced with the words "Source: Mets Medicine".
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