Clin Cancer Res: Apatamine is used for non-metastatic desopathic prostate cancer exposure-response analysis.

Objective: The purpose of this study was to evaluate the relationship between apalutamine (apalutamide) and its active metabolite N-methamphetamine exposure, as well as the application of selected clinical efficacy and safety parameters in patients with high-risk non-metastatic despotic resistance prostate cancer.
: This is an exploratory exposure-reactive analysis that included data from 1207 patients in the SPARTAN study (806 in the apatamine group and 401 in the placebo group).
single-factor and multi-factor Cox regression models assessed the correlation between apatamine and N-methamphetamine exposure (expressed in area under a steady-state concentration-time curve) and non-transferable lifetime (MFS) and common treatment of emergency adverse reactions.
Kaplan-Meier diagram: The correlation between the exposure of the active portion (C) (Q1, Q2, Q3, Q4) under the active portion (C) of Aparuamine (A), N-dmyl aparumide (B) and plasma stable curve was associated with no transfer lifetime (MFS): overall, 21% of patients in the apatamine group experienced a dose reduction (240 mg/day to 209 mg/day).
there was no statistically significant relationship between MFS and Apatamine and N-methamphetamine exposure in a relatively narrow exposure range.
in patients treated with apatamine, rashes and weight loss were statistically significant with higher apatamine exposure.
conclusion: Regardless of exposure level, the recommended dose of 240 mg/day of apatamine had a similar metastasis delay in patients with high-risk non-metastatic despotical prostate cancer in the SPARTAN trial.
- safety analysis supports dose reduction in patients with adverse events.
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