"Looking at the effect of the darolutamide on docetaxel, we didn't see much of a difference in dose reduction, dose modification, or dose hold for docetaxel, telling you that darolutamide didn't really affect the dosing of docetaxel," says Arash Rezazadah Kalebasty, MD.
In this video, Arash Rezazadeh Kalebasty, MD, discusses the study, “Dosing, safety, and pharmacokinetics (PK) of combination therapy with darolutamide (DARO), androgen-deprivation therapy (ADT), and docetaxel (DOC) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the ARASENS study.” The findings were presented at the 2023 ASCO Genitourinary Cancers Symposium in San Francisco, California. Rezazadeh is a medical oncologist at University of California, Irvine Medical Center.
ARASENS was a phase 3 trial where we randomized patients with metastatic hormone-sensitive prostate cancer to 2 arms, either ADT plus docetaxel or ADT plus docetaxel plus darolutamide, which was the experimental arm. The data is out, and it has shown overall survival benefit for patients in the experimental arm, which sets a new standard of care regimen.
In this study, we looked at the safety and dosing and pharmacokinetics of the patients who were on ARASENS. So basically, we looked at the effect of the darolutamide on docetaxel, side effects and dose modification and such. And vice versa, docetaxel on darolutamide, which, again, we extrapolated that from a different data set for comparison.
To start with, I want to mention that the number of patients who were on this study were more than twice at the time of data cutoff in October 2021. At that time, we looked at the side effects for overall patient population for the duration that they were on the study. The fact that more than twice patients remained in this study at the time of data cutoff tells you about the tolerability and efficacy of these data to start with.
Looking at the effect of the darolutamide on docetaxel, we didn't see much of a difference in dose reduction, dose modification, or dose hold for docetaxel, telling you that darolutamide didn't really affect the dosing of docetaxel. About 85% of patients received full dose docetaxel, 6 cycles of it. We didn't see much of a difference in side effects like neutropenia to be worried about the effect of darolutamide on docetaxel and side effects of the docetaxel. Neutropenia was actually the most prevalent side effect that we were worried about, and that lead led to dose modification more than anything else.
This transcription has been edited for clarity.