The Impact of Darolutamide on Dose Modification of mHSPC

Arash Rezazadeh Kalebasty, MD, associate clinical professor, division of hematology/oncology, Medicine at the University of California Irvine School of Medicine, discusses the impact on the dosing level of treatment with the addition of darolutamide (Nubeqa) to androgen-deprivation therapy (ADT) and docetaxel.

These data come from the randomized, double-blind, placebo controlled, multicenter phase 3 ARASENS trial (NCT02799602) that looked at 1305 patients with both high and low metastatic hormone sensitive prostate cancer that showed a 32.5% reduction in the risk of death for these patients (HR, 0.68; 95% CI, 0.57-0.80, P <.0001). Moreover, the results of the study showed that the addition of darolutamide to ADT and docetaxel prolonged the overall survival rate regardless of a patient’s disease volume risk.

Similar results were seen with treatment-emergent adverse events (TEAEs) from this regimen as they were consistent across all groups and with previous findings. Here, Kalebasty discusses how the addition of darolutamide to this treatment did not impact the dose of docetaxel and what dosing modifications were seen.

Transcript:

0:08 | So, to start with, I want to mention that the number of patients who were on this study were more than [double] at the time of data cut off in October 2021. So, at that time, we looked at the AEs for the overall patient population for the duration that there were on the study. So, the fact that more than twice the patients remained in this study, at the time of data cut off, tells you about the tolerability and efficacy of these data.

0:39 | 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. [This was] telling you that darolutamide didn't really affect the dosing of docetaxel. About 85% of patients received full dose docetaxel, 6 cycles of it, and we didn't see much of a difference in AEs like neutropenia to be worried about the effect of darolutamide on docetaxel and AEs of the docetaxel. So, neutropenia was actually the most prevalent AE that we were worried about, and that led to dose modification more than anything else.