KEY TAKEAWAYS
- The phase 3 ARASENS trial studied the combination of darolutamide with ADT and docetaxel in mHSPC patients.
- The study demonstrated that darolutamide is safe and effective in combination therapy.
Several factors contribute to the treatment burden for patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC), including adverse events (AEs) and potential drug interactions (DDIs). Darolutamide has demonstrated improved survival with a favorable safety profile and a low potential for DDIs.
In the phase 3 ARASENS trial, darolutamide, when combined with androgen-deprivation therapy (ADT) and docetaxel, reduced the death risk by 32.5% compared to standard ADT and docetaxel alone. The incidence of most AEs was similar between the groups, with the highest occurrence of common AEs (associated with docetaxel) during overlapping treatment with docetaxel. Darolutamide did not affect the completion of docetaxel therapy, with most pts in both groups receiving the full treatment course.
AEs that led to discontinuation or dose reduction of docetaxel were comparable in both groups. Based on this data, darolutamide received FDA approval for mHSPC treatment in combination with docetaxel. The evaluation of DDIs between darolutamide and docetaxel in ARASENS showed no significant impact on darolutamide exposure from docetaxel and only a slight, clinically insignificant increase in docetaxel exposure from darolutamide.
The results provided information for oncology nurses to help patients understand the benefits and risks of combination therapy. This sets a new standard of care in treating mHSPC patients. Darolutamide can safely and effectively be combined with docetaxel to extend patient survival.
Source: https://ons.confex.com/ons/2023/meetingapp.cgi/Paper/12851
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02799602
Martone, B., Smith, M., Tombal, B., Hussain, M., Kapur, S., Kalebasty, A.R. P108 – Darolutamide Can Be Effectively and Safely Administered in Combination With Androgen-Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone-Sensitive Prostate Cancer.
