Arash Rezazadeh Kalebasty Discusses Darolutamide Combination Safety in the ARASENS Study


Arash Rezazadeh Kalebasty, MD, discusses the rates of dose reduction and treatment discontinuation for patients with hormone-sensitive prostate cancer receiving combination therapy with darolutamide.

Darolutamide (Nubeqa) in combination with androgen-deprivation therapy (ADT) and docetaxel, demonstrated a similar rate of treatment-emergent adverse events (TEAEs) in patients with metastatic hormone-sensitive prostate cancer compared with ADT and docetaxel alone, according to Arash Rezazadeh Kalebasty, MD.

Rezazadeh, who is a medical oncologist at University of California, Irvine Medical Center, recently presented on the dosing, safety, and pharmacokinetics of combination therapy with darolutamide during the 2023 ASCO Genitourinary Cancers Symposium. In an interview with Oncology Nursing News®, he recounted the key takeaways from the presentation.

In the ARASENS trial (NCT02799602), more than twice as many patients were receiving darolutamide at the time of data cutoff as those who were receiving placebo. The median treatment duration with darolutamide was 41.0 months compared with 16.7 months without darolutamide. The rate of patients still receiving treatment on October 25, 2021, was 45.9% vs 19.1%, respectively; the rates of patients who completed 6 cycles of docetaxel was 87.6% vs 85.5%, respectively.

“We didn’t see much of a difference in dose reduction, dose modification or dose hold for docetaxel—telling [us] that the darolutamide didn't really affect the dosing of docetaxel,” Rezazadeh Kalebasty explained.

Moreover, the proportions of patients requiring docetaxel dose modifications were similar between the 2 treatment groups. Between the darolutamide and placebo group, the rates of TEAE-inspired dose modifications were 46.5% vs 43.2%, respectively. The TEAE most responsible for docetaxel dose reductions in either group was decreased neutrophil counts. This resulted in dose reductions in 5.4% and 6.0% of patients, respectively, and in discontinuation in 0.8% and 0.5% of patients. For any TEAEs, the percentage of patients who required dose modifications between the 2 groups was 60.0% and 62.9%, and the rate of dose reduction was 19.9% vs 19.5%. Eight percent of patients receiving darolutamide needed to discontinue docetaxel compared with 10.3% of patients receiving ADT and docetaxel alone.

“Neutropenia was the most prevalent [AE] that we were worried about. And that led to dose modification more than anything else,” Rezazadeh Kalebasty said.

Of note, docetaxel was not found to show an effect on the docetaxel exposure either, he added.

“The bottom line is that darolutamide really didn’t have any significant effect on docetaxel exposure and vice versa,” he concluded, noting that this data set shows promise for the toxicity of combination therapy in this setting.


Rezazadeh Kalebasty A, Tombal B, Hussain M, et al. 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. J Clin Oncol. 2023;41(suppl 6):148. doi:10.1200/JCO.2023.41.6_suppl.148

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