Best Practices on Managing AEs With Darolutamide Plus ADT/Docetaxel in mHPSC


Data presented during the ONS Annual Congress offers guidance for nurses caring for patients receiving darolutamide, docetaxel, and androgen deprivation therapy.

Brenda K. Martone, MSN, ANP-BC, AOCNP

Brenda K. Martone, MSN, ANP-BC, AOCNP

Darolutamide (Nubeqa) in combination with androgen-deprivation therapy (ADT) and docetaxel can be safely administered in patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to data presented by Brenda K. Martone, MSN, ANP-BC, AOCNP, at the 48th Annual Oncology Nursing Society Congress.

Patients receiving darolutamide in combination with ADT and docetaxel (n = 651) in the phase 3 ARASENS trial (NCT02799602) experienced a 32.5% reduction in the risk of death vs ADT and docetaxel alone, the previous standard of care, (n= 655; HR, 0.68; 95% CI, 0.57-0.80; P < .0001).2 Further, 87.6% of patients in the investigative arm completed 6 cycles of docetaxel vs 85.5% in the control arm demonstrating that adding darolutamide did not affect patient’s ability to complete treatment.1

Adverse effects (AEs) that led to discontinuation and dose reductions of treatment were similar in the investigative arm (8.0% and 19.9%) and control arm (10.3% and 19.5%), respectively, as adding darolutamide to the combination did not result in more AEs when compared with the combination alone. Darolutamide and placebo were discontinued because of AEs in 13.5% and 10.6% of patients.

Decreased neutrophil count served as the most common treatment-emergent AE leading to dose reductions (5.4% vs 6.0%) and discontinuation of docetaxel (0.8% vs 0.5%) in the docetaxel and placebo arms, respectively. The study authors noted that the use of granulocyte colony-stimulating factor was similar among the investigative and placebo arms (42.4% vs 44.6%) occuring primarily after the first cycle of docetaxel (41.9% vs 44.3%), respectively.1

There were no clinically relevant drug-drug interactions in the global, randomized, double-blind trial and docetaxel did not have a clinically relevant effect on darolutamide exposure.

Investigators determined there was not an effect of darolutamide on docetaxel pharmacokinetics as concentrations of docetaxel with and without darolutamide overlapped at most time points. However, darolutamide led to a small but clinically irrelevant increase in docetaxel exposure.

“The addition of darolutamide to ADT and docetaxel improved survival and did not result in more AEs compared with ADT and docetaxel alone,” Martone said. “These findings set a new standard of care for the treatment of patients with mHSPC. “

How to Help Patients Manage Frequent AEs That May Occur

Docetaxel-related AEs may include decreased blood cell count, fatigue, nausea, diarrhea, constipation, and peripheral neuropathies.

To manage decreases in blood cell count, which usually occur 7 to 10 days after the infusion, nurses should schedule laboratory tests, and contact the healthcare team if the patient presents with fever or chills. They may also administer granulocyte colony-stimulating factor.1

Fatigue occurs in most patients and is cumulative—usually presenting 2 to 3 days after a docetaxel infusion. Patients can care for themselves by staying hydrated as well as active. Patients should contact the healthcare team if they spend more than half a day in a chair or bed.

For patients who experience nausea that is mild to moderate in severity, anti-emetics should be given as needed. Ginger chews, ginger ale, frequent snacks and small portions or a BRAT diet are encouraged. Staying hydrated, and avoiding greasy as well as spicy foods will also help manage the AE.

The study authors advised that patients with constipation should take stool softeners and increase their intake of liquids and high fiber foods while those experiencing diarrhea can manage symptoms by recording the number of stools per day, switching to the BRAT diet, and increasing their hydration and antidiarrheal medications. Of note, patients sometimes experience diarrhea or constipation following the docetaxel infusion or because of anti-emetic medications.1

Finally, peripheral neuropathies may manifest as skin sensations, such as a weakness or feeling of heaviness in the hands or feet, or as a numbness that results in clumsiness, unsteady gait, and dexterity loss. While it is normally mild and will resolve following docetaxel treatment completion, management of peripheral neuropathies includes assessing for the AE at all visits by watching the patient perform tasks such as walking without looking down. Additionally, patients should be advised to take steps to prevent injuries at home such as using night lights and wearing supportive footwear.

Findings in Context

Patients enrolled to ARASENS received darolutamide at 600 mg twice daily with ADT and 6 cycles of docetaxel or placebo twice daily with ADT and 6 cycles of docetaxel. The primary end point was overall survival. Secondary end points included time to castration-resistant prostate cancer, time to pain progression, symptomatic skeletal event-free survival, time to first symptomatic skeletal event, time to initiation of subsequent systemic antineoplastic therapy, time to worsening of disease-related symptoms, time to initiation of opioid use for 7 or more consecutive days, and safety.1,2

According to study authors, these data have provided a new standard of care for patients with metastatic hormone-sensitive prostate cancer, and have also provided oncology nurses with the information needed to assist patients in evaluating the benefits and potential risks of the combination therapy.1

The study authors wrote that oncology nurse navigators can help optimize treatment outcomes through good communication, which may consist of frequent check-in calls with patients, assistance in the management of symptoms and AEs, and identifying area of needed support.1

“Oncology nurses play a crucial role in helping patients with metastatic hormone sensitive prostate cancer understand their treatment options and associated tolerability profiles to optimize outcomes and ensure successful disease management,” they concluded.


  1. Martone BK, Smith M, Tombal B, Hussain M, Kapur S, Rezazadeh Kalebasty A. Darolutamide can be effectively and safely administered in combination with androgen-deprivation therapy and docetaxel in patients with metastatic hormone-sensitive prostate cancer. Poster Presented at: 48th Annual Oncology Nursing Society Congress; April 26-30, 2023; San Antonio, Texas. Accessed April 12, 2023.
  2. Smith MR, Hussain M, Saad F, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med. 2022;386(12):1132-1142. doi:10.1056/NEJMoa2119115
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