Martone Comments on the Safety Profile of Darolutamide for Metastatic Hormone-Sensitive Prostate Cancer


Brenda Martone MSN, ANP-BC, AOCNP, discusses the safety data from the phase 3 ARASENS trial.

Brenda Martone MSN, ANP-BC, AOCNP

Brenda Martone MSN, ANP-BC, AOCNP

Darolutamide has a manageable safety profile that is similar to docetaxel, according to Brenda Martone MSN, ANP-BC, AOCNP, who noted that nurses specializing in genitourinary oncology should feel well equipped to care for patients receiving this treatment.

Martone, who is a nurse practitioner at Northwestern Medicine, recently presented on darolutamide during the 48th Annual Oncology Nursing Society Congress. In August of 2022, the FDA approved darolutamide in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer.1 The approval was supported by data from the phase 3 ARASENS (NCT02799602) trial, which showed that the agent significantly improved overall survival (OS; HR, 0.68; 95% CI, 0.57-0.80; P < .0001). Among patients who were randomly assigned to receive darolutamide plus docetaxel (n = 651) the median OS was not reached (NR; 95% CI, NR-NR) vs 48.9 months (95% CI, 44.4-NR) for those who received placebo plus docetaxel (n = 655). The addition of darolutamide also improved the time-to-pain progression in this setting (95% CI, 0.66-0.95; 1-sided P = .006). Of note all patients on this trial also received androgen deprivation therapy (ADT) or had a bilateral orchiectomy.1

Moreover, as Martone demonstrated in her poster presentation, the addition of darolutamide did not compromise treatment completion rates. Most patients in both groups completed all 6 cycles of docetaxel (87.6% and 85.5%, respectively). The rates of treatment discontinuations and dose reductions were also similar between the experimental (8.0% and 19.9%) and control groups (10.3% and 19.5%), respectively.2

In an interview with Oncology Nursing News®, Martone discussed the significance of ARASENS and what oncology nurses caring for patients with prostate cancer should know about this agent.

Oncology Nursing News: Can you briefly describe the rationale for this research and the study design?

Martone: The phase 3 ARASENs study looked at adding darolutamide to docetaxel and ADT. In prostate cancer, treatments are being moved up [to earlier lines]. [Since darolutamide] was used in the castration setting, we are looking to see if there are better outcomes if we move that treatment up.

Every patient [received] docetaxel plus ADT because that is the standard of care. Then there was a 2:1 randomization either to darolutamide or placebo. Those patients were treated for at least 6 cycles of the docetaxel.

What were the findings from this study? Did anything surprise you?

I think what really surprised me was the adverse event [AE] profile, and that the addition of darolutamide did not add any AEs. In both groups, the AE incidence and severity was the same. That is good to know; you can have the most efficacious treatment, [but] if it is not tolerable, patients are not going to be able to continue treatment and get the therapeutic benefit.

The minimum amount of drug-drug interactions without any effect, either on docetaxel or the darolutamide, [was also surprising] and [the finding] that most patients were able to complete the docetaxel was important. Of course, the efficacy in the reduction of death and the OS [rates] with the triplet therapy [were] very exciting.

From a nursing perspective, what does AE management look like with this combination?

The AEs that we saw most commonly were those that we see with docetaxel, which has been around for a long time. Oncology nurses are pretty familiar with the expected AEs, and they were no different in the study. The most common grade 3 and 4 AE was neutropenia; it was similar between the 2 groups [and] it generally occurred after the first cycle. Patients received growth colony stimulating factors in similar amounts in both of the arms.

There was some nausea and diarrhea and, of course, oncology nurses can manage nausea and diarrhea in our sleep, but antiemetics, frequent hydration, and] finding low-fat meals [for our patients is helpful].

Fatigue, a common AE, is difficult to manage because it is so subjective, but just acknowledging that patients have fatigue [and] encouraging them to remain active—even though it seems counterintuitive—does a lot for patients.

The peripheral neuropathy was usually mild to moderate [and] can [present as] numbness and tingling in the fingers and toes. It is very important that we assess this prior to each dose of docetaxel. [If] patients are developing these AEs, we either consider holding [treatment] or [trying] a dose reduction or to mitigate those symptoms early on. [We also consider] physical therapy, or occupational therapy.

What is the biggest takeaway from the poster from the trial for nurses?

This is a very safe and effective treatment. It is well tolerated, it leads to improved outcomes, [which] we are certainly looking for in the metastatic hormone-sensitive patient population.

This is exciting, nurses can definitely [manage] this medication. They should feel really comfortable in taking care of their patients and managing AEs.


  1. FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer. FDA. August 5, 2022. Accessed June 15, 2023.
  2. 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, TX. Accessed June 15, 2023.
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