Nubeqa plus hormone remedy improved progression-free survival and delayed PSA development in metastatic prostate most cancers with manageable unwanted side effects.
Whereas the addition of Nubeqa (darolutamide) to androgen deprivation remedy proved clinically helpful amongst sufferers with metastatic hormone-sensitive prostate most cancers, the nurse’s position in educating sufferers on its impact and its security is essential, in keeping with Brenda Martone, registered nurse and superior apply supplier.
On the fiftieth Annual Oncology Nursing Society Congress, security and efficacy information from the section 3 ARANOTE examine had been shared with oncology nurses in order that they will higher educate, and counsel sufferers being handled with this method. The info, which had been shared in a poster and beforehand introduced, underscored that the Nubeqa mixture (446 sufferers) resulted in a 46% discount within the danger of radiological development or demise versus placebo and androgen deprivation remedy (223 sufferers). The median radiological progression-free survival in these respective arms was not reached versus 25 months, respectively. The 24-month radiological progression-free survival charge was 70.3% with Nubeqa versus 52.1% with out it.
A constructive development in total survival was additionally noticed, with Nubeqa plus androgen deprivation remedy resulting in a 19% discount within the danger of demise versus androgen deprivation remedy alone. Furthermore, the Nubeqa mixture led to a 60% discount in danger of development to metastatic castration-resistant prostate most cancers; the median time to metastatic castration-resistant prostate most cancers in these respective arms was not reached and 13.8 months.
The next proportion of sufferers within the Nubeqa arm achieved undetectable prostate-specific antigen, outlined as lower than 0.2 nanograms per milliliter, versus these within the placebo arm, at 62.6% and 18.5%, respectively. The addition of Nubeqa to androgen deprivation remedy additionally delayed time to prostate-specific antigen development, resulting in a 69% discount within the danger of prostate-specific antigen development. The median time to prostate-specific antigen development within the Nubeqa arm was not reached versus 16.8 months within the placebo arm.
Lastly, Nubeqa demonstrated clear advantages over placebo by way of time to ache development, an vital patient-relevant finish level. The median time to ache development was not reached with Nubeqa versus 29.9 months with out, translating to a 28% discount within the danger of ache development.
“When discussing remedy choices with sufferers, you will need to contemplate efficacy, security, and the influence of remedy on sufferers’ high quality of life, and nurses play an vital position in offering training to assist sufferers handle illness signs and remedy unwanted side effects,” Martone, of Northwestern College, Feinberg Faculty of Medication in Chicago, and colleagues wrote in a poster of the information. “Along with the constructive outcomes of the section 3 ARASENS examine, the findings from ARANOTE present the choice to pick remedy in metastatic hormone-sensitive prostate most cancers with and with out Taxotere to satisfy sufferers’ particular person wants and preferences.”
Security Highlight
The incidence of unwanted side effects was reported to be low and comparable between the remedy arms. Any unwanted side effects had been skilled by 91% of these within the Nubeqa arm versus 90% of these within the placebo arm; grade 3 (extreme) or 4 (life-threatening) unwanted side effects had been skilled by 30.8% and 30.3% of sufferers, respectively. Furthermore, critical unwanted side effects had been reported in 23.6% of those that obtained Nubeqa plus androgen deprivation remedy versus 23.5% of those that solely obtained androgen deprivation remedy.
Notably, a smaller proportion of sufferers within the Nubeqa arm skilled unwanted side effects that led to remedy discontinuation versus these within the placebo arm, at 6.1% versus 9%, respectively. Authors underscored that it is a “measure of drug tolerability.”
Furthermore, the incidence of unwanted side effects linked with androgen receptor inhibitor remedy was low in each arms. Negative effects included hypertension (Nubeqa, 9.4%; placebo, 9.5%), vasodilation or flushing (9.2%; 7.2%), diabetes or hyperglycemia (9%; 9.5%), cardiac arrhythmias (8.8%; 6.8%), fatigue (5.6%; 8.1%), rash (4.3%; 3.6%), bone fracture (4%; 2.3%), coronary artery issues (3.6%; 1.4%), psychological impairment (1.6%; 0.5%), falls (1.3%; 0.9%) and coronary heart failure (0.9%; 0.9%).
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