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A dose reduction of Erleada may result in fewer skin-related side effects for men with advanced prostate cancer — but only for those with a smaller body size, research showed.
A dose reduction of Erleada (apalutamide) did not result in a significant decrease of skin-related side effects for men with advanced prostate cancer, according to study results presented at the 2023 American Urological Association Annual Meeting.
“However, dose reduction for patients with small body size may alleviate skin (side effects) without sacrificing oncological outcomes,” Kyo Togashi, from the department of urology at Hirosaki University Graduate School of Medicine in Japan, said during his presentation.
According to the study investigators, 51.47% of patients in the study who were treated with Erleada experienced skin-related side effects, compared with just 23.8% in the phase 3 SPARTAN trial and 27.1% of patients in the phase 3 TITAN trial. Therefore, a sub-analysis was conducted of the clinical trial, from which it was shown that the small body size of Japanese patients may lead to higher levels of the agent in blood.
In their study, Togashi and colleagues aimed to evaluate if the dose reduction of Erleada would affect skin-related side effects and castration-resistant prostate cancer-free survival in 107 patients with metastatic castration-sensitive prostate cancer (72 patients) or nonmetastatic castration-resistant prostate cancer (35 patients) who were diagnosed between June 2019 and June 2022.
Of the 65 patients treated with the full dose of 240 milligrams of Erleada, 42 were dose reduced to receive a range between 60 milligrams to 180 milligrams.
The incidence rate of skin-related side effects served as the main goal of the trial; secondary end points included skin side effects among patients with small body size and treatment discontinuations in patients with metastatic castration-sensitive prostate cancer who were treated with upfront Erleada plus androgen deprivation therapy.
The investigators observed that skin-related side effects occurred in 55.4% of patients in the full-dose group (36 patients), including 44.6% that were mild to moderate (grade 1 to 2) and 10.8% that were moderate to severe (grade 3 to 5), compared with 42.9% of patients in the dose-reduction group (18 patients), including 38.1% that were grade 1 to 2 and 4.8% that were grade 3 to 5, which, overall, was not a statistically significant difference. Similarly, skin-related side effect-free survival was not statistically different between the groups.
However, among patients with a small body size (body weight, less than 67 kg; body mass index [BMI], less than 24 kg/m2), dose reductions led to a lower incidence rate of skin-related side effects, compared with the full dose (46% versus 74%, respectively).
Further, only 50% of patients treated with the full dose of Erleada continued treatment, whereas 83.3% of patients in the dose-reduction arm continued on therapy.
Lastly, patients with metastatic castration-sensitive prostate cancer, as well as those with or without skin-related side effects did not demonstrate a difference in castration-resistant prostate cancer-free survival between dose groups.
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