Expert Perspectives: ARANOTE: Subgroup Analysis in Black Patients

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Dr McKay discusses the significant subgroup analysis of Black patients in the ARANOTE trial, which enrolled 65 Black patients primarily from Brazil, South Africa, and Australia. This analysis demonstrates consistent treatment benefits with darolutamide plus androgen deprivation therapy, showing an HR of 0.5 for radiographic progression-free survival, with median survival not yet reached. The 60% rate of undetectable prostate-specific antigen levels in Black patients suggests potential enhanced sensitivity to androgen deprivation therapy in this population.

The biological rationale for differential treatment responses includes genetic variations such as reduced HSD3B1 and resistance Single Nucleotide Polymorphisms (SNPs) in Black populations, which may contribute to enhanced sensitivity to hormonal therapies. Treatment-related adverse events were similar between arms, supporting the safety profile of darolutamide across diverse populations. These findings align with previous research suggesting biological differences in androgen metabolism and treatment response among different racial groups.

Dr Shore emphasizes the exceptional diversity of the ARANOTE trial compared with typical phase 3 studies, which often include only single-digit percentages of Black patients. This diversity is crucial for understanding treatment efficacy across different populations and addressing health care disparities. The success of international collaboration in achieving diverse enrollment provides a model for future studies and highlights the importance of global clinical research partnerships in advancing equitable cancer care for all patients, regardless of race or geographic location.