European urology focus · 2025
Strategies to Mitigate Breast-related Adverse Events in Patients with High-risk Biochemically Recurrent Prostate Cancer Receiving Enzalutamide Monotherapy: Perspectives and Challenges.
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Shore Neal D, Freedland Stephen J, Horvath Lisa G, O'Sullivan Joe M, De Giorgi Ugo, Ray Edward C, Ross Ashley E, Tang Yiyun, Russell David, Iwata Kenneth K, Rosales Matt, Ganguli Arijit, Tombal Bertrand
Аннотация
BACKGROUND AND OBJECTIVE: Enzalutamide (Enza) is the only androgen receptor pathway inhibitor approved as monotherapy for high-risk biochemically recurrent prostate cancer. Breast-related adverse events (BRAEs) are common among patients treated with Enza monotherapy (Enza-Mono). We review relevant clinical trial data, including unpublished data, on measures to prevent BRAEs. Given the absence of data on mitigating strategies for Enza-associated BRAEs, we draw on pertinent prophylactic strategies used in studies of bicalutamide, a nonsteroidal antiandrogen with a similar mechanism of action. We critically discuss the clinical implications of such strategies to support decision-making in patients receiving Enza-Mono.
METHODS: We searched PubMed for clinical trials on the safety of Enza-Mono, with a focus on BRAEs. We added relevant unpublished data from the EMBARK and ENACT trials. We also explored the literature and summarize prophylactic strategies for bicalutamide-induced BRAEs.
KEY FINDINGS AND LIMITATIONS: In three trials involving 533 patients treated with Enza-Mono, Enza-Mono (160 mg/d) was commonly associated with gynecomastia (37-49%), breast pain or tenderness (14-26%), and/or nipple pain (15-30%). No prophylactic measures for BRAEs were protocol-specified in these studies. Previous studies with bicalutamide (150 mg/d) reported the benefits and relative tolerability of prophylactic radiation therapy and/or tamoxifen or prophylactic anastrozole to mitigate gynecomastia or breast pain.
CONCLUSIONS AND CLINICAL IMPLICATIONS: Given the absence of data on prophylactic strategies for Enza-associated BRAEs, findings from bicalutamide studies could be extrapolated to Enza-Mono. Prospective trials are needed to optimize prophylactic strategies for BRAEs with Enza-Mono.
METHODS: We searched PubMed for clinical trials on the safety of Enza-Mono, with a focus on BRAEs. We added relevant unpublished data from the EMBARK and ENACT trials. We also explored the literature and summarize prophylactic strategies for bicalutamide-induced BRAEs.
KEY FINDINGS AND LIMITATIONS: In three trials involving 533 patients treated with Enza-Mono, Enza-Mono (160 mg/d) was commonly associated with gynecomastia (37-49%), breast pain or tenderness (14-26%), and/or nipple pain (15-30%). No prophylactic measures for BRAEs were protocol-specified in these studies. Previous studies with bicalutamide (150 mg/d) reported the benefits and relative tolerability of prophylactic radiation therapy and/or tamoxifen or prophylactic anastrozole to mitigate gynecomastia or breast pain.
CONCLUSIONS AND CLINICAL IMPLICATIONS: Given the absence of data on prophylactic strategies for Enza-associated BRAEs, findings from bicalutamide studies could be extrapolated to Enza-Mono. Prospective trials are needed to optimize prophylactic strategies for BRAEs with Enza-Mono.