High dose Estetrol curbs hot flushes and improves QOl in prostate cancer patients on ADT

A new study found that high-dose fetal estrogen estetrol along with androgen deprivation therapy prevented the occurrence of hot flushes and improved quality of life and well-being in patients with advanced prostate cancer. The study results were published in the journal European Urology Open Science.  

Androgen deprivation therapy (ADT) for prostate cancer (PCa) is accompanied by side effects affecting health-related quality of life (HRQL). Hence researchers conducted a phase 2, double-blind, randomized, placebo-controlled study in patients with advanced PCa to assess the effects of the fetal estrogen estetrol (E4) on symptoms related to estrogen and androgen deficiency, and on HRQL measured using the validated Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. 

Patients receiving ADT were randomly assigned at a 2:1 ratio to daily treatment with a high dose of E4 (HDE4; n = 41) or placebo (n = 21) for 24 wk. The primary outcome was the effect of HDE4 cotreatment on hot flushes (HFs). Secondary outcomes were the Q-Man questionnaire for evaluation of the effect on estrogen and androgen deficiency symptoms, and the FACT-P questionnaire for evaluating HRQL. 

Results: 

• Patients in the HDE4 group experienced significantly lower HFs than in the placebo group (14.3% vs 60.0%; p < 0.001) at 24 wk. 
• HDE4 treatment was associated with a lower incidence of night sweats, arthralgia, and fatigue, but more nipple tenderness and gynecomastia.
• The mean HRQL score favored HDE4 over placebo for the FACT-P total score (122.2 ± 12.3 vs 118.7 ± 19.7) and several other FACT subscales at 24 wk. 

Take-home message: 

Cotreatment of androgen deprivation therapy along with a high dose of estetrol for patients with advanced prostate cancer nearly prevented the occurrence of hot flushes and improved quality of life and well-being, but nipple sensitivity and an increase in breast size were seen. 

Further reading: Zimmerman Y, Frydenberg M, van Poppel H, et al. Estetrol Prevents Hot Flushes and Improves Quality of Life in Patients with Advanced Prostate Cancer Treated with Androgen Deprivation Therapy: The PCombi Study. Eur Urol Open Sci. 2022;45:59-67. Published 2022 Oct 3. doi:10.1016/j.euros.2022.09.006