Endocrine Therapy for Men With Breast Cancer: Estradiol Levels, Sexual Function, and Quality of Life
Posted: Friday, March 26, 2021
To assess the changes in estradiol levels after 3 months of endocrine therapy in men with breast cancer, Sibylle Loibl, MD, PhD, Chair of the German Breast Group, and colleagues conducted the phase II randomized, multicenter MALE trial. Their study findings, which were published in JAMA Oncology, showed that aromatase inhibitor or tamoxifen plus gonadotropin-releasing hormone analog (GnRHa) versus tamoxifen alone resulted in a sustained decrease in estradiol levels. In addition, impaired sexual function and quality of life were associated with decreased hormonal parameters.
“The strength of the MALE study is its prospective character with the implementation of validated questionnaires to extensively describe the range of adverse effects in addition to the corresponding laboratory values,” the investigators commented.
A total of 52 of 56 male patients with breast cancer were randomly assigned to one of three treatments for 6 months: tamoxifen alone; tamoxifen plus GnRHa; or aromatase inhibitor plus GnRHa. The median age of the men was 61.5. Fifty patients were evaluable for the primary study endpoint—change in estradiol levels from baseline to 3 months.
The investigators reported that after 3 months of therapy, tamoxifen alone resulted in a 67% increase in median estradiol levels (+17 ng/L), tamoxifen plus GnRHa resulted in an 85% decrease in median estradiol levels (–23 ng/L), and aromatase inhibitor plus GnRHa resulted in a 64% decrease in median estradiol levels (–17 ng/L); the corresponding P value was .001. After 6 months of therapy, the median estradiol levels increased by 41% (+12 ng/L) with tamoxifen, decreased by 61% (–19.5 ng/L) with tamoxifen plus GnRHa, and decreased by 64% (–17 ng/L) with aromatase inhibitor plus GnRHa; again, the corresponding P value was .001.
In terms of secondary study endpoints, tamoxifen alone resulted in no change in sexual function and quality of life. However, there was a decrease in both sexual function and quality of life with the addition of GnRHa to the treatment regimen.
Disclosure: For full disclosures of the study authors, visit jamanetwork.com.
