Efficacy and safety of leuprorelin (Boennuokang) plus endocrine therapy in premenopausal women with HR/HER2 breast cancer.

BACKGROUND

Leuprorelin shows good efficacy in premenopausal women with hormone receptor-positive (HR)/human epidermal growth factor receptor 2-negative (HER2) breast cancer. However, more real-world evidence is required. This real-world study aimed to explore the efficacy and safety of leuprorelin (Boennuokang) plus endocrine therapy in premenopausal women with HR/HER2 breast cancer.

METHODS

A total of 229 premenopausal women with HR/HER2 breast cancer receiving adjuvant leuprorelin plus endocrine therapy were included in this retrospective study. Leuprorelin (Boennuokang) was administered 3.75 mg subcutaneously every 28 days following surgery. Endocrine therapy contained aromatase inhibitors, selective estrogen receptor modulators, and selective estrogen receptor degraders. The median follow-up duration of this study was 38.1 months.

RESULTS

The estradiol (E2) level was declined from 46.0 to 19.0 pg/mL over 24 months ( < 0.001). E2 from month 3 to month 24 was maintained below 30 pg/mL (menopausal level). During 24 months, the follicle-stimulating hormone level was decreased from 7.7 to 4.8 mIU/mL, and the luteinizing hormone level was decreased from 7.9 to 0.2 mIU/mL (both < 0.001). During the follow-up period, 9 patients experienced disease recurrence. The 10-year accumulating progression-free survival (PFS) rate was 91.7%. Comorbidity (yes vs no) was independently related to shorter progression-free survival (hazard ratio: 10.957, = 0.003). Bone soreness (6.1%) was the most common adverse event, followed by hot flushes (3.5%), morning stiffness (1.3%), and muscle soreness (1.3%).

CONCLUSION

Leuprorelin (Boennuokang) plus endocrine therapy reduces gonadotropins and sex hormones and results in satisfactory survival rates with good safety profiles in premenopausal women with HR/HER2 breast cancer.