Goserelin 10.8 mg 3-monthly depot demonstrated non-inferior to 3.6 mg monthly depot in randomized clinical trials. This first retrospective, observational, non-inferiority, real-world study compared effectiveness of goserelin 10.8 mg 3-monthly depot to 3.6 mg monthly depot in breast cancer (BC) patients.
Data were extracted from electronic records of pre- and perimenopausal BC patients who received the first dose of goserelin between January 2015 to December 2022 at Sun Yat-sen University Cancer Center, China. The primary endpoint was non-inferiority analysis of proportion of patients with serum estradiol (E2) suppression. Secondary endpoints included overall survival (OS), disease-free survival (DFS) for early BC, progression-free survival (PFS) for advanced BC. Propensity score matching (PSM) was used to balance baseline characteristics considering age, prior chemotherapy, and BMI as covariates with caliper of -25%.
In total, 240 (goserelin 10.8 mg, n = 143; goserelin 3.6 mg, n = 97) HR+ BC patients with E2 tests were included. Post PSM, 96 patients in each group were considered for the primary analysis. E2 suppression rate was 98.96% in goserelin 10.8 mg and 92.71% in goserelin 3.6 mg with a RD of 0.065 (95%CI: 0.021, 0.135;
Goserelin 10.8 mg was non-inferior to goserelin 3.6 mg in peri- and premenopausal BC patients in terms of E2 suppression.
The authors.
This research was supported by National Natural Science Foundation of China (No.81974444, Xinhua Xie; No.82203569, Hao Wu).
All authors have declared no conflicts of interest.