Poster viewing and lunch

111P - Goserelin 3 monthly depot is noninferior to Goserelin monthly depot in the treatment of Breast Cancer: A Real-World Evidence Study (ID 327)

Lecture Time
12:15 - 12:15
Session Name
Poster viewing and lunch
Room
Exhibition area
Date
Fri, 12.05.2023
Time
12:15 - 13:00
Speakers
  • Hao Wu (Guangzhou, China)
Authors
  • Hao Wu (Guangzhou, China)
  • Lei Bian (Guangzhou, China)
  • Jindong Xie (Guangzhou, China)
  • Yutian Zou (Guangzhou, China)
  • Linyu Wu (Guangzhou, China)
  • Shanshan Huang (Guangzhou, China)
  • Xinhua Xie (Guangzhou, China)
  • Xi Wang (Guangzhou, China)

Abstract

Background

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.

Methods

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%. P <0.05 was statistically significant. Non-inferiority was calculated using the risk difference (RD) by Miettinen-Nurminen method. Multivariate logistic regression analyzed the independent factors (age, chemotherapy, BMI, stage, and radiotherapy) associated with E2 suppression.

Results

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; P=0.0187), confirming the non-inferiority between the goserelin 10.8mg and goserelin 3.6mg groups at a margin of -15%. None of the factors showed significant association with E2 suppression. Goserelin 10.8 mg vs 3.6 mg 5year OS, DFS, and 3.2year PFS rates were 96.6% vs 93.8%, 99.0% vs 96.7%, and 77.1% vs 80.0%, respectively.

Conclusions

Goserelin 10.8 mg was non-inferior to goserelin 3.6 mg in peri- and premenopausal BC patients in terms of E2 suppression.

Legal entity responsible for the study

The authors.

Funding

This research was supported by National Natural Science Foundation of China (No.81974444, Xinhua Xie; No.82203569, Hao Wu).

Disclosure

All authors have declared no conflicts of interest.

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