Efficacy and safety of goserelin vs. leuprolide in premenopausal breast cancer patients receiving adjuvant endocrine therapy: A retrospective cohort study.
Goserelin and leuprolide show similar efficacy in estrogen reduction for premenopausal breast cancer patients, but leuprolide may increase the risk of liver issues while goserelin may affect thyroid function.
Where it sits
this study against the rest of the goserelin corpusSummary and findings
This study compared the efficacy and safety of goserelin versus leuprolide in premenopausal breast cancer patients receiving adjuvant endocrine therapy. A total of 187 patients were included, with 90 receiving leuprolide and 97 receiving goserelin. After six months, both groups showed similar efficacy in estrogen reduction, but differences in safety profiles were noted.
Abstract
<h4>Introduction</h4>Goserelin and leuprolide are gonadotropin-releasing hormone (GnRH) agonists used for ovarian function suppression in premenopausal breast cancer patients. Whether their different molecular structures lead to clinically meaningful differences in efficacy and safety remains unclear.<h4>Objectives</h4>To compare the efficacy and safety of goserelin versus leuprolide as adjuvant endocrine therapy (combined with tamoxifen) in premenopausal women with hormone receptor-positive breast cancer after curative surgery.<h4>Methods</h4>This retrospective cohort study initially recruited 215 young cancer patients receiving adjuvant chemotherapy with tamoxifen combined with a gonadotropin-releasing hormone agonist. After applying inclusion and exclusion criteria, 187 patients were included and divided into two groups according to the gonadotropin-releasing hormone agonist they actually received: leuprolide (n=90) or goserelin (n=97). The primary efficacy outcome was the proportion of patients achieving substantial estrogen reduction (estradiol ≤30 pg/mL or falling into the pre-specified laboratory range) after 6 months. Secondary outcomes included liver function parameters and thyroid function parameters. Exploratory outcomes included changes from baseline to six months in testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prolactin levels, as well as descriptive assessment of the tumor marker carcinoembryonic antigen (CEA). Between-group differences were expressed as risk differences (RDs) with 95% confidence intervals (CIs).<h4>Results</h4>Baseline demographic and cancer-related characteristics were balanced between the two groups. After six months of adjuvant therapy, the two groups showed similar primary efficacy: the proportion of patients with substantial estrogen reduction was 88.89% in the leuprolide group and 92.78% in the goserelin group (RD = -3.89%, 95% CI: -12.18% to 4.40%; p = 0.354). Regarding safety, the leuprolide group had a significantly higher rate of liver function abnormalities (30.00% vs. 13.40%; RD = 16.60%, 95% CI: 4.96% to 28.24%; p = 0.012), driven mainly by a lower rate of normal aspartate aminotransferase (AST) levels (85.56% vs. 96.91%; RD = -11.35%, 95% CI: -19.39% to -3.31%; p < 0.05). In contrast, the leuprolide group had a higher rate of normal thyroid function (88.89% vs. 76.29%; RD = 12.60%, 95% CI: 1.94% to 23.26%; p = 0.018), mainly due to a higher normal thyroid-stimulating hormone rate (93.33% vs. 83.51%; RD = 9.82%, 95% CI: 0.82% to 18.82%; p < 0.05). Carcinoembryonic antigen normalization rates were also comparable (93.33% vs. 92.78%; RD = 0.55%, 95% CI: -6.74% to 7.84%; p = 0.549).<h4>Conclusions</h4>Leuprolide and goserelin demonstrate similar efficacy when used as adjuvant therapy in combination with tamoxifen for young women with breast cancer. However, leuprolide may pose a potential risk of hepatic impairment, whereas goserelin appears to be associated with a higher incidence of thyroid injury. These findings provide a theoretical basis for personalized clinical management in this patient population.
Background
This paper addresses the comparative efficacy and safety of goserelin and leuprolide in premenopausal women with hormone receptor-positive breast cancer undergoing adjuvant endocrine therapy. Prior studies have indicated that both agents are effective in suppressing ovarian function, but differences in their safety profiles remain unclear. Understanding these differences is crucial for optimizing treatment strategies in this patient population.
Methods
This retrospective cohort study included 215 young cancer patients initially, with 187 ultimately meeting inclusion criteria. Participants were divided into two groups based on the gonadotropin-releasing hormone agonist received: leuprolide (n=90) and goserelin (n=97). The primary efficacy outcome was the proportion of patients achieving substantial estrogen reduction (estradiol ≤30 pg/mL) after 6 months, with secondary outcomes assessing liver and thyroid function.
Results
After six months, the proportion of patients achieving substantial estrogen reduction was 88.89% in the leuprolide group and 92.78% in the goserelin group (RD = -3.89%, 95% CI: -12.18% to 4.40%; p = 0.354). The leuprolide group exhibited a significantly higher rate of liver function abnormalities (30.00% vs. 13.40%; RD = 16.60%, 95% CI: 4.96% to 28.24%; p = 0.012). Conversely, the leuprolide group had a higher rate of normal thyroid function (88.89% vs. 76.29%; RD = 12.60%, 95% CI: 1.94% to 23.26%; p = 0.018).
Interpretation
The findings suggest that goserelin and leuprolide have similar efficacy in estrogen reduction, which aligns with previous literature. However, the safety profiles differ, with leuprolide associated with a higher risk of liver function abnormalities and goserelin linked to thyroid injury. The small sample size and retrospective nature of the study limit the conclusions that can be drawn, indicating a need for further research to confirm these findings.
Key findings
- 88.89% of leuprolide patients achieved substantial estrogen reduction vs 92.78% of goserelin patients, RD = -3.89%, 95% CI: -12.18% to 4.40%; p = 0.354.
- 30.00% of leuprolide patients had liver function abnormalities vs 13.40% of goserelin patients, RD = 16.60%, 95% CI: 4.96% to 28.24%; p = 0.012.
- 85.56% of leuprolide patients had normal AST levels vs 96.91% of goserelin patients, RD = -11.35%, 95% CI: -19.39% to -3.31%; p < 0.05.
- 88.89% of leuprolide patients had normal thyroid function vs 76.29% of goserelin patients, RD = 12.60%, 95% CI: 1.94% to 23.26%; p = 0.018.
- Carcinoembryonic antigen normalization rates were 93.33% in leuprolide vs 92.78% in goserelin, RD = 0.55%, 95% CI: -6.74% to 7.84%; p = 0.549.
Limitations
- retrospective design may introduce selection bias
- small sample size (n=187) limits generalizability
- no long-term follow-up data reported
- single-site study may not reflect broader population