A clinical study in per-menopausal Asian women with early breast cancer has found that administering gonadotropin-releasing hormone analogues (GnRHa) with chemotherapy (CT) protects against ovarian insufficiency.
The primary concern with the use of CT in pre-menopausal women is that CT tends to induce menopause. Therefore, to address this issue, a randomised clinical trial has evaluated the effect of GnRHa treatment on ovarian function in women undergoing CT.
A multicenter, open-label, randomised clinical study enrolled 330 patients (18-49 years) who were randomly divided into two groups to receive either cyclophosphamide-containing CT with GnRHa (n=165) or CT alone (control group, n=165). GnRHa was subcutaneously (3.6 mg goserelin or 3.75 mg leuprorelin) administered once every 28 days from 1 to 2 weeks before the first cycle of CT to 4 weeks after the last cycle of CT. The study’s primary endpoint was the incidence of premature ovarian insufficiency (POI-defined as anti-mullerian hormone levels of <0.5 ng/mL).
After a median follow up of 49 months (25-60 months), differences in 4-year overall survival (OS) and tumour-free survival (TFS) was not significant. However, after a year of CT, treatment with GnRHa resulted in a lower incidence of POI than CT alone (10.3% vs 44.5%, odds ratio, 0.23; 95% CI, 0.14-0.39; P < .001). Additionally, the GnRHa group had a significantly better anti-mullerian hormone resumption versus the control group (15 of 25 vs 6 of 44; odds ratio, 4.40; 95% CI, 1.96-9.89; P < .001). Finally, a post hoc analysis in patients aged <35 showed that the GnRHa group had a higher four year TFS than the control group (93% vs 62%; P = .004; hazard ratio, 0.15; 95% CI, 0.03-0.82; P = .03).
The randomised clinical study demonstrated that GnRHa treatment with CT reduces the risk of POI and promotes recovery of ovarian function in premenopausal patients with breast cancer.
Reference
Top
