Multiple randomised controlled trials and meta-analyses in patients with breast cancer receiving chemotherapy have shown that GnRHa therapy may reduce the rate of POI. However, comparisons and conclusions are limited by varying definitions of POI as well as the use of surrogate markers for ovarian function such as amenorrhoea and follicle stimulating hormone (FSH) levels, with few studies reporting long term pregnancy rates.r
Goserelin is well tolerated with reversible side effects generally of mild to moderate severity including headaches, vasomotor symptoms, fluid retention and oedema, hyperlipidaemia and hypercholesterolaemia, decreased libido, and vaginal dryness. Available data indicates no safety concerns with concurrent use of GnRHa and chemotherapy with no negative impact on disease free survival and overall survival in both oestrogen receptor negative and positive breast cancer patients.r,r
Summary of major randomised controlled trials in early breast cancer
Study and year published |
Number of patients (goserelin/control) |
Oestrogen receptor status |
Definition of premature ovarian insufficiency (POI) |
POI rate (goserelin vs control) |
Number of pregnancies (%) (goserelin vs control) |
OPTION 2017r |
95/107 |
Negative or positive |
Amenorrhoea 12-24 months after randomisation and elevated FSH |
18.5% vs 34.8% (p=0.048) |
7 vs 5 |
POEMS-SWOG S0230 2015r |
105/113 |
Negative only |
Amenorrhoea for prior 6 months and post-menopausal FSH level at 2 years |
8% vs 22% (OR=0.30, 95% CI, 0.09-0.97, p=0.04) |
21 vs 11 (OR 2.45, p=0.03) |
GBG-37 ZORO 2011r |
30/30 |
Negative only |
Absence of regular menses 6 months post chemotherapy |
30% vs 43.3% (p=0.284) |
3 vs 3 |
Summary of major meta-analyses
Study and year published |
Number of studies included |
Type of malignancy |
Number of patients (goserelin/control) |
POI rate (goserelin vs control) |
Number of pregnancies (%) (goserelin vs control) |
Lambertini et al 2018r |
5 |
Breast |
436/437 |
14.1% vs 30.9% (OR=0.38, 95% CI, 0.26-0.57, p<0.001) |
10.3 vs 5.5 (IRR=1.83, 95% CI, 1.06-3.15, p=0.03) |
Munhoz et al 2016r |
7 |
Breast |
856 total |
NR (OR=2.41, 95% CI, 1.40-4.15, p=0.002) |
NR (OR=1.82, 95% CI, 1.02-3.36, p=0.04) |
Elgindy et al 2015r |
10 |
Breast, lymphoma, ovarian |
468/439 |
31.6% vs 40.1% (RR=0.79, 95% CI, 0.66-0.94) |
7 vs 5 (RR=1.63, 95% CI, 0.94-2.82) |
Lambertini et al 2015r |
12 |
Breast |
616/615 |
18.5% vs 33.5% (OR=0.36, 95% CI 0.23-0.57, p<0.001) |
9.2 vs 5.5 (OR=1.83, 95% CI, 1.02-3.28, p=0.041) |
NR = not reported