FDA Highlights: Goserelin helps prevent early menopause caused by breast cancer treatment

by Bruce Sylvester – Adding goserelin to standard chemotherapy significantly reduces the risk of early menopause in breast cancer patients, researchers reported in May of 2014 at the ASCO/American Society of Clinical Oncology annual meeting.  

Goserelin  is FDA-approved for prostate cancer, certain benign gynecological disorders and certain breast cancers.

“We found that, in addition to reducing the risk of early menopause, and all of the symptoms that go along with menopause, goserelin was very safe and may even improve survival,” said Kathy Albain, MD, of Loyola University Medical Center in Maywood, Illinois and lead author of the study. “I think these findings are going to change our clinical practice,” she added.

In this Phase 3 trial, investigators enrolled premenopausal women under 50 years old who had estrogen and progesterone receptor negative, early-stage breast cancer.  They randomized 139 subjects to standard chemotherapy and 126 subjects to receive chemotherapy plus goserelin.

Two years following treatment, 45 percent of the subjects receiving standard chemotherapy had stopped menstruating or had elevated levels of a hormone known as FSH, an signal of reduced estrogen production and egg supply. Comparatively, 20 percent of the women receiving goserelin had stopped menstruating or had elevated FSH. The pregnancy rate was twice as high in the goserelin group than in the standard chemotherapy group (21 percent vs. 11 percent).

Four years following treatment, 89 percent of the goserelin subjects showed no signs or symptoms of cancer, compared with 78 percent of the standard chemotherapy subjects.

And at four years overall survival was 92 percent in the goserelin group and 82 percent in the standard chemotherapy group.

“Premenopausal women beginning chemotherapy for early breast cancer should consider this new option to prevent premature ovarian failure,” the investigators concluded.