Goserelin can help reduce the risk of early menopause in young women with breast cancer -
Among young women treated for breast cancer, one of the most distressing side effects of chemotherapy is early menopause.
But a large clinical trial showed that the risk of early menopause can be significantly reduced by adding a drug called goserelin to chemotherapy. In addition, women who took goserelin and wanted to have children were more likely to get pregnant and give birth to a healthy baby.
The results were released during the 2014 American Society of Clinical Oncology 50th Annual Meeting in Chicago. Kathy Albain, MD, of Loyola University Medical Center is the lead author of the study.
The overall objective of goserlin is temporarily put ovaries "at rest" during chemotherapy. "We found that, in addition to reducing the risk of early menopause and all the symptoms that are associated with menopause, goserelin was very safe and may even improve survival," Albain said. "I think these our results will change clinical practice. "
the multi-center phase 3 trial included premenopausal women under 50 who had certain types of breast cancer early (estrogen and progesterone receptor negative) . one hundred thirty-one patients were randomized to receive standard chemotherapy and 126 were assigned to receive a goserelin chemotherapy.
After two years, 45 percent of women receiving standard chemotherapy had stopped menstruation or had high levels of a hormone known as FSH name, an indication of reduced production of estrogen and egg supply. by comparison, only 20 percent of women receiving goserelin had stopped menstruating or had high FSH. The pregnancy rate was almost twice as high in the goserelin group (21 percent against 11 percent).
After four years, 89 percent of patients who received goserelin had no signs or symptoms of cancer, compared to 78 percent of those receiving standard chemotherapy. Overall survival at four years was 92 percent in the goserelin group and 82 percent in the standard chemotherapy group.
"Premenopausal women starting chemotherapy for early breast cancer should consider this new option to prevent premature ovarian failure," Albain and colleagues concluded.
Goserelin (trade name, Zoladex®) is similar to a natural hormone produced by the body. It is approved by the FDA for prostate cancer, certain benign gynecological disorders and certain breast cancers.
Goserelin is administered by injection. In the clinical trial, women assigned to the goserelin group was hit once every four weeks during their chemotherapy treatment. The side effects of goserelin were rare, and mostly included more symptoms associated with reduced activity of the ovaries during chemotherapy.
Approximately 25 percent of breast cancers occur in women under 50 years of breast cancer chemotherapy can trigger early menopause in women in their 20s, 30s and 40s. After completing chemotherapy, some women return to menstruation and are able to have children should they choose to do so. But for many women after chemotherapy, menopause is permanent.
menopause induced by chemotherapy tends to appear suddenly, and therefore, the symptoms are much more intense. These symptoms include irregular periods and cessation of periods completely; vaginal dryness; hot flashes; night sweats; sleep problems; mood changes; weight gain; hair thinning; dry skin; and loss of breast fullness. "Early menopause in patients younger breast cancer can be very debilitating," said Albain.
The clinical trial is called "Prevention of early menopause studies (POEMS) S0230." It is sponsored by national cooperative group research SWOG cancer and employees of SWOG groups, including the Cancer Study Group, Eastern Cooperative Oncology Group and the Alliance for International Breast oncology clinical trials. First author is Halle CF. Moore, MD, of the Cleveland Clinic. The study was funded in part by the National Cancer Institute
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