Researchers have found that young women with breast cancer were able to better preserve their fertility during cancer treatments by using hormone-blocking drug injections that put them into temporary menopause. The results announced today at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago are from the Prevention of Early Menopause Study (POEMS), a clinical trial sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (ASCO late breaking abstract #505). Women receiving the injections were only about one-third as likely to experience ovarian failure, a common long-term toxicity of chemotherapy treatments, and were more than twice as likely to have a normal pregnancy after their cancer treatment compared to women in the trial who did not receive the injections.
In POEMS, premenopausal women with hormone-receptor negative breast cancer ages 18 to 49 were randomly assigned to receive standard chemotherapy with or without goserelin every four weeks. Goserelin is a drug that disrupts the body’s hormonal feedback systems, resulting in reduced estrogen production, which puts the women into a chemical menopause. Under usual use, that chemical menopause is reversible; POEMS was carried out to see if the treatment allowed the women to recover fertility after cancer treatment while not interfering with the cancer treatment itself.
The researchers compared the ovarian failure rate of the women two years after entering the study and found that 22 percent of patients on the standard therapy had ovarian failure (15 of 69 patients) compared to 8 percent of those who also had goserelin treatment (5 of 66 patients). Of the 218 patients enrolled in the trial, 12 patients on the standard arm (11 percent) became pregnant vs 22 patients on the goserelin treatment arm (21 percent).
“This trial was the first demonstration of improved fertility prospects and more successful pregnancies when goserelin was used,” said Halle Moore, M.D., Cleveland Clinical Foundation and the lead investigator for POEMS. “Premenopausal women beginning chemotherapy for early breast cancer should consider this new option to prevent premature ovarian failure.”
The trial was conducted by SWOG, one of NCI’s five National Clinical Trial Network groups, with the collaboration of the ECOG-ACRIN Cancer Research Group and the Alliance for Clinical Trials in Oncology, and international access provided through the International Breast Cancer Study Group which includes the Australia New Zealand Breast Cancer Group.
The standard approach to preserving fertility in young female cancer patients is to harvest and store ovarian tissue, ovarian follicles, or embryos prior to cancer treatment. “Finding a simple and accessible way to protect fertility in young breast cancer patients while not harming cancer outcomes is an important issue,” said Lori Minasian, M.D., deputy director of the NCI Division of Cancer Prevention and one of the researchers on POEMS.
Fertility-preserving treatment was not expected to have an effect on cancer outcomes and this data was analyzed only to ensure there were no detrimental effects from that treatment.
In the United States alone almost 49,000 women under age 50 are diagnosed with invasive breast cancer each year; nearly 11,000 of those are under age 40. Of this population, about 15 percent have breast cancer that is hormone-receptor negative, meaning the disease does not feed on hormones or respond to therapy against hormones.
Reference: Moore HCF, et al. Prevention of Early Menopause Study (POEMS)/S0230, a Phase III Trial of LHRH Agonist Administration During Chemotherapy to Reduce Ovarian Failure in Early Stage, Hormone Receptor-Negative Breast Cancer: An International Intergroup Trial of SWOG, IBCSG, ECOG, and CALGB (Alliance). ASCO abstract LBA505. ClinicalTrials.gov
POEMS was coordinated by SWOG, an NCI-supported cancer research cooperative group that designs and conducts multidisciplinary clinical trials to improve the practice of medicine in preventing, detecting, and treating cancer, and to enhance the quality of life for cancer survivors. An international study, POEMS was available worldwide through the International Breast Cancer Study Group, and supported by grants from the U.S. National Cancer Institute and in part by the Australia and New Zealand Breast Cancer Trials Group, the Breast Cancer Institute of Australia, and AstraZeneca Pharmaceuticals.
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