Results from a federally funded phase III clinical trial presented at the 50th Annual Meeting of the American Society of Clinical Oncologyshows that adding a hormone suppressing drug called goserelin (Zoladex?; AstraZeneca), to standard chemotherapy may be an effective method of preserving fertility among women with early-stage hormone receptor-negative breast cancer.[1][2]
The S0230/POEMS study showed that women who received goserelin, a luteinizing hormone?releasing hormone (LHRH) analog, along with chemotherapy, were 64% less likely to develop premature ovarian failure compared to women who received chemotherapy alone. The study also showed 
that these women were more likely to have successful pregnancies.
Furthermore, survival was also improved among women in the goserelin arm: women were 50% more likely to be alive four years after starting chemotherapy compared to those in the standard arm.
Preserving fertility
?Preserving fertility is a common and important concern among younger women diagnosed with cancer, and these findings offer a simple, new option for women with breast cancer, or possibly other cancers,? said lead study author Halle Moore, MD, a staff physician at Cleveland Clinic in Cleveland, OH. ?Goserelin appears to be not only highly safe but also effective, as it increased the odds of becoming pregnant and delivering a healthy baby following chemotherapy.?
Ovarian failure (OF) ? defined in this study as cessation of menstrual periods and postmenopausal levels of follicle-stimulating hormone (FSH)? is a common side effect of chemotherapy. OF risk depends on the type and dose of chemotherapy as well as patient age and perhaps ovarian cycling (monthly development of eggs in ovaries) at the time of chemotherapy.
Goserelin and similar luteinizing hormone-releasing hormone analogs temporarily shut down ovarian function, essentially putting the patient into a postmenopausal state. It is speculated that this protects follicles from chemotherapy damage. These medications are widely used to control ovulation timing for infertility procedures, such as in vitro fertilization. LHRH drugs are also widely used as hormonal therapies to treat advanced prostate and breast cancer.
This study provides strong evidence for a safe and effective strategy for younger women with breast cancer to preserve ovarian function and the possibility of pregnancy…
Trial design
In this study, 257 premenopausal women with stage I-IIIA hormone receptor-negative breast cancer were randomized to treatment with cyclophosphamide-containing chemotherapy alone (standard arm) or chemotherapy plus goserelin. Goserelin was given as monthly injections starting one week before the first dose of chemotherapy.
Trial results
Two years after starting chemotherapy, 8% of women in the goserelin arm had OF vs. 22% of women in the standard arm. There was not a statistically significant difference in the number of women who reported attempting to conceive in the two arms.
Twenty-one percent of women (22 individuals) assigned to goserelin plus chemotherapy became pregnant, and only 11% (12 women) among those assigned to chemotherapy alone became pregnant. These pregnancies resulted in 16 patients (15% of the group) delivering at least one baby on the goserelin arm compared with eight patients (7%) on the control arm. An additional three patients on the goserelin arm and two on the standard arm had not had a documented delivery but were still pregnant at the time of data submission.
The study also found goserelin was safe ? it was not associated with an increased risk of either miscarriage or pregnancy termination.
Researchers were surprised to find that goserelin also affected disease-free (DF) and overall survival (OS). After adjusting for disease stage, women in the goserelin arm were 50% more likely to be alive four years after starting treatment compared to those in the standard arm.
While these early results are very encouraging, Moore cautioned that more research is needed to understand any role of goserelin in the treatment of ER-negative breast cancer. On the other hand, the POEMS findings do establish a role for LHRH analogs in preserving ovarian function and fertility prospects for women treated with curative intent chemotherapy for breast cancer.
Quality of Survivorship
Patricia Ganz, MD, FASCO, ASCO Expert and director of Cancer Prevention and Control Research at the Jonsson Comprehensive Cancer Center, University of California, Los Angeles, CA. noted: ?Preserving fertility is an important component of quality survivorship care. This study provides strong evidence for a safe and effective strategy for younger women with breast cancer to preserve ovarian function and the possibility of pregnancy.”
The S0230/POEMS study confirms initial findings published in the Annals of Oncology which suggested that goserelin, given with chemotherapy for early breast cancer (EBC) is associated with a low risk of long-term chemotherapy-induced amenorrhea – the absence of a menstrual period in a woman of reproductive age – and a high chance of pregnancy.[3]
For more information:
[1] Moore HCF, Unger JM, Phillips KA, Boyle FM, Hitre E, Porter DJ, Francis PA, et al. Phase III trial (Prevention of Early Menopause Study [POEMS]-SWOG S0230) of LHRH analog during chemotherapy (CT) to reduce ovarian failure in early-stage, hormone receptor-negative breast cancer: An international Intergroup trial of SWOG, IBCSG, ECOG, and CALGB (Alliance).2014 ASCO Annual Meeting. Oral Abstract Session, Saturday May 31, 3:00 PM to 6:00 PM.Abstract No: LBA505, Citation: J Clin Oncol 32:5s, 2014 (suppl; abstr LBA505)[Abstract]
[2] NCT00068601 – S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer [Study Record Detail]
[3]Wong M, O’Neill S, Walsh G, Smith IE. Goserelin with chemotherapy to preserve ovarian function in pre-menopausal women with early breast cancer: menstruation and pregnancy outcomes. Ann Oncol. 2013 Jan;24(1):133-8.[Article][PubMed]
Photo: Halle Moore at the 50th Annual Meeting of the American Society of Clinical Oncology. Photo Courtesy: ?ASCO/Brian Powers.
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