JACKSONVILLE, Fl – Each year, nearly 49-thousand women under age 50 are diagnosed with invasive breast cancer in the u-s. Nearly 11-thousand of them are under age 40. Many of these women have dreams of starting a family. But toxic treatments like chemo can affect their fertility. Now there's a new drug on the horizon that could offer hope.
Stephanie Moisio had just married her best friend when doctors told her she had stage-two breast cancer.
"I couldn't even, I couldn't believe it," Stephanie Moisio told Ivanhoe.
The 29-year-old needed surgery, chemo and radiation – treatments that could jeopardize her chances of starting a family.
"So we came home, digested all of this and then we started thinking, oh my god, we're never going to have kids," said Moisio.
Stephanie chose to freeze her eggs and Cleveland Clinic doctor Halle Moore offered her an additional option – the injectable drug goserelin it's a synthetic hormone that puts a woman's ovaries in a "resting" state.
"To basically put them in a temporary menopause during the chemotherapy treatment in the hopes of improving prospects for long-term ovarian function," Halle Moore, M.D., Medical Oncologist at Cleveland Clinic told Ivanhoe.
In a study of 200 patients, 22-percent who received standard chemo had ovarian failure compared to only eight percent who received goserelin and chemo. Only eight of the women who had standard chemo had successful pregnancies compared to 16 who took goserelin during chemotherapy.
Stephanie and her husband tried in-vitro – but it wasn't successful. One month later, she got pregnant on her own – and then again a few years later.
"Everybody kind of knows these girls shouldn't have really been here, and we were very, very blessed," Moisio explained.
Now – she's cancer-free and enjoying every minute with her daughters.
"I never take for granted every single day," said Moisio.
Side effects of the drug include menopause-like symptoms such as hot flashes. The researchers also noticed that the patients who took goserelin were not only more likely to become pregnant ─ they actually had better cancer outcomes. Researchers plan to explore this finding in future studies.
TOXIC AND NON-TOXIC CANCER TREATMENTS: Chemotherapy is the key form of cancer treatment: however, it not only targets the cancerous cells, it can also harm good cells. This is because chemotherapy drugs are cytotoxic, meaning that they kill cells all cells that are extremely active. The result of this causes the common symptoms due to treatment: loss of hair, weight loss, vomiting and immune deficiencies. Alternative cancer treatments are considered complementary to another standard treatment. These include, but may not be limited to, non-toxic supplements such as: vitamins and minerals, herbs, amino acids, and peptides.
FERTILITY PRESERVATION: For both men and women undergoing chemotherapy or another form of cancer treatment, there are several options to preserve fertility. If radiation treatment is being performed on an area far enough from the pelvic region, gonadal shielding can reduce testicle and reproductive organ exposure to the radiation. Cryopreservation of sperm and eggs is another option to ensure future fertilization techniques. Specifically for women, if radiation is being applied to the pelvis, an ovarian transposition (oophoropexy) can be performed to surgically reposition the ovaries as far away from the treatment site as possible. Removal of the cervix, or radial trachelectomy, can also preserve fertility in early stages of cervical cancer.
NEW DRUG TREATMENT: Goserelin (or Zoladex) is a form of hormone therapy used in treatments for prostate cancer, breast cancer, and a non-cancerous condition called endometriosis. Classified as a leutinizing hormone releasing hormone (LHRH) agonist, the drug tells the pituitary gland to stop producing the leutinizing hormone, which in women stimulates the release of estrogen in the ovaries. The resulting lack of estrogen production interferes with cell growth in estrogen-dependent cancer cells. Goserelin has no effect on the cancer itself, only the ovaries (or testicles in men).
Halle Moore, M.D., Medical Oncologist and Staff Physician in the Taussig Cancer Center at Cleveland Clinic, discusses a new drug that can help survivors of toxic cancer treatments suffering with infertility.
Interview conducted by Ivanhoe Broadcast News in September 2014.
What did they find in the study?
Dr. Moore: The main purpose of our study was to look at the rate of ovarian failure in women with early-stage breast cancer who were premenopausal and treated with chemotherapy with or without the ovarian suppressing drug, goserelin. The study found that the use of goserelin with chemotherapy significantly reduced the risk of women going into ovarian failure; that difference was from about twenty-two percent to about eight percent.
How long have you been working with women with breast cancer?
Dr. Moore: I've been on staff at the Cleveland Clinic since about 1999 seeing pretty much only breast cancer patients.
I could imagine that seeing these young women in the prime of their life or even seeing a teenager, that it would be hard to have a family that would be difficult for her.
Dr. Moore: For a young woman with a new diagnosis of breast cancer it can really be quite devastating to learn not only that she has cancer, but that the treatments even if they're successful may result in significant long-term side effects , such as not being able to have a child in the future.
What happens to these women during treatment that makes it so difficult for them to get pregnant?
Dr. Moore: Certain tissues in the body seem to be more susceptible to damage from chemotherapy and the ovaries are one of those tissues. One of the most common long-term side effects that we see from chemotherapy is the induction of early menopause.
So what is P.O.E.M.S., and what does this research involve?
Dr. Moore: P.O.E.M.S. is the prevention of early menopause study. This is an international research study that involved over two hundred and fifty young women who were diagnosed with early-stage breast cancer. These women were all requiring chemotherapy as a part of their curative intent cancer treatment and were, therefor, at risk for going into early menopause as a result of their cancer treatment. In the study we randomized patients to either receive chemotherapy in the usual way or to receive their chemotherapy along with a treatment called goserelin to basically put them into a temporary menopause during the chemotherapy treatment in the hopes of improving prospects for long-term ovarian function.
What does it do?
Dr. Moore: Goserelin is one of a class of medications called GNRH agonists and it's basically a synthetic version of a hormone that we normally have that regulates the estrogen levels and other hormone levels. When we give it in the manner we did in the clinical trial it will suppress the ovaries from cycling.
What is the protocol? Is it a shot or how many times do they take it and how long?
Dr. Moore: The treatment was a shot that was given once every four weeks, so about once a month beginning a week before the first chemotherapy treatment and continuing just for the duration of chemotherapy treatment. Typically patients receive between 3 to 6 months of treatment depending on the chemotherapy regimen.
Tell us about the study and then the results.
Dr. Moore: I mentioned the study design and in this study we found that the women who received the goserelin were significantly less likely to develop premature ovarian failure compared to those women who got regular chemotherapy without the goserelin. The rate of ovarian failure in the women who didn't receive the intervention was about twenty-one percent compared with about eight percent in the women who received the intervention. We also found that those women who received the goserelin were more likely to become pregnant in the five years following their treatment. That was a very exciting finding of this study.
Are there any side effects to goserelin or any dangers?
Dr. Moore: In general the goserelin treatment was found to be very safe; its major side effects are menopause-type symptoms such as hot flashes. But of course the trade-off is that the temporary side effects may reduce the incidence of long-term menopausal symptoms for these women.
Could this also be used for women with other cancers?
Dr. Moore: This treatment probably could be used in other types of cancer that are treated with similar chemotherapy to what we used in this study. In our study we only included women receiving cyclophosphamide-based standard chemotherapy for breast cancer.
What about children with cancer?
Dr. Moore: For young girls who have not yet gone through puberty this type of treatment would not be applicable because they don't have cycling ovarian function.
This could really help change the lives of young women and really give them hope.
Dr. Moore: I think this is a really important breakthrough for young women with newly diagnosed breast cancer. It is important that in the prevention of long-term side effects of our treatments we still give patients the aggressive treatment required without modifications that may impair effectiveness. What's next in your research?
Dr. Moore: One of the other findings in this study was not only did women do better in terms of both fertility outcomes and ovarian function outcomes, but they also did better in terms of reducing the risk of their breast cancer from coming back and they had better survival when they received the GNRH agonist. Now this medication has been used for treatment of hormone sensitive breast cancer but our study only included women with hormone receptor negative breast cancer. It's really not clear why this intervention would apparently improve their outcome. I think further research needs to be done on whether this class of medication is going to somehow contribute to the anti-cancer treatment of women with hormone receptor negative breast cancer. In addition we would like to do further research to try to see which other patient groups, including those with other cancer types or event non-malignant conditions treated with chemotherapy, can benefit from this intervention.
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