Study Finds 5-7 Years Post-Menopausal Hormone Therapy Not Associated with Increased Risk of Mortality

MedicalResearch.com Interview with:

JoAnn E. Manson, MD, DrPH Chief, Division of Preventive Medicine Brigham and Women's Hospital Professor of Medicine and the Michael and Lee Bell Professor of Women's Health Harvard Medical School Boston, Massachusetts  02215

Dr. Manson

JoAnn E. Manson, MD, DrPH
Chief, Division of Preventive Medicine
Brigham and Women’s Hospital
Professor of Medicine and the
Michael and Lee Bell Professor of Women’s Health
Harvard Medical School
Boston, Massachusetts  02215 

MedicalResearch.com: What is the background for this study?

Response: The current report provides new information on total mortality and the rates of death from specific causes (cardiovascular disease, cancer, other major illnesses) over 18 years of follow-up in the Women’s Health Initiative (WHI) randomized trials of hormone therapy (estrogen + progestin and estrogen alone). This is the first WHI report to focus on all-cause and cause-specific mortality. It includes all of the 27,347 women in the 2 hormone therapy trials with >98% follow-up over 18 years, during which time 7,489 deaths occurred. This is more than twice as many deaths as were included in earlier reports. The report also provides detailed information on differences in results by age group (ages 50-59, 60-69, 70-79) at time of study enrollment.

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Late Menopause and Oral Hormone Therapy Linked To High Risk of Hearing Loss

MedicalResearch.com Interview with:

Sharon G. Curhan, MD, ScM Channing Division of Network Medicine Department of Medicine Brigham and Women's Hospital Harvard Medical School Boston, MA 02115

Dr. Curhan

Sharon G. Curhan, MD, ScM
Channing Division of Network Medicine
Department of Medicine
Brigham and Women’s Hospital
Harvard Medical School
Boston, MA 02115

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Hearing loss affects approximately 48 million Americans and the number is expected to increase as the population ages. Some previous studies suggested that menopause may increase the risk for hearing loss, presumably due to the reduction in circulating estrogen levels, and that postmenopausal hormone therapy might slow hearing decline by “replacing” estrogen. To evaluate the role of menopause and postmenopausal hormone therapy as risk factors for hearing loss, we examined the independent associations between menopausal status, oral hormone therapy, and risk of self-reported hearing loss in 80,972 women who are participants in the Nurses’ Health Study II, aged 27-44 years at baseline, and were followed from 1991 to 2013.

After more than 1.4 million person-years of follow-up, 18,558 cases of hearing loss were reported (~23% of the women developed hearing loss). We did not observe an overall independent association between menopausal status and risk of hearing loss.

However, the risk among women who underwent natural menopause at an older age was higher. Specifically, the risk among women who underwent natural menopause at age 50 or older was 10% higher than among those who underwent natural menopause before age 50 [multivariable-adjusted relative risk (MVRR): 1.10, 95% CI 1.03, 1.17]. When we conducted an analysis restricted to women who underwent natural menopause and did not use hormone therapy (HT), the multivariable-adjusted relative risk among women who underwent natural menopause at age 50-54 years was 21% higher (MVRR: 1.12, 95% CI: 1.10, 1.34), and among women who underwent natural menopause at age 55+ years was 29% higher (MVRR: 1.29, 95% CI: 1.11, 1.50), compared with women who underwent natural menopause before age 50.

Among postmenopausal women, we also found that use of oral HT was associated with higher risk of hearing loss, and the magnitude of the risk tended to increase with longer duration of use (p-trend < 0.001). Compared with women who never used any type of HT, the MVRR of hearing loss among women who used oral HT for 5-9.9 years was 15% higher (MVRR: 1.15, 95% CI: 1.06, 1.24), and for 10+ years was 21% higher (MVRR: 1.21, 95% CI: 1.07, 1.37). When specific types of oral HT were examined, longer duration of use of either oral estrogen-only or of combined estrogen plus progestogen HT were each associated with higher risk. Fewer women reported use of progestogen-only oral HT, yet among these women a higher risk was suggested, but not significant (MVRR: 1.15, 95% CI: 0.98, 1.35). Transdermal HT use was less common, but the associations observed were similar to those with oral hormone therapy. When examined separately by type of menopause, the results for HT use were similar.

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Breast Cancer: 21-gene assay Can Help Choose Neoadjuvant Therapy

MedicalResearch.com Interview with:

Harry D. Bear, MD, PhD Walter Lawrence, Jr. Distinguished Professor of Oncology; Chair, Division of Surgical Oncology, Department of Surgery; Professor, Departments of Surgery, Microbiology & Immunology, VCU School of Medicine; Director, Breast Health Center, VCU Massey Cancer Center; Medical Director Massey Cancer Center Clinical Trials Office Virginia Commonwealth University

Dr. Harry Bear

Harry D. Bear, MD, PhD
Walter Lawrence, Jr. Distinguished Professor of Oncology;
Chair, Division of Surgical Oncology, Department of Surgery;
Professor, Departments of Surgery, Microbiology & Immunology,
VCU School of Medicine; Director, Breast Health Center,
VCU Massey Cancer Center; Medical Director
Massey Cancer Center Clinical Trials Office
Virginia Commonwealth University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This was based on the utility of using the 21-gene assay of breast cancers to guide the decision to add chemotherapy to the adjuvant therapy for patients with hormone-responsive breast cancer.

We hypothesized that the Recurrence Score could be used to guide the choice of neoadjuvant therapy for women with hormone responsive breast cancer who needed pre-operative treatment to shrink the tumor and make breast conservation feasible.

The main findings were:
1) Using the 21-gene RS assay to guide  neoadjuvant therapy is feasible.
2) Clinical and pathologic responses were not negatively impacted by using neoadjuvant hormonal therapy in patients with RS<25.
3) Patients whose tumors have a low recurrence score can be safely and effectively treated with hormone therapy alone.

MedicalResearch.com: What should readers take away from your report?

Response: These results support the use of the recurrence score to choose hormonal vs. chemotherapy, enabling more personalized care and optimizing outcomes for patients with ER+ early breast cancerwho are candidates for NST.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: I would like to see a larger prospective trial to build on the evidence from this pilot study that would provide definitive evidence for the use of genomic profiling of breast cancers to guide neoadjuvant therapy.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Disclosure:  Study supported by Genomic Health Inc.

Citation:
39th Annual SABCS 2016
Abstract: P2-10-04
Poster: “Using the 21-gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer: A multicenter trial”
Authors: Bear HD, Wan W, Robidoux A, Rubin P, Limentani S, White, Jr. RL, Granfortuna J, Hopkins JO, Oldham D, Rodriguez A, Sing AP.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

Androgen Deprivation For Prostate Cancer Linked to Dementia

MedicalResearch.com Interview with:
Kevin T. Nead, MD, MPhil

Resident, Radiation Oncology
Perelman School of Medicine
Hospital of the University of Pennsylvania.

MedicalResearch.com: What is the background for this study?

Response: Androgen deprivation therapy is a primary treatment for prostate cancer and works by lowering testosterone levels. There is a strong body of research suggesting that low testosterone can negatively impact neurovascular health and function. We were therefore interested in whether androgen deprivation therapy is associated with dementia through an adverse impact on underlying neurovascular function.

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Abuse of Anabolic Steroids May Impair Insulin Resistance For Years After Discontinuation

MedicalResearch.com Interview with:
Jon Rasmussen, MD, PhD fellow
Department of Internal Medicine
Herlev Hospital, Denmark

MedicalResearch.com: What is the background for this study?

Response: Abuse of anabolic androgenic steroids has become highly prevalent among young men involved in recreational strength training. A recent meta-analysis estimated that approximately 18% of young men involved recreational strength training abuse anabolic steroids.

Well-known adverse effects following abuse of anabolic steroids include hypogonadism (For those who have interest, we have recently published a paper concerning this issue, it can be read and downloaded at: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0161208).

Yet, we have a poor understanding on the adverse effects these compounds might have on the metabolism and insulin sensitivity.

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Post Menopausal Hormones Improve Mood But Not Cognition

Dr.Carey Gleason Ph.D School of Medicine and Public Health, University of Wisconsin Geriatric Research, Education and Clinical Center William S. Middleton Memorial Veterans Hospital Wisconsin Alzheimer's Disease Research Center, Madison, WisconsinMedicalResearch.com Interview with:
Dr.Carey Gleason Ph.D

School of Medicine and Public Health, University of Wisconsin
Geriatric Research, Education and Clinical Center
William S. Middleton Memorial Veterans Hospital
Wisconsin Alzheimer’s Disease Research Center, Madison, Wisconsin

Dr. Gleason: In this response I refer to hormone therapy (HT), which was formally called hormone “replacement” therapy. In particular, we examined menopausal HT, i.e., the use of HT during the menopausal transition to address menopausal symptoms.

Medical Research: What is the background for this study? What are the main findings?

Dr. Gleason: The WHI Memory Study (WHIMS) suggested that HT was associated with cognitive harm for women age 65 and older. In contrast, we found that the cognitive performance of women randomized to receive menopausal hormone therapy did not differ from that of women randomized to receive the placebo. On a measure of mood states, women treated with conjugated equine estrogens showed improvements compared to those on placebo.

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Menopausal Hormone Therapy and Health Outcomes

JoAnn E. Manson, MD, DrPH Chief, Division of Preventive Medicine Brigham and Women's Hospital Professor of Medicine and the Michael and Lee Bell Professor of Women's Health Harvard Medical School 900 Commonwealth Avenue , 3rd fl Boston , Massachusetts   02215 MedicalResearch.com Interview with:
JoAnn E. Manson, MD, DrPH
Chief, Division of Preventive Medicine
Brigham and Women’s Hospital
Professor of Medicine and the
Michael and Lee Bell Professor of Women’s Health
Harvard Medical School
Boston , Massachusetts   02215

WHI investigators publish most comprehensive report to date on the two Hormone Therapy Trials and extend follow-up to 13 years: Results inform clinical decision making

Researchers from the Women’s Health Initiative (WHI) Hormone Therapy (HT) Trials provide new information from extended follow-up of postmenopausal women in the two HT trials (estrogen plus progestin and estrogen alone) and the most comprehensive look at the findings to date. The study, published October 2 in the Journal of the American Medical Association, presents information on a wide range of diseases and quality-of-life outcomes, comparisons of the two trials side-by-side, and a full breakdown of results by age and time since menopause onset. The WHI, which enrolled 27,347 women nation-wide in the two hormone therapy trials, is sponsored by the National Institutes of Health.

“Our main goal was to provide as much information as possible from the WHI hormone therapy trials to help women and their clinicians make the most informed decisions about hormone therapy use. The WHI findings, presented in detail by age group and time since menopause onset, help to guide clinical decision making,”, said JoAnn Manson, MD, DrPH, first author of the report and Chief of Preventive Medicine at Brigham and Women’s Hospital. Manson is one of the Principal Investigators of the WHI and the Michael and Lee Bell Professor of Women’s Health at Harvard Medical School .

 

Key findings of the report are that hormone therapy has a complex pattern of health risks and benefits and that younger women tend to have a more favorable risk-to-benefit profile than older women. The researchers also found that combination estrogen plus progestin (in women with an intact uterus) had more risks than estrogen alone (used in women with hysterectomy), primarily due to an increased risk of breast cancer with the former but not the latter. Both forms of hormone therapy increased the risk of stroke, blood clots in the legs, gallstones, and urinary incontinence, while benefits included decreased risk of hip fractures, other fractures, diabetes, and hot flashes/night sweats. Estrogen plus progestin increased dementia (in women >65 years), but neither treatment affected cognition in younger women. For estrogen alone, younger women (ages 50-59) had more favorable results for all-cause mortality, heart attacks, and colorectal cancer, and their overall risk-to-benefit profile on estrogen alone was more favorable than for older women.  Effects on quality-of-life outcomes with HT were mixed, with improvement in sleep and joint pain but increases in breast tendernes.

After stopping hormone therapy, most risks and benefits of hormone therapy dissipated. However, over the 13-yr cumulative follow-up period, breast cancer risk remained slightly elevated for estrogen plus progestin but became significantly reduced for estrogen alone. For estrogen plus progestin, a significant reduction in uterine (endometrial) cancer emerged during follow up and the risk of hip fracture remained significantly (but modestly) reduced. For both forms of hormone therapy, there was no significant increase or decrease in the rate of total cancer (all types combined), cancer mortality, cardiovascular mortality, or all-cause mortality in the overall study population.

 

The researchers conclude that the findings from the two WHI trials do not support use of hormone therapy for prevention of chronic disease, but treatment is appropriate for symptom management in some women. The absolute risks of adverse events in younger women are lower than in older women, menopausal symptoms are more common in younger age groups, and the quality-of-life benefits are likely to outweigh the risks for many women who seek treatment for symptoms during the menopause transition.  “Short-term use of hormone therapy to manage moderate-to-severe hot flashes or other symptoms in early menopause remains appropriate,  A clear distinction between the use of hormone therapy for symptom management in women with indications for treatment and its use for the purpose of chronic disease prevention is essential,” added Manson.  “Although studies of other hormone therapy formulations , doses, and routes of delivery are needed to find treatments with fewer risks, these medications are now among the best studied treatments in medical history. Clinicians can share information from the WHI trials with their patients and help them make more informed choices.”

Citation:

Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phases of the Women’s Health Initiative Randomized Trials. JAMA. 2013;310(13):1353-1368. doi:10.1001/jama.2013.278040.

Study finds estrogen may prevent younger menopausal women from strokes

ROCHESTER, Minn. – Estrogen may prevent strokes in premature or early menopausal women, Mayo Clinic researchers say. Their findings challenge the conventional wisdom that estrogen is a risk factor for stroke at all ages. The study was published in the journal Menopause.

Researchers combined the results from a recent Mayo Clinic study with six other studies from across the world and found that estrogen is protective for stroke before age 50. That is roughly the average age when women go through menopause.

“We were very surprised because these results were unexpected,” says study author Walter Rocca, M.D., an epidemiologist and neurologist at Mayo Clinic. “The old idea that estrogen is always a problem in the brain has to be corrected.” Estrogen can be a problem in older women, he explains, but in younger women, estrogen may be important to protect the brain from strokes.

The study has implications for women who experience premature (before age 40) or early menopause (before age 45) from natural causes or from ovary removal. Women in these groups should consider taking estrogen up to approximately age 50 to prevent stroke, Dr. Rocca says.

Ischemic stroke occurs as a result of an obstruction within a blood vessel supplying blood to the brain. According to the American Stroke Association, these types of strokes account for 87 percent of all stroke cases.

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Co-authors of the study include: Brandon Grossardt, M.S.; Virginia Miller, Ph.D.; Lynne Shuster, M.D.; Robert Brown, Jr., M.D.

Hormone therapy may be hazardous for men with heart conditions

Fairfax, Va., July 26, 2011 – Adding hormone therapy to radiation therapy has been proven in randomized clinical trials to improve overall survival for men with intermediate- and high-risk prostate cancer. However, adding hormone therapy may reduce overall survival in men with pre-existing heart conditions, even if they have high-risk prostate cancer according to a new study just published online in advance of print in the International Journal of Radiation Oncology•Biology•Physics, the official scientific journal of ASTRO.

From 1991 to 2006, 14,594 men with prostate cancer were treated with brachytherapy-based radiation therapy. Of these, 1,378 (9.4 percent) had a history of congestive heart failure or myocardial infarction. Among these men with heart conditions, 22.6 percent received supplemental external beam radiation therapy and 42.9 percent received four months of androgen deprivation therapy to reduce testosterone in their bodies, which can help the cancer grow.

For the entire group of men with a history of heart problems, adding hormone therapy led to a significant increase in overall mortality. For men with pre-existing heart conditions and high-risk prostate cancer, researchers found that by 5 years, 31.8 percent of the men who received hormones had died compared to 19.5 percent of the men who did not receive hormone therapy.

“We found that for men with localized prostate cancer and a history of heart problems, treatment with hormones plus radiation was associated with a higher all-cause mortality than treatment with radiation alone, even for patients with high-risk malignant disease,” Paul L. Nguyen, M.D., lead author of the study and a radiation oncologist at the Dana-Farber/Brigham and Women’s Cancer Center in Boston, said. “Despite Phase III data supporting hormone therapy use for men with high-risk disease, the subgroup of men with a history of heart disease may be harmed by hormone therapy.”

He added, “Future research is necessary to understand the mechanisms of this effect. In the meantime, I encourage men with prostate cancer and a history of heart disease to talk to their doctor about the benefits and risks of hormone therapy.”