News from NAMS 2017: Postmenopausal bleeding is always a red flag, unless proven benign

Every postmenopausal bleeding mandates a complete and systematic investigation to rule out endometrial malignancy and blind biopsies are no longer the norm, according to a presentation by Steven R. Goldstein, MD, a professor of obstetrics and gynecology at New York University School of Medicine, New York City here at the North American Menopause Society (NAMS) 2017 Annual Meeting.

“If you’re postmenopausal and not on hormone therapy or tamoxifen, you shouldn’t be bleeding,” he further added.

American Cancer Society estimates that in year 2017, about 61,380 new cases of endometrial cancer and uterine sarcoma will be diagnosed and about 10,920 women will die from these cancers. The average age at diagnosis is 60 and postmenopausal bleeding is the most common presentation in nearly all the cases.

In majority of women who present with postmenopausal bleeding, the cause is atrophic changes of endometrium or vagina, but depending upon other risk factors, 1-14% of these women will harbor a malignancy and it is important not to miss these women.

ACOG advocates endometrial evaluation in any women presenting with abnormal uterine bleeding (AUB), but blind biopsy is no longer sufficient in ruling out uterine malignancy.

Blind biopsy alone could miss the diagnosis of focal lesions in up to 18% of patients
Endosee

Dr Goldstein said, “The standard of care has changed. Now the standard of care corroborates that a negative blind biopsy is not a stopping point. Clinicians can still begin with a blind biopsy, but unless it is malignant or complex atypical hyperplasia, the endometrial evaluation is not complete."

If cancers occupy less than 50% of the surface area of the uterine cavity, it can very much be missed with a blind biopsy.

if cancer occupies less than 50%, of the surface area of the endometrial cavity, the cancer can be missed by a blind biopsy
Endosee

The Evaluation Algorithm

The investigation should ideally begin with transvaginal ultrasonography(TVS), or sonomicroscopy, to determine the thickness of the endometrium. If distinct endometrial echo or lining, less than or equal to 4 mm is visualized, no further endometrial sampling is required. (99.8%- 100% negative predictive value)

But, in many patients it is not possible to see the endometrial lining because of obesity, adenomyosis structural nonalignment or fibroids.  So, if the endometrial thickness is more than 4 mm or the endometrial echo is difficult to visualize, the next logical step is to perform a sonohysterography or hysteroscopy.

By infusing fluid, clinicians can delineate clearly whether the thickening is focal or global throughout the cavity. If the thickness is global, go for a biopsy. If it is focal occupying more than 20-30% of uterine cavity, plan for a biopsy under hysteroscopic guidance.

It’s easy and timesaving to perform office hysteroscopy, with US FDA approved disposable hysteroscope called Endosee (Cooper Surgical). It provides a quick point of care option and does not require sterilization or special storage. Physicians can take a biopsy under direct vision and resolve the dilemma.

If the patient’s first point of contact is not an obgyn but a primary care physician, an internist or physician from some other specialty, they should at least order a TVS, so that by the time the patient is seen by a gynecologist, the initial sonography report is ready.

NAMS press release

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News from NAMS 2017: “Bisphosphonate drug holiday” not mandatory

A presentation at the North American Menopause Society (NAMS) Annual Meeting in Philadelphia October 11-14, will  present new evidence regarding long term safety and effectiveness of Bisphosphonates and denosumab in treating postmenopausal osteoporosis.

According to International Osteoporosis Foundation, Osteoporosis is estimated to affect 200 million women worldwide - approximately one-tenth of women aged 60, one-fifth of women aged 70, two-fifths of women aged 80 and two-thirds of women aged 90.

Bisphosphonates and denosumab are the most commonly prescribed treatments for osteoporosis. There is no cure for osteoporosis and the effects of these drugs wear-off as treatment ceases, hence prevention is the best bet.

As Bisphosphonates therapy is started, protection from osteoporosis is gained in first few months and persists as long as treatment is continued.

If Bisphosphonate treatment is continued beyond 3 years, increasing risk of unusual or “atypical” fractures of the femur (thigh bone) is observed. The risk increases gradually as patient continue to take the drug beyond 3 years: the risk is 20/100,000 patients at 5 years and 1/1,000 patients at 8-10 years.

If the drug is stopped, protection from fractures is lost gradually in 3-5 years.

This combination of increased risk of atypical fractures on continued treatment and decline in protection from fractures as treatment is stopped led to the confusing concept of a “bisphosphonate holiday.”

The American Society for Bone and Mineral Research (ASBMR) has recently provided clear recommendations about “bisphosphonate holidays.”

ASBMR recommends that, after 3-5 years of treatment with bisphosphonates, a patient risk of fracture should be evaluated. If the patient remains at ‘high risk’ for fracture because of low BMD, previous history of hip, spine, or multiple other fractures, the treatment should not be stopped.

Patient can continue the same treatment or change to some other drugs like denosumab.

Those patients who are at ‘low risk’ for fracture, the treatment can be stopped for 3-4 years, but it is not mandatory.

The concept of ‘drug holiday’ only holds good for Bisphosphonates only, and not for other drugs like raloxifene, teriparatide, and denosumab because beneficial effects of these drugs are lost as soon as they are stopped.

Dr. Michael McClung of the Oregon Osteoporosis Center in Portland, Oregon, who will be presenting his recommendations on long-term osteoporosis therapy at the NAMS Annual Meeting said, “Because protection from fractures disappears quickly if denosumab treatment is stopped, and since there are no currently known safety issues that limit the duration of denosumab therapy, there is no justification for a drug holiday with this treatment.”

“Just as we do not recommend stopping treatment for high blood pressure or diabetes, it is necessary to have a long-term treatment plan for postmenopausal women with osteoporosis if the benefits of our therapies are to be realized,” he further added.

Dr. JoAnn Pinkerton, NAMS executive director said, “Prevention of osteoporosis should be a goal for those treating menopausal women, as up to 20% of bone loss occurs within the first five years of menopause. Once diagnosed with osteoporosis, the goal becomes lowering the risk of fractures as fractures can be life changing or life limiting. This presentation will offer valuable insights about the need for long-term treatment and will change the way health care providers approach long-term osteoporosis management.”

NAMS updates position statement about Hormone Therapy at the 2017 annual meeting

courtesy: dailytimes.com

The North American Menopause Society(NAMS) executive director, JoAnn Pinkerton, MD, from the University of Virginia in Charlottesville, issued the updated Hormone Therapy(HT) Position statement at the ongoing annual meeting at Philadelphia October 11-14, 2017.

This update’s the 2012 statement from NAMS, and includes special needs population like women who had early menopause or breast cancer.

The recent findings from Women’s Health Initiative(WHI) follow-up study, published recently reinforced the development of this position statement. The results of follow-up study showed no increase in all-cause or disease specific mortality in women taking hormone therapy.

The advisory panel reviewed WHI data along with 13 years of follow -up, plus newer randomized trial and other observational data and studied the effect of HT on a wide range of diseases.

Recommendations:

NAMS urges the health practitioners to assess each individual woman based on her unique health risk and co-morbidities, and make a shared, informed decision about staring the HT. The women should be revaluated and her risk reassessed periodically.

The practitioners should choose the best dose, combination, route and duration of therapy for each individual patient.

HT is most effective in treating hot flashes, night sweats, and sleep disruption caused by menopause in addition to preventing bone loss and fractures.

Risk of HT differ according to the duration, timing of starting the therapy, type and route of administration and formulation. Risks vary according to the addition of progesterone.

Always use the lowest and safest dose that brings about relief of symptoms.

HT is safe for most menopausal women age less than 60 years or when started within 10 years of menopause.

The benefits of starting HT decreases and the risk increases (Increased benefit/risk ratio) if started 10-20 years after menopause or after the age of 60 years. In these women low dose vaginal estrogen is recommended for relief of Genitourinary syndrome(GSM).

Special populations:

Breast cancer: The WHI study data analysis did not show any increased risks with conjugated estrogen alone during the study period (7 years), but some studies have suggested increased risk after 15-20 years. The rare risk of <1/1000 for breast cancer appears to be due to combination of estrogen and progesterone or extended duration of estrogen alone.

CVD: HT reduces the risk of CHD when started at younger age or within 10 years of menopause and no effect of risk reduction was observed when it was initiated 10-20 years after menopause or after the age of 60 years.

Early menopause: Unless contraindicated, women who have had premature ovarian failure or surgically induced menopause should receive HT till median age of 52 years as benefits outweigh the risks. (Level II).

Family history of breast cancer: Evidence shows that HT does not alter the risk of breast cancer in women with FH of the disease, however she should undergo counselling about it. (Level II).

BRCA-positive women without breast cancer: These group of women are at high risk of primarily estrogen-receptor negative breast cancer. To mitigate the health risk caused by oophorectomy, systematic HT can be started after shared decision making until the median age of natural menopause. (Level II).

Extended use of HT: The recent data does not support the routine discontinuation of HT after the age of 65 years as per Beers criteria. Each woman should be individually assessed to continue HT beyond the age of 60 years. Her risk should be reassessed and close follow-up is needed. (Level III).

Easing the menopause transition by latest technology- upcoming North American Menopause Society (NAMS) 2017 Annual Meeting.

The upcoming NAMS 2017 annual meeting that will be held at Philadelphia October 11-14 is sure to be an academic feast. The scientific session will bring in all the latest and comprehensive updates from world renowned speakers with focus on the technological advances that can help women in seemingly smooth transition through the menopausal years.

The meeting is going to kick start with a pre-meeting symposium about Musculoskeletal Health in Postmenopausal Women: Assessment and Management of Fracture Risk by Co-Chair, Michael R. McClung, MD.  This symposium will cover assessment of postmenopausal osteoporosis; including dual-energy x-ray absorptiometry(DXA) best practices and new imaging modalities. It will also cover the new pharmacological therapies for osteoporosis and ways to improve the muscle functions.

This will be followed by President’s Reception and other CME activities. The topics that are expected to be covered include: Vaginal Health and Pelvic Pain, Hormone Therapy, Uterine Bleeding and Adnexal Masses, Lesbian Health and Sexuality, Cardiovascular Disease Risk Factors, Migraines and Mood Disorders in Midlife Women, Advances in Breast Imaging, Musculoskeletal Health Concerns, Social Media and Technology: Driving the Direction of Women’s Health and Update on MsFLASH Trials.

The NAMS updated position statement on Hormone therapy will be presented by JoAnn Pinkerton, MD, from the University of Virginia in Charlottesville, who is executive director of NAMS.

The findings of WHI follow -up study published in JAMA, played a key role in supporting some of the recommendations.

Technological advances, especially mobile health technology and its role in improving patient’s engagement and health will also be focused upon.

In all, the meeting will engage a diverse, multiracial, multiethnic and multispecialty group of people with varied interests, but there will be something for everyone.

Looking forward seeing latest updates and good clinical research abstracts from the meeting.

Related Links

WHI Study: No increased all-cause mortality with menopausal hormone therapy