Saturday, March 31, 2018

In case you missed it: Here are the top 5 posts this month


Blob and Bagel sign on Ultrasound can be labeled as definitive for Ectopic Pregnancy

Women with the Blob and Bagel ultrasound sign should be reclassified from having ‘probable’ ectopic pregnancy (EP) to ‘definitive’ EP and should be treated as such reports the result of a large retrospective cohort study published March 11, 2018, in Journal of Ultrasound in Obstetrics and Gynecology.




The Dos and Don’ts in Pregnancy: An evidence-based review

Every Pregnant woman receives tons of advice regarding precautions she needs to take to optimize the pregnancy outcome. In this digital age, she is constantly exposed to ideas and suggestions about the dos and don’ts in pregnancy, a lot of which is confusing and conflicting, as a result, the woman is often unsure of what is correct for her and the baby. She often turns to her healthcare provider to direct her regarding her daily routine in pregnancy, but the healthcare provider is also exposed to myriads of opinion on this topic.



New oral drug treatment found highly effective in reducing menopausal hot flashes

A neurokinin 3 receptor (NK3R) antagonist (MLE4901) rapidly reduced hot flashes for short and long-term in postmenopausal women; thus, eliminating the need for estrogen therapy report researchers from Imperial College London. The study was published on March 12, ahead of print in North American Menopause Society Journal Menopause. 

The neurokinin 3 receptor (NK3R) antagonist (MLE4901) is manufactured by Millendo Therapeutics Inc, based at Ann Arbor, Michigan.



A new study quantifies the risk of occult gynecological malignancy in women undergoing hysterectomy or myomectomy for benign indications 

The risk of finding occult gynecological malignancy in women undergoing hysterectomy or myomectomy is not negligible, especially in women more than 55 years in age reports the results of a large population-based study published ahead of print in Journal of Obstetrics and Gynecology. 

This timely and interesting study not only looked at the prevalence of gynecological malignancy in women undergoing hysterectomy and myomectomy for benign conditions but also looked at the utility of power morcellators in selected patient populations.


Could modified PapTest help detect endometrial and ovarian malignancy?

A new multiplex PCR-based test called PapSEEK was able to detect endometrial and ovarian malignancy from fluid samples collected during routine Pap test, reported Yuxuan Wang, MD, of Johns Hopkins University School of Medicine in Baltimore.

The authors also used a longer sampling brush that sweeps cells from the lining of the uterus called Tao brush, to further increase the sensitivity of detection for the less accessible tumors.




Now change the scalpel blade in a jiffy without even touching it


Surgeons can now load or change the scalpel blades without exposing and handling them directly.

Four biomedical students from Georgia Tech University have designed an automatic dispenser called Scal-Pal for scalpel blades much like razor blade dispenser for a razor.

This makes changing or loading a scalpel blade easier and much safer. Currently, surgeons or nurses must rely on another person, who opens the foil packet, to expose the blade and then they grab the blade with a needle holder or another instrument to mount it on the handle.

While exposing the blade from the foil package there is always a chance of injury. But, not anymore.

Scal-Pal works the same way as an automatic razor blade dispenser. The blade is stored inside a box made from pre-recycled polyethylene and when needed to replace or load, the handle is inserted in the box, which comes out with a new blade. The old blade is trapped inside the box. When the box runs out of blades, it is disposed off and a new box is used.

 “Our design works because the blade is never exposed. No one has to touch it directly,” said Sydney Platt, who is one of the four inventors of the device.

Scal-Pal is one of the six inventions chosen for InVenture Prize, an innovation competition held every year at Georgia Tech.

Watch a video of the device.





New Release
Media Courtesy: by Allison Carter



Thursday, March 29, 2018

News from SGO annual meeting: Cervical cancer screening should not be stopped at age 65


One in every 5 women diagnosed with cervical cancer is above the age of 65 years in the USA, which suggests a reconsideration of current cervical cancer screening guidelines which advice to stop the screening at the age 65 years for women who are at low risk and have received adequate screening in the past.

The data was presented by the lead researcher Sarah Dilley, MD, MPH, a fellow in gynecologic oncology at The University of Alabama at Birmingham at the Society of Gynecologic Oncology’s 2018 Annual Meeting on Women’s Cancer.



The current recommendations by American Cancer Society, American Society for Clinical Pathology and American Society of Colposcopy and Cervical Pathology advice that cervical screening should stop after women turn 65 years of age if they have had adequate screening and are at low risk. The guidelines do not address the risk stratification for cervical cancer in women over the age of 65. 

The researchers analyzed the 2014-15 data Surveillance, Epidemiology and End Results (SEER-18) program database which showed that 19.7 percent of cervical cancer cases were diagnosed in women age 65 or older.

Analysis of the National Cancer Database for the year 2014-15 showed that 18.9% of cervical cancer were diagnosed in women who were who were 65 years or older.

Risk stratification by ethnicity showed that in 22.9 percent of African American women were age 65 or older, compared to 20.5 percent of non-Hispanic white women at the time of diagnosis of cervical cancer.

When the incidence was analyzed by age, only 5.1 percent of cervical cancer cases were diagnosed from age 20 to 29, while 8 percent were diagnosed from age 70 to 79.

Dr. Dilley said in a news release, “This data point contradicts the misperception that women usually only are diagnosed with cervical cancer at a younger age.”

“Our data suggest that a considerable proportion of women are diagnosed with cervical cancer after age 65, which suggests that patients are being aged out too soon or not getting screened at all,” Dr. Dilley continued. “Professional societies should consider extending the age screening requirements to improve outcomes for this older population of women.”

The results of this study suggest that the decision to stop cervical cancer screening should only be taken after an informed shared decision-making between patient and her doctor and some women over the age of 65 years may still benefit from screening to prevent age-based disparities in cervical cancer diagnoses.


Media courtesy: LA times and JAMA

Wednesday, March 28, 2018

Could modified PapTest help detect endometrial and ovarian malignancy?


A new multiplex PCR-based test called PapSEEK was able to detect endometrial and ovarian malignancy from fluid samples collected during routine Pap test, reported Yuxuan Wang, MD, of Johns Hopkins University School of Medicine in Baltimore.

The authors also used a longer sampling brush that sweeps cells from the lining of the uterus called Tao brush, to further increase the sensitivity of detection for the less accessible tumors.

The paper was published in Journal Science Translational Medicine on March 21, 2018, and the study identified endometrial cancer with high sensitivity from samples collected by Pap test and Tao brush, while sensitivity for reporting ovarian cancer was low, but increased when it was combined with DNA testing in the blood samples.

Pap test has been instrumental in bringing down the incidence of cervical cancer by about 60% since its introduction in 1940 but it is not able to detect endometrial and cervical cancers. The researchers at John Hopkins University based this test on the evidence put forth by the previous study published in Journal Science Translational Medicine that both endometrial cancer and ovarian cancer shed cells that collect at the cervix. These cells can be identified by looking for ‘Tumor DNA’ in the samples.

It is to be noted that DNA mutations have already been identified for specific cancers. In the study, the researchers tested for 18 genes common to endometrial and cervical cancer.



The researchers looked at 1915 samples from 1658 individuals, including 656 patients with endometrial or ovarian cancers and 1002 healthy controls.

PapSEEK was used on Pap test samples of 382 women with endometrial cancer, 245 women with ovarian cancer, and 714 women without cancer.

PapSEEK gave a positive result in 81% of endometrial cancer patients, which included 78% of patients with stage I or stage II disease, and 92% of patients with stage III or stage IV disease.

While 33% of Pap test samples were PapSEEK-positive in ovarian cancer patients, including 34% of patients with stage I or stage II disease and 33% of patients with stage III or stage IV disease.

When samples collected by Tao brush was examined, they tested positive in 93% of cases endometrial cancer and 45% cases of ovarian cancer.

The researchers then tested plasma samples from 83 ovarian cancer patients and found that 43% of these patients had detectable circulating tumor DNA. On applying the papSEEK test to the Pap test samples from this group, it was seen that positive results were obtained in 63% of patients.

Currently, there are no screening tests for both endometrial and ovarian cancer and incidence of both is on the rise.  

More than 63,000 women are diagnosed with endometrial cancer in the U.S. each year, and more than 11,000 die each year from the disease. Ovarian cancer is less common but more lethal, affecting more than 22,000 women and killing about 14,000 in the U.S. each year.

Yuxuan Wang, first author on the study said, “Our study demonstrates the ability to detect endometrial and ovarian cancer using cervical fluids obtained using two different methods.”

Media Courtesy: John Hopkins University 

Tuesday, March 20, 2018

New oral drug treatment found highly effective in reducing menopausal hot flashes


A neurokinin 3 receptor (NK3R) antagonist (MLE4901) rapidly reduced hot flashes for short and long-term in postmenopausal women; thus, eliminating the need for estrogen therapy report researchers from Imperial College London. The study was published on March 12, ahead of print in North American Menopause Society Journal Menopause.

The neurokinin 3 receptor (NK3R) antagonist (MLE4901) is manufactured by Millendo Therapeutics Inc, based at Ann Arbor, Michigan.

Nearly 73% of postmenopausal women experience hot flashes with disruptive effects on activities of daily life along with increased use of hormonal medications. Although estrogen is crucial for the maintenance of bone and cardiovascular health during menopausal years, the maximum efficacy takes weeks to develop and women often discontinue the estrogen therapy for fear of side effects. 

In this phase 2, randomized, double-blind, placebo-controlled, single-center, crossover trial (NCT02668185) the researchers recruited 37 women between the age of 40 to 62 years, experiencing ≥7 HF/24 hours to receive either NK3R antagonist MLE4901 40mg bd for 4 weeks or placebo 40 mg bd in random order.
After a gap of 2 weeks, the women received another drug which they didn’t receive first time for4weeks.

The oral NK3R antagonist MLE4901 not only reduced the frequency of hot flashes by 72% by day 3 of treatment but also reduced the severity of HF by 38% (44% by end of 4 weeks) as compared to baseline symptoms (all P < 0.0001).

The interference due to HF was also reduced by 61% (70% by end of 4 weeks) and level of bother by 39% (50% by end of 4 weeks) at the end of 3 weeks of treatment as compared to a placebo.

Professor Waljit Dhillo, the lead author of the study said: “If a woman is having more than seven flushes a day and the drug is getting rid of three-quarters of them, that’s pretty life-changing.

“For day to day living and work, that’s a significant impact on quality of life. If we can reduce flushing by 73 percent it’s a game-changer for those patients,” he further added.

JoAnn Pinkerton, MD, executive director of The North American Menopause Society opined that further large-scale trials to bring the drug into clinical practice would be game-changing for women with a history of estrogen-dependent cancers like breast and uterine cancers.

"Relief of hot flashes is an important, unmet need for these women, as other nonhormonal therapies such as low dose antidepressants or gabapentin have not been as effective as hormone therapy at relieving severe hot flashes," she further added.

She also suggested looking at the long-term effect of this drug, specifically after continued use for 3-5 years as some women continue to experience HF for 15-20 years past menopause.

Media courtesy: Getty Images



Monday, March 19, 2018

Subclinical Hypothyroidism linked to unexplained infertility


Women with unexplained infertility (UI) were twice as likely to have a raised TSH level as compared to women who were not able to conceive because of male factor infertility reports the results of a cross-sectional study published in February issue of Endocrine Society's Journal of Clinical Endocrinology & Metabolism.

About 10-30% of the infertile couples have unexplained infertility, defined as an inability to conceive with 12 months of unprotected intercourse with no explainable cause.

Data on the association between subclinical hypothyroidism and infertility is so far limited because of different levels of TSH cutoffs.

For this study, the Harvard based researchers looked at data from large academic health system over a period of 12 years and recruited 239 women with TSH (≤5 mIU/L) and prolactin levels (≤20 ng/ml) within normal range.  Of these women, 187 were diagnosed as UI (study arm), while in 52 women the male partner suffered from azoospermia or severely oligospermia with no other factor diagnosed for infertility (control arm).

After accounting for age, body mass index, and smoking status, it was seen that nearly 27% of women in UI group had TSH ≥2.5 mIU/L as compared to 13% in control group (P < 0.05).

The prolactin levels were comparable between both the groups.

Pouneh K. Fazeli, study’s senior author and a researcher at Massachusetts General Hospital and Harvard Medical School in Boston said, “Since our study shows that women with unexplained infertility have higher TSH levels compared to women experiencing infertility due to a known cause, more research is needed to determine whether treating these higher TSH levels with thyroid hormone can improve their chances of getting pregnant.”




Sunday, March 18, 2018

BewellConnect launches its smart wireless multi-action perineal probe to strengthen the pelvic floor


BewellConnect, a Boston based healthcare company recently unveiled its new wireless pelvic floor muscle trainer, MyPeriTens at the Consumer Electronics Show (CES) 2018 in Las Vegas. The probe is designed by a physiotherapist and help strengthen weakened pelvic floor muscles.

The device can be used as short-term treatment for perineal weakness after labor and heavy intensity exercise or as an ongoing treatment for stress incontinence, urge incontinence, or both.

The product is categorized as class IIa medical device and can be used for self-training sessions at home or in collaboration with a physiotherapist.

It has dual functions of EMS (electrical muscle stimulation) and TENS (transcutaneous electrical nerve stimulation) and during a Neuromuscular Electrical Stimulation (NMES) session the targeted muscle is stimulated through an electrical impulse resulting in muscle strengthening and rehab.

It is controlled by a smartphone app via Bluetooth and is also compatible with the tablet. The patient can choose from 16 preset programs and 10 intensity levels to suit her personal needs.  The data can be shared with the physiotherapist over a secured connection.

Alexia Sibony, Director of Clinical Research Quality and Innovation for BewellConnect Corp said, "Post-partum pelvic floor dysfunction is widely underreported due to the sensitive nature of the problem. MyPeriTens will allow women and their physicians to address this challenge with a discreet and highly effective therapy, from the comfort of their own home."

Pending FDA approval in USA, it is expected to hit the market at the end of 2018. 

MyPeriTens app is available on Apple Store and Google Play



Media Courtesy: bewell-connect.com





Blob and Bagel sign on Ultrasound can be labelled as definitive for Ectopic Pregnancy

. blob sign of ectopic pregnancy.

Women with the Blob and Bagel ultrasound sign should be reclassified from having ‘probable’ ectopic pregnancy (EP) to ‘definitive’ EP and should be treated as such reports the result of a large retrospective cohort study published March 11, 2018, in Journal of Ultrasound in Obstetrics and Gynecology.

Ectopic Pregnancy is still the leading cause of first-trimester maternal deaths and constitutes 4% of all pregnancy-related deaths. The incidence of ectopic is highest in women undergoing In-Vitro Fertilization(IVF) and ranges from 4% to 11% of all pregnancies.

The broken arrow depicts the right ovary and the solid arrow shows ectopic pregnancy characterized by the ‘bagel sign’.
With the advent of high-resolution transvaginal ultrasound (TVS), more ectopic pregnancies are diagnosed at clinically early and hemodynamically stable stages that are amenable to various modes of management. In modern times TVS has replaced laparoscopy as the diagnostic tool of choice.

Barnhart et al have published a recent consensus statement of nomenclature, definitions, and outcome of pregnancy of unknown location (PUL) in Journal Fertility and Sterility. In which, research papers originating from the US diagnose EP based on findings of an extrauterine gestational sac with the visualization of a yolk sac or embryo, while literature from the UK and European countries diagnose EP based on finding of an extrauterine inhomogeneous mass (blob sign), or an extrauterine empty gestational sac (bagel sign). 
   
This study was undertaken with an aim to determine whether these ultrasound markers can be used to definitely predict EP, instead of just raising a probability of its presence. The study recruited 849 of 7490 consecutive women who attended the Early Pregnancy Unit (EPU) of the Nepean Hospital, Sydney, Australia over a period of 10 years.

At TVS, 240 of 849 women were diagnosed as probable EP, of which 174 (72.5%) exhibited the blob sign and 66 (27.5%) exhibited bagel sign. The rest 609 were labeled as PUL, of which 47 received a final diagnosis of EP (including 24 blob signs, 19 bagel signs and four gestational sacs with embryo/yolk sac.

Nearly 51% of patient with blob sign and 59% of patients with bagel sign underwent laparoscopic salpingectomy, and HPE proved the diagnosis in 97% of patients with blob sign and 96% of patients with bagel sign.


The sensitivity for the blob and bagel signs in the prediction of definite tubal EP was 89.8% and 83.3%, respectively, the specificity was 99.5% and 99.6%, PPV was 96.7% and 95.2% and NPV was 98.3% and 98.6%.

All the parameters were comparable to the corresponding parameters of the extrauterine gestational sac with yolk sac and/or embryo on TVS used in the prediction of definite tubal EP.

The authors concluded that Blob and bagel signs are the commonest presentation of tubal ectopic on TVS, and because of high PPV of >95%, it can be used for the definitive diagnosis of EP. Majority of women who present with EP during early pregnancy can have a definitive diagnosis with only standalone TVS, with laparoscopy being used as the treatment modality.



Saturday, March 17, 2018

The Dos and Don’ts in Pregnancy: An evidence-based review


Every Pregnant woman receives tons of advice regarding precautions she needs to take to optimize the pregnancy outcome. In this digital age, she is constantly exposed to ideas and suggestions about the dos and don’ts in pregnancy, a lot of which is confusing and conflicting, as a result, the woman is often unsure of what is correct for her and the baby. She often turns to her healthcare provider to direct her regarding her daily routine in pregnancy, but the healthcare provider is also exposed to myriads of opinion on this topic.

This recent article published ahead of print as a part of clinical expert series in the Journal of Obstetrics and Gynecology provides an evidence-based review on things routinely advised or avoided during pregnancy.

The author has looked upon Cochrane systematic reviews, guidelines from the American College of Obstetricians and Gynecologists(ACOG) and other international organizations to formulate the recommendations that can be used to direct a pregnant woman on this confusing and much-advised topic.

Prenatal Vitamins

The necessity of taking or not taking a prenatal vitamin for women has not yet been proven, especially in women taking a balanced diet. But, they are not harmful and may be consumed during pregnancy. Any simple multivitamin will suffice and there is no ideal formulation for a prenatal vitamin. A woman needs to take:
  • Folic acid 400–800 micrograms (until the end of the first trimester)
  • Iron 30 mg (or be screened for anemia)
  • Vitamin D 600 international units
  • Calcium 1,000 mg


Nutrition and weight gain

According to the National Academy of Medicine, weight gain in pregnancy is determined by pre-pregnancy BMI. A woman should consume an additional 350–450 calories per day in the second and third trimesters but it also depends upon her activity levels, height and weight and her metabolism rate.
So, the exact calories required should be individualized.

Alcohol consumption

The safe threshold for alcohol intake is not known and higher alcohol consumption is known to cause fetal alcohol syndrome. It is best avoided in pregnancy.

Artificial sweeteners

Artificial sweeteners are safe in pregnancy as no evidence exists to link them with an increase in birth defects, but it is advisable to keep the intake at the lowest possible level.

Caffeine

Low to moderate caffeine intake is presumed to be safe during pregnancy based on most human studies. It is advisable to limit the intake to less than 300 mg/day. An 8-ounce cup of brewed coffee has about 130 mg of caffeine while a cup of tea or soda has about 50 mg of caffeine.

Eating Fish

Fish intake during pregnancy is associated with improved neurodevelopment in children and is also linked to decreased risk of preterm birth. But, because of increased mercury content, the fetus may suffer neurological damage.

Women should try to eat 2-3 servings of fish/week that is low in mercury and high in omega-3 long-chain polyunsaturated fatty acids and docosahexaenoic acid (DHS).

Raw fish should be avoided during pregnancy.

Other Food choices

Food restrictions are mainly put in place to avoid toxoplasmosis and listeria infection.

To prevent toxoplasmosis, pregnant women should avoid eating raw and undercooked meat, and should wash all fruits and vegetables before consumption.

To avoid Listeria, pregnant women should avoid unpasteurized dairy products, raw sprouts, unwashed vegetables, and unheated deli meats. However, Listeria outbreaks can happen from many other food sources and are difficult to compile a list of foods to be avoided. Pregnant women are in general asked to be aware of local outbreaks of food poisoning and listeriosis and avoid those specific foods.

Smoking, Nicotine patch and vaping

Women are advised against smoking in pregnancy but the use of nicotine patch or gum to help quit smoking is acceptable while pregnant.

Marijuana

No long-term data about fetal neurodevelopmental outcomes after Marijuana consumption is currently available, hence women are advised against Marijuana use in pregnancy.

Physical activity and bedrest

Women with uncomplicated pregnancies are advised to have regular aerobic and strength conditioning exercise during pregnancy. They should aim at average 20–30 minutes of moderate-intensity exercise four to five times per week.

Bed rest or activity restriction has no role in pregnancy and has not shown to prevent preterm birth or pregnancy loss nor does it benefit women with hypertensive disorders of pregnancy, premature rupture of membranes, fetal growth restriction, or placenta previa.

Precautions while driving

Women are advised to continue using three-point seat-belts while pregnant, the belt should be placed low in lap, below the uterus. ACOG recommends against disabling the airbags, but the benefits or harm of airbag is unclear in pregnancy.

Oral Health

The importance of maintaining good dental hygiene should be emphasized during prenatal visits. Routine preventive dentistry should be practiced while pregnant and procedures like cleanings, extraction, scaling, root canal, radiographs and restoration and fillings should be carried out while taking appropriate precautions for exposure to X-rays.

Swimming and Hot-tub baths

Hot-tub baths are not advisable in pregnancy because they raise the risk of miscarriage and birth defects as they increase the maternal temperature.  On the other hand, a woman can continue to enjoy swimming while pregnant.

Travel

Air travel is safe during pregnancy as the cosmic and screening radiation exposures are below the threshold for any sort of fetal risk. Women should be aware of their travel destination and the necessary information on potential infections prevalent in those areas.

But, as the pregnancy progresses, it is difficult to adjust to the demands of traveling. There is no specific cut-off for gestational age after which travel is not advisable. Each woman should take her decision keeping in mind the benefits and harms of the proposed travel.

Intimacy

Sexual intimacy and orgasm are not associated with increased risk of pregnancy complications. In women with placenta previa, intercourse is avoided after 20weeks of pregnancy, although no data exists. In cases of vaginal bleeding or PROM, it is not known whether intimacy increases the risk of bleeding or infection.

Sleeping position

Currently, no data exists to advice a pregnant woman about exact gestational age at which she should start sleeping on her side.

Hair-dye and insect repellents

Hair-dye results in minimum systematic absorption and hence presumed to be safe during pregnancy. Topical insect repellents can be safely used in pregnancy, especially in areas where mosquito-borne illnesses, including West Nile and Zika virus, are rife.

All these are general guidelines and can be appropriate for a broad class of pregnant women, but still, each case needs to be evaluated at an individual level and the advice should be tailored to the specific circumstances.




Friday, March 16, 2018

New study quantifies the risk of occult gynecological malignancy in women undergoing hysterectomy or myomectomy for benign indications


The risk of finding occult gynecological malignancy in women undergoing hysterectomy or myomectomy is not negligible, especially in women more than 55 years in age reports the results of a large population-based study published ahead of print in Journal of Obstetrics and Gynecology.

This timely and interesting study not only looked at the prevalence of gynecological malignancy in women undergoing hysterectomy and myomectomy for benign conditions but also looked at the utility of power morcellators in selected patient populations.


In 2014 US-FDA issued a warning against the use of power morcellators in hysterectomy or myomectomy in women with uterine fibroids because of the risk of spreading and upstaging the cancerous tissue beyond the uterus. The researchers of this study started on the project because, besides few studies, there was no real data to support FDA’s decision to ban the use of power morcellator.

FDA has issued the warning following advocacy by Amy Reed, MD, Ph.D., an anesthesiologist who died following a laparoscopic hysterectomy in October 2013. The use of power morcellator to remove the specimen dispersed and upstaged her undiagnosed uterine sarcoma inside her abdomen.
  
The study led by Vrunda B. Desai, MD, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut looked at data from the American College of Surgeons National Surgical Quality Improvement Program (NISQIP) for the year 2014-2015.

The sample included 24,076 women who underwent the hysterectomy and 2,368 women who had myomectomy for benign indication at the time of surgery. The researchers did not include data from surgeries performed by gynecologic oncosurgeon to eliminate the possibility of including cases of suspected malignancy before surgery.

After regression analysis, it was seen that the incidence of corpus uteri was found in 1.44%, with variation according to the route of hysterectomy. The highest incidence of 1.89% was found in specimens from total laparoscopic or laparoscopic-assisted vaginal hysterectomy followed by 1.86% in samples from the total abdominal hysterectomy. The lowest incidence of 0.23% was noted in patients who underwent the laparoscopic supracervical hysterectomy.

Other gynecological malignancies identified in the study were cervical cancer in .60% of patient and ovarian cancer in .19% of patients.

The older the women, the greater the risk of detecting malignancy with an adjusted odds ratio of 6.46 for women aged 55 years and older vs women aged 40 to 54 years. Occult cancer of uterine corpus was seen in 9.72% of those aged 55 years and older as compared to only 1.06% of women aged 40 to 54 years.

Prevalence of cancer in patients undergoing myomectomy was very rare with only five women testing positive for cancer of uterine corpus. Out of 5, two underwent vaginal myomectomy while three patients had undergone the abdominal hysterectomy. No cancer was detected in women undergoing laparoscopic myomectomy.

Hence, Desai and colleagues suggested that power morcellators can be of use in selected patients with careful preop evaluation and shared decision making. In these selected group of patients, the benefits of minimally invasive surgery may outweigh the potential risk of cancer dissemination, especially with the recent advancement in techniques such as contained power morcellation inside anisolation bag, which offers additional protection. 

Despite few limitations, the authors say that the study has important clinical implications. The study emphasizes the need of advancing research in screening methods for gynecological malignancies especially cancers of uterine corpus and ovaries. The study also calls for improvement in screening techniques for endometrial and cervical cancers.








Thursday, March 1, 2018

In case you missed it: Here are the top 5 posts from last month

Novel cross-over sign in cesarean scar pregnancy helps predicts the risk of invasive placentation
First trimester ultrasound scan evaluating the relationship between the gestational sac and the endometrial line in women with cesarean scar pregnancy(CSP) helps predicts the development of abnormally invasive placenta (AIP) and consecutive intra and post-operative surgical morbidities reports the results of a retrospective case series published in Journal of International Society of Ultrasound in Obstetrics and Gynecology.

Negative sliding sign by ultrasound in repeat cesarean section predicts presence of severe intrabdominal adhesions
A negative sliding sign by ultrasonography (USG) in patients with previous cesarean section helps alert the surgeon to expect massive intraabdominal adhesions, difficult repeat cesarean section and need of blood transfusion during surgery reports the results of a prospective observational study published ahead of print in the February issue of Journal Obstetrics and Gynecology.

A practical guide to counting ovarian antral follicles by ultrasound
A consensus opinion highlighting the main techniques of ovarian antral follicle count (AFC), and providing recommendations for future research is published in special issue on Reproductive Medicine of the journal Ultrasound in Obstetrics and Gynecology.

The consensus makes several recommendations for varied methods used in counting the antral follicles, but no single method is superior over others and the choice should make best use of resources available in a particular setting.

Novel emerging infectious diseases in pregnancy
Last two decades have seen epidemics of several infectious diseases which were previously not so prevalent worldwide. Pregnant mothers are especially prone to many infections because of anatomical and physiological changes that accompany pregnancy. The immune tolerance to semiallogenic fetus is because of down regulation of immunity, which puts the pregnant women at high risk of other infectious diseases reports a paper published in May 2017 issue of Journal Obstetrics and Gynecology.

Innovative force sensing technology enables the surgeons to feel again from a distance
SensOR Medical Laboratories, a medical device start-up based out of Toronto, Canada has developed a novel force-sensing electronic skin called ForceFilm, that when paired with the existing laparoscopic tools enables the surgeons to get the ‘tactile sensation’ so easily felt during open surgeries.

Handling the tissues from a distance makes it difficult to get the idea of the amount of force applied and increases the rate of surgical complications.



Eli Lilly’s Verzenio cleared by FDA as first line therapy in advance metastatic breast cancer


U.S. Food and Drug Administration (FDA) today cleared Eli Lilly’s VerzenioTM (abemaciclib) for use as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with an aromatase inhibitor (AI).

Verzenio has already received FDA’s approval as first and only cyclin-dependent kinase (CDK)4 & 6 inhibitor approved as a single agent or in combination in metastatic breast cancer.

It is used alone to treat adults with HR-positive, HER2–negative advanced breast cancer or metastatic breast cancer whose disease has progressed after hormonal therapy and prior chemotherapy.

It is specifically used in combination with fulvestrant to treat women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer or breast cancer that has metastasized to after hormonal therapy.

The initial approval of Verzenio followed the results of MONARCH 3 trial (ClinicalTrials.gov: NCT02246621) which suggested that initial abemaciclib improves progression-free survival (PFS) among patients with hormone receptor-positive, HER2-negative advanced breast cancer. The findings were published in the Journal of Clinical Oncology.

In the trial it was seen that patient receiving abemaciclib plus an AI (anastrozole or letrozole) has nearly double progression-free survival(PFS) as compared to patients receiving placebo plus AI (28.2 months vs 14.8 months).

The combination of abemaciclib plus AI also provides 46% more chances of survival as compared to abemaciclib plus placebo (HR: 0.54; 95% CI: 0.418-0.698, P <0.0001).

It also resulted in significant tumor shrinkage in 59 percent of patients compared with 44 percent of those who received endocrine drugs alone in the study.

Richard Pazdur, the FDA’s head of oncology drug evaluation, said in a statement, “Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy.”

Verzenio is given as oral 150mg two-times-a-day dose; thus, eliminating the need for patients to get admitted for infusion. Lilly’s Verzenio competes with Pfizer's Ibrance and Kisqali from Novartis. 

The most common side effects are diarrhea, neutropenia, and Liver problems. It is contraindicated in pregnancy.

Breast cancer is the most common cancer in women worldwide and it is estimated that 266,120 new cases of invasive breast cancer will be diagnosed in women in the U.S. in 2018.

This Verzenio new drug application received clearance as a part of the FDA's Expedited Programs for Serious Conditions, specially reserved for therapies that address an unmet medical need in the treatment of serious or life-threatening conditions, such as metastatic breast cancer.

According to Lilly, Verzenio will be in the market in October in the US.