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.

Abstract

Media courtesy:  https://injuryrecoveryinstitute.com, https://www.dashdc.org, https://www.medpagetoday.com

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

Ethicon STRATAFIX™ Spiral Plus Devices transforms wound closure experience for surgeons.

Ethicon has launched Stratafix Spiral PDS Plus and Stratafix Spiral Monocryl Plus Knotless Tissue Control Devices that provides a unique edge over traditional suturing.

Stratafix sutures enables more strength, consistency, security and efficiency over its predecessors because the surgeon can manage tension and control tissue approximation with each pass. It also eliminates the need to tie knots.

https://obgynupdated.blogspot.com/2017/04/ethicon-stratafix-spiral-plus-devices.html

Mayo Clinic Tampon Test for detecting Endometrial Cancer at early stage.

There is no standard screening test to identify endometrial cancer, hence it is often detected late when the disease has already advanced.

Mayo clinic expert Jamie N. Bakkum-Gamez, M.D. and her team are in the process of developing a simple screening test that can be done at home using a tampon. It is based on the concept of detecting tumor DNA hypermethylation in vaginal pool DNA picked up by ordinary tampon.

https://obgynupdated.blogspot.com/2017/04/mayo-clinic-tampon-test-for-detecting.html

At last, a no surgery, no knife, noninvasive treatment for uterine fibroid receives European approval.

Mirabilis Medical, a Seattle based company received CE Mark authorization for marketing of the Mirabilis System for treatment of uterine fibroids throughout the European Union.  It also announced that it had received a green signal from US-FDA to begin its clinical studies in US.

The Mirabilis system is a High-Intensity Focused Ultrasound (HIFU) system consists of an ultrasound system that has two parts: the imaging part and the therapy part.

https://obgynupdated.blogspot.com/2017/04/at-last-no-surgery-no-knife-noninvasive.html

Synthetic progestogens, but not natural progesterone, lowers miscarriage risk among women with unexplained RPL: Systematic review and meta-analysis.

Women taking progestogens have a 28% lower risk of miscarriage (RR 0.72; 95% CI 0.53-0.97).  and 7% higher chances of live births as compared to women who did not receive any supplementation. (RR 1.07, 95% CI 1.02–1.15).

The Meta-analysis included 10 trials comprising a total of 1,586 women with history of recurrent miscarriage.

https://obgynupdated.blogspot.com/2017/04/synthetic-progestogens-but-not-natural.html

Sperms used as vehicle for targeted drug delivery in gynecological cancers.

Sperms are not just for baby-making anymore, but can be used as cargo agents for delivering drugs inside the body.

Getting the chemotherapeutic agent to only kill the tumor cells without affecting the normal cells is a dream come true in area of cancer therapeutics because of Targeted drug delivery systems(TDDS).

Targeted drug delivery systems using polymeric nanoparticles have opened up new avenues in cancer chemotherapy.  Liposomes have shown to be effective among an array of nano- and microcarriers but have the drawback of dilution by body fluids, decreased penetration and uptake by non-target tissues.

https://obgynupdated.blogspot.com/2017/04/sperms-used-as-vehicle-for-targeted.html

Ulipristal acetate in medical management of fibroid

All symptomatic fibroid will eventually require treatment.

Absolute treatment is surgery consisting of  removing the myoma or the entire uterus, but there are patients  in whom Hysterectomy is not a feasible option, or patients who refuse surgery.

These patients have a choice between radiological or medical management. Radiological management consists of uterine artery embolization/ ultrasound ablation. All medical management offer short term relief and consists of progestin, aromatase inhibitors, GnRH analogues, and selective estrogen receptors modulators.  All these agents modify the hormonal milieu leading to shrinkage in size and decreasing the severity of symptoms.

Ulipristal acetate (UPA) is a possible option for medical therapy. It most common use is for preoperative shrinkage of fibroids in reproductive age group women.  It is a steroid that reversibly binds to the progesterone (P) receptor in its target tissue, acting as a potent orally active P receptor modulator. It belongs to the class of drugs known as elective P receptor modulators (SPRMs).

This study aims to investigate the long term intermittent use of UPA in relieving fibroid symptoms.  It was designed by the sponsor (PregLem S.A.) makers of ESMYA, with the involvement of academic investigators and a contract study statistician (CROS NT).

This is the first double blind RCT for UPA  by Donnez J et al published in the January issue of journal of  Fertlity  and Sterility.

Study subjects consist of premenopausal women with fibroid size between 3-12 mm in diameter, menorrhagia and uterine size less than 16 weeks. All study participants were aged between 18 and 50 years inclusive, with body mass index 18–40 (kg/m²) and regular menstrual cycles of 22–35 days with FSH ≤20 IU/L.

The subjects were assigned to receive UPA 5mg or 10 mg and matching placebos for four 12-week courses. A drug holiday was held after each course and the subsequent course was started on second menstruation during the drug free period.

The primary endpoints were percentage of subjects with amenorrhea at the end of four course treatments, the safety endpoint included number of women withdrawing from the treatment due to the adverse effects.

At the end of completion of the study, it was seen that:

• 75% of the subjects remained in the study for 20 months, demonstrating a very good compliance.
• UPA 5 and 10 mg both resulted in amenorrhea, ≥70% of subjects achieved it in a week and the average post-treatment menstrual bleeding was markedly less comparing with pretreatment bleeding.
• 73% of all subjects ended in amenorrhea with ≥25% reduction in fibroid volume at the end of treatment period.
• The endometrial changes were benign and returned to pretreatment levels in 3 months post treatment.
• Levels of E₂ remained well above postmenopausal levels, evading the fear of decreased bone mineral density.

It was concluded that treatment with four 12-week treatment courses of UPA at doses of 5 and 10 mg was well tolerated. No differences were observed between the 5 and 10 mg dosing groups. At the end of treatment cycle more than three fourth women achieved amenorrhea and a reduction in fibroid size. 

This study also showed that UPA 5 mg as an intermittent therapy can be a good medical alternative in those women with fibroid who wish to avoid surgery or surgery is contraindicated.

References:

http://www.fertstert.org/article/S0015-0282%2815%2901960-3/fulltext