Breaking News
May 3, 2019 - Vaping and Smoking May Signal Greater Motivation to Quit
May 3, 2019 - Dementia looks different in brains of Hispanics
May 3, 2019 - Short-Staffed Nursing Homes See Drop In Medicare Ratings
May 3, 2019 - Study of teens with eating disorders explores how substance users differ from non-substance users
May 3, 2019 - Scientists develop new video game that may help in the study of Alzheimer’s
May 3, 2019 - Arc Bio introduces Galileo Pathogen Solution product line at ASM Clinical Virology Symposium
May 3, 2019 - Cornell University study uncovers relationship between starch digestion gene and gut bacteria
May 3, 2019 - How to Safely Use Glucose Meters and Test Strips for Diabetes
May 3, 2019 - Anti-inflammatory drugs ineffective for prevention of Alzheimer’s disease
May 3, 2019 - Study tracks Pennsylvania’s oil and gas waste-disposal practices
May 3, 2019 - Creating a better radiation diagnostic test for astronauts
May 3, 2019 - Vegans are often deficient in these four nutrients
May 3, 2019 - PPDC announces seed grants to develop medical devices for children
May 3, 2019 - Study maps out the frequency and impact of water polo head injuries
May 3, 2019 - Research on Reddit identifies risks associated with unproven treatments for opioid addiction
May 3, 2019 - Good smells may help ease tobacco cravings
May 3, 2019 - Medical financial hardship found to be very common among people in the United States
May 3, 2019 - Researchers develop multimodal system for personalized post-stroke rehabilitation
May 3, 2019 - Study shows significant mortality benefit with CABG over percutaneous coronary intervention
May 3, 2019 - Will gene-editing of human embryos ever be justifiable?
May 3, 2019 - FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions
May 3, 2019 - Why Tonsillitis Keeps Coming Back
May 3, 2019 - Fighting the opioid epidemic with data
May 3, 2019 - Maggot sausages may soon be a reality
May 3, 2019 - Deletion of ATDC gene prevents development of pancreatic cancer in mice
May 2, 2019 - Targeted Therapy Promising for Rare Hematologic Cancer
May 2, 2019 - Alzheimer’s disease is a ‘double-prion disorder,’ study shows
May 2, 2019 - Reservoir bugs: How one bacterial menace makes its home in the human stomach
May 2, 2019 - Clinical, Admin Staff From Cardiology Get Sneak Peek at Epic
May 2, 2019 - Depression increases hospital use and mortality in children
May 2, 2019 - Vicon and NOC support CURE International to create first gait lab in Ethiopia
May 2, 2019 - Researchers use 3D printer to make paper organs
May 2, 2019 - Viral infection in utero associated with behavioral abnormalities in offspring
May 2, 2019 - U.S. Teen Opioid Deaths Soaring
May 2, 2019 - Opioid distribution data should be public
May 2, 2019 - In the Spotlight: “I’m learning every single day”
May 2, 2019 - 2019 Schaefer Scholars Announced
May 2, 2019 - Podcast: KHN’s ‘What The Health?’ Bye-Bye, ACA, And Hello ‘Medicare-For-All’?
May 2, 2019 - Study describes new viral molecular evasion mechanism used by cytomegalovirus
May 2, 2019 - SLU study suggests a more equitable way for Medicare reimbursement
May 2, 2019 - Scientists discover first gene involved in lower urinary tract obstruction
May 2, 2019 - Researchers identify 34 genes associated with increased risk of ovarian cancer
May 2, 2019 - Many low-income infants receive formula in the first few days of life, finds study
May 2, 2019 - Global study finds high success rate for hip and knee replacements
May 2, 2019 - Taking depression seriously: What is it?
May 2, 2019 - With Head Injuries Mounting, Will Cities Put Their Feet Down On E-Scooters?
May 2, 2019 - Scientists develop small fluorophores for tracking metabolites in living cells
May 2, 2019 - Study casts new light into how mothers’ and babies’ genes influence birth weight
May 2, 2019 - Researchers uncover new brain mechanisms regulating body weight
May 2, 2019 - Organ-on-chip systems offered to Asia-Pacific regions by Sydney’s AXT
May 2, 2019 - Adoption of new rules drops readmission penalties against safety net hospitals
May 2, 2019 - Kids and teens who consume zero-calorie sweetened beverages do not save calories
May 2, 2019 - Improved procedure for cancer-related erectile dysfunction
May 2, 2019 - Hormone may improve social behavior in autism
May 2, 2019 - Alzheimer’s disease may be caused by infectious proteins called prions
May 2, 2019 - Even Doctors Can’t Navigate Our ‘Broken Health Care System’
May 2, 2019 - Study looks at the impact on criminal persistence of head injuries
May 2, 2019 - Honey ‘as high in sugars as table sugar’
May 2, 2019 - Innovations to U.S. food system could help consumers in choosing healthy foods
May 2, 2019 - FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients
May 2, 2019 - Women underreport prevalence and intensity of their own snoring
May 2, 2019 - Concussion summit focuses on science behind brain injury
May 2, 2019 - Booker’s Argument For Environmental Justice Stays Within The Lines
May 2, 2019 - Cornell research explains increased metastatic cancer risk in diabetics
May 2, 2019 - Mount Sinai study provides fresh insights into cellular pathways that cause cancer
May 2, 2019 - Researchers to study link between prenatal pesticide exposures and childhood ADHD
May 2, 2019 - CoGEN Congress 2019: Speakers’ overviews
May 2, 2019 - A new strategy for managing diabetic macular edema in people with good vision
May 2, 2019 - Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance
May 2, 2019 - Screen time associated with behavioral problems in preschoolers
May 2, 2019 - Hormone reduces social impairment in kids with autism | News Center
May 2, 2019 - Researchers synthesize peroxidase-mimicking nanozyme with low cost and superior catalytic activity
May 2, 2019 - Study results of a potential drug to treat Type 2 diabetes in children announced
May 2, 2019 - Multigene test helps doctors to make effective treatment decisions for breast cancer patients
May 2, 2019 - UNC School of Medicine initiative providing unique care to dementia patients
May 2, 2019 - Nestlé Health Science and VHP join forces to launch innovative COPES program for cancer patients
May 2, 2019 - Study examines how our brain generates consciousness and loses it during anesthesia
May 2, 2019 - Transition Support Program May Aid Young Adults With Type 1 Diabetes
May 2, 2019 - Study shows how neutrophils exacerbate atherosclerosis by inducing smooth muscle-cell death
May 2, 2019 - Research reveals complexity of how we make decisions
Minimally invasive surgery associated with worse survival for women with cervical cancer compared to open hysterectomy

Minimally invasive surgery associated with worse survival for women with cervical cancer compared to open hysterectomy

J. Alejandro Rauh-Hain, M.D. Credit: MD Anderson Cancer Center

When comparing standard-of-care surgical options for women with early-stage cervical cancer, two studies led by researchers at The University of Texas MD Anderson Cancer Center discovered that minimally invasive radical hysterectomy is associated with higher recurrence rates and worse overall survival (OS), compared to abdominal radical hysterectomy.

The results of both studies are published today in the New England Journal of Medicine. The first, a randomized-controlled Phase III trial, was led by Pedro Ramirez, M.D., professor, Gynecologic Oncology and Reproductive Medicine. The second, an epidemiologic study, was led by J. Alejandro Rauh-Hain, M.D., assistant professor, Gynecologic Oncology and Reproductive Medicine and Health Services Research.

According to the authors, the findings already have changed care at MD Anderson and could impact the surgical management of all women with early-stage disease, which accounts for nearly half of the 13,240 cervical cancers expected to be diagnosed this year.

“Minimally invasive surgery was adopted as an alternative to open radical hysterectomy before high-quality evidence regarding its impact on survival was available,” said Rauh-Hain. “Both Dr. Ramirez and I were surprised to find that in our respective studies, surgical approach negatively affected oncologic outcomes for women with early-stage cervical cancer.”

In the gynecologic oncology community, minimally invasive surgery for cervical cancer gained acceptance more than a decade ago as an alternative to abdominal radical hysterectomy when laparoscopy and then robotic technology were introduced. However, impact on survival and other cancer-related outcomes had not been studied in randomized trials or large, well-designed observational studies.

“Until now, data focused primarily on surgical outcomes and the immediate period after, such as the recovery of the patient, length of stay, transfusion needs, and overall return to functional daily activities,” said Ramirez. “Our research is the first to prospectively compare the two surgical approaches and evaluate oncologic outcomes, including disease-free and overall survival and recurrence rates.”

The findings are critical, say the researchers, because cervical cancer is curable with surgery in its earliest stage but treatments are much less effective after disease recurrence.

Phase III clinical trial reports worse outcomes with minimally invasive hysterectomy

In their study, Ramirez and colleagues hypothesized that minimally-invasive radical hysterectomy was equivalent to the open approach in terms of disease-free survival (DFS). The international study was a multi-institutional collaboration with 33 centers worldwide. It opened in 2008 and was designed to randomize 740 women with early-stage (1A or 1B) cervical cancer to undergo either minimally invasive or open radical hysterectomy (1:1 ratio). Patients were equally stratified for risk factors, such as histologic subtypes, tumor size, stage, lymph node involvement, and adjuvant treatment.

In 2017, with 631 patients enrolled, the study was stopped because of a noted safety signal. Women receiving minimally invasive radical hysterectomy were found to have higher rates of recurrences, worse progression-free survival (PFS), and worse OS.

The researchers found:

  • Minimally invasive radical hysterectomy was associated with a three-fold increase in disease progression, compared to open radical hysterectomy.
  • The rate of disease-free survival at 4.5 years was 86 percent with a minimally invasive surgery and 96.5 percent with open surgery.
  • The three-year OS overall survival was 91.2 percent in the minimally invasive group compared to 97.1 percent in the open surgery arm.

“Our study reinforces the need for more randomized clinical trials in the field of surgery,” said Ramirez. “Too often, success of a new intervention in surgery is measured by retrospective data. We always need to test and measure our procedures to determine what is best for our patients.”

Pedro Ramirez, M.D., discusses the results of his clinical trial comparing surgical options for women with early-stage cervical cancer. Credit: MD Anderson Cancer Center

The study also highlights the need for further research, said Ramirez. We should consider evaluation of the impact of minimally invasive surgery in other scenarios, like fertility preserving surgery in early-cervical cancer, where such an approach is still commonly used.

Retrospective study reinforces clinical trial findings

Rauh-Hain’s retrospective, epidemiologic study also confirmed that minimally invasive radical hysterectomy was associated with worse OS than abdominal radical hysterectomy among patients with early-stage cervical cancer. The study, performed in collaboration with Harvard, Columbia University, and Northwestern University, includes analysis of data from two large cancer databases to compare survival rates between patients who underwent either of the two surgery types.

The team first analyzed the National Cancer Database (NCDB); this nationwide outcomes registry covers approximately 70 percent of newly diagnosed cancer cases in over 1,500 U.S. hospitals. The secondary analysis reviewed data from the National Cancer Institute’s (NCI) Surveillance, Epidemiology and End Results (SEER) database.

Analysis of the data revealed:

  • Over a 45-month median follow-up, the four-year mortality risks were 9.1 percent among women receiving minimally invasive radical hysterectomy compared to 5.3 percent for abdominal radical hysterectomy.
  • Adoption of minimally invasive radical hysterectomy coincided with the beginning of a decline in four-year relative survival rates of 0.8 percent per year between 2006 and 2010 in this population.

“Our research also found that compared with open surgery, minimally invasive surgery increased the risk of death among women who underwent radical hysterectomy for early-stage cervical cancer,” said Rauh-Hain. “Given these two studies, we believe that we can no longer recommend minimally invasive radical hysterectomies for our patients with early-stage cervical cancer.”

An important limitation of the retrospective study is the inability to explain why minimally invasive radical hysterectomy was associated with inferior survival. Additional studies are needed to understand the cause of the survival differences, explained Rauh-Hain.

Overall impact to the field

The findings have impacted care and management of women with early-stage cervical cancer at MD Anderson. These patients are no longer offered minimally invasive radical hysterectomy; only open radical hysterectomy is performed. Trial participants enrolled at MD Anderson and randomized to minimally invasive radical hysterectomy will be considered for closer surveillance at the time of follow up.

The research could impact national treatment guidelines for the management of the disease, say Ramirez and Rauh-Hain.

Both strongly encourage women who have undergone laparoscopic or robotic radical hysterectomy, either on the trial or as part of standard care, to have an informed conversation with their physician regarding the findings of this study, which should include their personal need for monitoring surveillance.

Ramirez and Rauh-Hain both note that their respective findings solely affect the care and management of patients with early-stage cervical cancer. However, the findings could impact fertility-sparing surgeries, such as radical trachelectomy, for women with early-stage cervical cancer, said Ramirez. As follow up, an international multi-institutional registry comparing minimally invasive to open radical trachelectomy is being led by MD Anderson.


Explore further:
Minimally invasive hysterectomy may be underused

More information:
New England Journal of Medicine (2018). dx.doi.org/10.1056/NEJMoa1804923

Journal reference:
New England Journal of Medicine

Provided by:
University of Texas M. D. Anderson Cancer Center

Tagged with:

About author

Related Articles