1. Gallagher, Amy

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Throughout the past 4 decades, minimally invasive surgery (MIS) has been applied to several surgical specialties. However, in the practice of treating cervical cancer, the MIS approach is considered a higher risk, specifically with its "higher rate of mortality," said David Sheyn, MD, gynecologist at University Hospitals (UH) Cleveland Medical Center and Assistant Professor at the UH Urology Institute. "MIS has been widely adopted for the treatment of cancer despite few randomized, controlled trials assessing outcomes."

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Treating cervical cancer-specifically Stage IB1 cervical cancer-is different from other cancers, Sheyn noted. "Cervical cancer is a different beast as it grows and spreads. Cervical cancer metastasizes by direct spread, which makes it very important that operations used to treat [it] are removing all of the tumor with clean margins."


Comparing Two Trials, Two Approaches

The November 15, 2018, issue of the New England Journal of Medicine published study results from the Laparoscopic Approach to Cervical Cancer (LACC) trial comparing oncological outcomes between open surgery and MIS for radical hysterectomy (RH) for early-stage cervical cancer (doi: 10.1056/NEJMoa1806395). The results showed "gynecologic oncologists globally were surprised to find that MIS for an RH showed significantly lower disease-free survival and overall survival rates than those for open RH."


Fast forward 3 years to the trial results published in the April 29, 2021, New England Journal of Medicine, researchers found a substantial reduction using MIS for cervical cancer after the results of the LACC trial were published (doi: 10.1056/NEJMc2035819).


Sheyn said it is important to note that the LACC trial began in 2008, but concluded in 2017 due to the recommendation of potential harm to patients in the MIS group, with the knowledge of the higher mortality rate of MIS. The average/mean age of the MIS group was 47.7 +/- 13.2 years and the open group mean age at 50.9 +/- 13.9.


The researchers conducted the effect of a randomized, controlled trial comparing two surgical options for cervical cancer, leading to further explore the extent to which surgeons have changed their practice by assessing the use of MIS compared with open RH for cervical cancer before and after publication of the LACC trial.


"People tend to like a 'one-size-fits-all' approach, but it is not the appropriate approach to many problems in medicine," he said. "We need to be careful not to apply these findings to other types of cervical cancers, while creating different solutions for different problems for each type and subtype of cancer, knowing each behaves differently."


With the use of robotic and/or laparoscopic surgery, magnified margins appear wider during the MIS procedure, which gives a false sense of security with the margins, Sheyn noted.


"When using robotics, one might think the margins are wide, but in fact, the magnification could be making the margins appear wider than they actually are. MIS prevents us from getting the wide margins we need to remove all of the cervical cancer."


But with cervical cancer, you have to get it all out, he said. "We're looking for disease-free margins when treating cervical cancer."


2021 Trial Results

Research showed 61 percent of patients were treated at academic centers compared to 39 percent at non-academic centers, with the percentage of hysterectomies performed using the minimally invasive approach calculated each month. The study involved 2,437 patients receiving care at 283 centers, November 2015 to March 2020. Percentages before and after the published results from the LACC trial were compared, showing MIS decreasing dramatically.


After adjusting for the hospital census region and patient age, race or ethnic group; Charlson comorbidity index score; and insurance, the odds of MIS after publication of the trial results were 59 percent lower than the odds of MIS before publication of the them. "This demonstrates a remarkably fast response to solid clinical data," Sheyn said.


Prior to the published trials results, the minimally invasive approach was used in 58 percent of hysterectomies compared with 42.9 percent after publication. The patient cohort, representing 33 hospitals throughout the world and every continent, included 1,482 patients at 141 academic centers and 955 patients at 142 nonacademic centers.


"Our study builds on previous data suggesting changes in practice patterns, which highlight the effect on clinical practice of data generated by randomized, controlled trials of surgical approaches," he said.


The greatest change in cervical cancer, he noted, is discovering more practitioners performing fewer MIS, specifically for this disease.


Data Dissemination

While the 2021 research results recognized surgeons are changing their methods by adopting open radical hysterectomies to treat cervical cancer, Sheyn said room for improvement remains.


"MIS was associated with worse disease-free and overall survival than open surgery," said Sheyn. "Mortality is higher when performing MIS, specifically for cervical cancer."


A population-based study and a meta-analysis showed similar associations, he said. "Accordingly, guidelines now favor open surgery," Sheyn stated.


A 3-month period to allow for the dissemination of the LACC trial results was excluded from this comparison. Sheyn said the most important question is: "How do we disseminate the results from the research with more efficient, broad distribution? We give national talks and write articles, but we also need to broadcast these findings to market the research to all communities," he emphasized.


"It's OK to question the evidence, but not to openly defy the findings. We need to analyze and reflect on the data, then review the cases to make adjustments in our practice while studying other practitioners and their trial outcomes."


Ultimately, Sheyn said the profession needs improvement with the adoption and dissemination of research results. "It's worth investigating longer."


Amy Gallagher is a contributing writer.