Higher Death Risk With Minimally Invasive Surgery in Gyne Cancers

Roxanne Nelson, RN, BSN

June 22, 2020

Minimally invasive surgery (MIS) is associated with a higher risk for death in comparison to open surgery for patients with gynecologic cancers, according to two new reports.

In the first study, use of MIS for patients with early-stage ovarian cancer was associated with an increased risk for capsule rupture, which in turn led to an increase in mortality.

"There was a striking association between an increased risk of capsule rupture with use of minimally invasive surgery," said Jason D. Wright, MD, chief, Division of Gynecologic Oncology, Columbia University Herbert Irving Cancer Comprehensive Center, New York City, who was a coauthor for both studies.

"This is certainly worrisome, as there are limited data describing the safety of minimally invasive surgery for ovarian cancer, and we noted that the use of minimally invasive procedures increased substantially," he added.

The second article, a meta-analysis of 15 studies, found that minimally invasive radical hysterectomy was associated with a higher risk for recurrence and death in comparison to open surgery for women with early-stage cervical cancer. This confirms previous reports of worse outcomes, including a randomized trial (the LACC study) published in 2018. The results of that trial showed an increased risk for death, which was "unexpected and alarming."

The meta-analysis confirms and "demonstrates the magnitude of this risk on recurrence rates and survival," Wright told Medscape Medical News.

"Given these data, I think that clinicians should use great caution in performing this procedure and that the majority of women with cervical cancer who undergo radical hysterectomy should likely have an open surgery," said Wright.

Both articles were published on June 11 in JAMA Oncology.

These "two important studies add to the growing body of literature that suggest a worse outcome for patients with gynecologic cancers who are treated with MIS," said Amer Karam, MD, and Oliver Dorigo, MD, PhD, both from Stanford University, in California, writing in an accompanying editorial.

Ovarian Cancer MIS and Capsule Rupture

In the study of MIS in ovarian cancer, observational data were collected on 8850 women (mean age, 55.6 years) with stage I epithelial ovarian cancer who were registered in the National Cancer Database and who underwent surgery between 2010 and 2015. Roughly one third (n = 2600) underwent MIS; the remainder underwent open surgery.

During the 5 years of the study period, there was a 1.8-fold increase in the use of MIS, from 19.8% to 34.9% (P < .001).

The data show that 1994 patients (22.5%) experienced capsule rupture and that the rate of rupture rose from 20.2% in 2010 to 23.9% in 2015. This extrapolates to an 18.3% relative increase (Cochran-Armitage trend test P = 0.02).

Multivariable analysis showed that MIS was independently associated with capsule rupture (adjusted relative risk, 1.17), as was larger tumor size. Additionally, receipt of chemotherapy increased the risk for rupture (unilateral tumors: 67.0% vs 38.6%; bilateral tumors: 80.0% vs 58.9%; P < .001).

The 4-year overall survival rate was 91% in 2010 and fell to 86% in 2015.

Among those with ruptured tumors, the 4-year overall survival was 86.8% for those who underwent open surgery and 88.9% for patients who underwent MIS.

Among women with nonruptured tumors, these rates were 90.5% and 91.5%, respectively (log-rank test, P = .001).

An adjusted model showed that the use of MIS with capsule rupture was independently associated with an increase in all-cause mortality in comparison with MIS in which capsule rupture did not occur (adjusted hazard ratio [HR], 1.41). In addition, laparotomy with capsule rupture was also independently associated with a greater risk for all-cause mortality compared with laparotomy without capsule rupture (adjusted HR, 1.43).

"I think clinicians need to carefully weigh the risks and benefits of minimally invasive surgery and the risk of rupture of an ovarian cancer in women, and high-quality studies are clearly needed to address this topic," said Wright.

Lower Survival in Cervical Cancer

The second study was a meta-analysis of 15 studies involving 9499 women who underwent radical hysterectomy for stage IA1 to IIA cervical cancer.

Nearly half of the cohort (n = 4,684; 49%) underwent MIS. Of those, 57% (n = 2,675) underwent robot-assisted laparoscopy.

A total of 530 recurrences and 451 deaths were reported. The pooled hazard of recurrence or death was 71% higher among patients who underwent MIS in comparison with those who underwent open surgery (HR, 1.71; P < .001). The hazard of death was 56% higher in the MIS group than in the open surgery group (HR, 1.56; P = .004).

"The magnitude of the effect, while lower than that reported in the LACC trial, is still notable and likely reflects real-world outcomes," say the editorialists.

They also note that the "results of the LACC trial remain controversial but were followed by a global decrease in the use of MIS for treatment of early-stage cervical cancer."

However, the editorialists also highlight the advantages of MIS, saying it has "considerable benefits" in the treatment of gynecologic cancer.

They cite an article from the American College of Surgeons National Quality Improvement Program, which reports an analysis of 2076 endometrial cancer cases that found a much lower complication rate after MIS compared with laparotomy (12% vs 31%).

"Shorter hospital stays and lower complication rates could result in an estimated cost savings of $534 million if MIS was used in 90% of all patients with endometrial cancer in the USA," they write.

Nevertheless, they add that "the short-term advantages of MIS for gynecologic cancers should be weighed against the risks of potentially worse long-term outcomes."

These two latest studies should serve as another call to action, they conclude, adding, "We owe it to patients to study any surgical or medical intervention adhering to the highest standards of clinical investigation."

The ovarian cancer study was supported by grants from the National Cancer Institute Cancer Center and the National Institutes of Health. The cervical cancer meta-analysis study was funded by the National Cancer Institute, the American Cancer Society, and the Frank McGraw Memorial Chair in Cancer Research and Ensign Endowment for Gynecologic Cancer Research. Wright has received grants from Merck and consultation fees from Clovis Oncology outside the submitted work; several coauthors from both articles report relationships with industry. Karam has received personal fees from Clovis Oncology, AstraZeneca, GSK, and UpToDate outside the submitted work. Dorigo has received fees from many pharmaceutical companies and salary for medical legal expert witness testimony.

JAMA Oncol. Published online June 11, 2020. First study, Abstract; Second study, Abstract; Editorial

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