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.
“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, 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,” Dr. Wright said in an interview.
“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 Dr. 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,” Amer Karam, MD, and Oliver Dorigo, MD, PhD, both from Stanford (Calif.) University, wrote 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 = 2,600) underwent MIS; the remainder underwent open surgery.
During the 5 years of the study period, there was a 80% increase in the use of MIS, from 19.8% to 34.9% (P < .001).
The data show that 1,994 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, 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 (aHR, 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 Dr. Wright.