Perspective from Stephen C. Rubin, MD
Disclosures: Melamed reports no relevant financial disclosures. Wright reports grants from Merck and consultant fees from Clovis Oncology outside the submitted work. Please see the studies for all other authors’ relevant financial disclosures. Dorigo reports personal fees from Clovis, Genentech, Geneos, GlaxoSmithKline, Merck, Myriad, Nektar and Personalized Adoptive Cell Therapy Pharma; support for lectures from AstraZeneca, GlaxoSmithKline and Tesaro; salary support for clinical trial activities from AbbVie, Clovis, Genentech, IMV Inc., Millennium and PharmaMar; and travel support from IMV Inc. outside the submitted work. Karam reports personal fees from AstraZeneca, Clovis Oncology, GlaxoSmithKline and UptoDate.
June 11, 2020
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Minimally invasive surgery may increase risk for death in early-stage gynecologic cancers

Perspective from Stephen C. Rubin, MD
Disclosures: Melamed reports no relevant financial disclosures. Wright reports grants from Merck and consultant fees from Clovis Oncology outside the submitted work. Please see the studies for all other authors’ relevant financial disclosures. Dorigo reports personal fees from Clovis, Genentech, Geneos, GlaxoSmithKline, Merck, Myriad, Nektar and Personalized Adoptive Cell Therapy Pharma; support for lectures from AstraZeneca, GlaxoSmithKline and Tesaro; salary support for clinical trial activities from AbbVie, Clovis, Genentech, IMV Inc., Millennium and PharmaMar; and travel support from IMV Inc. outside the submitted work. Karam reports personal fees from AstraZeneca, Clovis Oncology, GlaxoSmithKline and UptoDate.
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Minimally invasive surgical procedures appeared associated with an elevated risk for recurrence or death vs. open surgery among women with early-stage gynecologic cancers, according to results of two studies published in JAMA Oncology.

“In 2018, two studies found that minimally invasive surgery was associated with inferior survival outcomes compared with traditional open surgery among women with early-stage cervical cancer, and these studies raised a bit of a stir in the gynecologic oncology community,” Alexander Melamed, MD, MPH, assistant professor in the division of gynecologic oncology in the department of obstetrics and gynecology at Columbia University Vagelos College of Physicians and Surgeons, told Healio. “Until then, it was largely taken for granted that the oncologic efficacy of minimally invasive and open radical hysterectomy was identical. The publication of these papers was followed by renewed interest in comparing outcomes among women who received open surgery compared with minimally invasive surgery for gynecologic cancer in observational studies.”

Infographic showing risks with minimally invasive hysterectomy vs. open surgery
Minimally invasive surgical procedures appeared associated with an elevated risk for recurrence or death vs. open surgery among women with early-stage gynecologic cancers.

For cervical cancer

Melamed and colleagues conducted a systemic review and meta-analysis that included data on 9,499 women who underwent radical hysterectomy for stage IA1 to IIA cervical cancer. About half of the women (n = 4,684; 49%) underwent minimally invasive surgery, and 57% (n = 2,675) of those women received robot-assisted laparoscopy.

Alexander Melamed, MD, MPH
Alexander Melamed

Overall, researchers observed 530 recurrences and 451 deaths among the cohort.

Compared with open surgery, minimally invasive radical hysterectomy appeared associated with a 71% higher pooled hazard for recurrence or death (HR = 1.71; 95% CI, 1.36-2.15) and a 56% higher hazard for death (HR = 1.56; 95% CI, 1.16-2.11).

Researchers observed no association between robot-assisted surgery prevalence and the magnitude of association between minimally invasive radical hysterectomy and hazard for recurrence or death or all-cause mortality.

“The observational and randomized data are largely concordant on the subject of minimally invasive surgery for cervical cancer — it is inferior to open surgery. At this time, minimally invasive radical hysterectomy for cervical cancer should only be conducted under a research protocol with informed consent or in unusual clinical circumstance,” Melamed said. “Minimally invasive oncologic surgery is on the rise across disease sites and surgical disciplines, and it is vital that the oncologic efficacy of such techniques is rigorously evaluated for each individual indication.”

For ovarian cancer

Jason D. Wright, MD
Jason D. Wright

In the second study, Jason D. Wright, MD, associate professor of obstetrics and gynecology at Columbia University Vagelos College of Physicians and Surgeons and chief of gynecologic oncology at NewYork-Presbyterian/Columbia University Irving Medical Center, and colleagues sought to explore changes in surgical approach and incidence of ovarian capsule rupture among 8,850 women (mean age, 55.6 years) with stage I epithelial ovarian cancer. Nearly one-third of the women (n = 2,600) underwent minimally invasive surgery.

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During the study period between 2010 and 2015, researchers observed a 1.8-fold increase in the use of minimally invasive surgery, from 19.8% to 34.9% (P < .001).

“The use of minimally invasive surgery has increased rapidly over the last decade,” Wright told Healio. “In women with ovarian cysts or masses, the lesions must be removed through small incisions used for these procedures. Removal often requires significant manipulation, which may in turn lead to rupture of the capsule of the ovary.”

Median follow-up was 39.4 months, during which time 1,994 women experienced capsule rupture.

Results of a multivariable analysis showed an independent association between minimally invasive surgery and capsule rupture (adjusted RR = 1.17; 95% CI, 1.06-1.29).

Among women with ruptured tumors, results showed 4-year OS rates of 86.8% for those who underwent open surgery and 88.9% for those who underwent minimally invasive surgery. Four-year OS among women with nonruptured tumors was 90.5% with open surgery vs. 91.5% with minimally invasive surgery (log-rank test, P = .001).

Results of an adjusted model showed an independent association between use of minimally invasive surgery with capsule rupture and an increase in all-cause mortality compared with minimally invasive surgery with nonruptured capsules (adjusted HR = 1.41; 95% CI, 1.01-1.97). Additionally, use of laparotomy with capsule rupture was independently associated with increased all-cause mortality vs. laparotomy with nonruptured capsules (adjusted HR = 1.43; 95% CI, 1.18-1.73).

“Use of minimally invasive surgery was associated with ovarian capsule rupture, and among women who underwent minimally invasive surgery, those who had capsule rupture had worse prognosis,” Wright said. “This suggests that surgeons should be cautious in performing minimally invasive surgery in women with suspicious ovarian masses in which the risk for capsule rupture is high. We are now performing additional studies to validate these findings and further understand risk factors for ovarian capsule rupture at the time of surgery.”

The two studies serve as another call to action for clinicians, according to an editorial accompanying both studies by Amer Karam, MD, gynecologic oncologist at Stanford Cancer Center, and Oliver Dorigo, MD, PhD, gynecologic oncologist in the division of gynecologic oncology and the department of obstetrics and gynecology at Stanford University.

“We owe it to patients to study any surgical or medical intervention adhering to the highest standards of clinical investigation,” they wrote. “The short-term advantages of minimally invasive surgery for gynecologic cancers should be weighed against the risks [for] potentially worse long-term outcomes.”

References:

For more information:

Alexander Melamed, MD, MPH, can be reached at Columbia University Vagelos College of Physicians and Surgeons, 161 Fort Washington Ave., New York, NY 10032; email: am5195@cumc.columbia.edu.

Jason D. Wright, MD, can be reached at Columbia University Vagelos College of Physicians and Surgeons, 161 Fort Washington Ave., New York, NY 10032; email: jw2459@cumc.columbia.edu.