Another blow has been dealt for minimally invasive surgery (MIS) in patients with cervical cancer — this time by Canadian researchers.
They report a population cohort study, which they say better reflects ‘the real world impact’ of such surgery. Their review of nearly 1000 patients with early stage cervical cancer found a twofold higher risk of death and cancer recurrence in those who underwent minimally invasive surgery (MIS) compared with those who had an open radical hysterectomy. The finding held even after controlling for surgeon volume.
The study was published online July 6 in the American Journal of Obstetrics and Gynecology.
The new findings echo those reported last year from two studies published in the New England Journal of Medicine.
“Rather surprisingly, and some would say shockingly, both studies showed a significant inferior survival associated with the use of the minimally invasive procedures,” Maurie Markman, MD, from Cancer Treatment Centers of America in Philadelphia, commented at the time.
The data from the two studies “have shown rather convincingly — and I would say definitively — that these minimally invasive procedures should not be performed, except under perhaps extraordinary circumstances where there is a serious risk for the patient associated with the standard approach,” he said.
Now, with the newly published Canadian findings, Markman is even more convinced that there are real dangers in using a minimally invasive approach in the treatment of cervical cancer.
“These disturbing data…again emphasize the critical need for well-designed and well-controlled clinical trials before a ‘novel surgical approach’ should be accepted as standard-of-care in cancer management,” he told Medscape Medical News in an email.
Monica Bertagnolli, MD, chief of surgical oncology at the Dana-Farber Cancer Institute in Boston, Massachusetts, and president of the American Society of Clinical Oncology, told Medscape Medical News recently that the results showing inferior oncologic outcomes after minimally invasive surgery in cervical cancer are “very very sobering.”
In general, more rigorous studies of minimally invasive cancer surgery are needed. What is most important, said Bertagnolli emphatically, is cancer outcomes — and not short-term benefits.
The Food and Drug Administration (FDA) has also expressed concern. In February, the agency issued a ‘caution’ about the use of robotically-assisted surgical devices in women’s health, and this included minimally invasive surgery for cervical and breast cancer.
The agency urged caution about any such use, noting that robotic devices are approved for use in prostate cancer but not in most cancers.
Advantages of Minimally Invasive Approach?
Arguments in favor of the minimally invasive approach include a shorter postoperative hospital stay, fewer complications, and smaller incisions, resulting in quicker recovery time and improved patient satisfaction compared with open surgery.
However, as one Medscape reader working in Ob/Gyn and women’s health commented: “I would suggest that the protocol of minimally invasive radical hysterectomy has benefited the bottom line of hospitals and insurance providers.
“I challenge all gynecologists to search for any protocol change that financially benefits hospitals and insurance companies that has truly benefited the patient,” the reader wrote in the comment section of the Markman article.
Another clinician in women’s health commented in agreement: “Well, finally, someone who has the good sense to state the obvious. Minimally invasive surgery for cancer has as its main beneficiaries the health insurance industry (reduced length of stay) and the companies that manufacture all that wonderfully expensive equipment used for the procedure, not the patient whose survival time is not a factor in revenue to the medical system.”
New Data From Canada
The new data from Canada come from a population-based retrospective cohort study of patients with cervical cancer who underwent a primary radical hysterectomy by a gynecologic oncologist from 2006–2017 in Ontario.
The team identified 958 women,958 women (mean age, 45.9 years) with predominantly stage 1B cervical cancer who underwent radical hysterectomy within 9 months of their diagnosis.
Open radical hysterectomy was done in half of the cohort; in the other half, 90% of the minimally invasive procedures were performed laparoscopically.
Patients undergoing minimally invasive radical hysterectomy were less likely to have high-risk features and fewer comorbidities than women who underwent open radical hysterectomy, the researchers note.
At a median follow-up of 6 years, “minimally invasive radical hysterectomy was associated with a two-fold higher rate of all-cause death and recurrence compared to open radical hysterectomy in patients with stage 1B disease, but not 1A or 2+ disease,” Maria Cusimano, MD, from the University of Toronto, and colleagues report.
This relationship held even after adjusting for patient factors as well as surgeon volume, they add.
The researchers note that, in contrast to the previously reported studies, “this population-based patient-level analysis reflects the real-world impact of minimally invasive radical hysterectomy, as performed by unselected surgeons on unselected early-stage cervical cancer patients,” the investigators write.
“Open hysterectomy should be the recommended approach in this population,” they conclude.
MIS Now Used in at Least Half of Cases
The new Canadian findings will undoubtedly fuel the argument that minimally invasive surgery is not as favorable as open radical hysterectomy in early cervical cancer — and this at a time when the proportion of early cervical cancer being treated with less invasive surgery is exploding.
For example, minimally invasive procedures accounted for more than half of all radical hysterectomies done for the treatment of cervical cancer in 2013, according to the authors of the National Cancer Database analysis that was published in the New England Journal of Medicine last year.
In the new Canadian cohort study, the proportion of cervical cancers treated using minimally invasive techniques — at least in the province of Ontario — climbed from 4.8% of all hysterectomies in 2006 to 65% in 2017.
Experts Caution Against It
Commenting on the National Cancer Database results last year in an accompanying NEJM editorial, Amanda Fader, MD, Johns Hopkins School of Medicine, Baltimore, Maryland suggested that select patient subgroups may still benefit from the less invasive approach. One example would be patients with tumors measuring less than 2 cm prior to surgery — for these types of patients, the outcomes were not worse with MIS in either of the two studies.
However, until it’s clear that the less invasive approach is equivalent to open hysterectomy in specific subgroups of patients, Fader urged surgeons to proceed with caution and to counsel their patients about these findings so that women are aware that there is a higher risk of recurrence with minimally invasive surgery than with open radical hysterectomy.
However, Markman in his Medscape commentary went a step further, and said that, at least from his perspective, minimally invasive radical hysterectomy should no longer be considered a standard-of-care for the treatment of early-stage cervical cancer.
In another commentary about the two studies, published earlier this year in the Journal of the National Comprehensive Cancer Network, Kathryn Pennington, MD, from the University of Washington Medicine in Seattle, and colleagues say that open radical hysterectomy and not a less invasive approach should now be considered standard-of-care for stage 1A2-1B1 cervical cancer.
Patients who still want to undergo less invasive surgery should be “guided appropriately”, they suggest, in order to make a more informed decision about which approach they would prefer their surgeon to take.
The Canadian authors have disclosed no relevant financial relationships. Markman has received grants from Genentech, AstraZeneca, Celgene, Clovis, and Amgen. Fader has received personal fees from Ethicon outside the submitted work. Pennington and Bertagnolli have disclosed no relevant financial relationships.
Am J Obstet Gynecol. Published online July 6, 2019.