Simple hysterectomy safe for early-stage, low-risk cervical cancer
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Key takeaways:
- Results showed 3-year pelvic recurrence rates of 2.52% with simple hysterectomy vs. 2.17% with radical hysterectomy.
- Simple hysterectomy appeared safe and improved quality of life.
CHICAGO — Pelvic node dissection and simple hysterectomy appeared noninferior to radical hysterectomy at 3 years among women with early-stage, low-risk cervical cancer, according to data from the SHAPE study.
Results of the international phase 3 study, presented during a press conference ahead of ASCO Annual Meeting, additionally showed simple hysterectomy helped improve quality of life and sexual function for this patient population.
Rationale and methods
“Standard treatment for early-stage cervical cancer is radical hysterectomy, which involves the removal the uterus and cervix, as well as removal of parametrial tissue in the upper vagina. It is a much more extensive and complicated surgery that requires more surgical skills, is potentially associated with more surgical complications and has long-term impacts on quality of life, especially at the level of the bladder and sexual function,” Marie Plante, MD, gynecologic oncologist and professor in the department of obstetrics and gynecology at Laval University in Quebec, Canada, told Healio. “While the procedure is very effective, retrospective studies have shown that in patients with low-risk disease, the chances of parametrial extension is less than 1%. This has questioned the necessity of radical surgery in such cases because the risk is so low. We, therefore, wanted to know if we could de-escalate radical hysterectomy to simple hysterectomy in certain patients, which would provide just as good oncologic outcome but with less impact on morbidity, mortality and quality of life.”
The SHAPE trial included 700 women aged 24 to 80 years with low-risk, early-stage cervical cancer. Researchers randomly assigned patients 1:1 to pelvic node dissection and radical hysterectomy (n = 350) or simple hysterectomy (n = 350). They assessed and compared pelvic recurrence rates at 3 years between the two groups.
Median follow-up was 4.5 years.
Findings
Overall, 50% of hysterectomies were performed laparoscopically, 25% robotically and 23% abdominally.
Results showed a 3-year pelvic recurrence rate for simple hysterectomy of 2.52% vs. 2.17% for radical hysterectomy.
Researchers additionally observed comparable rates with simple vs. radical hysterectomy in extra-pelvic recurrence-free survival (2% vs. 0.6%) and combined pelvic and extra pelvic recurrences (0.9% vs. 0.6%).
Surgical deaths associated with cervical cancer also appeared comparable between the two groups (1.1% vs. 0.3%), according to Plante.
“In terms of surgical complications, there were no statistically significant differences between the two groups, but we did observe threefold higher bladder injuries [n = 9 vs. 3] and nearly twofold higher ureteral injuries [n = 5 vs. 3] in the radical hysterectomy group,” Plante said.
Results further showed more surgery-related adverse events among women in the radical hysterectomy group vs. the simple hysterectomy group within 4 weeks of surgery (50.6% vs. 42.6%; P = .04) and after 4 weeks of surgery (60.5% vs. 53.6%).
“Importantly, urinary incontinence and urinary retention appeared statistically worse among patients in the radical hysterectomy group within 4 weeks of surgery and persisted after 4 weeks,” Plante said. “We also assessed patient quality of life and sexual health and found that sexual vaginal functioning appeared better in the simple hysterectomy group. Reported sexual pain was also lower in the simple hysterectomy group and was statistically significant.”
Implications
The findings suggest that with adequate and rigorous preoperative assessment, simple hysterectomy may now be considered the new standard of care for women with low-risk early-stage cervical cancer, Plante told Healio.
“Within the past decade, there have been quite a lot of retrospective data pointing in the same direction as our trial results, but it is important to demonstrate in a prospective, randomized fashion that those findings are true,” she said. “It is extremely important to very carefully select the patients who fulfill the criteria for low-risk disease because the danger is that if patients with larger lesions are offered less radical surgery, then they may experience recurrence and worse survival outcomes.”
She said the results are preliminary.
“We will have to dig into the data a bit more to examine the impact of less radical surgery on quality of life because we want survivors to experience less surgical side effects and better quality of life without jeopardizing outcomes,” she said. “Moreover, simple hysterectomy could be a wonderful option for select patients in low-resource countries, as it is easier to perform and is a safe option for certain women.”
Perspective
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Kathleen N. Moore, MD, MS
These results have been a long-awaited advance in the field of surgical gynecologic oncology. This is a very big deal for certain women with cervical cancer.
Well-designed clinical trials are so important in surgical oncology, across a multitude of solid tumor types, testing new surgical techniques, technologies and de-escalation of surgical radicality in an attempt to decrease morbidity and/or disfigurement but importantly without loss of oncologic control — which is all very hard to do.
Cervical cancer is not common in the U.S., Canada or most parts of Europe and Asia, but it is endemic in low- and middle-income countries. Annually, we see more than 600,000 cases and almost 350,000 deaths globally due to cervical cancer, the majority of which are in the low- and middle-income countries where there are a variety of barriers that lead to the increased morbidity and mortality, including access to treatment and interventions.
The SHAPE trial shows that among carefully selected tumors, radical hysterectomy can be converted to simple hysterectomy, and we can do so without loss of oncologic control and, importantly, with reduction in surgical complications and postoperative morbidity.
This will be the new standard of care and represents a huge step forward in the care of women with early-stage cervical cancer. This has broad implications on the global scale, which is one of the biggest take-home messages of this presentation.
As a gynecologic-oncologist, I am so proud of Plante and colleagues and extremely grateful to all the women who volunteered for this study, most of whom are alive and disease-free. I hope they recognize the huge contribution they have made to all women who will be diagnosed in the future. They have changed the trajectory of cervical cancer globally.
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Plante M, et al. Abstract LBA5511. Presented at: ASCO Annual Meeting; June 2-6, 2023; Chicago.
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