New data ‘challenge’ understanding of simple vs. radical hysterectomy for cervical cancer
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Key takeaways:
- Radical hysterectomy had a lower incidence of cervical cancer pelvic recurrence at 3 years vs. simple hysterectomy.
- Simple hysterectomy had lower incidence of urinary incontinence and urinary retention.
Simple hysterectomy is not inferior to radical hysterectomy in terms of 3-year incidence of pelvic disease recurrence among women with low-risk cervical cancer, according to study data published in The New England Journal of Medicine.
Researchers also reported an association between simple hysterectomy and lower risk for urinary incontinence or retention.
“Because the literature suggest[ed] that less radical might be safe and feasible for women with early-stage low-risk cervical cancer, but the available data only came from retrospective series [subject to biases], we felt it was important and necessary to confirm these retrospective data in a large prospective randomized clinical trial,” Marie Plante, MD, professor in the department of obstetrics and gynecology at Centre Hospitalier Universitaire de Québec, told Healio.
“We were not surprised,” she said regarding the study’s results.
“This is what we anticipated — but we had to prove it,” she added. “Fewer surgical complications and better quality of life were also anticipated.”
Researchers conducted a multicenter, randomized noninferiority trial comparing simple hysterectomy to radical hysterectomy in 700 women (350 in each cohort) with low-risk cervical cancer who had lesions of 2 cm or less with limited stromal invasion.
Cancer recurrence in the pelvic area at 3 years served as the study’s primary outcome measurement; researchers determined the prespecified noninferiority margin for the between-group difference in pelvic recurrence at 3 years to be 4 percentage points.
Among the 700 women in the study, 91.7% had stage IB tumors as determined by the 2009 International Federation of Gynecology and Obstetrics criteria, 61.7% had squamous-cell histologic features and 59.3% had grade 1 or 2 tumors.
At a median follow-up of 4.5 years, researchers noted the incidence of pelvic recurrence at 3 years to be 2.17% among women in the radical hysterectomy group and 2.52% among those in the simple hysterectomy group (absolute difference = 0.35 percentage points; 90% CI, 1.62 to 2.32).
Study investigators also observed lower incidence of urinary incontinence in the simple hysterectomy cohort compared with radical hysterectomy within 4 weeks following surgery (2.4% vs. 5.5%; P = .048) and after 4 weeks (4.7% vs. 11%; P = .003). They also noted lower incidence of urinary retention in the simple hysterectomy group vs. those who underwent radical hysterectomy within 4 weeks following surgery (0.6% vs. 11%; P < .001) and beyond 4 weeks (0.6% vs 9.9%; P < .001).
According to researchers, the confirmatory data revealed just how vital it is for patients to receive thorough vetting and analysis before receiving the appropriate treatment for their respective disease situation, while also reminding oncologists of a question that still lacks a definitive answer.
“The important message is that although shape showed that less radical surgery is safe in low-risk disease, it is absolutely essential that patients are carefully selected by physicians with expertise and knowledge in cervical cancer after thorough preoperative evaluation by gynecologists, and following careful review of the pathology and imaging,” Plante told Healio. “What we don’t want is that patients with disease that falls outside the selection criteria of shape — ie, bigger lesions or more deeply invasive cancers — are offered less radical surgery.
“To ensure good outcome, physicians need to stay within the study parameters,” she added. “One should never underestimate cervical cancer.”
In an accompanying editorial, Pedro T. Ramirez, MD, chair of the department of obstetrics and gynecology at Houston Methodist Hospital, said the study findings “challenge our current standards and provide evidence that simple hysterectomy, in selected patients, appears to be safe, yielding oncologic outcomes similar to those of radical hysterectomy,” but that certain points require additional analyzation, due to the specificity of the disease and patient factors.
“It is critical to ensure that the use of simple hysterectomy is limited to patients who have low-risk tumors and who meet the criteria for eligibility for this conservative approach,” he wrote. “Patients who do not meet such inclusion criteria should continue to be offered radical hysterectomy.”
References:
- Plante M, et al. N Engl J Med. 2024;doi:10.1056/NEJMoa2308900.
- Ramirez PT. N Engl J Med. 2024;doi:10.1056/NEJMe2400423.
Perspective
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Lisa Rauh-Benoit, MD, MPH
The results of the SHAPE trial are practice-changing and can improve the quality of life for patients with early-stage cervical cancer. After 4.5 years of follow-up, there was no difference in pelvic recurrence between simple and radical hysterectomy. The trial also demonstrated a significant reduction in urinary retention for patients randomly assigned to the simple hysterectomy arm, with a rate less than 1%.
These findings continue to push the field forward as we consider how to improve quality of life for patients with cervical cancer without compromising outcomes.
This study does raise questions worthy of future investigation. Approximately 80% of the simple hysterectomy and 70% of the radical hysterectomy cohorts underwent a minimally invasive approach. We will need to consider how to reconcile this with the results of the LACC trial, which showed worse DFS and OS for patients undergoing a minimally invasive surgical approach.
In addition, a majority of patients had an excisional procedure of the cervix prior to surgery. Retrospective data from the SUCCOR trial suggest that patients undergoing a cone procedure prior to minimally invasive hysterectomy for cervical cancer had similar relapse rates as those undergoing open surgery.
SHAPE was not designed to understand if certain tumor characteristics and/or mitigating interventions can allow for a minimally invasive surgery for early-stage cervical cancer without compromising outcomes, but it does raise the possibility that such a cohort could exist.
References:
Chacon E, et al. Int J Gynecol Cancer. 2022;doi:10.1136/ijgc-2021-002544.
Plante M, et al. N Engl J Med. 2024;doi:10.1056/NEJMoa2308900.
Ramirez PT, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1806395.
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