Simple hysterectomy with pelvic lymph node dissection may be a safe treatment option for patients with early-stage, low-risk cervical cancer and may help improve quality of life, according to results from the large, international phase III SHAPE clinical trial. The research was presented by Plante et al at the 2023 ASCO Annual Meeting (Abstract LBA5511).
A radical hysterectomy is more extensive than a simple hysterectomy and includes the removal of the uterus, cervix, upper vagina, and the tissue around the cervix; during a simple hysterectomy, only the uterus and cervix are removed. For patients with cervical cancer, a pelvic lymph node dissection is also an integral part of either type of surgery to exclude the presence of lymph node metastasis (with or without sentinel node mapping). Because radical hysterectomy is a more complex surgery, it requires more extensive surgical training and is potentially associated with more acute and long-term side effects, such as bleeding, bladder and ureteral injury, and bladder and bowel dysfunction, as well as potential impacts on quality of life and sexual health.
The current standard of care for people with early-stage, low-risk cervical cancer is pelvic node dissection and radical hysterectomy for people not wishing to preserve fertility, or radical trachelectomy for those wishing to preserve fertility. About 44% of people with cervical cancer in the United States are diagnosed with early-stage disease, of which a significant proportion will meet low-risk criteria, according to the study authors.
About the SHAPE Study
The SHAPE study included 700 patients aged 24 to 80 years with low-risk, early-stage cervical cancer, defined as stage IA2 or IB1 disease; grade 1, 2, or 3; with lesions ≤ 2 cm. The participants, who came from 12 different countries, were randomly assigned to receive pelvic node dissection and either radical hysterectomy or simple hysterectomy. Half of the hysterectomies were done laparoscopically (56% of simple procedures vs 44% of radical procedures), 25% were done robotically (24% of simple vs 25% of radical), and 23% were done abdominally (17% simple vs 29% radical).
The primary endpoint of the study was to determine whether the pelvic recurrence rate at 3 years for simple hysterectomy was noninferior to radical hysterectomy. In order to demonstrate noninferiority of simple to radical hysterectomy, the upper limit of a one-sided 95% confidence interval for the difference in the pelvic recurrence rate at 3 years had to be lower than or equal to 4%. Secondary endpoints included extrapelvic relapse-free survival, relapse-free survival, overall survival, and quality of life.
The pelvic recurrence rate at 3 years with simple hysterectomy (2.5%) was not inferior to radical hysterectomy (2.2%). Extrapelvic relapse-free survival—98.1% with simple hysterectomy vs 99.7% with radical hysterectomy—and overall survival—99.1% with simple hysterectomy vs 99.4% with radical hysterectomy—were also comparable between the two groups. Overall, 21 pelvic recurrences were identified after a median follow-up of 4.5 years: 11 in the simple hysterectomy group vs 10 in the radical hysterectomy group.
Additionally, patients in the simple hysterectomy group experienced fewer intraoperative urologic surgical complications and fewer immediate and long-term bladder problems. Several quality-of-life aspects—such as body image, pain, and level of sexual activity—were also more favorable in the simple hysterectomy group. The surgical approach used (abdominal surgery vs minimally invasive surgical approach) did not seem to influence risk of recurrence in either group. The rate of positive surgical margins was also low in both groups (2.6% overall; 2.1% with simple hysterectomy vs 2.9% with radical hysterectomy).
“These results are important because it demonstrates, for the first time, that a simple hysterectomy is a safe option for [carefully selected] women with early-stage, low-risk cervical cancer,” said presenting author Marie Plante, MD, a gynecologic oncologist at CHU de Quebec and Professor in the Department of Obstetrics and Gynaecology at Laval University in Quebec. “This trial will likely be practice-changing, with the new standard-of-care treatment for patients with low-risk disease being a simple hysterectomy instead of radical hysterectomy.”
Researchers plan to further investigate the quality of life and sexual health data, conduct a cost-effectiveness and cost utility analysis of radical vs simple hysterectomy, and identify risk factors associated with recurrences in future studies.
“For patients with stage I cervical cancer who are eligible for surgery, radical hysterectomy has been the standard of care for decades, and discussions about de-escalating this intervention have long been tempered by the potential of negatively impacting the chance of a cure,” said ASCO Expert Kathleen N. Moore, MD, MS. “The SHAPE study confirms that in carefully selected patients, the surgery could be safely de-escalated to a simple hysterectomy without impacting outcomes and ushers in a new, more individualized surgical approach for women with early-stage cervical cancer.”
Disclosure: This study was led by the Canadian Cancer Trials Group and funded by the Canadian Institutes of Health Research and Canadian Cancer Society. For full disclosures of the study authors, visit coi.asco.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.