A simple hysterectomy with pelvic node dissection vs. a radical hysterectomy is a safe treatment option for women with early-stage, low-risk cervical cancer.  This approach may also may help improve the health related Quality of Life (hrQoL) of patients.

This conclusion is based on study outcomes from the SHAPE study (NCT01658930), a large, international phase 3 clinical trial, led by the Canadian Cancer Trials Group and funded by the Canadian Institutes of Health Research and Canadian Cancer Society. The study results were presented at the annual meeting of the American Society of Clinical Oncology (ASCO), held June 2 – 6, 2023, in Chicago, Illinois.

Treatment for early-stage, low-risk cervical cancers
The current standard of care for patients diagnosed with early-stage, low-risk cervical cancer is pelvic node dissection and radical hysterectomy for patients not wishing to preserve fertility, or radical trachelectomy, in which the cervix is removed but the uterus is left intact, 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 authors of the study. When detected at an early stage, the 5-year relative survival rate for invasive cervical cancer is 92%. Worldwide, cervical cancer is the fourth most commonly diagnosed cancer and fourth most common cause of cancer death in women.

Extensive procedure
A radical hysterectomy is a more extensive procedure than a simple hysterectomy and includes the removal of the uterus, cervix, upper vagina, and the tissue around the cervix.

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During a simple hysterectomy, only the uterus and cervix are removed. For people with cervical cancer, a pelvic lymph node dissection—when the lymph nodes are removed—is an integral part of either type of surgery to exclude the presence of lymph node metastasis (with or without sentinel node mapping, which is the use of dyes and radioactive substances to identify the first lymph node to which cancer is likely to spread from the primary tumor).

Either procedure can be done using a large cut in the abdomen, called laparotomy, or using smaller cuts, called laparoscopy. 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.

Study design
The SHAPE study included 700 patients ages 24 to 80 with low-risk, early-stage cervical cancer, defined as stage 1A2 or 1B1 disease, grade 1, 2, or 3, with lesions less than or equal to 2 centimeters. The participants, who came from 12 different countries, and were randomized to receive pelvic node dissection and either radical hysterectomy (RH) or simple hysterectomy (SH).

Half of the hysterectomies were done laparoscopically (56% SH vs. 44% RH); 25% robotically (24% SH vs. 25% RH); and 23% abdominally (17% SH vs. 29% RH).

The primary endpoint of the study was to determine whether the pelvic recurrence rate at 3 years for simple hysterectomy was non-inferior to radical hysterectomy. In order to demonstrate non-inferiority of simple hysterectomy 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 health related Quality of Life (hrQoL).

Study outcomes
The pelvic recurrence rate at three years with simple hysterectomy was not inferior to radical hysterectomy (2.5% with SH vs. 2.2% with RH). The extrapelvic relapse-free survival (98.1% with simple hysterectomy vs. 99.7% with RH) and the overall survival (99.1% with SH vs. 99.4% with RH) 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 RH group).

Additionally, those in the simple hysterectomy group experienced fewer intraoperative urological surgical complications and fewer immediate and long-term bladder problems. Several health related Quality-of-Life (hrQoL) aspects, such as body image, pain, and more 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 women with carefully selected early-stage low-risk cervical cancer,” explained Marie Plante, MD, Gynecologic Oncologist, CHU de Quebec, and Professor, Department of Obstetrics and Gynecology at Laval University in Quebec, Canada.

“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,” Plante concluded.

What’s Next
Researchers plan to further investigate the quality of life and sexual health data, conduct a cost-effectiveness and cost utility analysis of radical hysterectomy vs. simple hysterectomy, and identify risk factors associated with recurrences in future studies.

Clinical trial
Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer (SHAPE) – NCT01658930

Reference
[1] Plante M, Kwon JS, Ferguson S, Samouëlian V, Ferron G, Maulard A, De Kroon C, Van Driel W, et al. An international randomized phase III trial comparing radical hysterectomy and pelvic node dissection (RH) vs simple hysterectomy and pelvic node dissection (SH) in patients with low-risk early-stage cervical cancer (LRESCC): A Gynecologic Cancer Intergroup study led by the Canadian Cancer Trials Group (CCTG CX.5-SHAPE). J Clin Oncol 41, 2023 (suppl 17; abstr LBA5511). DOI 10.1200/JCO.2023.41.17_suppl.LBA5511

Featured image: ASCO 2023, McCormick Place, Chicago, IL. Photo courtesy: © 2023 ASCO/Luke Franke.

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