Simple Hysterectomy as Standard of Care for Low-Risk Cervical Cancer

Cervical Cancer: Cervical CancerSimple hysterectomy with pelvic node dissection is a safe treatment option for patients with early-stage, low-risk cervical cancer, offering fewer surgical complications and better quality of life than radical hysterectomy, ushering in a new, more individualized surgical approach. In the large, Phase III, prospective, randomized SHAPE trial, after a median follow-up of 4.5 years, the pelvic recurrence rate at 3 years with simple hysterectomy (2.5%) was not inferior to radical hysterectomy (2.2%), meeting its primary endpoint. “Following adequate, rigorous preoperative assessment in carefully selected patients, simple hysterectomy can now be considered the new standard of care for patients with low-risk, early-stage cervical cancer, leading to surgical de-escalation,” said lead author Marie Plante, MD, Gynecologic Oncologist at CHU de Quebec and Professor in the Department of Obstetrics and Gynecology at Laval University in Quebec, Canada. She presented the results at the 2023 ASCO Annual Meeting (Abstract LBA5511). As a result of effective screening in developed countries, the overall incidence of cervical cancer has decreased over the past 20 years, with a higher proportion of women presenting at a younger age and with low-risk, early-stage disease. “Although radical surgery is highly effective for the treatment of low-risk disease, women are at risk of suffering survivorship issues related to long-term surgical side effects, including compromised bladder, bowel, and sexual health,” Plante explained. In a radical hysterectomy, surgeons remove the uterus, cervix, upper vagina, and the tissue around the cervix. In a simple hysterectomy, the surgeon removes only the uterus and cervix. Simple hysterectomy is a less technically difficult procedure than radical hysterectomy, and the results could impact lower-income countries in which cervical cancer carries a heavier burden, she noted. About the Study The SHAPE study included 700 patients ages 24-80 with low-risk, early-stage cervical cancer defined as Stage IA2 or IB1 disease Grade 1, 2, or 3 with lesions less than or equal to 2 centimeters. The patients, who came from 12 countries and 130 centers, were randomized to receive pelvic node dissection and either radical hysterectomy or simple hysterectomy. Half of the hysterectomies were done laparoscopically (56% simple vs. 44% radical), 25 percent robotically (24% simple vs. 25% radical); and 23 percent abdominally (17% simple vs. 29% radical). Per-protocol analysis included patients eligible at baseline and without evidence of more advanced disease found at the time of surgery or final pathology based on treatment received. Patient characteristics were well balanced with a median age of 44 years; 91.7 percent were Stage IB1 and 61.7 percent had squamous histology. A total of 4.4 percent of patients had lymph node metastasis (4.1% simple hysterectomy and 5.1% radical hysterectomy) and 3.1 percent had extrauterine extension (2.6% simple hysterectomy and 3.7% radical hysterectomy). A total of 8.8 percent of women received post-surgical adjuvant therapy (9.2% simple hysterectomy and 8.4% radical hysterectomy). Trial Results With a median follow-up of 4.5 years, 21 pelvic recurrences were identified (11 simple hysterectomy and 10 radical hysterectomy). The 3-year extrapelvic relapse-free survival and overall survival were respectively 98.1 percent and 99.1 percent with simple hysterectomy and 99.7 percent and 99.4 percent with radical hysterectomy. Radical hysterectomy led to significantly higher surgery-related incidence of urinary incontinence (11%) than simple hysterectomy (4.7%) and urinary retention (9.9% radical vs. 0.6% simple) during follow-up. The surgical approach (abdominal surgery vs. minimally invasive surgical approach) did not influence risk of recurrence in either group, she said. The rate of positive surgical margins was low in both groups: 2.6 percent overall; 2.1 percent with simple hysterectomy versus 2.9 percent with radical hysterectomy. Several quality-of-life measures, such as body image, pain, and sexual activity, were more favorable in the simple hysterectomy group. Significant differences were seen between the two groups over time and all were in favor of the simple hysterectomy group, she said. “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,” Plante said. “This trial will likely be practice-changing.” The current standard of care for patients with early-stage, low-risk cervical cancer is pelvic node dissection and radical hysterectomy for patients not wishing to preserve fertility or radical trachelectomy. About 44 percent of people with cervical cancer in the U.S. are diagnosed with early-stage disease and a significant proportion of them meet low-risk criteria. When detected at an early stage, the 5-year relative survival rate for invasive cervical cancer is 92 percent. “In early-stage, low-risk cervical cancer, pelvic recurrence rates at 3 years with simple hysterectomy was not inferior to radical hysterectomy,” Plante stated. “Fewer urological surgical complications and better quality of life sexual health measures were seen following simple hysterectomy.” Mark L. Fuerst is a contributing writer.

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