ASCO Perspective

“For patients with stage 1 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 Kathleen N. Moore, MD, MS, ASCO Expert. “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.”

Simple hysterectomy with pelvic node dissection is a safe treatment option for people with early-stage, low-risk cervical cancer and may help improve quality of life, according to results from a large, international phase III clinical trial.

Study at a Glance

Key Findings

The pelvic recurrence rate at three years with SH was not inferior to RH (2.5% with SH vs. 2.2% with RH). The extrapelvic relapse-free survival (98.1% with SH 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 SH group vs. 10 in the RH group).  

Additionally, those in the SH group experienced fewer intraoperative urological surgical complications and fewer immediate and long-term bladder problems. Several quality-of-life aspects, such as body image, pain, and more sexual activity, were also more favorable in the SH 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 SH vs. 2.9% with RH).

“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,” said Marie Plante, MD, Gynecologic Oncologist, CHU de Quebec, and Professor, Department of Obstetrics and Gynaecology 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.”

A RH is a more extensive procedure than a SH and includes the removal of the uterus, cervix, upper vagina, and the tissue around the cervix. During a SH, 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 RH 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 RH for people 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 study authors. 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.

About the Study

The SHAPE study included 700 people 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, were randomized to receive pelvic node dissection and either RH or 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 SH was non-inferior to RH. In order to demonstrate non-inferiority of SH to RH, 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.

Next Steps

Researchers plan to further investigate the quality of life and sexual health data, conduct a cost-effectiveness and cost utility analysis of RH vs. SH, and identify risk factors associated with recurrences in future studies.