The randomized-controlled Phase III study — led by Pedro Ramirez, M.D., professor of Gynecologic Oncology and Reproductive Medicine — compared the two techniques and found that cervical cancer patients who had minimally invasive radical hysterectomies were four times more likely to experience recurrence compared to those who had traditional abdominal hysterectomies, which are also known as open hysterectomies. In addition, disease-free survival was much higher at 4.5 years for patients who had open surgery.
A separate NEJM study led by J. Alejandro Rauh-Hain, M.D., assistant professor of Gynecologic Oncology and Reproductive Medicine and Health Services Research, also confirmed that minimally invasive radical hysterectomy was associated with worse overall survival than abdominal radical hysterectomy among patients with early-stage cervical cancer. That study, a retrospective, epidemiologic analysis based on two national databases, showed an almost 50% higher risk of dying within four years for patients who underwent a minimally invasive surgery.
Studies’ results are practice-changing
Radical hysterectomies are considered the standard of care for early stage cervical cancer treatment. The results signify a practice-change in the way surgeons perform hysterectomies for cervical cancer patients. Based on the findings, MD Anderson gynecological oncologists decided to stop performing minimally invasive radical hysterectomies on cervical cancer patients; all MD Anderson patients receive abdominal hysterectomies instead. The results could impact the surgical management of all women with early-stage disease.
“Minimally invasive surgery was adopted as an alternative to open radical hysterectomy before high-quality evidence regarding its impact on survival was available,” says Rauh-Hain. “Both Dr. Ramirez and I were surprised to find that in our respective studies, the minimally invasive surgical approach negatively affected oncologic outcomes for women with early-stage cervical cancer.”
The findings are critical, according to the researchers, because cervical cancer is curable with surgery in its earliest stage but treatments are much less effective after disease recurrence.
“Hysterectomies are still the standard of care for early cervical cancer,” says Ramirez. “But if we change how we do hysterectomies, we can save more patients’ lives.”
Helping patients make informed decisions
There were 631 patients enrolled in Ramirez’s multi-institutional collaborative study that involved 33 care centers around the world. Most of the patients who participated in the trial were stage IB1, an early stage of cervical cancer. Early stage cervical cancer typically is found in younger women in their 20s, 30s and 40s, who otherwise are healthy. The risk factors for the patients were the same in both types of surgery included; and the only difference between the groups was the approach to radical hysterectomy. Early-stage cervical cancer accounts for nearly half of the 13,240 cervical cancers expected to be diagnosed this year.
“It’s important that cervical cancer patients review this information before scheduling their surgeries,” Ramirez says. “The patients are entitled to have a discussion with an experienced gynecological oncologist to make the decision that’s ultimately best for them and their cancer treatment.”
Over a 45-month median follow-up, the four-year mortality risks were 9.1 percent among women receiving minimally invasive radical hysterectomy, compared to 5.3 percent for abdominal radical hysterectomy.
Adoption of minimally invasive radical hysterectomy coincided with the beginning of a decline in four-year relative survival rates of 0.8 percent per year between 2006 and 2010 in this population.
“Our research also found that compared with open surgery, minimally invasive surgery increased the risk of death among women who underwent radical hysterectomy for early-stage cervical cancer,” said Rauh-Hain. “Given these two studies, we believe that we can no longer recommend minimally invasive radical hysterectomies for our patients with early-stage cervical cancer.”