Studies warn about cervical cancer procedure
MD Anderson-led research finds minimally invasive surgery carries higher risk of recurrence, death
Minimally invasive surgery for cervical cancer, increasingly the preference of patients, carries a significantly higher risk of the disease returning and causing death, according to two new Houston studies.
MD Anderson Cancer Center, which led the studies, this year began offering only open surgery for cervical center as a result of the surprising finding, which contrasts starkly with what doctors have advised patients over the past decade. Other cancer centers are expected to follow suit.
“The takeaway is simple: stop doing minimally invasive surgery for radical hysterectomy,” said Dr. Pedro Ramirez, an MD Anderson professor of gynecologic oncology and reproductive medicine and the primary investigator of one of the studies. “It results in more cancer than open surgery.”
Ramirez’s study, a randomized trial conducted at more than 30 sites in a dozen countries, found a four times higher rate of the disease recurring in patients who received
minimally invasive surgery compared to open surgery. It also found deaths from cervical cancer in 14 of 319 patients who got minimally invasive surgery compared to two of 312 patients who got open surgery.
The study was stopped early so that all patients could receive open surgery.
The study results were published online Wednesday in the New England Journal of Medicine. An accompanying editorial in the journal asked whether the studies “signal a death knell” for minimally invasive radical hysterectomy for cervical cancer.
Because the studies were designed only to assess outcomes, the researchers don’t know why minimally invasive surgery failed to stack up. They speculated that techniques and instruments used in the procedure inadvertently might spread cancer cells, but emphasized follow-up studies will have to determine any causes.
Cervical cancer is the fourth most frequently diagnosed cancer and fourth leading cause of cancer-related death in women worldwide. The American Cancer Society estimates there will be 13,240 new cases of cervical cancer in the United States this year and 4,170 deaths.
Nearly 56 percent of newly diagnosed cases are candidates for surgery, said Ramirez. The latterstage of the disease is treated with chemotherapy and radiation.
Radical hysterectomy, an operation to remove the uterus, cervix, an upper part of the vagina and nearby lymph tissue, is standard treatment for early stages of cervical cancer. Both studies compared the two methods — open surgery, which involves a major cut in the lower abdomen; and minimally invasive surgery, or laparoscopic surgery, which involves small incisions.
Minimally invasive surgery has become the preferred option for many patients, despite a shortage of long-term studies of outcomes, because it allows for faster recovery. The assumption has been that because it has proved safe for nearby cancer locations, such as endometrial cancer, it was safe for cervical cancer too.
The two new studies are by far the largest ever to analyze such outcomes. Ramirez’ study is the first to follow over time earlystage cervical cancer patients randomly assigned to the two methods of radical hysterectomy. The second retrospectively analyzed outcomes in a nationwide database that includes 70 percent of cancer cases in more than 1,500 U.S. hospitals.
Alicia Ackley figured she’d get minimally invasive surgery after she was diagnosed with cervical cancer and went to MD Anderson in late spring. But the Houston cancer center, already armed with preliminary study results, advised her to do open surgery given the risks of minimally invasive surgery.
“I was surprised, but I trusted my doctor — he knows a lot more about the disease than me,” said Ackley, 32, an Alvin stay-at-home mom.
“I’m glad I did — the open surgery got everything,” she said. “It’s great to have peace of mind and confidence that I have a much lower risk of the disease coming back and having to undergo chemotherapy, radiation or additional surgery.”
Ackley stayed in the hospital two nights, longer than laparoscopic surgery requires, but shorter than the old days when open surgery could require up to five or six nights. Ramirez said new strategies are enabling patients to go home from open surgery much sooner now, sometimes even the next day.
Ramirez’ study enrolled 631 patients, about 100 less than planned because of the early stop. It found that 4 1/2 years after treatment, 96 of those who had open surgery were still living and disease-free, compared to 86 percent of those who had laparoscopic surgery.
Researchers from Harvard, Columbia and Northwestern universities assisted MD Anderson in the second study, which reviewed the outcomes of 2,461 women with cervical cancer who had a radical hysterectomy between 2010 and 2013. It found a death rate of 5.3 percent among those who had open surgery, compared to 9.1 percent among those who got minimally invasive surgery.
The study also found the adoption of minimally invasive hysterectomies coincided with the beginning of a nearly .1 percent annual decrease in four-year survival rates in hysterectomy patients in the years studied.
“The findings were a big surprise,” said Dr. Alejandro RauhHain, the second study’s principal investigator who is an MD Anderson professor of gynecologic oncology and reproductive medicine and health services research. “We expected to find minimally invasive surgery was safe.”
The New England Journal editorial, by Dr. Amanda Fader of Johns Hopkins School of Medicine, stopped short of calling the studies a death knell for minimally invasive radical hysterectomy for cervical cancer, but called the data “alarming” and said the approach has been “dealt a great blow.”
Fader wrote that select patient subgroups may still benefit from a less invasive approach, but acknowledged that information still needs to be teased out. Pending more data, Johns Hopkins has stopped doing less invasive hysterectomies for cervical cancer.
“Until further details are known,” wrote Fader, “surgeons should proceed cautiously, counsel their patients regarding these collective study results, and assess each woman’s individual risks and benefits with respect to minimally invasive as compared with open radical hysterectomy.”