Rethinking a common surgery technique for early cervical cancer

摘要

The studies were led by researchers from The University of Texas MD Anderson Cancer Center in Houston. They include the Laparoscopic Approach to Cervical Cancer (LACC) trial, a randomized controlled phase 3 trial helmed by Pedro Ramirez, MD, director of minimally invasive surgical research and education in the center's Department of Gynecologic Oncology and Reproductive Medicine, and an epidemiologic study led by J. Alejandro Rauh-Hain, MD, MPH, an assistant professor of gynecologic oncology, reproductive medicine, and health services research. Since the findings were published, several studies in journals such as Gynecologic Oncology,3, 4 the International Journal of Gynecological Cancer,5 and the American Journal of Obstetrics and Gynecology6 have corroborated the results. That a prospective, randomized trial—the gold standard of treatment evaluation—is among the research being discussed is noteworthy according to Elise Kohn, MD, head of gynecologic cancer therapeutics in the National Cancer Institute's Cancer Therapy Evaluation Program. When this is coupled with “the fact that you have other retrospective studies saying the same thing,” she says, “then the findings should be practice-changing.” There has already been some movement in this direction. The National Comprehensive Cancer Network, which is made up of representatives from National Cancer Institute–designated comprehensive cancer centers across the country, had previously advised that minimally invasive surgery could be used to perform radical hysterectomy with either conventional or robotic-assisted laparoscopic techniques. However, in March it revised its recommendations to take into account the findings from the MD Anderson randomized study and others, noting that patients with earlystage cervical cancer should be carefully counseled about short- and long-term outcomes of MIS-RH. The European Society of Gynecologic Oncology made similar changes to its guidelines. Furthermore, MD Anderson surgeons no longer teach MIS-RH to their trainees or offer it to the majority of their patients with early-stage cervical cancer. “We already had a lot of information on lengths of stay and blood loss with MIS-RH for cervical cancer, but we didn't have a lot of answers about cancer recurrence rates and disease-free survival—ours was the only prospective, randomized trial to look at this specific question.” —Pedro Ramirez, MD Expecting to show that MIS-RH was equivalent to open surgery in terms of disease-free survival, he and colleagues at 33 centers worldwide randomized 631 women with earlystage cervical cancer (IA to IB) to undergo either MIS-RH or the open approach. However, the study was stopped in 2017 because the MIS-RH patients showed higher rates of recurrence and worse progression-free and overall survival. Among the researchers' findings, MIS-RH showed a 3-fold increase in disease progression in comparison with open surgery, and the rate of disease-free survival at 4.5 years was 86% with MIS-RH and 96.5% with open radical hysterectomy. Furthermore, the 3-year overall survival rate was 91.2% for MIS-RH but 97.1% for the open procedure. The retrospective epidemiologic study, which Dr. Rauh-Hain conducted in collaboration with Harvard University, Columbia University, and Northwestern University, analyzed 2 large cancer databases to show that MIS-RH in early-stage cervical cancer was associated with worse overall survival than open surgery. Specifically, it revealed a 48% higher risk of death from any cause within 4 years after MIS-RH and pelvic lymphadenectomy for stage IA2 to IB1 cervical cancer. According to Dr. Ramirez, these results point to one resounding message: “They tell us that in surgery we need to do more randomized studies to evaluate the surgical approaches we take,” he says. “We often are performing procedures that haven't been evaluated in that way.” Shitanshu Uppal, MD, associate professor in the University of Michigan's Division of Gynecologic Oncology,