Researchers take next steps to understand COVID-19’s impact on people infected during pregnancy
OSUCCC – James gynecologic oncologist leads new research to compare minimally invasive and open surgical approaches
Gynecologic oncology surgeons were quick to adopt minimally invasive surgery (MIS) techniques for early-stage cervical cancer in the early 1990s. Within about 15 years, most radical hysterectomies in the United States for this patient population were being done laparoscopically or with a robotic-assisted system.
Then came the Laparoscopic Approach to Cervical Cancer (LACC) trial, published in November 2018. This study showed poorer disease-free and overall survival with MIS compared to open radical hysterectomy for early-stage cervical cancer. The LACC study closed early due to concern for patient harm. Utilization of MIS for early-stage cervical cancer dropped dramatically.
…To which Kristin Bixel, MD, said, “Not so fast.”
Like many gynecologic oncologists, Bixel observed weaknesses in the LACC trial and decided that further study was warranted. A physician-researcher at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), began thinking about how MIS may differ from open surgeries and which elements of the procedure may subject patients to increased risk.
Bixel developed a new research study with Mario Leitao Jr., MD, from Memorial Sloan Kettering Cancer Center, and Leslie Randall, MD, from Virginia Commonwealth University, who leads cervical cancer research for GOG Partners. The goal is to provide more definitive data comparing open versus robotic techniques for patients with early-stage cervical cancer.
After years of planning, the study will begin enrolling patients in early 2022. Called ROCC (Robotic versus Open Radical Hysterectomy for Cervical Cancer), the randomized controlled trial addresses what Bixel and others consider shortcomings in the LACC trial.
“LACC didn’t use a uniform preoperative assessment and relied solely on a clinical exam for tumor size assessment,” says Bixel, principal investigator for the ROCC study. “It also failed to control for manipulator use or colpotomy method, both of which have been shown in retrospective studies to increase the risk for poor outcomes.”
When designing the ROCC study, Bixel and her colleagues also considered the results of the SUCCOR study, published in 2020. SUCCOR (Surgery in Cervical Cancer Comparing Different Surgical Approaches in Stage IB1 Cervical Cancer) demonstrated that MIS in cervical cancer increased the risk of relapse and death compared with open surgery.
However, this study also showed that patients having MIS without an intrauterine manipulator and with a protective vaginal closure prior to colpotomy had similar outcomes to open surgery. When looking at the impact of protective vaginal closure, disease-free survival after MIS at 4.5 years was 93%, versus 74% without.
The ROCC study prioritizes appropriate patient selection and adheres to basic principles of oncologic surgery, ensuring in both arms of the study that the tumor is not disrupted or exposed to the peritoneal cavity at the time of surgery. Study inclusion guidelines require:
- A preoperative assessment using pelvic magnetic resonance imaging to make sure surgeons are operating on appropriately sized tumors
- Tumor staging of 1A2-1B2 (tumor size of less than 4 centimeters)
- The use of the robotic surgical platform for those randomized to the MIS arm
- Vaginal closure prior to colpotomy, without the use of manipulators. The study describes four different robotic techniques and three open techniques that can be used.
ROCC is funded by an unrestricted research grant from Intuitive Research and is the first surgical clinical trial ever supported by GOG Partners. Bixel hopes to enroll 840 patients from 80 institutions, first from the United States and subsequently internationally. Patients will be followed for five years after surgery. The study’s primary outcome is three-year disease-free survival.
“We are always striving to do better for our patients. There are clear benefits of MIS with respect to short-term outcomes related to blood loss, pain, infectious morbidity, length of hospital stay and recovery time. Of course, the oncologic outcomes are prioritized as we counsel our patients about surgery,” Bixel says. “With a growing body of data to suggest that modifications in surgical technique may equalize the oncologic outcomes, we are excited to bring this study to our patients.”
To learn more, contact Kristin Bixel at kristin.bixel@osumc.edu.
