clinical research
Trailblazing New Perspectives: Treating Gynecological Cancers
Trailblazing New Perspectives: Treating Gynecological Cancers
Although medical innovations have saved countless lives by increasing health care efficiency and efficacy, not all innovations benefit patient health outcomes compared to traditional treatment methods.
That’s why Houston Methodist’s Pedro T. Ramirez, MD, FACOG, prescribes a healthy dose of scrutiny toward such innovations.
Pedro T. Ramirez, MD, FACOG
As chair of the Department of Obstetrics & Gynecology, Ramirez is well-known for trailblazing the first prospective randomized clinical trial (RCT) that challenged minimally invasive surgery (MIS) as the standard of care for treating cervical cancer. This 2018 landmark study revealed worse long-term health outcomes for patients treated with the innovative technology compared to the traditional open surgery approach.
His findings came as a surprise to the field and have since instigated more research challenging MIS as a treatment option for gynecological cancers, including epithelial ovarian cancer.
However, before prospective RCTs can be used to compare health outcomes for different surgical treatments, such studies must be tested for feasibility. Study design and ethical concerns are just some of the major factors to consider.
As physicians and surgeons, we have a responsibility to provide treatment based on evidence-based research. I believe that the way forward in medicine is to provide a level of scrutiny that ensures the best outcomes for patients.
Pedro T. Ramirez, MD, FACOG
Chair, Department of Obstetrics and Gynecology
Recently, Ramirez and colleagues achieved this step forward in establishing study feasibility in JAMA Network Open. Ramirez explained what the feasibility study results mean for future evaluations of gynecological cancer treatment.
Q&A
Q: The goal of this new study was to evaluate the feasibility of a phase three, multi-center RCT comparing the efficacy of MIS with that of the traditional open method approach (laparotomy) in treating epithelial ovarian cancer. What did your team find?
A: “One hundred women were randomly assigned to either the MIS treatment group (49) or the laparotomy group (51). We were able to keep our conversation rate from MIS to laparotomy low (12.5 percent), while achieving comparable rates of complete gross resection in MIS patients (88 percent) and laparotomy patients (83 percent). Therefore, feasibility of this type of study is possible.”
Q: Where does the study go from here?
A: “We’ve already started phase three of the clinical trial in which we will evaluate oncologic outcomes of the two surgical approaches. To do this, we will recruit another 480 patients across multiple cancer centers. We hope to complete accrual in 2026 and publish our results shortly thereafter.”
Q: What happens if MIS is found to have worse long-term health outcomes compared to the open method approach? Will the standard of care change?
A: “Currently, the open approach is considered the standard of care. If MIS shows inferior outcomes compared to the open approach, then we will have level-one evidence that MIS should not be offered as an option when performing interval cytoreductive surgery in patients with advanced ovarian cancer.”
Q: Why are health care providers, such as yourself, scrutinizing MIS as a treatment for epithelial ovarian cancer?
A: “Despite its wide use, there is a concerning absence of high-quality evidence supporting this surgery’s safety and effectiveness. We need to confirm that we’re not putting patients at a disadvantage by using MIS, especially given the results of my cervical cancer treatment study. As physicians and surgeons, we have a responsibility to provide treatment based on evidence-based research. I believe that the way forward in medicine is to provide a level of scrutiny that ensures the best outcomes for patients.”
Q: Can you give a brief history of how MIS became an option in the surgical approach for advanced epithelial ovarian cancer?
A: “The traditional method for treating epithelial ovarian cancer is an open surgery followed by chemotherapy. These two treatments combined allow for a thorough evaluation of the abdominal cavity to remove the disease and eliminate any microscopic cancer cells left behind. However, this method requires an extensive surgery that may be prone to complications.
“Through the years, evidence from retrospective RCTs suggested that some patients may benefit from interval cytoreductive surgery with neoadjuvant chemotherapy. This process typically involves three cycles of chemotherapy prior to undergoing surgery – thereby reducing tumor size and lessening surgery extensiveness – followed by three additional chemotherapy cycles to eliminate any remaining cancer.
“Although evolving research revealed interval cytoreductive surgery with neoadjuvant chemotherapy was not associated with lower survival rates compared to the traditional open surgery approach, this newer treatment method has become the preferred approach for many patients with advanced ovarian cancer because of its decreased surgery complication risk and faster recovery. With MIS, patients had shorter hospital stays, less blood loss, and smaller surgical scars.
“That brings us to the point where MIS was being offered to many patients as an option for interval cytoreductive surgery; albeit, without high-quality prospective data to support its role in this setting. To that end, our team is evaluating this question to establish the standard of care moving forward.”
Rauh-Hain JA, Melamed A, Pareja R, May T, Sinno A, McNally L, Horowitz NS, De Iaco P, Michener CM, Van Lonkhuijzen L, Iniesta MD, Yuan Y, Ramirez PT, Fagotti A.
Callie Rainosek Wren, MS
January 2025
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