Data from a retrospective study presented at the 2023 Society of Gynecologic Oncology (SGO) Annual Meeting show that interval cytoreductive surgery after neoadjuvant chemotherapy is superior to neoadjuvant chemotherapy alone. improved overall survival (OS) in patients with initially unresectable stage IV ovarian cancer. cancer in women.
In this retrospective analysis, researchers collected data on 111 patients. These patients included 30 (31%) who received primary debulking surgery, 65 (58.6%) who received neoadjuvant chemotherapy followed by cytoreductive surgery, and neoadjuvant chemotherapy alone. 16 (14%) included. .
Median OS was 56 months for patients who received primary debulking surgery, 36.9 months for patients who received neoadjuvant chemotherapy and interval cytoreductive surgery, and 18.3 months for those who received neoadjuvant chemotherapy alone. It was the month (P. < .001). Median progression-free survival for the three groups was 27.8, 14.2, and 10.4 months, respectively (P. < .001).
Comparing the two groups of patients receiving neoadjuvant chemotherapy, multivariate analysis controlling for stage and age showed that the OS advantage remained significant with interval cytoreductive surgery (HR, 0.24 95% CI, 0.09–0.61; 95% CI, 0.09–0.61; P. = .003).
“What if [patients with ovarian cancer] Although not a good candidate for primary debulking surgery, interval cytoreductive surgery is beneficial in terms of survival. Even if patients require extensive surgical intervention during interval cytoreductive surgery, we have to provide it for them. I am a gynecologic oncologist at Princess Margaret Cancer Center in Toronto, Ontario, Canada.
in an interview with on live®, Hogen discussed the potential benefits of cytoreductive surgery in patients with initially unresectable stage IV epithelial ovarian cancer and the implications of findings from this retrospective analysis for future clinical decisions.
on live®: Please explain the rationale for conducting a study investigating interval cytoreductive surgery in patients with early unresectable stage IV ovarian cancer.
Hogen: It is known that ovarian cancer patients are usually diagnosed at an advanced stage. Most patients are diagnosed at stage III and some at stage IV. [Approximately]progresses in 70% to 80% of patients [disease] at diagnosis. When discussing treatment options, we aim to start with neoadjuvant chemotherapy followed by primary debulking surgery. However, some patients are not suitable for this type of intervention and require neoadjuvant chemotherapy, usually followed by spaced cytoreductive surgery. [of getting] No visible residual disease or at least optimal [residual disease]which is less than 1 cm.
A challenge for some patients with unresectable disease at initial presentation is that the disease persists even after preoperative chemotherapy. It is not known whether total resection is possible during interval cytoreductive surgery.This is where it is important to characterize this population and see if surgical intervention benefits [these patients. This could help us] Get a better understanding of the subpopulations in this category and which patients are likely to benefit from surgical intervention.
Could you elaborate on the factors that make patients with stage IVB epithelial ovarian cancer unsuitable for primary debulking surgery? Why is interval cytoreductive surgery a potentially advantageous approach over neoadjuvant chemotherapy alone? what is it?
When we look at patients at initial diagnosis, we see [certain] Factors that help us decide [between] Primary Cytoreductive Surgery and Neoadjuvants [chemotherapy]It has to do with disease distribution. If there are parts that are difficult to surgically remove, such as brain metastases, bone metastases, multiple liver metastases, and intraparenchymal lung disease, [patients] Not subject to surgical resection.
There are other factors, such as the amount of disease.If you have multiple areas [of disease] Abdominal, thoracic, and retroperitoneal lymph nodes require very large and extensive procedures and may not be beneficial to the patient. In addition, some patients present with ECOG performance status as low as 2 or higher. In such situations, extensive surgical procedures can lead to significant complications or even death in these patients.
These are the criteria we consider, and the same criteria apply to interval cytoreductive surgery. However, after neoadjuvant chemotherapy, the disease burden is usually reduced, and initially unresectable disease areas may now become resectable. Chemotherapy may improve the general condition. [a reduction in] burden of illness.
Could you elaborate on the goals of the retrospective study presented at the 2023 SGO Annual Meeting on Women’s Cancer? What are the main results?
We had three main objectives. One was to characterize this population. [disease], describes the sites of disease in patients with stage IVB high-grade ovarian cancer. These data are compared between patients who have undergone surgery and those who have not. We also aimed to compare survival rates between these two groups and to define parameters associated with not offering surgical intervention to patients.
There were 111 patients who met the eligibility criteria. [31%] Underwent primary cytoreductive surgery that was included in the survival analysis but not included in the comparative prognostic analysis [interval cytoreductive surgery and neoadjuvant chemotherapy alone] group.the translation of it [patients who underwent primary debulking surgery] It had the best prognosis among all groups for survival.Additionally, patients receiving neoadjuvant [chemotherapy] and interval cytoreductive surgery [accounted for] We found that 58.6% and 14% of patients received neoadjuvant chemotherapy and were not candidates for interval cytoreductive surgery.
Comparing the areas of disease, we found that most patients with stage IVB have intrathoracic disease in the form of metastatic lymph nodes in the chest. Some of them had enlarged lymph nodes in the groin. [their disease] At stage IVB, a minority of patients had brain metastases, bone metastases, or intraparenchymal lung disease. A small proportion of patients also had intrasplenic disease or multiple liver lesions.
In terms of survival, patients who underwent primary debulking surgery had the best prognosis. Patients who received neoadjuvant chemotherapy and interval cytoreductive surgery had a better prognosis than those who did not undergo surgical intervention. Most patients were found to be in optimal condition, even though they initially had unresectable stage IV disease. [residual disease] After surgery, most had no gross residue [disease] After interval cytoreductive surgery.
Factors associated with not proceeding to interval cytoreductive surgery were older patients and those with parenchymal liver disease. Multivariate analysis found interval cytoreductive surgery to be one of the most important factors for survival benefit.
What impact might this analysis have on future treatment decisions in clinical practice?
There is a lot of information about predictive models for which patients should be brought to the operating room for their first cytoreductive surgery. However, he was not a good candidate for primary debulking surgery, received neoadjuvant chemotherapy, had some response but still had disease, and had undergone extensive surgery to eliminate gross residual disease or optimize conditions. Little is known about patients who require surgical intervention. Cytoreductive surgery.
There is a need to better characterize these patients and find different ways to determine who will benefit from surgery. For example, building predictive models with better radiological assessment, using biochemical markers such as CA-125, or hormone recombination deficiency profiling for molecular analysis. Perhaps the use of machine learning algorithms in these patients could help select patients who would benefit from surgical intervention.
We often talk about intraperitoneal hyperthermia chemotherapy [HIPEC] Intended for patients with stage III disease, but the main [phase 3] study [NCT00426257] did not include [patients with] Stage IV [disease]The role of HIPEC in patients with stage IV disease is unknown.Patients with stage IV [may] If you have metastatic lymph nodes in your chest or lungs, you have a huge amount of disease in your abdomen that will eventually cause problems.may have a role [for] These patients require HIPEC and further research into this group is warranted.
How do you approach patients who may not be candidates for interval cytoreductive surgery?
Most of the patients we do not have surgery for are those with advanced disease or their ECOG. [performance status] Aggravated by chemotherapy. Those are few patients. It’s unclear to them what the next step should be. Medical intervention could be the next step for these patients.
reference
Hogen L, Denen A, May T, et al. Interval cytoreductive surgery in patients with early unresectable stage IV ovarian cancer. Presented at the 2023 Society of Gynecologic Oncology Women’s Cancer Annual Meeting. March 25-28, 2023.Tampa, Florida