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Hello and welcome to the Gynecologic Oncology Journal Podcast.
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This is Greg Nelson, social media editor of the journal.
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Today I'm joined by Dr.
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Jennifer Mueller from the Gynecology Service Department of Surgery at Memorial Sloan Kettering Cancer Center in New York, New York.
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She is the lead author on Sentinel Lymph node mapping in patients with endometrial hyperplasia, a practice to preserve or abandon.
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I'm also joined by Dr.
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Ahmad Matanes from the Division of Gynecologic Oncology, Jewish General Hospital at McGill University in Montreal, Canada, and the lead author on Is Sentinel Lymph Node Assessment Useful in Patients with a Preoperative Diagnosis of Endometrial Intraepithelioplasia.
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Both of these articles are editor's choice papers and appear in the January 2023 issues.
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And last but certainly not least is Dr.
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Emma Rossi from the Division of Gynecologic Oncology at Duke University in Durham, North Carolina.
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Dr.
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Rossi is the senior author of the accompanying editorial for today's articles, all of which can be found at Gynacologic Oncology-online.net.
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Thank you for joining us, Drs.
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Mueller, Matanes, and Rossi.
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I'll start with you first, Dr.
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Mueller.
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Before we dive into the details of your study, I think it would be important for you to explain to our listeners the connection between complex atypical hyperplasia and concurrent endometrial cancer.
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There are probably lots of general gynecologists and also gynecologic oncologists who believe that complex atypical hyperplasia is a relatively harmless diagnosis and does not warrant lymph node assessment.
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So tell us, what's the big deal?
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First of all, thank you so much for inviting me on behalf of our study team to talk about this important topic.
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And that is a great question and sets the stage really well for our conversation.
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It's true, the good news is a simple hysterectomy is all that's needed to definitively treat complex atypical hyperplasia.
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The not so great news is that the biopsy may not reveal the entire story.
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About 40% of the time, patients who have complex atypical hyperplasia on a biopsy will be diagnosed with endometrial cancer at the time of their hysterectomy.
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The nomenclature has evolved over time, and some pathologists might refer to complex atypical hyperplasia as endometrial interepithelial neoplasia.
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Others may make the delineation between hyperplasia and a hyperplasia with areas that border on a well-differentiated endometral cancer.
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In situations where complex atypical hyperplasia plus areas bordering on endometrial cancer, that risk of upstaging to endometrial cancer can be as high as 66%.
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This is why we feel it's an important population of patients to study.
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There are significant numbers of patients who could benefit from lymph node evaluation at the time of their hysterectomy.
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And with the gradual adoption of sentinel lymph node mapping and early stage endometrial cancers that has occurred in the United States and abroad in the past several years, it's possible that adding sentinel lymph node mapping could be a benefit for those 40 plus percent of patients who will be diagnosed with endometrial cancer.
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Our current society guidelines haven't yet addressed how to best incorporate sentinel lymph node mapping into counseling and management, and we wanted to add to the literature on the topic.
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Great.
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Okay, thank you so much for providing that overall context.
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Now, can you briefly tell us about your study objective methods and key findings?
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The main objectives of our study was to compare the outcomes of patients with complex atypical hyperplasia who underwent a hysterectomy with and without sentinel lymph node evaluation at our institution with the goal of assessing for any differences in adverse events, operative time, cancer upstaging on final pathology, the need for postoperative treatment.
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And because for many years now we have collected data on molecular subtyping in endometrial cancer, including some patients with complex atypical hyperplasia, we wanted to also provide descriptive reporting on those patients with molecular profile data that was available.
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For our methods, our study spans 2017 through the end of 2021.
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This is a timeframe where we began to offer sentinel lymph node mapping for patients with complex atypical hyperplasia as part of shared decision making across our D UN oncology surgery department.
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We also, around this time, had begun to uniformly offer molecular profiling of endometrial cancer.
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We have a uterine complaints database at our institution, which includes all patients seen across all locations and departments that are counted in the database for a complete denominator of all patients we see.
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From this database, we included patients who had a preoperative diagnosis of complex atypical hyperplasia with pathology reviewed at our institution who had undergone definitive management with surgery that could include hysterectomy with or without sentinel lymph node mapping.
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We abstracted clinical, pathologic, surgical, and treatment data from this database.
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We were able to identify 221 patients for our analysis, 60 patients with hysterectomy alone, and 161 patients who underwent hysterectomy with sentinel lymph node mapping.
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Comparisons between these groups were made with appropriate statistical tests.
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Adverse events were recorded and graded in real time for patients using our institutional adverse events reporting mechanism.
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Our main findings were that operative time was just over two hours in each group and wasn't statistically significantly different.
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That was also true for age, body mass index, and self-reported race, not statistically significant across these groups.
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In terms of complications, there was a 13% complication rate for the hysterectomy alone patients, 9% for patients who underwent hysterectomy plus sentinel lymph node removal, with all but 3% of these complications graded as 1 or 2, which is our a primarily infectious in nature grading that requires bedside care, oral, or IV medications to resolve.
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There were no complications due to retroperitoneal dissection or nodal removal.
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There were 98 patients or 44% of our cohort who were upstaged from hyperplasia to endometrial cancer on final pathology.
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10% of the patients who were upstaged to endometrial cancer at the time of their hysterectomy were given postoperative therapy.
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And the majority of those patients were recommended based on uterine risk factors.
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Most had received IVRT, although some were also recommended for chemotherapy.
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One patient who had stage 3A disease on final pathology, and another patient with stage 3C disease.
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Only one patient in our cohort had occult nodal disease.
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And all patients in this group who received treatment had had an SLN assessment.
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Also interesting that of those 33 patients in our study who had molecular profile data available, which was about 15% of the total cohort, all four subgroups were represented.
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Most were copy number low, but there were two pole E mutated tumors, three MSI high tumors, and one copy number high tumor.
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Thank you very much.
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Very, very interesting findings.
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Dr.
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Metanis, you also performed a study on sentinel lymph node assessment in endometrial intraepithelial neoplasia.
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Can you tell us about your study objective, methods, and key findings?
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Hi, Dr.
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Nelson.
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Thank you so much for inviting me today.
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It's a great honor to be with you, especially with Dr.
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Mueller and Dr.
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Rossi.
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Thank you for organizing this very important podcast discussing a very hot topic.
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When you look at the data, in the last two years, there are more than, I think, more than 10 cohort studies dealing with this specific question.
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Should we or shouldn't we assess the nodes when we have a pre-operative diagnosis of EIN?
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Now, the common state of these studies is no.
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Node assessment is not warranted.
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And the reason most of these studies give is that the risk of nodal disease in the presenter of EIN is between 1 to 2%.
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And this is a low percentage, a low rate of nodal detestative, and this procedure is not justified with this low rate.
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Here we disagree a bit with the statement, and we think we could approach the data in another way and analyze the data in another way, and then the conclusions would be different.
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Now let me tell you about our study.
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So it's a retrospective cohort study of patients diagnosed with DIN.
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All our patients underwent hystrectomy, the B2 was optional, but unlike most of the other studies and most of the actually the common practice, all of our patients had lymph node assessment.
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The surgeries were performed between 2010 and 2021.
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Overall, we had 162 patients, almost 40% of them were ultimately diagnosed with cancer, including 15 patients, 25% out of the 61 patients who had cancer, and 10% of the all EIM cohort.
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These 15 patients we had a high intermediate to high-risk disease as per BOG99.
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12 patients had a grade 2 to 3 disease, 8 more than 50% might be invasion, one patient had an ovarian metastasis, two patients end up having carcinoma.
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Now, this high prevalence of concurrent high-risk endometrial cancer correlates closely with the previous report, and in most of the reports it's it ranges between 15 to 25%.
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Now, what about the node involvement?
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So previous studies found a low incidence of lymph node metastasis and suggested that employing lymph node assessment for all women undergoing surgical treatment would have limited benefit.
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In our study, actually, we got pretty the same results.
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Only two patients had node limits and they were stayed at 31, but definitely we don't believe that lymph node evaluation could be omitted because of this.
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Lymph node information, also when it's negative, it has a pivotal impact on the adjuvant treatment of these patients.
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Knowing that the sentinels were free of metastasis allowed 10 patients to be offered adjuvant vaginal bracket therapy instead of external B review.
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This is one example.
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I'll continue with example two.
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Seven patients out of the 15 patients who had high permet to high-risk disease, seven patients had grade two disease with more than 50% parameter in data.
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The risk of pelvic and paraortic lymph node involvement in these patients, grade 2 with more than 50% metal risk is 19% and 14% for physic and paraortic respectively, as per 23.
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It's a very high risk of lymph nodes involvement.
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And if node's we're not expecting these patients, we have actually two options.
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The first is to treat these patients with EPRT, which would represent an over-treatment for them.
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And the second option is to re-evaluate the nodes, take these patients back to surgery, and that surgery would be most likely very challenging due to the post-trical lymphatic construction and the absence of curvature detection applied.
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This would lead for fundamental detection and increased risk for appropriated morbidity instead of minimal procedure than done in the primary surgery.
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I can give you more and more examples on how sentiment came and it affected our treatment.
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For example, there were two patients with ERA, right?
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So these two patients had an early stage disease.
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And the fact that the center is negative and the fact that we know that the center is negative allows us to treat them as per POG 249 with chemo followed by brachytherapy instead of chemo followed by EBRT.
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So for all of these reasons, we believe that the inclusion of sentinel lymph sampling in the surgery as a routine practice can be very, very helpful with minimal morbidity and it will allow us to avoid both under-treatment and over-treatment.
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Great.
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Thank you very much, Dr.
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Matanes.
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Now over to you, Dr.
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Rossi.
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You had the opportunity to review these papers in detail, and thank you again for writing an excellent editorial.
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Can you tell us how you think the studies of Dr.
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Mueller and Metanes contribute to the current landscape of studies on sentinel lymph node mapping in antimetrial hyperplasia and cancer?
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I'm particularly interested in the concept of the value equation that you raised in your editorial.
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And also, should we be including patients in the decision-making for interventions such as sentinel lymph node mapping?
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Thank you so much for the opportunity to discuss this very controversial and very clinically relevant topic.
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And I congratulate the authors of these two papers that were published in gynecologic oncology for really contributing to the body of literature some evidence regarding the virtues and pitfalls of this technique.
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You know, how I think this contributes is these are large series of, in some cases, prospectively maintained databases of patients with this condition shedding light into issues such as complication rates, as well as the true incidence of findings of occult cancer for patients with endometrial hyperplasia.
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And so this really helps us with our decision making as clinicians.
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We can fall back now on some literature and some evidence to support our decision making.
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And how that decision making plays out, as you mentioned, is sort of effectively a value equation.
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And the way I think about value equations with adopting techniques or technologies is it's not necessarily that more is better, but rather for a new technique or procedure to be adopted, the clinician should think about the pros and the cons in light of high quality and low cost.
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And it's not necessarily that cheaper is lower cost.
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There's many things that contribute to cost.
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But with respect to what makes high quality, high quality are things like the efficacy of the technique.
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So what's the ability of the technique, in this case, sentinel lymph node biopsy for EIN, to find metastases in the lymph nodes, to help surgeons or clinicians determine therapies for their patients postoperatively, including the de-escalation.
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So not prescribing unnecessary treatments like, for example, radiation postoperatively because we lack information about nodal status.
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That's part of the value equation, that's part of the efficacy and quality of the procedure.
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So that needs to be high.
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Also, part of that quality part of the equation is complication rates.
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So what we observed from these two papers was that there were no increased risks for complications, perioperative complications, that were observed with the addition of sentinel lymph node biopsy.
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What I think is interesting is that these are two very high-volume centers in, particularly in this technique, with a long history of experience in publishing in sentinel lymph node biopsy for endometrial cancer and now in EIN.
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And so the question that I ask is while these groups demonstrated high quality in their performance of sentinel lymph node biopsy for EIN, the question is, would that be true for all clinicians with their own individual levels of experience, their own tool sets available to them, et cetera?
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So that's the that's the quality element of the value equation, and that needs to be high.
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And it seems to be, at least in these studies, that the the ability for sentinel nodes to find metastatic disease is high, and the ability to do that while incurring damage to the patient in form of complications is low.
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Then the other element of that value equation is cost, and that's we divide quality by cost, and that provides value.
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And so costs need to be low for value to be high.
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And while these papers did not evaluate costs, cost has been evaluated in other papers looking and evaluating sentinel lymphnobsy for EIN.
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It's a complicated question to ask because there are many things that contribute to the cost of surgery, and the cost of surgery is not ubiquitous for all surgeons and for all sites.
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It's been proposed that sentinel lymph nobiopsy for EIN is perhaps not as cost effective as using hysterectomy alone or lymph nodiopsy guided by frozen section.
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However, there are many things that contribute to that, and those cost-effectiveness analyses make assumptions based on averages.
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And clearly, averages don't apply to each individual surgeon or each individual site, or even certainly each individual patient.
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And so we really have to think about how long does it take at our institutions to obtain that information through frozen section?
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And what is the cost of operating room time for that procedure to be put on hold waiting for a frozen section versus the cost of the dye and the time to perform a sentinel lymph node biopsy.
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So these are all sort of important cost considerations to make and really individualize for individual surgeons and individual sites.
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But each practitioner needs to keep that value equation in their mind when they're making a decision about adopting or not considering adopting a new procedure or more ubiquitously applying a procedure such as sentinel lymph nodiopsy for EIN.
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In addition to value, it's also important to consider patients' feelings about the procedure and the value of the procedure to them, which may be a different value equation to what it means to us as clinicians.
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It's we we when we consider value and we consider risks to patients, we're often not considering what they value and consider to be beneficial, such as, for example, complete information about the status of their disease rather than guesstimates about the likelihood or probability of lymph node metastases.
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Many patients may enjoy or prefer to know with greater certitude the status of lymph nodes and may be prepared to take on a small potential increased risk if one exists to having lymph node assessment for that.
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And we shouldn't dismiss patients' desire to have complete staging information in the case of endometrial cancer.
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And that should be part of the decision.
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Now, some patients may actually be more concerned or worried about the potential for, for example, lymphedema or other complications or length of surgery.
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So we can't make assumptions as to what things patients are going to be more concerned about, incomplete staging information or risks of surgery or added operative time, but rather open that up to patients in our discussion.
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And that's really what we all mean by shared decision making is not having our own values about a procedure be the dominant verdict, but rather have our patients weigh in and share with us what their values are as well.
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Very, very interesting.
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Thank you so much.
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Another question I had, you also indicated that there's a need for the American College of Obstetricians and Gynecologists and also the Society of Gynecological Oncology to revisit their practice statements in this domain.
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Can you tell us a little bit more about that and how should we go about advocating for this change?
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Right now, clinicians frequently will look to guidelines in practice statements and bulletins.
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And this is true particularly for, for example, a general OBGYN who might make a diagnosis of EIN in their office and be making a decision: should I operate on this patient or refer this patient to a GYN oncologist?
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And unfortunately, the statements that are provided to date are fairly gray and don't provide a lot of clear guidance as to the extent of surgery that should be done or could be done for these patients.
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And so I do think that now that we have sentinel lymph node biopsy much more broadly practiced than perhaps when those position statements were originally written.
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And because of that, a comfort level skill set and low complication rate associated with it, it's really provided a new alternative to lymph node assessment for endometrial cancer.
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And I think it's time to revisit those statements and provide some better guidance that include data such as that presented in the gynecologic oncology journal last month.
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And so for those reasons, I feel that it's time for groups such as the SGO, for example, the Clinical Practice Committee might be a place that potentially a position statement could begin.
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And that could help guide our societies as to updating their own position statements.
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The NCCN guidelines as another opportunity for us to update our recommendations with both updated data as well as recommendations.
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But as I think you'll appreciate from my editorial, while I think there's an opportunity to provide more data for decision making for patients and clinicians, I don't think we're quite at a point where a ubiquitous statement of, for example, sentinel lymph nobiopsy should be performed for all patients or for no patients.
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I don't think we're at that point.
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I think we're at a position where we can provide clinicians with information about what we know about the likelihood of finding metastatic disease with a sentinel noobiopsy, what we believe are the observed risks of complications to the procedure, the potential costs to the procedure, and the potential benefits to the procedure of understanding about the extent of disease and being able to either escalate or de escalate therapies for patients post operatively when they're identified.
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To have cancer on their final hysterectomy specimen pathology evaluation.
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Again, thank you so much for your valuable insights into the importance of these studies.
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You clearly were the right person to invite for this editorial.
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To wrap up, I'd like to come back to the study authors.
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Dr.
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Mueller, can you tell me if there are any limitations of your study?
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And do you have any future studies planned?
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Yes, of course.
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So there are inherent limitations to a single institution study, and also there's the potential for referral bias because our institution is a large cancer center.
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And I think our results need to be considered in that context.
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It's also important to note that we're an institution that has ready access to gynecologic oncologists as a community resource, and all of the surgeons in our department are well trained in central lymph node mapping techniques.
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And that may not be the case across all institutions, and that limits the applicability of these findings.
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An area I very much find interesting and wish to pursue in the future is the decision-making process that a patient goes through to make choices in this clinical scenario, as there are multiple reasonable options.
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Concepts like decisional regret, stress, anxiety all can factor in if patients are not presented with all the options before having a surgery.
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And the literature is limited on this.
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And so I think that more patient-centered research could be really valuable in this particular space.
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I also think the molecular profile of endometrial hyperplasia can be of potential benefit in the future as we're learning a lot more about molecular subtyping and whether subtype could correlate to the risk of nodal metastasis, which is ultimately one potential way that we could try and allocate the utilization of the technique of SLN mapping in this particular circumstance.
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How about you, Dr.
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Mitanis?
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Anything you would like to tell us about your study limitations?
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And do you have any future studies planned?
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Yeah, limitations for sure.
00:24:04.559 --> 00:24:06.640
We had uh several limitations for the study.
00:24:06.799 --> 00:24:15.519
The first one and the major one is that the fact that this study is a retrospective evaluation with the potential for inherent and selection biases.
00:24:15.839 --> 00:24:18.880
Our study had a very low number of events.
00:24:19.119 --> 00:24:24.160
So, sure, further prospective studies with bigger sample size should be done.
00:24:24.319 --> 00:24:28.079
We didn't look at the cost effectiveness of this procedure.
00:24:28.319 --> 00:24:43.440
And lastly, the rate of concurrent high intermediate and high risk endometric cancer is slightly high in our cohort, and this could be explained by the fact that we are a tertiary referral center that receives referrals from many smaller centers.
00:24:43.680 --> 00:24:51.599
Having said all of this, this series is the largest series that includes patients with EIN undergoing lymph node assessment.
00:24:51.759 --> 00:25:17.759
All of our patients had lymph node assessment, and our take-home message was and still that the information from Sentinel, even when negative, is very helpful in the management of patients with endometrial with endometrial cancer after pre-operative EIN, as a proportion of these patients are found to have high intermediate to high risk disease, and these patients would be exposed to either under-treatment or over-treatment.
00:25:18.000 --> 00:25:22.799
Both could be avoided by primary sentinel lymph node sampling.
00:25:23.359 --> 00:25:23.920
Excellent.
00:25:24.079 --> 00:25:24.799
Thank you.
00:25:25.039 --> 00:25:27.119
Well, I've really enjoyed speaking with you all today.
00:25:27.200 --> 00:25:30.799
I've certainly learned a lot, and hopefully so too have our listeners.
00:25:31.039 --> 00:25:33.279
My thanks to our guests for joining us today.
00:25:33.440 --> 00:25:45.599
The articles and the editorial we've discussed are available at gynecologic oncology online.net, and you can access our podcast at the journal's homepage, Apple iTunes, Google Play, and Spotify.
00:25:45.839 --> 00:25:47.279
Thank you for listening.
00:00:05.120 --> 00:00:09.519
Hello and welcome to the Gynecologic Oncology Journal Podcast.
00:00:09.599 --> 00:00:12.720
This is Greg Nelson, social media editor of the journal.
00:00:12.960 --> 00:00:14.320
Today I'm joined by Dr.
00:00:14.400 --> 00:00:21.760
Jennifer Mueller from the Gynecology Service Department of Surgery at Memorial Sloan Kettering Cancer Center in New York, New York.
00:00:21.920 --> 00:00:29.839
She is the lead author on Sentinel Lymph node mapping in patients with endometrial hyperplasia, a practice to preserve or abandon.
00:00:30.079 --> 00:00:31.359
I'm also joined by Dr.
00:00:31.519 --> 00:00:47.759
Ahmad Matanes from the Division of Gynecologic Oncology, Jewish General Hospital at McGill University in Montreal, Canada, and the lead author on Is Sentinel Lymph Node Assessment Useful in Patients with a Preoperative Diagnosis of Endometrial Intraepithelioplasia.
00:00:48.000 --> 00:00:53.600
Both of these articles are editor's choice papers and appear in the January 2023 issues.
00:00:53.759 --> 00:00:55.679
And last but certainly not least is Dr.
00:00:55.759 --> 00:01:01.359
Emma Rossi from the Division of Gynecologic Oncology at Duke University in Durham, North Carolina.
00:01:01.600 --> 00:01:01.840
Dr.
00:01:01.920 --> 00:01:11.120
Rossi is the senior author of the accompanying editorial for today's articles, all of which can be found at Gynacologic Oncology-online.net.
00:01:11.599 --> 00:01:12.879
Thank you for joining us, Drs.
00:01:13.040 --> 00:01:15.200
Mueller, Matanes, and Rossi.
00:01:15.599 --> 00:01:16.799
I'll start with you first, Dr.
00:01:16.879 --> 00:01:17.280
Mueller.
00:01:17.760 --> 00:01:26.959
Before we dive into the details of your study, I think it would be important for you to explain to our listeners the connection between complex atypical hyperplasia and concurrent endometrial cancer.
00:01:27.200 --> 00:01:37.040
There are probably lots of general gynecologists and also gynecologic oncologists who believe that complex atypical hyperplasia is a relatively harmless diagnosis and does not warrant lymph node assessment.
00:01:37.200 --> 00:01:38.879
So tell us, what's the big deal?
00:01:39.359 --> 00:01:44.400
First of all, thank you so much for inviting me on behalf of our study team to talk about this important topic.
00:01:44.480 --> 00:01:48.319
And that is a great question and sets the stage really well for our conversation.
00:01:48.560 --> 00:01:55.359
It's true, the good news is a simple hysterectomy is all that's needed to definitively treat complex atypical hyperplasia.
00:01:55.680 --> 00:02:00.319
The not so great news is that the biopsy may not reveal the entire story.
00:02:00.560 --> 00:02:09.439
About 40% of the time, patients who have complex atypical hyperplasia on a biopsy will be diagnosed with endometrial cancer at the time of their hysterectomy.
00:02:09.680 --> 00:02:19.199
The nomenclature has evolved over time, and some pathologists might refer to complex atypical hyperplasia as endometrial interepithelial neoplasia.
00:02:19.439 --> 00:02:26.800
Others may make the delineation between hyperplasia and a hyperplasia with areas that border on a well-differentiated endometral cancer.
00:02:27.120 --> 00:02:37.039
In situations where complex atypical hyperplasia plus areas bordering on endometrial cancer, that risk of upstaging to endometrial cancer can be as high as 66%.
00:02:38.000 --> 00:02:41.840
This is why we feel it's an important population of patients to study.
00:02:42.080 --> 00:02:47.919
There are significant numbers of patients who could benefit from lymph node evaluation at the time of their hysterectomy.
00:02:48.319 --> 00:03:05.759
And with the gradual adoption of sentinel lymph node mapping and early stage endometrial cancers that has occurred in the United States and abroad in the past several years, it's possible that adding sentinel lymph node mapping could be a benefit for those 40 plus percent of patients who will be diagnosed with endometrial cancer.
00:03:06.080 --> 00:03:15.599
Our current society guidelines haven't yet addressed how to best incorporate sentinel lymph node mapping into counseling and management, and we wanted to add to the literature on the topic.
00:03:16.240 --> 00:03:16.479
Great.
00:03:16.639 --> 00:03:20.000
Okay, thank you so much for providing that overall context.
00:03:20.319 --> 00:03:25.199
Now, can you briefly tell us about your study objective methods and key findings?
00:03:25.599 --> 00:03:47.439
The main objectives of our study was to compare the outcomes of patients with complex atypical hyperplasia who underwent a hysterectomy with and without sentinel lymph node evaluation at our institution with the goal of assessing for any differences in adverse events, operative time, cancer upstaging on final pathology, the need for postoperative treatment.
00:03:47.840 --> 00:04:03.599
And because for many years now we have collected data on molecular subtyping in endometrial cancer, including some patients with complex atypical hyperplasia, we wanted to also provide descriptive reporting on those patients with molecular profile data that was available.
00:04:04.240 --> 00:04:09.199
For our methods, our study spans 2017 through the end of 2021.
00:04:09.599 --> 00:04:20.800
This is a timeframe where we began to offer sentinel lymph node mapping for patients with complex atypical hyperplasia as part of shared decision making across our D UN oncology surgery department.
00:04:21.360 --> 00:04:27.040
We also, around this time, had begun to uniformly offer molecular profiling of endometrial cancer.
00:04:27.519 --> 00:04:40.079
We have a uterine complaints database at our institution, which includes all patients seen across all locations and departments that are counted in the database for a complete denominator of all patients we see.
00:04:40.560 --> 00:04:56.000
From this database, we included patients who had a preoperative diagnosis of complex atypical hyperplasia with pathology reviewed at our institution who had undergone definitive management with surgery that could include hysterectomy with or without sentinel lymph node mapping.
00:04:56.480 --> 00:05:01.519
We abstracted clinical, pathologic, surgical, and treatment data from this database.
00:05:02.240 --> 00:05:13.759
We were able to identify 221 patients for our analysis, 60 patients with hysterectomy alone, and 161 patients who underwent hysterectomy with sentinel lymph node mapping.
00:05:14.319 --> 00:05:18.399
Comparisons between these groups were made with appropriate statistical tests.
00:05:18.720 --> 00:05:25.920
Adverse events were recorded and graded in real time for patients using our institutional adverse events reporting mechanism.
00:05:26.399 --> 00:05:33.439
Our main findings were that operative time was just over two hours in each group and wasn't statistically significantly different.
00:05:33.920 --> 00:05:40.720
That was also true for age, body mass index, and self-reported race, not statistically significant across these groups.
00:05:41.360 --> 00:06:04.399
In terms of complications, there was a 13% complication rate for the hysterectomy alone patients, 9% for patients who underwent hysterectomy plus sentinel lymph node removal, with all but 3% of these complications graded as 1 or 2, which is our a primarily infectious in nature grading that requires bedside care, oral, or IV medications to resolve.
00:06:04.800 --> 00:06:10.319
There were no complications due to retroperitoneal dissection or nodal removal.
00:06:10.639 --> 00:06:18.079
There were 98 patients or 44% of our cohort who were upstaged from hyperplasia to endometrial cancer on final pathology.
00:06:18.639 --> 00:06:24.879
10% of the patients who were upstaged to endometrial cancer at the time of their hysterectomy were given postoperative therapy.
00:06:25.120 --> 00:06:28.879
And the majority of those patients were recommended based on uterine risk factors.
00:06:29.199 --> 00:06:34.240
Most had received IVRT, although some were also recommended for chemotherapy.
00:06:34.560 --> 00:06:40.160
One patient who had stage 3A disease on final pathology, and another patient with stage 3C disease.
00:06:40.800 --> 00:06:44.399
Only one patient in our cohort had occult nodal disease.
00:06:45.120 --> 00:06:50.240
And all patients in this group who received treatment had had an SLN assessment.
00:06:51.439 --> 00:07:02.959
Also interesting that of those 33 patients in our study who had molecular profile data available, which was about 15% of the total cohort, all four subgroups were represented.
00:07:03.439 --> 00:07:11.199
Most were copy number low, but there were two pole E mutated tumors, three MSI high tumors, and one copy number high tumor.
00:07:12.160 --> 00:07:12.879
Thank you very much.
00:07:13.120 --> 00:07:14.639
Very, very interesting findings.
00:07:15.040 --> 00:07:15.279
Dr.
00:07:15.439 --> 00:07:22.000
Metanis, you also performed a study on sentinel lymph node assessment in endometrial intraepithelial neoplasia.
00:07:22.399 --> 00:07:26.720
Can you tell us about your study objective, methods, and key findings?
00:07:27.279 --> 00:07:27.759
Hi, Dr.
00:07:27.920 --> 00:07:28.480
Nelson.
00:07:28.639 --> 00:07:30.720
Thank you so much for inviting me today.
00:07:30.879 --> 00:07:33.360
It's a great honor to be with you, especially with Dr.
00:07:33.439 --> 00:07:34.160
Mueller and Dr.
00:07:34.240 --> 00:07:34.800
Rossi.
00:07:35.199 --> 00:07:39.439
Thank you for organizing this very important podcast discussing a very hot topic.
00:07:39.600 --> 00:07:47.120
When you look at the data, in the last two years, there are more than, I think, more than 10 cohort studies dealing with this specific question.
00:07:47.439 --> 00:07:53.759
Should we or shouldn't we assess the nodes when we have a pre-operative diagnosis of EIN?
00:07:54.240 --> 00:07:56.879
Now, the common state of these studies is no.
00:07:57.120 --> 00:07:59.199
Node assessment is not warranted.
00:07:59.519 --> 00:08:07.199
And the reason most of these studies give is that the risk of nodal disease in the presenter of EIN is between 1 to 2%.
00:08:07.839 --> 00:08:15.759
And this is a low percentage, a low rate of nodal detestative, and this procedure is not justified with this low rate.
00:08:16.319 --> 00:08:27.439
Here we disagree a bit with the statement, and we think we could approach the data in another way and analyze the data in another way, and then the conclusions would be different.
00:08:27.759 --> 00:08:29.680
Now let me tell you about our study.
00:08:29.759 --> 00:08:34.320
So it's a retrospective cohort study of patients diagnosed with DIN.
00:08:34.639 --> 00:08:46.720
All our patients underwent hystrectomy, the B2 was optional, but unlike most of the other studies and most of the actually the common practice, all of our patients had lymph node assessment.
00:08:47.039 --> 00:08:50.960
The surgeries were performed between 2010 and 2021.
00:08:51.440 --> 00:09:10.480
Overall, we had 162 patients, almost 40% of them were ultimately diagnosed with cancer, including 15 patients, 25% out of the 61 patients who had cancer, and 10% of the all EIM cohort.
00:09:10.879 --> 00:09:17.039
These 15 patients we had a high intermediate to high-risk disease as per BOG99.
00:09:17.200 --> 00:09:29.679
12 patients had a grade 2 to 3 disease, 8 more than 50% might be invasion, one patient had an ovarian metastasis, two patients end up having carcinoma.
00:09:30.080 --> 00:09:41.919
Now, this high prevalence of concurrent high-risk endometrial cancer correlates closely with the previous report, and in most of the reports it's it ranges between 15 to 25%.
00:09:42.960 --> 00:09:45.200
Now, what about the node involvement?
00:09:45.519 --> 00:09:57.039
So previous studies found a low incidence of lymph node metastasis and suggested that employing lymph node assessment for all women undergoing surgical treatment would have limited benefit.
00:09:57.519 --> 00:10:01.600
In our study, actually, we got pretty the same results.
00:10:01.759 --> 00:10:11.039
Only two patients had node limits and they were stayed at 31, but definitely we don't believe that lymph node evaluation could be omitted because of this.
00:10:11.679 --> 00:10:20.720
Lymph node information, also when it's negative, it has a pivotal impact on the adjuvant treatment of these patients.
00:10:21.120 --> 00:10:31.200
Knowing that the sentinels were free of metastasis allowed 10 patients to be offered adjuvant vaginal bracket therapy instead of external B review.
00:10:31.440 --> 00:10:32.399
This is one example.
00:10:32.879 --> 00:10:34.559
I'll continue with example two.
00:10:35.360 --> 00:10:45.360
Seven patients out of the 15 patients who had high permet to high-risk disease, seven patients had grade two disease with more than 50% parameter in data.
00:10:45.840 --> 00:11:00.960
The risk of pelvic and paraortic lymph node involvement in these patients, grade 2 with more than 50% metal risk is 19% and 14% for physic and paraortic respectively, as per 23.
00:11:01.200 --> 00:11:03.600
It's a very high risk of lymph nodes involvement.
00:11:04.000 --> 00:11:09.039
And if node's we're not expecting these patients, we have actually two options.
00:11:09.279 --> 00:11:15.840
The first is to treat these patients with EPRT, which would represent an over-treatment for them.
00:11:15.919 --> 00:11:30.960
And the second option is to re-evaluate the nodes, take these patients back to surgery, and that surgery would be most likely very challenging due to the post-trical lymphatic construction and the absence of curvature detection applied.
00:11:31.679 --> 00:11:40.960
This would lead for fundamental detection and increased risk for appropriated morbidity instead of minimal procedure than done in the primary surgery.
00:11:41.759 --> 00:11:48.879
I can give you more and more examples on how sentiment came and it affected our treatment.
00:11:49.120 --> 00:11:51.840
For example, there were two patients with ERA, right?
00:11:52.000 --> 00:11:55.440
So these two patients had an early stage disease.
00:11:55.840 --> 00:12:08.799
And the fact that the center is negative and the fact that we know that the center is negative allows us to treat them as per POG 249 with chemo followed by brachytherapy instead of chemo followed by EBRT.
00:12:09.440 --> 00:12:25.279
So for all of these reasons, we believe that the inclusion of sentinel lymph sampling in the surgery as a routine practice can be very, very helpful with minimal morbidity and it will allow us to avoid both under-treatment and over-treatment.
00:12:25.759 --> 00:12:26.159
Great.
00:12:26.240 --> 00:12:27.039
Thank you very much, Dr.
00:12:27.200 --> 00:12:27.919
Matanes.
00:12:28.320 --> 00:12:29.200
Now over to you, Dr.
00:12:29.279 --> 00:12:29.840
Rossi.
00:12:30.240 --> 00:12:35.679
You had the opportunity to review these papers in detail, and thank you again for writing an excellent editorial.
00:12:35.919 --> 00:12:37.840
Can you tell us how you think the studies of Dr.
00:12:38.000 --> 00:12:45.039
Mueller and Metanes contribute to the current landscape of studies on sentinel lymph node mapping in antimetrial hyperplasia and cancer?
00:12:45.200 --> 00:12:50.000
I'm particularly interested in the concept of the value equation that you raised in your editorial.
00:12:50.159 --> 00:12:56.480
And also, should we be including patients in the decision-making for interventions such as sentinel lymph node mapping?
00:12:57.679 --> 00:13:04.879
Thank you so much for the opportunity to discuss this very controversial and very clinically relevant topic.
00:13:05.120 --> 00:13:19.759
And I congratulate the authors of these two papers that were published in gynecologic oncology for really contributing to the body of literature some evidence regarding the virtues and pitfalls of this technique.
00:13:20.000 --> 00:13:40.480
You know, how I think this contributes is these are large series of, in some cases, prospectively maintained databases of patients with this condition shedding light into issues such as complication rates, as well as the true incidence of findings of occult cancer for patients with endometrial hyperplasia.
00:13:40.559 --> 00:13:44.159
And so this really helps us with our decision making as clinicians.
00:13:44.240 --> 00:13:50.320
We can fall back now on some literature and some evidence to support our decision making.
00:13:50.639 --> 00:13:55.679
And how that decision making plays out, as you mentioned, is sort of effectively a value equation.
00:13:55.759 --> 00:14:15.679
And the way I think about value equations with adopting techniques or technologies is it's not necessarily that more is better, but rather for a new technique or procedure to be adopted, the clinician should think about the pros and the cons in light of high quality and low cost.
00:14:16.000 --> 00:14:19.039
And it's not necessarily that cheaper is lower cost.
00:14:19.120 --> 00:14:21.279
There's many things that contribute to cost.
00:14:21.759 --> 00:14:28.000
But with respect to what makes high quality, high quality are things like the efficacy of the technique.
00:14:28.159 --> 00:14:44.720
So what's the ability of the technique, in this case, sentinel lymph node biopsy for EIN, to find metastases in the lymph nodes, to help surgeons or clinicians determine therapies for their patients postoperatively, including the de-escalation.
00:14:44.799 --> 00:14:54.000
So not prescribing unnecessary treatments like, for example, radiation postoperatively because we lack information about nodal status.
00:14:54.240 --> 00:14:59.440
That's part of the value equation, that's part of the efficacy and quality of the procedure.
00:14:59.519 --> 00:15:01.200
So that needs to be high.
00:15:01.519 --> 00:15:05.840
Also, part of that quality part of the equation is complication rates.
00:15:06.000 --> 00:15:17.679
So what we observed from these two papers was that there were no increased risks for complications, perioperative complications, that were observed with the addition of sentinel lymph node biopsy.
00:15:17.919 --> 00:15:32.080
What I think is interesting is that these are two very high-volume centers in, particularly in this technique, with a long history of experience in publishing in sentinel lymph node biopsy for endometrial cancer and now in EIN.
00:15:32.320 --> 00:15:49.679
And so the question that I ask is while these groups demonstrated high quality in their performance of sentinel lymph node biopsy for EIN, the question is, would that be true for all clinicians with their own individual levels of experience, their own tool sets available to them, et cetera?
00:15:49.840 --> 00:15:54.480
So that's the that's the quality element of the value equation, and that needs to be high.
00:15:54.639 --> 00:16:07.840
And it seems to be, at least in these studies, that the the ability for sentinel nodes to find metastatic disease is high, and the ability to do that while incurring damage to the patient in form of complications is low.
00:16:08.159 --> 00:16:14.879
Then the other element of that value equation is cost, and that's we divide quality by cost, and that provides value.
00:16:14.960 --> 00:16:18.159
And so costs need to be low for value to be high.
00:16:18.399 --> 00:16:26.960
And while these papers did not evaluate costs, cost has been evaluated in other papers looking and evaluating sentinel lymphnobsy for EIN.
00:16:27.120 --> 00:16:37.440
It's a complicated question to ask because there are many things that contribute to the cost of surgery, and the cost of surgery is not ubiquitous for all surgeons and for all sites.
00:16:37.600 --> 00:16:49.120
It's been proposed that sentinel lymph nobiopsy for EIN is perhaps not as cost effective as using hysterectomy alone or lymph nodiopsy guided by frozen section.
00:16:49.600 --> 00:16:58.000
However, there are many things that contribute to that, and those cost-effectiveness analyses make assumptions based on averages.
00:16:58.159 --> 00:17:05.680
And clearly, averages don't apply to each individual surgeon or each individual site, or even certainly each individual patient.
00:17:05.920 --> 00:17:12.799
And so we really have to think about how long does it take at our institutions to obtain that information through frozen section?
00:17:12.880 --> 00:17:24.720
And what is the cost of operating room time for that procedure to be put on hold waiting for a frozen section versus the cost of the dye and the time to perform a sentinel lymph node biopsy.
00:17:24.880 --> 00:17:32.240
So these are all sort of important cost considerations to make and really individualize for individual surgeons and individual sites.
00:17:32.400 --> 00:17:47.200
But each practitioner needs to keep that value equation in their mind when they're making a decision about adopting or not considering adopting a new procedure or more ubiquitously applying a procedure such as sentinel lymph nodiopsy for EIN.
00:17:47.519 --> 00:18:00.000
In addition to value, it's also important to consider patients' feelings about the procedure and the value of the procedure to them, which may be a different value equation to what it means to us as clinicians.
00:18:00.400 --> 00:18:21.599
It's we we when we consider value and we consider risks to patients, we're often not considering what they value and consider to be beneficial, such as, for example, complete information about the status of their disease rather than guesstimates about the likelihood or probability of lymph node metastases.
00:18:21.839 --> 00:18:35.359
Many patients may enjoy or prefer to know with greater certitude the status of lymph nodes and may be prepared to take on a small potential increased risk if one exists to having lymph node assessment for that.
00:18:35.440 --> 00:18:41.920
And we shouldn't dismiss patients' desire to have complete staging information in the case of endometrial cancer.
00:18:42.079 --> 00:18:43.839
And that should be part of the decision.
00:18:44.000 --> 00:18:54.559
Now, some patients may actually be more concerned or worried about the potential for, for example, lymphedema or other complications or length of surgery.
00:18:54.720 --> 00:19:06.640
So we can't make assumptions as to what things patients are going to be more concerned about, incomplete staging information or risks of surgery or added operative time, but rather open that up to patients in our discussion.
00:19:06.720 --> 00:19:18.319
And that's really what we all mean by shared decision making is not having our own values about a procedure be the dominant verdict, but rather have our patients weigh in and share with us what their values are as well.
00:19:18.720 --> 00:19:19.759
Very, very interesting.
00:19:19.920 --> 00:19:20.720
Thank you so much.
00:19:20.880 --> 00:19:34.240
Another question I had, you also indicated that there's a need for the American College of Obstetricians and Gynecologists and also the Society of Gynecological Oncology to revisit their practice statements in this domain.
00:19:34.480 --> 00:19:39.200
Can you tell us a little bit more about that and how should we go about advocating for this change?
00:19:39.920 --> 00:19:45.519
Right now, clinicians frequently will look to guidelines in practice statements and bulletins.
00:19:45.599 --> 00:19:58.799
And this is true particularly for, for example, a general OBGYN who might make a diagnosis of EIN in their office and be making a decision: should I operate on this patient or refer this patient to a GYN oncologist?
00:19:59.119 --> 00:20:12.079
And unfortunately, the statements that are provided to date are fairly gray and don't provide a lot of clear guidance as to the extent of surgery that should be done or could be done for these patients.
00:20:12.400 --> 00:20:21.680
And so I do think that now that we have sentinel lymph node biopsy much more broadly practiced than perhaps when those position statements were originally written.
00:20:21.839 --> 00:20:32.240
And because of that, a comfort level skill set and low complication rate associated with it, it's really provided a new alternative to lymph node assessment for endometrial cancer.
00:20:32.319 --> 00:20:43.119
And I think it's time to revisit those statements and provide some better guidance that include data such as that presented in the gynecologic oncology journal last month.
00:20:43.279 --> 00:20:55.119
And so for those reasons, I feel that it's time for groups such as the SGO, for example, the Clinical Practice Committee might be a place that potentially a position statement could begin.
00:20:55.200 --> 00:20:59.920
And that could help guide our societies as to updating their own position statements.
00:21:00.160 --> 00:21:09.519
The NCCN guidelines as another opportunity for us to update our recommendations with both updated data as well as recommendations.
00:21:09.759 --> 00:21:28.640
But as I think you'll appreciate from my editorial, while I think there's an opportunity to provide more data for decision making for patients and clinicians, I don't think we're quite at a point where a ubiquitous statement of, for example, sentinel lymph nobiopsy should be performed for all patients or for no patients.
00:21:28.799 --> 00:21:30.400
I don't think we're at that point.
00:21:30.720 --> 00:21:59.680
I think we're at a position where we can provide clinicians with information about what we know about the likelihood of finding metastatic disease with a sentinel noobiopsy, what we believe are the observed risks of complications to the procedure, the potential costs to the procedure, and the potential benefits to the procedure of understanding about the extent of disease and being able to either escalate or de escalate therapies for patients post operatively when they're identified.
00:22:00.319 --> 00:22:04.799
To have cancer on their final hysterectomy specimen pathology evaluation.
00:22:05.200 --> 00:22:08.960
Again, thank you so much for your valuable insights into the importance of these studies.
00:22:09.119 --> 00:22:12.559
You clearly were the right person to invite for this editorial.
00:22:12.880 --> 00:22:15.519
To wrap up, I'd like to come back to the study authors.
00:22:15.759 --> 00:22:16.000
Dr.
00:22:16.079 --> 00:22:18.960
Mueller, can you tell me if there are any limitations of your study?
00:22:19.039 --> 00:22:21.119
And do you have any future studies planned?
00:22:21.680 --> 00:22:22.559
Yes, of course.
00:22:22.799 --> 00:22:32.960
So there are inherent limitations to a single institution study, and also there's the potential for referral bias because our institution is a large cancer center.
00:22:33.200 --> 00:22:36.240
And I think our results need to be considered in that context.
00:22:36.640 --> 00:22:49.359
It's also important to note that we're an institution that has ready access to gynecologic oncologists as a community resource, and all of the surgeons in our department are well trained in central lymph node mapping techniques.
00:22:49.599 --> 00:22:55.759
And that may not be the case across all institutions, and that limits the applicability of these findings.
00:22:56.640 --> 00:23:12.400
An area I very much find interesting and wish to pursue in the future is the decision-making process that a patient goes through to make choices in this clinical scenario, as there are multiple reasonable options.
00:23:13.039 --> 00:23:23.200
Concepts like decisional regret, stress, anxiety all can factor in if patients are not presented with all the options before having a surgery.
00:23:23.920 --> 00:23:26.079
And the literature is limited on this.
00:23:26.319 --> 00:23:31.440
And so I think that more patient-centered research could be really valuable in this particular space.
00:23:32.000 --> 00:23:54.799
I also think the molecular profile of endometrial hyperplasia can be of potential benefit in the future as we're learning a lot more about molecular subtyping and whether subtype could correlate to the risk of nodal metastasis, which is ultimately one potential way that we could try and allocate the utilization of the technique of SLN mapping in this particular circumstance.
00:23:55.200 --> 00:23:56.160
How about you, Dr.
00:23:56.319 --> 00:23:57.039
Mitanis?
00:23:57.119 --> 00:23:59.759
Anything you would like to tell us about your study limitations?
00:23:59.920 --> 00:24:02.400
And do you have any future studies planned?
00:24:02.880 --> 00:24:04.480
Yeah, limitations for sure.
00:24:04.559 --> 00:24:06.640
We had uh several limitations for the study.
00:24:06.799 --> 00:24:15.519
The first one and the major one is that the fact that this study is a retrospective evaluation with the potential for inherent and selection biases.
00:24:15.839 --> 00:24:18.880
Our study had a very low number of events.
00:24:19.119 --> 00:24:24.160
So, sure, further prospective studies with bigger sample size should be done.
00:24:24.319 --> 00:24:28.079
We didn't look at the cost effectiveness of this procedure.
00:24:28.319 --> 00:24:43.440
And lastly, the rate of concurrent high intermediate and high risk endometric cancer is slightly high in our cohort, and this could be explained by the fact that we are a tertiary referral center that receives referrals from many smaller centers.
00:24:43.680 --> 00:24:51.599
Having said all of this, this series is the largest series that includes patients with EIN undergoing lymph node assessment.
00:24:51.759 --> 00:25:17.759
All of our patients had lymph node assessment, and our take-home message was and still that the information from Sentinel, even when negative, is very helpful in the management of patients with endometrial with endometrial cancer after pre-operative EIN, as a proportion of these patients are found to have high intermediate to high risk disease, and these patients would be exposed to either under-treatment or over-treatment.
00:25:18.000 --> 00:25:22.799
Both could be avoided by primary sentinel lymph node sampling.
00:25:23.359 --> 00:25:23.920
Excellent.
00:25:24.079 --> 00:25:24.799
Thank you.
00:25:25.039 --> 00:25:27.119
Well, I've really enjoyed speaking with you all today.
00:25:27.200 --> 00:25:30.799
I've certainly learned a lot, and hopefully so too have our listeners.
00:25:31.039 --> 00:25:33.279
My thanks to our guests for joining us today.
00:25:33.440 --> 00:25:45.599
The articles and the editorial we've discussed are available at gynecologic oncology online.net, and you can access our podcast at the journal's homepage, Apple iTunes, Google Play, and Spotify.
00:25:45.839 --> 00:25:47.279
Thank you for listening.
