Intra-operative frozen section results reliably predict final pathology in endometrial cancer

doi:10.1016/j.ygyno.2014.03.569

Gynecologic Oncology

Volume 133, Issue 3, June 2014, Pages 499-505

https://doi.org/10.1016/j.ygyno.2014.03.569 Get rights and content

Highlights

•
Correlation between frozen section and paraffin section for histology, grade, and depth of invasion was 97.5%, 88%, and 98.2% respectively.
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Our results support frozen section analysis as a means to guide intra-operative decision-making regarding the necessity of a lymphadenectomy.
•
Frozen section is a reasonable alternative to the “all or none” approach regarding lymphadenectomy for low-risk endometrial cancer patients.

Abstract

Objectives

Typically, complete surgical staging is necessary for patients with high-risk endometrial cancer. However, patients with low-risk disease may be able to avoid lymphadenectomy and its associated morbidity. We sought to evaluate the agreement rates between the intra-operative frozen sections (FSs) and the final paraffin sections (PSs) at our institution, and to determine if this was a reliable method for guiding our intra-operative decision-making with regard to the necessity of lymphadenectomy.

Materials and methods

116 patients with a pre-operative diagnosis of endometrioid adenocarcinoma of the uterus or complex atypical hyperplasia (CAH) underwent surgery at our institution. Demographic data, as well as information on stage, grade, histology and depth of invasion determined at FS and on PS were collected. Cohen's kappa statistic was used to assess the agreement rate between FS and final PS with regard to depth of invasion, grade, and histology.

Results

Our correlation rate between FS and final PS for histologic subtype, grade, and depth of myometrial invasion was 97.5%, 88%, and 98.2% respectively. Seven cases identified as complex atypical hyperplasia on FS were later determined to be cancerous on final PS, resulting in two patients being undertreated.

Conclusions

Our results support the use of FS analysis as a means to guide intra-operative decisions regarding lymphadenectomy. Determination of histologic subtype, depth of invasion and grade is reliable at our institution, and demonstrates high concordance rates between FS and PS. These factors should be used to guide intra-operative decision-making regarding the necessity of a lymphadenectomy in patients with endometrial cancer.

Introduction

With an estimated incidence of 49,560 new cases in 2013, endometrial cancer is the most common gynecologic malignancy in the United States [1]. More than 70% of women present with disease confined to the uterus, with the remainder having more advanced disease [2]. The cornerstone of treatment for endometrial cancer involves a hysterectomy and bilateral salpingo-oophorectomy. The indication and extent of lymph node dissection in the surgical management of endometrial cancer remain highly controversial [3], [4], [5]. In fact, whereas there is general agreement about the necessity of complete surgical staging for high-risk endometrial cancer patients [6], this is less clear in patients with apparent low-risk disease. The identification of those patients with low-risk disease who also have a high probability of nodal involvement, and therefore might benefit from a lymphadenectomy is a current clinical question that remains unanswered.

One common approach is the use of intra-operative frozen section (FS) to identify pathologic high-risk features, such as deep myometrial invasion, tumor size and/or high-grade disease, to guide intra-operative decision-making. However, because the correlation between those high-risk factors and lymph node involvement is derived from studies examining paraffin sections (PSs), the accuracy of intra-operative FS is key in the guidance of intra-operative decision-making. There have been conflicting reports in the literature about the accuracy and reliability of findings based upon intra-operative frozen sections in endometrial cancer tissue specimens. In some centers it was found to be a useful tool for guiding intra-operative decision-making [7], [8], [9], whereas in others it was found to be inconsistent [10], [11]. At our institution, a lymphadenectomy is usually performed on all patients with grade 2 and 3 endometrial cancers independent of the histology or depth of tumor invasion, as well as on all patients with grade 1 endometrioid adenocarcinoma with more than 50% myometrial invasion. We sought to evaluate the reliability and agreement rates between the intra-operative FS and the final PS at our institution, and to determine if this was a reliable method for guiding our intra-operative decision-making with regard to the necessity of lymphadenectomy.

Section snippets

Material and methods

This study was approved by the Institutional Review Board of the University of Iowa Hospitals and Clinics (UIHC). Between January and December 2012, one hundred and sixteen patients with a pre-operative diagnosis of endometrioid adenocarcinoma of the uterus, complex atypical hyperplasia (CAH) or a suspicion of endometrial carcinoma underwent surgery at our institution as part of their treatment. All patients had had pre-operative endometrial sampling performed locally, and the slides were

Results

A total of 116 patients underwent surgery and were treated at our institution during the study period. Patient characteristics are shown in Table 1. As shown in Table 2, there were 94 patients with a pre-operative diagnosis of endometrial carcinoma, 20 patients with complex atypical hyperplasia (CAH), and two patients with suspicion for carcinoma. All patients were evaluated initially by intra-operative FS, and then by a definitive PS to determine the degree of concordance between FS and PS. A

Discussion

Published in 1987, the Gynecologic Oncology Group (GOG) study GOG 33 identified several histopathological risk factors that were important in determining lymph node metastasis, primarily tumor grade and depth of invasion [6]. Deeply invasive, poorly differentiated tumors have a greater likelihood of metastasizing to the pelvic and/or para-aortic lymph nodes. These factors, with the addition of tumor size, still remain important prognostic indicators of lymph node metastasis today [7]. Although

Conflict of interest

There are no conflicts of interest.

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Hysterectomy with a general gynecologist vs gynecologic-oncologist in the setting of endometrial intraepithelial neoplasia: a cost-effectiveness analysis
2022, American Journal of Obstetrics and Gynecology
Standard treatment for patients with endometrial intraepithelial neoplasia (EIN) is a hysterectomy, which has a 43% risk of concomitant endometrial cancer on final pathology. General gynecologists and gynecologic-oncologists perform hysterectomies; however, patients who have a hysterectomy for EIN with a general gynecologist and are found to have cancer may require a second surgery by a gynecologic-oncologist to complete staging. There is ongoing discussion regarding whether patients with EIN should be provided the option to receive the initial hysterectomy with a gynecologic-oncologist.
This study aimed to better understand if patients with EIN should be initially referred to a gynecologic-oncologist for treatment. We examined the cost-effectiveness of hysterectomy by general gynecologists vs gynecologic-oncologists for patients with EIN.
We created a decision-analytical model using TreeAge Pro software to compare outcomes between hysterectomies by general gynecologists and those by gynecologic-oncologists in patients with EIN. Our theoretical cohort contained 200,000 patients, an estimate of the number of individuals diagnosed with EIN each year in the United States. Outcomes included costs, quality-adjusted life years, primary lymph node dissection, secondary lymph node dissection, surgical site infection, and perioperative mortality. We assumed that surgical morbidity and mortality were the same under generalist and specialist care and applied costs of travel and lost work for those seeing a gynecologic-oncologist. We performed univariable sensitivity analyses and multivariable probabilistic sensitivity analysis to assess the model’s robustness given the uncertainty of model inputs.
In our theoretical cohort of 200,000 patients with EIN, hysterectomy with a gynecologic-oncologist was associated with a decrease of 10,811 second surgeries for lymph node dissection, 87 surgical site infections, and 9 perioperative mortalities. When hysterectomy was performed by a general gynecologist, 9 fewer patients had a lymph node dissection because of perioperative mortalities that occurred before lymph node dissection with a gynecologic-oncologist. Hysterectomy with a gynecologic-oncologist was the dominant, cost-effective strategy because it saved $116 million and increased quality-adjusted life years by 180. In our univariable analyses, hysterectomy with a gynecologic-oncologist was cost-saving and increased quality-adjusted life years over a wide range of probabilities and costs for lymph node dissection, surgical site infection, and perioperative mortality. However, hysterectomy with a gynecologic-oncologist was only a cost-effective and cost-saving strategy in just over 50% of multivariable simulations, demonstrating that there is significant uncertainty in the model’s cost-effectiveness.
In our model, hysterectomy with a gynecologic-oncologist for patients with EIN was associated with cost savings and increased quality-adjusted life years. Our study supports that patients undergoing hysterectomy for EIN at institutions using Mayo criteria to determine need for lymphadenectomy may benefit from surgery with a gynecologic-oncologist rather than a general gynecologist to reduce costs and adverse events associated with a second surgery.
Determining the stage of endometrial cancer for its surgical treatment
2022, American Journal of Obstetrics and Gynecology
Evaluation of frozen section biopsy for fast track diagnosis of endometrial pathology in high-risk women with abnormal uterine bleeding
2021, European Journal of Obstetrics and Gynecology and Reproductive Biology
To study the accuracy of frozen section biopsy for endometrial pathology in high-risk women with abnormal uterine bleeding (AUB).
A case-control study was conducted between November 2017 to April 2019, a total of 150 women with postmenopausal bleeding, perimenopausal AUB, and high-risk women of age < 40 years with AUB were recruited. All women underwent transvaginal sonography and Doppler, based on age-appropriate endometrial thickness cut-offs 80 women then underwent hysteroscopy. Based on hysteroscopy, women suspicious of malignancy were taken as cases (n = 40) and those with benign findings as controls (n = 40). All cases and controls underwent dilatation and curettage (D & C) with frozen section (FS) and routine histopathology.
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR), negative LR, and overall test accuracy of FS were 90.9%, 93.19%, 83.33%, 96.19%, 13.8, 0.1 and 86.25% respectively for diagnosing endometrial hyperplasia and cancer taking histopathology as the gold standard. Correlation between frozen section biopsy and histopathology was highly significant (p < 0.001) on D & C specimens and the level of agreement was good (K = 0.778).
In women suspicious of malignancy on hysteroscopy, frozen section has high accuracy on D&C specimen and can be used to diagnose endometrial hyperplasia and cancer in an effort to fast-track investigations and work-up for definitive treatment while awaiting final histopathology.
Accuracy of preoperative endometrial biopsy and intraoperative frozen section in predicting the final pathological diagnosis of endometrial cancer
2020, Surgical Oncology
Citation Excerpt :
Unfortunately, wide discrepancy rate (23%–56%) was reported between preoperative and postoperative ESMO risk groups. Moreover, the range of FS-accuracy rate is 58–98% for tumor grade and 54–95% for depth of myoinvasion [10–18]. This variability could have clinical impact: unnecessary lymphadenectomy may have been performed in case of overestimation of the risk group, while further surgery or adjuvant therapies are required in case of risk underestimation.
Histotype and grade of endometrial cancer (EC) are prognostic factors of nodal involvement and thus of survival. Preoperative biopsy (PB) and intraoperative frozen section (FS) are usually used to guide surgical staging on which the choice of adjuvant therapy will be based successively.
The aim of this study was to assess the agreement rate between PB and FS with final diagnosis (FD) in a series of surgically resected EC.
All patients submitted to hysterectomy for EC or atypical endometrial hyperplasia in the Reggio Emilia Province hospitals from 2007 to 2018 were included. Concordance rate differences in histotype, grading, myoinvasion, risk of recurrence between PB, FS and FD were assessed with Fisher's exact test and Mc Nemar contingency test.
A total of 352 patients were identified. For 345 patients it was possible to compare PB and FD results. FS examination was performed in 201/352 (57%) cases, while for 21/352 (6%) patients only an intraoperative macroscopic evaluation was done; in the remaining women, FS-exam was omitted. In 14/201 (7%) cases the tumor wasn't grossly identifiable and the random FS-sampling wasn't able to find the tumor site.
High diagnostic concordance of tumor type between PB and FD was observed: no significant differences were registered in type 1 and type 2-endometrial cancer identification (83%, 73%, p = 0.121). Significant differences (p = 0.005) were observed comparing FS and FD results: 95% of type 1-ECs were correctly diagnosed by FS, while only 76% of type 2-ECs received a correct diagnosis on FS. PB showed a concordance with FD among tumor grading close to 55% whilst concordance achieved 71% grouping low grade (G1-G2) EC. No significant differences in FS and FD concordance rate were observed between tumor grades. Concordance for low grade was significantly higher than for high grade ECs (89% vs 50%, respectively, p value = 0.014).
The concordance rate in evaluating the myoinvasion status between FS and FD was 80% (n: 199 patients), reaching 99% after combining the first 2 groups (0–49% vs ≥ 50%). Twenty-two cases underwent only intraoperative macroscopic evaluation of the myoinvasion, with an accuracy of 91%: only in 1 case the invasion of the cervical stroma was not detected (Stage II), and 1 case the patient was overstaged as Ib.
Discrepancies were observed in FS capacity to correctly predict the final ESMO risk group in stage I patients: FS resulted particularly reliable in predicting a low-risk (concordance with FD: 91%) while the accuracy sharply decreased for intermediate- and high-risk patients (62% and 40%, respectively).
To investigate the usefulness of FS in EC management, we compared patients who underwent FS (FS-group) or not (no–FS–group). Especially for low risk patients, the FS significantly increased the adequacy of surgical treatment from 53% (no–FS–group) to 72% (FS-group) (p = 0.016).
FS remains a useful tool to tailor surgery in EC-patients, avoiding secondary surgery to complete staging particularly in patients with AH + AHBA, low and intermediate risk ECs that could benefit from adjuvant therapy.
Endometrial cancer: Preoperative versus intraoperative staging
2020, Journal of Gynecology Obstetrics and Human Reproduction
To determine the accuracy of transvaginal ultrasonography (TVS) and pelvic magnetic resonance imaging (MRI) in preoperative staging of endometrial cancer in comparison to frozen section (FS) for the assessment of myometrial invasion, considering permanent section as the gold standard.
A retrospective longitudinal study of all endometrial carcinomas diagnosed in our institution between March 2012 and October 2018 was conducted. Women with histologically confirmed endometrial malignancy, planned for surgery as primary treatment and submitted either to TVS, MRI and/or intraoperative FS followed by comprehensive surgical staging were eligible.
From a total of 187 endometrial carcinomas, 156 were eligible for the study. The most frequent histology was endometrioid carcinoma (n = 115), followed by serous carcinoma (n = 25); the majority presented a FIGO stage IA (n = 85) or IB (n = 21). TVS, MRI and FS presented a sensitivity 56 %, 71 % and 67 % [95 %CI 0.35-0.75; 0.49-0.87; 0.45-0.84] and a specificity of 90 %, 78 % and 94 % [95 %CI 0.79-0.97; 0.58-0.91; 0.84-0.98], respectively. FS was the method with the lowest overestimation rate (6.5 %, 95 %CI 0.02-0.16), whereas MRI showed the lowest underestimation rate (29.2 %, 95 %CI 0.13-0.51). Agreement was superior between MRI and FS (Pa = 0.79, K = 0.56) and secondly between MRI and TVS (Pa = 0.78, K = 0.47).
Intraoperative FS presents the higher specificity and the lowest overestimation rate, while MRI seems to be the exam with the highest sensitivity in the evaluation of myometrial invasion. Agreement between the different methods is reasonable, suggesting that the best alternative will be highly dependent on the availability and experience of each institution.
Guideline No. 390-Classification and Management of Endometrial Hyperplasia
2019, Journal of Obstetrics and Gynaecology Canada
The aim of this guideline is to aid primary care physicians and gynaecologists in the initial evaluation of women with suspected endometrial hyperplasia, to recommend the use of the 2014 World Health Organization classification for endometrial hyperplasia by all health care providers, and to guide the optimal treatment of women diagnosed with endometrial hyperplasia.
Physicians, including gynaecologists, obstetricians, family physicians, general surgeons, emergency medicine specialists; nurses, including registered nurses and nurse practitioners; medical trainees, including medical students, residents, and fellows; and all other health care providers.
Adult women (18 years and older) presenting with suspected or confirmed endometrial hyperplasia.
The discussion relates to the medical therapy as well as surgical treatment options for women with and without atypical endometrial hyperplasia.
For this guideline, relevant studies were searched in PubMed, Cochrane Wiley, and the Cochrane Systematic Reviews using the following terms, either alone or in combination, with the search limited to English language materials, human subjects, and published since 2000: (endometrial hyperplasia, endometrial intraepithelial neoplasia, endometrial sampling, endometrial curettage, diagnosis) AND (treatment, progestin therapy, surgery, LNG-IUS, aromatase inhibitors, metformin ), AND (obesity). The search was performed in April 2018. Relevant evidence was selected for inclusion in the following order: meta-analyses, systematic reviews, guidelines, randomized controlled trials, prospective cohort studies, observational studies, non-systematic reviews, case series, and reports. Additional significant articles were identified through cross-referencing the identified reviews. The total number of studies identified was 2152, and 82 studies were included in this review.
The content and recommendations were drafted and agreed upon by the authors. The Executive and Board of the Society of Gynecologic Oncology of Canada reviewed the content and submitted comments for consideration, and the Board of the Society of Obstetricians and Gynaecologists of Canada approved the final draft for publication. The quality of evidence was rated using the criteria described in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology framework. The interpretation of strong and weak recommendations was also included. The Summary of Findings is available upon request.
It is expected that this guideline will benefit women with endometrial hyperplasia. This should guide patient informed consent before both medical and surgical management of this condition.
Evidence will be reviewed 5 years after publication to decide whether all or part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations.
- 1
  In addition to epidemiologic risk factors related to estrogen exposure, intermenstrual bleeding and postmenopausal bleeding are associated with increased risk of endometrial hyperplasia. Endometrial sampling should be carried out as per published algorithms with particular attention to women 40 years or older or with a body mass index of 30 kg/m² or greater (moderate).
- 2
  Since the majority of cases of endometrial hyperplasia without atypia are successfully managed medically, hysterectomy is not considered first-line treatment and surgery is reserved for specific circumstances (moderate).
- 3
  A minimally invasive approach to hysterectomy is preferred for endometrial hyperplasia as it decreases perioperative morbidity and mortality (high).
- 4
  If hysterectomy is indicated for endometrial hyperplasia without atypia then postmenopausal women should also be offered bilateral salpingo-oophorectomy. This decision is individualized for premenopausal women due to increased mortality and morbidity associated with removal of the ovaries in young women with benign disease (moderate).
- 5
  Hysterectomy and bilateral salpingo-oophorectomy are the recommended treatment for atypical endometrial hyperplasia due to the underlying risk of malignancy or progression to endometrial cancer. Retention of the ovaries in premenopausal women may be considered (low).
- 6
  There is no evidence to support routine intraoperative frozen section analysis in cases of endometrial hyperplasia (low).
- 7
  There is no evidence to support routine lymphadenectomy for atypical endometrial hyperplasia (moderate).
- 8
  There is insufficient evidence to support endometrial ablation as first-line surgical treatment for endometrial hyperplasia without atypia (low).
- 9
  Endometrial hyperplasia found in endometrial polyps should be treated according to its histologic classification (low).
- 1
  Health care providers should use the 2014 World Health Organization histopathologic classification of endometrial hyperplasia (strong, low). If endometrial cancer is suspected, endometrial tissue sampling using a Pipelle device in an outpatient setting is the most appropriate first step for diagnosis (strong, high).
- 2
  Those with recurrent symptoms of abnormal uterine bleeding after initial observation or medical treatment should be reassessed with an endometrial biopsy (strong, high).
- 3
  Patients with endometrial hyperplasia should be assessed for reversible risk factors and receive education and support from their clinicians in order to treat and reverse those conditions (strong, high).
- 4
  Patients with endometrial hyperplasia without atypia can be observed. They can be offered hormonal treatment if hyperplasia does not resolve with observation or experience abnormal uterine bleeding (weak, low).
- 5
  The levonorgestrel intrauterine system should be used as the first-line treatment for endometrial hyperplasia without atypia due to its effectiveness and favourable side effect profile (strong, high) and due to the fact that it can be kept in place for 5 years in patients showing treatment response (strong, moderate).
- 6
  Low-dose oral and injectable progestins remain an acceptable treatment option for women with endometrial hyperplasia with and without atypia desiring an alternative treatment modality (strong, high). For patients on oral progestins, we suggest starting on a low dose for a minimum of 6 months. We suggest that assessment of the endometrium be done mid-therapy as well as 3 weeks after completion of treatment to ensure proper interpretation (strong, very low).
- 7
  Surgical treatment of endometrial hyperplasia without atypia should be reserved for patients who do not want to preserve their fertility and experience progression to atypical hyperplasia or carcinoma during follow-up, whose hyperplasia fails to regress after 12 months of medical treatment or relapses after completing treatment with progestins, who continue to experience abnormal uterine bleeding despite treatment, or who decline endometrial surveillance or medical treatment (strong, high).
- 8
  If surgery is indicated for endometrial hyperplasia without atypia, the procedure should include total hysterectomy with opportunistic salpingectomy, with or without bilateral oophorectomy depending on menopausal status (strong, moderate).
- 9
  Total hysterectomy with bilateral salpingo-oophorectomy is recommended for treatment of atypical hyperplasia in premenopausal and postmenopausal women (strong, moderate). In premenopausal women, ovarian preservation should be discussed (strong, moderate).
- 10
  We recommend that subtotal (supracervical) hysterectomy and morcellation be avoided in all cases of endometrial hyperplasia (strong, low).

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Intra-operative frozen section results reliably predict final pathology in endometrial cancer

Highlights

Abstract

Objectives

Materials and methods

Results

Conclusions

Introduction

Section snippets

Material and methods

Results

Discussion

Conflict of interest

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Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths

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