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Endometrial Biopsy Using a Novel Endometrial Sampler is a Reliable Method for Detecting Endometrial Cancer with High Interobserver Agreement
Abstracts 54 The Effectiveness of Cytologic Evaluation of Urinary Diversion Specimens and UroVysion Assay as Surveillance Tests in the Detection of Recurrent Bladder Cancer Christopher Wienczewski, MD, Tomi Kuntzman, DO, Mitual Amin, MD, Gregory McLennan, MD, Emily Blum, MD. William Beaumont Hospital, Troy, Michigan Introduction: Different surveillance protocols exist for the detection of urothelial carcinoma recurrence in patients that have undergone radical cystectomy (RC) and each protocol varies in choice of test and frequency of testing. Cytologic examination of urinary diversion specimens and UroVysion assay are two surveillance tests that may be used to detect recurrent disease. The cytologic interpretation of urinary diversion specimens is suboptimal since they contain abundant degenerate glandular cells, histiocytes, bacteria, acute inflammation and non-specific debris. In this milieu recurrent disease can be obscured and identification made difficult, if not impossible. The purpose of this study is to evaluate the effectiveness of cytology and UroVysion assay in this subset of patients. Materials and Methods: A Retrospective chart review of 97 patients who underwent RC with cutaneous diversion or orthotopic neobladder reconstructions for bladder cancer and who also had a LIS (Laboratory Information System) word search result containing “ileal conduit urine” between January 2001 and January 2012 was performed. The cytopathology reports for urinary diversion specimens and any UroVysion assays from these patients were reviewed. Cytologic results were divided into positive, suspicious, atypical, negative and unsatisfactory. The atypical category did not imply malignancy or the potential for malignancy, but was used to indicate some degree of variation from cytology seen in traditional urine specimens. Results: A total of 355 urinary diversion cytology reports were reviewed with diagnoses as follows: positive e 0, suspicious e 3 (0.8%), atypical e 136 (38.3%), negative e 213 (60%) and unsatisfactory e 3 (0.8%). A total of 56 Urovysion molecular tests were reviewed with interpretations as follows: positive e 3 (5.3%), negative e 39 (69.6%), indeterminate e 2 (3.6%), insufficient e 12 (21.4%). Four of 97 patients (4.1%) had at least one abnormal cytologic result. One cytologic diagnosis of atypical showed no abnormality on pouch biopsy. The remaining 3 patients with abnormal cytologies had no subsequent biopsies at our institution. Two patients had positive Urovysion assays and both these patients had orthotopic neobladder reconstructions. One patient had two subsequent positive Urovysion assay results which are accounted for by the presence of residual transitional cell carcinoma in-situ (TCIS) in the urethra as this patient had a positive urethral margin at the time of his cystoprostatectomy. The second patient with a positive UroVysion assay result occurred in a patient with 5 normal urinary diversion cytologies who was ultimately diagnosed with Stage 4 urothelial cancer (urothelial carcinoma metastasis to skin). This was deemed to be a false positive test result based on clinical assessment. None of the four patients with abnormal cytology results were found to have recurrent disease. Conclusion: The results of this study question the effectiveness of cytologic evaluation of urinary diversion specimens and UroVysion assay as surveillance tests for detecting recurrent bladder cancer. We did not detect any upper tract/urethral recurrence in our series. Furthermore, the UroVysion assay is not FDA-approved for testing urine specimens derived from patients 55 Factors Potentially Associated with False Positive and False Negative UroVysion Testing in Diagnosing Bladder Cancers Jack Yang, MD, Christina Stallworth, MD, Daynna Wolff, PhD, Patricia Houser, MHS, CT(ASCP). Medical University of South Carolina, Charleston, South Carolina Introduction: UroVysion testing is a fluorescence in situ hybridization test that detects four chromosome abnormalities commonly occurring in urothelial cell carcinoma (UCC). The aim of this study was to identify the factors potentially associated with false positive (FP) and false negative (FN) UroVysion results.
S33 Design: Retrospective chart review was performed and cases that met the following criteria were selected: 1) valid results of both UroVysion and cytology from concurrent urine sample, and 2) histologic follow up within 4 months from the original test, or 3) at least 3 year clinical follow up information. FP and FN UroVysion results were determined by comparison with the “gold standard” that was derived from a combination of histologic and clinical follow up information. Specimen characteristics, including gender, clinical history, cellularity of urothelial cells and squamous cells, inflammation, and cytologic atypia, were reviewed to identify the potential confounding factors. Result: A total of 1,835 cases met the search criteria. UroVysion testing was positive in 343 cases, and negative in 1492 cases. 158 and 114 cases were determined to be FP and FN, respectively. Cytology slides from 126 FP and 95 FN cases were available for review. Factors identified in FP cases included the samples with great number of reactive mature urothelial cells (85 of 126 cases) and screening patients with hematuria (46 of 126); No significant cytologic atypia was observed in 84 of 126 FP cases. Factors in FN cases included heavy squamous cell contaminant (29 of 95), significant inflammation (31 of 95), and surveillance of patients with history of low grade UCC (49 of 95). Conclusion: Caution should be taken in the interpretation of positive UroVysion result in cases with great numbers of exuberant reactive urothelial cells; cases with a large number of squamous cells and/or significant inflammation may exhibit false negative results.
GYNECOLOGIC 56 Endometrial Biopsy Using a Novel Endometrial Sampler is a Reliable Method for Detecting Endometrial Cancer with High Interobserver Agreement Howard Wu, MD1, Robert Emerson, MD1, Shaoxiong Chen, MD1, M. Joe Ma, MD, PhD2, Muhammad Idrees, MD1, Xiaoyan Wang, MD, PhD2, Harvey Cramer, MD1, Giuseppe Del Priore, MD, MPH3. 1Indiana University, Indianapolis, Indiana; 2Florida Hospital, Orlando, Florida; 3Cancer Treatment Centers of America, Newman, Georgia Introduction: A novel outpatient endometrial sampler (GDP-Tao, Cook Medical) that is a modification of the original Indiana University Medical Center endometrial sampler (Tao brush) with a new, added built-in suction component was evaluated in this ex-vivo study. Materials and Methods: The GDP-Tao sampler was used to obtain endometrial cells and tissues from 35 fresh hysterectomy specimens. If there was scant tissue, only one SurePath slide was made (6 cases). Otherwise, both H&E-stained cell block sections and SurePath slides were prepared (29 cases). Six pathologists who were blinded to the final hysterectomy diagnoses interpreted the GDP-Tao biopsies independently, using a set of diagnostic terms including non-diagnostic (ND), benign (B), atypia of unknown significance (AUS), atypical hyperplasia (AH), suspicious for malignancy (SM) and malignant (M). The GDP-Tao diagnoses were correlated with the final diagnosis established by the hysterectomy specimens. Results: 17 out of 18 cases of AH/M were correctly diagnosed by the GDPTao. 11/11 samples were benign on both GDP-Tao and final pathology. One case diagnosed as benign by GDP-Tao showed focal AH in the hysterectomy specimen and one GDP-Tao case diagnosed as AUS showed only benign findings on the correlating hysterectomy. Among 4 ND samples on GDP-Tao, three hysterectomies showed benign endometrium and one lacking endometrium from recent ablation. The overall sensitivity, specificity, positive predictive and negative predictive values were 95%, 92%, 95% and 92%, respectively. There is a very high level of interobserver agreement (Cronbach’s alpha Z 0.988, p< 0.001) with only three cases in which the GDP-Tao diagnoses demonstrated disagreement between six pathologists. Conclusions: Pathologic interpretations using a combined cytologic and histologic approach on ex-vivo samples obtained by the new, outpatient GDP-Tao endometrial sampler provides a highly sensitive and specific method for accurately detecting endometrial cancer and can be performed with a high degree of interobserver agreement.
S33 Design: Retrospective chart review was performed and cases that met the following criteria were selected: 1) valid results of both UroVysion and cytology from concurrent urine sample, and 2) histologic follow up within 4 months from the original test, or 3) at least 3 year clinical follow up information. FP and FN UroVysion results were determined by comparison with the “gold standard” that was derived from a combination of histologic and clinical follow up information. Specimen characteristics, including gender, clinical history, cellularity of urothelial cells and squamous cells, inflammation, and cytologic atypia, were reviewed to identify the potential confounding factors. Result: A total of 1,835 cases met the search criteria. UroVysion testing was positive in 343 cases, and negative in 1492 cases. 158 and 114 cases were determined to be FP and FN, respectively. Cytology slides from 126 FP and 95 FN cases were available for review. Factors identified in FP cases included the samples with great number of reactive mature urothelial cells (85 of 126 cases) and screening patients with hematuria (46 of 126); No significant cytologic atypia was observed in 84 of 126 FP cases. Factors in FN cases included heavy squamous cell contaminant (29 of 95), significant inflammation (31 of 95), and surveillance of patients with history of low grade UCC (49 of 95). Conclusion: Caution should be taken in the interpretation of positive UroVysion result in cases with great numbers of exuberant reactive urothelial cells; cases with a large number of squamous cells and/or significant inflammation may exhibit false negative results.
GYNECOLOGIC 56 Endometrial Biopsy Using a Novel Endometrial Sampler is a Reliable Method for Detecting Endometrial Cancer with High Interobserver Agreement Howard Wu, MD1, Robert Emerson, MD1, Shaoxiong Chen, MD1, M. Joe Ma, MD, PhD2, Muhammad Idrees, MD1, Xiaoyan Wang, MD, PhD2, Harvey Cramer, MD1, Giuseppe Del Priore, MD, MPH3. 1Indiana University, Indianapolis, Indiana; 2Florida Hospital, Orlando, Florida; 3Cancer Treatment Centers of America, Newman, Georgia Introduction: A novel outpatient endometrial sampler (GDP-Tao, Cook Medical) that is a modification of the original Indiana University Medical Center endometrial sampler (Tao brush) with a new, added built-in suction component was evaluated in this ex-vivo study. Materials and Methods: The GDP-Tao sampler was used to obtain endometrial cells and tissues from 35 fresh hysterectomy specimens. If there was scant tissue, only one SurePath slide was made (6 cases). Otherwise, both H&E-stained cell block sections and SurePath slides were prepared (29 cases). Six pathologists who were blinded to the final hysterectomy diagnoses interpreted the GDP-Tao biopsies independently, using a set of diagnostic terms including non-diagnostic (ND), benign (B), atypia of unknown significance (AUS), atypical hyperplasia (AH), suspicious for malignancy (SM) and malignant (M). The GDP-Tao diagnoses were correlated with the final diagnosis established by the hysterectomy specimens. Results: 17 out of 18 cases of AH/M were correctly diagnosed by the GDPTao. 11/11 samples were benign on both GDP-Tao and final pathology. One case diagnosed as benign by GDP-Tao showed focal AH in the hysterectomy specimen and one GDP-Tao case diagnosed as AUS showed only benign findings on the correlating hysterectomy. Among 4 ND samples on GDP-Tao, three hysterectomies showed benign endometrium and one lacking endometrium from recent ablation. The overall sensitivity, specificity, positive predictive and negative predictive values were 95%, 92%, 95% and 92%, respectively. There is a very high level of interobserver agreement (Cronbach’s alpha Z 0.988, p< 0.001) with only three cases in which the GDP-Tao diagnoses demonstrated disagreement between six pathologists. Conclusions: Pathologic interpretations using a combined cytologic and histologic approach on ex-vivo samples obtained by the new, outpatient GDP-Tao endometrial sampler provides a highly sensitive and specific method for accurately detecting endometrial cancer and can be performed with a high degree of interobserver agreement.