Comparing Liquid-Based Cytology Methods in the Detection of Cervical Cancer: Perspectives from Dr. Ming Guo

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1 Transcript Details This is a transcript of an educational program accessible on the ReachMD network. Details about the program and additional media formats for the program are accessible by visiting: ReachMD info@reachmd.com (866) Comparing Liquid-Based Cytology Methods in the Detection of Cervical Cancer: Perspectives from Dr. Ming Guo Narrator: Welcome to ReachMD. You re listening to a special edition of Advances in Women s Health, sponsored by BD Diagnostics, committed to helping all people live healthy lives. This program is brought to you through an educational grant from BD Diagnostics. You host is Dr. Thomas C. Wright, Jr., Professor Emeritus of Pathology and Cell Biology at the Columbia University Medical Center. Dr. Wright welcomes Dr. Ming Guo, Associate Professor of Cytopathology in the Department of Pathology at the University of Texas MD Anderson Cancer Center in Houston, Texas. Drs. Wright and Guo will discuss the performance of BD SurePath and ThinPrep liquid-based cytology methods in the detection of cervical disease based upon data from several large national organized cervical disease screening programs. These interviews will discuss these data within the context of impact to clinical practice ReachMD Page 1 of 6

2 Welcome to a special edition of Advances in Women's Health sponsored by BD Diagnostics. I am your host, Dr. Thomas C. Wright, Jr., Professor Emeritus of Pathology at Columbia University in New York. This expert panel discussion will discuss data results from the Erasmus Medical Center comparing the performance of SurePath and ThinPrep liquid-based cytology methods in the detection of cervical disease and how these results impact clinical practice. Joining me today is Dr. Ming Guo, MD, with MD Anderson Cancer Center. Welcome to the program, Dr. Guo. Thank you, Dr. Wright. The data showed a statistical difference between SurePath and ThinPrep in terms of HSIL detection and biopsy-confirmed CIN2 plus. Do you believe that these differences are clinically significant? Yes, I believe that the differences are clinically significant. In the Dutch study, 3 different Pap cytology tests were compared for clinical performance. These are SurePath, ThinPrep and conventional Pap tests. Previous studies compared either ThinPrep versus conventional Pap or SurePath versus conventional Pap cytology. Published data of SurePath versus ThinPrep for Pap cytology clinical performance is extremely scant. The Dutch study compared the baseline results of the 3 Pap cytology testings. More interestingly, the Dutch study presented a 6-year followup for women with 3 different Pap cytology screens. In SurePath, Dutch study demonstrated higher rates of abnormal Pap results and follow-up biopsy confirmed the CIN2 and above lesions than those in the ThinPrep or conventional Pap tests; though increased the CIN detection rates were observed in ThinPrep compared with the conventional Pap test We know from the ALTS and the ATHENA trials that there is variability in pathologists' reading of cytology results. At least that has been shown with ThinPrep in both of those 2 trials. Is the inherent variability in cytology a confounding factor in these observed differences? 2018 ReachMD Page 2 of 6

3 There is no different comparison between ThinPrep and SurePath variability in pathologists' reading of cytology results. This inherent variability in cytology could be a confounding factor in these observed differences. However, if the size of the study cohort is large enough, with more pathologists involved in reading of cytology, these confounding factors can be minimized. A possible factor that may cause variability for pathologists in reading ThinPrep Pap specimens is the cytomorphology features of the ThinPrep. Cytomorphology is slightly different between ThinPrep and SurePath. The cytomorphology of a SurePath specimen is similar to that of conventional Pap specimens. The cytomorphology of ThinPrep specimens, however, is slightly different from that of a conventional Pap in nuclear, cellular and background features. These differences for cytomorphologic features in ThinPrep may affect the interpretation performance of cytopathologists, especially for cytopathologists who are trained and used to reading conventional Pap cytology specimens. So, all of MD Anderson uses SurePath for cervical cancer screening? Yes. You have seen data from the Netherlands Cervical Cancer Screening Program, and similar data has also been reported out of the United Kingdom National Screening Program. What do you make of the fact that 2 completely separate national screening programs, the UK and the Netherlands, have both reported this difference in clinical performance between SurePath and ThinPrep? The data presented by the Dutch and the UK cervical cancer screening programs show the similar findings. The evidences are convincing because 2 separate studies from 2 countries reported similar results; that is a better clinical performance of SurePath than ThinPrep. In addition, a cross-section study conducted by Dr. Cho in China also reported a high sensitivity for ASCUS for SurePath than for ThinPrep. In our practice we use SurePath for patient care. Our patient population is very unique with predominantly patients of older age with a mean age of 55 years. Many patients are post menopausal; therefore, atrophic scenarios are frequently encountered. In addition, many patients in our cancer center were treated for different malignancies such as breast cancer or lymphoma. Therapy effects are very common. It has been well recognized that SurePath has lower unsatisfactory rates compared 2018 ReachMD Page 3 of 6

4 with ThinPrep. In our patient population, we also observed increased age-associated unsatisfactory rates using SurePath. The unsatisfactory rate would have been significantly higher if we had used ThinPrep. The Dutch and the UK studies certainly support our practice to use SurePath. Even with Pap and HPV cotesting in our center, clinical performance of Pap cytology is critical for patient care. That's a very clear discussion of the satisfactory rates and the differences and the importance to your clinical practice. One of the issues with the Dutch screening program was that the data used the 5- year followup period as a timeframe to detect interval cervical cancer arising from an undetected or missed clinically-relevant CIN2 plus lesion. How relevant is this 5-year followup timeframe for the US using the newest cervical cancer screening guidelines? For cervical cancer screening, 5-year screening intervals for Pap cytology screening only, seems too long. The US guidelines of cervical cancer prevention recommended a 5-year interval for Pap and HPV cotesting for women with negative Pap and negative HPV testing results. Although large clinical trials support a longer screening interval for using Pap and HPV cotesting, recently published data shows that Pap and HPV cotesting provided the highest clinical benefits for women for cervical cancer prevention. Blatt and colleagues from Quest recently published the data in Cancer Cytopathology showing either HPV or Pap cytology alone missed the clinically-significant cases. For Pap and HPV cotesting, a better Pap cytology testing assay is certainly preferred, especially with a 5-year screening interval. In women age 21 to 29 years, Pap cytology testing with a 3-year interval is recommended by the US guidelines. Consequently, Pap cytology performance is critical for detection of cervical precancerous lesions. For example, Dr. Cho s study in China showed that ThinPrep samples had higher rates of unsatisfactory cytology and the insufficient residual volume HPV testing compared with SurePath. If you're just tuning in, you're listening to Advances in Women's Health sponsored by BD Diagnostics on ReachMD. I am your host, Dr. Thomas C. Wright, Jr., moderating a discussion comparing the performance of SurePath and ThinPrep liquid-based cytology methods in the detection of cervical disease and how these results impact clinical practice. We're speaking today with Dr. Guo from the MD Anderson Cancer Center. Doctor, the data from the Dutch Screening Program showed an increased detection of both CIN1 as 2018 ReachMD Page 4 of 6

5 well as CIN2+ lesions using SurePath. Can you comment on the issue of risk of overtreatment in younger women versus a detection of clinically-relevant lesions? The Dutch study is very unique because HPV was not a confounding factor for the difference of clinical performance between the 2 liquid-based Pap cytology assays. We may not see similar studies because HPV testing has been widely used as an integrated part of cervical cancer screening. Recently, Medicare announced to reimburse Pap and HPV cotesting in the United States. However, it is unknown whether a clinical performance of a Pap cytology has an impact on Pap and HPV cotesting. It will be interesting to compare clinical performance of a Pap and HPV cotesting using SurePath versus ThinPrep. You brought up role of cotesting and the fact that a lot of women in the United States, those over the age of 30, are now getting tested with both HPV and cervical cytology. The Dutch study just looked at cervical cytology alone. So a natural question would be for you to tell us how you think cotesting would benefit from using either ThinPrep versus SurePath for the sensitivity because we're talking 2 tests now rather than just 1 test. The presented data demonstrated a difference of clinical performance between the 2 mostly used commercial Pap cytology assays. The limitations of Pap cytology for cervical cancer screening were demonstrated by clinical studies to compare HPV and Pap cytology for cervical cancer screening, not by the Dutch study. The published clinical trial data showed higher sensitivity with lower specificity for CIN2 and above lesions by HPV testing compared with Pap cytology testing only. On the other hand, the Dutch study did not strengthen the argument for the use of HPV as a primary screen either. Recently published data showed that Pap and HPV cotesting have higher predicted value for CIN2 and above lesions than HPV testing alone. To support HPV primary screening for cervical cancer prevention, studies are necessary to determine whether the clinical performance of Pap and HPV cotesting is significantly better than that of HPV testing alone. Published data is very limited, especially in young women to use HPV as the primary screening tool. The other screening method which we're beginning to utilize in the United States is HPV primary screening; and with the FDA-approved algorithm for HPV primary screening, women who are positive 2018 ReachMD Page 5 of 6

6 for 12 other those are the non 16, 18 genotypes those women get reflex cytology and are only sent to immediate colposcopy if they have the positive reflex cytology, either ASCUS or greater. Does the data that you've seen on the Dutch experience and the UK experience, does that influence your choice for the liquid-based cytology to be used for reflex cytology after an HPV primary screening test result? Well, HPV primary screen Pap cytology will be used for a reflex followup for women with positive HPV testing results. For most women with a positive HPV testing result, HPV infection will clear. Even with a CIN1 or CIN2 lesion, most of these lesions will regress; therefore, Pap cytology would be critical for the triage of women for colposcopy followup. Consequently, a Pap cytology assay with better clinical performance will be preferred for the reflex followup. With several clinical trials of HPV testing in SurePath Pap cytology specimens, clinicians and the patients will have more options of using SurePath Pap cytology testing for cervical cancer prevention. I very much want to thank our faculty today, Dr. Ming Guo from MD Anderson, for joining ReachMD; and again, thanks so very much for your insight. Thank you so much. Narrator: You ve been listening to ReachMD. The preceding program was sponsored by BD Diagnostics, committed to helping all people live healthy lives. If you have missed any part of this discussion and to listen to others in this special series of Advances in Women s Health, visit ReachMD.com/womenshealth. Thank you for listening ReachMD Page 6 of 6

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