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1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045.

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Presentation on theme: "1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045."— Presentation transcript:

1 1 Literature Review Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045

2 2 Sunanda Kane, MD, 1 Bahar Khatibi B Sc 2 & Deepa Reddy, MD 1 Higher Incidence of Abnormal Pap Smears in Women With Inflammatory Bowel Disease. AM J Gastroenterol. 2008;103: Mayo Clinic, Rochester, Minnesota, and 2University of Chicago, Chicago, Illinois

3 3 Introduction Cervical cancer is one of the leading causes of cancer death among women world wide. 1 Cervical cancer is one of the leading causes of cancer death among women world wide. 1 Human Papilloma Virus (HPV) infection has been linked to cervical cancer. 2 Human Papilloma Virus (HPV) infection has been linked to cervical cancer. 2 American College of Obstetricians and Gynecologists (ACOG) recommend yearly Pap smears for women younger than 30 yrs and screenings every 2-3 yrs for older women who have has three consecutive negative Pap smears. 3 American College of Obstetricians and Gynecologists (ACOG) recommend yearly Pap smears for women younger than 30 yrs and screenings every 2-3 yrs for older women who have has three consecutive negative Pap smears. 3 Wright TC, et al. AJOG. 2007; Ellerbrock, et al. JAMA 2000;283: ACOG. Obstet Gynecol 2003;102: Wright TC, et al. AJOG. 2007; Ellerbrock, et al. JAMA 2000;283: ACOG. Obstet Gynecol 2003;102: Kane S, et al. AM J Gastroenterol. 2008;103;

4 4 Introduction Risk Factors for evolution of Cervical cancer 4,5 Risk Factors for evolution of Cervical cancer 4,5 – HPV (Human Papilloma Virus) infection of cervix – HIV – Immune suppression – Smoking Serial Pap smear has been show to effectively detect HPV infection and dysplastic changes of the cervix. Serial Pap smear has been show to effectively detect HPV infection and dysplastic changes of the cervix. Kane S, et al. AM J Gastroenterol. 2008;103; Edelman M, et al. Cancer. 1999;87;184-9.Bernatsky S, et al. Rheumatol. 2004;43: Edelman M, et al. Cancer. 1999;87; Bernatsky S, et al. Rheumatol. 2004;43:1386-9

5 5 Aim To determine if there is increased risk for abnormal Pap among patients with IBD compared to a like control population. To determine if there is increased risk for abnormal Pap among patients with IBD compared to a like control population. To determine if immune suppression medication among IBD patients increased the risk for abnormal Pap. To determine if immune suppression medication among IBD patients increased the risk for abnormal Pap. Kane S, et al. AM J Gastroenterol. 2008;103;

6 6 Study Design: Study Population Prospectively enrolled IBD patients over a 2 yr period of January 2004 through December Prospectively enrolled IBD patients over a 2 yr period of January 2004 through December Demographics Demographics – N=40 (8 UC and 32 CD) – Baseline normal Pap smear prior to diagnosis of IBD & at least 2 Pap smears after Dx IBD – All had at least 3 Pap smears available for review Exclusion Criteria Exclusion Criteria – Pap smears unavailable for review – History of total hysterectomy Kane S, et al. AM J Gastroenterol. 2008;103;

7 7 Study Design: Control Population Women receiving routine Pap smears in the University of Chicago Gynecology Clinic Women receiving routine Pap smears in the University of Chicago Gynecology Clinic All women without diagnosis of IBD or history of immune suppressant use All women without diagnosis of IBD or history of immune suppressant use Each IBD patient was control matched to 3 Each IBD patient was control matched to 3 – Age within 2 yrs – Race – Parity – Smoking Kane S, et al. AM J Gastroenterol. 2008;103;

8 8 Study Evaluations Definition of Immune Suppressant Rx (I-Rx) – Azathioprine/6MP for 3 months – Prednisone > 15 mg/day for > 8 consecutive weeks – Methotrexate > 100 mg – Infliximab within 8 wk of Pap smear Kane S, et al. AM J Gastroenterol. 2008;103;

9 9 Study Evaluations Pap Smears were conducted at University of Chicago Gynecology Clinics – Cytopapthology using Bethesda Criteria – All Pap smears tested using Digent Hybrid Capture II HPV-DNA test. Kane S, et al. AM J Gastroenterol. 2008;103;

10 10 Study Evaluations Definition of Pap Smear Abnormalities ASC: atypical squamous cells of unknown significance ASC-US:atypical squamous cells cannot r/o high grade lesion ASG-H: atypical glandular cells AGC: atypical glandular cells unknown significance AGS-US:glandular or squamous carcinoma SILs: atypical squamous cells with high grade intra- epithelial cells Kane S, et al. AM J Gastroenterol. 2008;103;

11 11 Study Evaluations Bethesda Criteria for Pap Smear Classification Pap Smear High Grade Pap Smear High Grade – ASG-H – SILs (low and high grade) Pap Smear Low Grade Pap Smear Low Grade – ASC – ASC-US – AGC – AGC-US Kane S, et al. AM J Gastroenterol. 2008;103;

12 12 Normal squamous cells Kane S, et al. AM J Gastroenterol. 2008;103; Illustrations Courtesy of: Mattu Rubina, MD, AFIP, Washington, DC

13 13 Normal endocervical cells Kane S, et al. AM J Gastroenterol. 2008;103; Illustrations Courtesy of: Mattu Rubina, MD, AFIP, Washington, DC

14 14 Low grade squamous intraepithelial lesion (LSIL) with koilocytes Kane S, et al. AM J Gastroenterol. 2008;103; Illustrations Courtesy of: Mattu Rubina, MD, AFIP, Washington, DC

15 15 High Grade Squamous Intraepithelial lesion (HSIL) High Grade Squamous Intraepithelial lesion (HSIL) Kane S, et al. AM J Gastroenterol. 2008;103; Illustrations Courtesy of: Mattu Rubina, MD, AFIP, Washington, DC

16 16 High Grade Squamous Intraepithelial lesion (HSIL) High Grade Squamous Intraepithelial lesion (HSIL)

17 17 Demographics: IBD vs. Controls VariableIBDN=40ControlsN=120 P value (+) I-Rx 23NANA Age 1 st abn Pap 24 +/- 4 yr 25+/- 3 yr NS Oral contraceptive 58%70%P=0.04 Sexually Active 97%96%NS Smoking37%34%NA Kane S, et al. AM J Gastroenterol. 2008;103;

18 18 Results: No. of women with history of abn Pap smear. VariableIBDIBD (+) I-Rx IBD (-) I-Rx Control Total Normal Pap Low Risk Pap 7946 High Risk Pap OR4.3( ) 4.5 ( ( NA Kane S, et al. AM J Gastroenterol. 2008;103;

19 19 Results: Results: No abnormal Pap smears among all pts for 2 yr. Variable IBD (+) I-Rx IBD (-) I-RxControls P value Normal Pap Low Risk Pap <0.001 High Risk Pap 1527<0.001 Kane S, et al. AM J Gastroenterol. 2008;103;

20 20 Results: IBD (+) I-Rx, IBD (-) I-Rx, vs. Controls Kane S, et al. AM J Gastroenterol. 2008;103; IBD (+) I-Rx IBD (-) I-Rx Control Percentage of women with any history of abnormal Pap smear. 50% 30% 7%

21 21 Results: HPV-DNA testing All high risk Pap smears were positive for HPV-DNA All high risk Pap smears were positive for HPV-DNA – Either serotype 16 or 18 50% of low risk Pap smears were (+) for HPV-DNA 50% of low risk Pap smears were (+) for HPV-DNA Kane S, et al. AM J Gastroenterol. 2008;103; Percentage of women with any history of abnormal Pap smear.

22 22 Results: Influence of I-Rx on Pap on multiple I-Rx more likely to have abnormal Pap smear (p < 0.04) on multiple I-Rx more likely to have abnormal Pap smear (p < 0.04) on I-Rx > 6 mo had a trend for abnormal pap (p=0.048) on I-Rx > 6 mo had a trend for abnormal pap (p=0.048) with low grade pap on I-Rx, lesions regressed with 6 mo of stopping I-Rx with low grade pap on I-Rx, lesions regressed with 6 mo of stopping I-Rx Kane S, et al. AM J Gastroenterol. 2008;103;

23 23 Conclusions: Abnormal Pap smears were more common among IBD pts (17/40) vs. matched controls (8/120) 42% vs. 7%, respectively, p < Abnormal Pap smears were more common among IBD pts (17/40) vs. matched controls (8/120) 42% vs. 7%, respectively, p < Both low risk and high risk Pap smears were more common in IBD group, P < for both Pap smear groups. Both low risk and high risk Pap smears were more common in IBD group, P < for both Pap smear groups. Stratification by IBD (+) I-Rx further increased risk over IBD (-) I-Rx for abnormal Pap smear, p < Stratification by IBD (+) I-Rx further increased risk over IBD (-) I-Rx for abnormal Pap smear, p < Kane S, et al. AM J Gastroenterol. 2008;103;

24 24 Reviewer Comments Kane, et al, have clearly shown the following: 1. IBD pts have greater risk for abnormal Pap smear than matched controls, p < IBD pts on I-Rx have greater risk for abnormal Pap smears that IBD pts not on I-Rx, p < All with IBD and more importantly those on I- Rx should be considered for inclusion among the ACOG guidelines for more frequent cancer screening for immune compromised pts. Kane S, et al. AM J Gastroenterol. 2008;103;

25 25 Reviewer Comments Kane, et al, do not answer the following questions? 1. What is the efficacy of quadrivalent HPV vaccine (Gardasil, Merck) among IBD pts? 2. Is vaccine protection of Gardasil (Merck) against HPV 16, 18 and 6, 11 as effective in IBD patients, especially those on I-Rx? 3. Should IBD pts still be undergo Pap smears after Gardasil (Merck) vaccination and how often? Kane S, et al. AM J Gastroenterol. 2008;103;

26 26 Reviewer Comments 1. Dr. Kane and colleagues are commended for demonstrating that IBD patients clearly have an increased risk for abnormal Pap smears in the decade prior to Gardasil vaccination against HPV 16 & We, as gastroenterologists should actively recommend Gardasil to ALL of our sexually active IBD pts. and caution that the vaccine is only 70% protective against cervical cancer. Hence, periodic gynecologic evaluation IS still advisable even after Gardasil in this high risk group. Kane S, et al. AM J Gastroenterol. 2008;103;


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