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Literature Review

Literature Review. Peter R. McNally, DO, FACP, FACG University Colorado School of Medicine Center for Human Simulation Aurora, Colorado 80045. Sunanda Kane, MD, 1 Bahar Khatibi B Sc 2 & Deepa Reddy, MD 1. Higher Incidence of Abnormal Pap Smears in Women

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Literature Review

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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

  2. Sunanda Kane, MD,1 Bahar Khatibi B Sc2 & Deepa Reddy, MD1 Higher Incidence of Abnormal Pap Smears in Women With Inflammatory Bowel Disease. AM J Gastroenterol. 2008;103:631-636 1Mayo Clinic, Rochester, Minnesota, and 2University of Chicago, Chicago, Illinois

  3. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Introduction • 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 • 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 1. Wright TC, et al. AJOG. 2007; 346-355. 2. Ellerbrock, et al. JAMA 2000;283:1031-7. 3. ACOG. Obstet Gynecol 2003;102:845-54.

  4. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Introduction • Risk Factors for evolution of Cervical cancer4,5 • 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. 4. Edelman M, et al. Cancer. 1999;87;184-9. 5. Bernatsky S, et al. Rheumatol. 2004;43:1386-9

  5. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Aim • 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.

  6. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Study Design: Study Population • Prospectively enrolled IBD patients over a 2 yr period of January 2004 through December 2005. • 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 • Pap smears unavailable for review • History of total hysterectomy

  7. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Study Design: Control Population • Women receiving routine Pap smears in the University of Chicago Gynecology Clinic • All women without diagnosis of IBD or history of immune suppressant use • Each IBD patient was control matched to 3 ♀ • Age within 2 yrs • Race • Parity • Smoking

  8. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 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

  9. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 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.

  10. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 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

  11. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Study Evaluations Bethesda Criteria for Pap Smear Classification • Pap Smear “High Grade” • ASG-H • SILs (low and high grade) • Pap Smear “Low Grade” • ASC • ASC-US • AGC • AGC-US

  12. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Normal squamous cells Illustrations Courtesy of: Mattu Rubina, MD, AFIP, Washington, DC

  13. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Normal endocervical cells Illustrations Courtesy of: Mattu Rubina, MD, AFIP, Washington, DC

  14. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Low grade squamous intraepithelial lesion (LSIL) with koilocytes Illustrations Courtesy of: Mattu Rubina, MD, AFIP, Washington, DC

  15. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 High Grade Squamous Intraepithelial lesion (HSIL) Illustrations Courtesy of: Mattu Rubina, MD, AFIP, Washington, DC

  16. High Grade Squamous Intraepithelial lesion (HSIL)

  17. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Demographics: IBD vs. Controls

  18. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Results: No. of women with history of abn Pap smear.

  19. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Results: No abnormal Pap smears among all pts for 2 yr.

  20. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Results: IBD (+) I-Rx, IBD (-) I-Rx, vs. Controls 50% 30% 7% IBD (+) I-Rx IBD (-) I-Rx Control Percentage of women with any history of abnormal Pap smear.

  21. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Results: HPV-DNA testing • 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 Percentage of women with any history of abnormal Pap smear.

  22. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Results: Influence of I-Rx on Pap • ♀ 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) • ♀ with “low grade” pap on I-Rx, lesions regressed with 6 mo of stopping I-Rx

  23. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Conclusions: • Abnormal Pap smears were more common among IBD pts (17/40) vs. matched controls (8/120) 42% vs. 7%, respectively, p < 0.001. • Both “low risk” and “high risk” Pap smears were more common in IBD group, P < 0.001 for both Pap smear groups. • Stratification by IBD (+) I-Rx further increased risk over IBD (-) I-Rx for abnormal Pap smear, p < 0.001.

  24. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Reviewer Comments Kane, et al, have clearly shown the following: • IBD pts have greater risk for abnormal Pap smear than matched controls, p < 0.001. • IBD pts on I-Rx have greater risk for abnormal Pap smears that IBD pts not on I-Rx, p < 0.001. • 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.

  25. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Reviewer Comments Kane, et al, do not answer the following questions? • What is the efficacy of quadrivalent HPV vaccine (Gardasil, Merck) among IBD pts? • Is vaccine protection of Gardasil (Merck) against HPV 16, 18 and 6, 11 as effective in IBD patients, especially those on I-Rx? • Should IBD pts still be undergo Pap smears after Gardasil (Merck) vaccination and how often?

  26. Kane S, et al. AM J Gastroenterol. 2008;103;631-636 Reviewer Comments • 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 & 18. • 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.

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