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The Burden of HPV Cancers Texas Pediatric Society HPV Half-Day Conference

Join us at the Texas Pediatric Society's HPV Half-Day Conference to review the types of HPV-associated cancers, discuss screening recommendations, and learn how to prevent these cancers. Presented by Dr. Lois M. Ramondetta, MD, Professor of Gynecologic Oncology and Co-Leader of the HPV-Related Cancers Moon Shot at UT MD Anderson Cancer Center & Harris Health System. No conflicts or disclosures.

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The Burden of HPV Cancers Texas Pediatric Society HPV Half-Day Conference

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  1. The Burden of HPV CancersTexas Pediatric Society HPV Half-Day Conference Lois M Ramondetta MD Professor Gynecologic Oncology Co-Leader HPV-Related Cancers Moon Shot UT MD Anderson Cancer Center & Harris Health System

  2. Disclosure • No conflicts or disclosures

  3. The Burden of HPV Cancers Objectives 1-Review types of HPV associated cancers 2-Discuss screening recommendations associated with these cancers

  4. Preventable…

  5. My Service

  6. HPV Infection & Disease:Understanding the Burden • Almost ALL will be infected with at least 1 type HPV at some point • Most will never know they’ve been infected • Can occur with any intimate sexual contact • Intercourse is not necessary for infection • Estimated 79 million Americans currently infected • 14 million new infections/year in the US • HPV infection most common in teens - 20s Jemal A et al. J Natl Cancer Inst2013;105:175-201

  7. HPV Types Differ in their Disease Associations Mucosal sites of infection Cutaneous sites of infection ~ 80 Types ~40 Types High risk (oncogenic)HPV 16, 18 most common Low risk (non-oncogenic)HPV 6, 11 most common Cervical Cancer Anogenital Cancers Oropharyngeal Cancer Cancer Precursors Low Grade Cervical Disease Genital Warts Laryngeal Papillomas Low Grade Cervical Disease “Common” Hand and Foot Warts

  8. Persistent infection and Integration in basal keratinocytes • Viral genome (8 genes as circular double-stranded DNA) incorporated into host cell genome. • the HPV genome is disrupted at E2 gene thus no more E2 protein made • E2 down-regulate two genes: E6 and E7. • Without functional E2, E6 and E7 expression is uncontrolled • E6 and E7 are oncogenes/oncoproteins. • E6 causes degradation of tumor suppressor protein 53. • E7 interferes with retinoblastoma protein and the host cell cycle. • E6 and E7 cause "immortalization” of these dysfunctional cells

  9. Numbers of Cancers and Genital Warts Attributed to HPV Infections, U.S. CDC. Human papillomavirus (HPV)-associated cancers. Atlanta, GA: US Department of Health and Human Services, CDC; 2013. Available at http://www.cdc.gov/cancer/hpv/statistics/cases.htm

  10. Cancers Caused by HPV, U.S. CDC, United States Cancer Statistics (USCS), 2006-2010

  11. J Natl Cancer Inst 2013

  12. HPV Infection & Progression to Cancer Schematic

  13. Cervical Cancer has a defined avoidable etiology, and if caught early is curable Despite these facts, In 2014, an estimated 12,360 new cases of cervical cancer in US

  14. What Makes Cervical Cancer Unique? • Worldwide epidemic • 500,000 new cases annually • 250,000 needless deaths • Median age 47 yrs • Known etiologic agent: high risk HPV (HR HPV) • Most women will clear the virus by age 30 years • Long pre-invasive state: CIN • Screening is highly effective • Cytology + HR HPV DNA testing • Prophylactic HPV vaccination available • Therapeutic options clearly defined by clinical FIGO stage

  15. Cervical Cancer and Young Women • 37% occur in women ages 20-44 • 13% (or nearly 1 in 8) between 20 and 34 • 24% ( or nearly 1 in 4) between 35 and 44 CDC. HPV–associated cancers—US, 2004–2008. MMWR 2012;61(15):258–261. Cervical Cancer Counts by Age. US Cancer Statistics data from 2010, CDC.gov.

  16. HPV: Natural History of Cervical Infection • Persistent infection with high-risk types required for progression to • precancer and cancer • Peak incidence of precancers in late 20’s and of cancers in mid to late 40’s Wright TC Jr, Schiffman M. N Engl J Med 2003;348:489-90

  17. Cervical Cancer Time Line • 1900 CxCa #1 killer of cancer in the US • 1927 Pap smear invented • 1943 Papanicolaou publishes • 1976 zurHausen identifies HPV as cause of CxCa • 1996 U.S. Preventive Services TF rec Pap q3yrs • 1996-1999 liquid based cytology introduced • 2006 Gardasil introduced • 2006-2009 HPV DNA test developed • 2012 Screening guidelines become consistent • 2014 FDA approves as primary screening tool

  18. New Cervical Cancer Screening Guidelines:ACS, USPSTF, ACOG *All guidelines recommend that women who have been adequately screened can discontinue Pap at age 65. ACS: American Cancer Society USPSTF: US Preventive Services Task Force ACOG: American College of Obstetricians and Gynecologists

  19. Therapeutic Options • CIN3 • LLETZ, cold knife conization, cryotherapy, CO2 laser vaporization • FIGO 1A1-IB2 (2 cm or less) • Fertility-preserving surgery (radical trachelectomy with lymphadenectomy and cerclage) • FIGO 1A2-IB1 (up to IIA1) • Radical surgery plus lymphadenectomy + adjuvant therapy • FIGO IB2-IVA • Chemoradiation plus high-dose-rate intracavitarybrachytherapy • Isolated, post-radiotherapy, central recurrence • Pelvic exenteration • FIGO IVB, recurrent/persistent (non-exenteration candidate) • Chemotherapy plus anti-angiogenesis therapy using bevacizumab

  20. HPV-Associated Cervical Cancer Incidence Rates by State, United States, 2006-2010 HPV-Associated Cervical Cancer Incidence Rates by State, United States, 2004–2008 10,000+ Cases and 4,000+ Deaths Every Year www.cdc.gov/cancer/npcr

  21. Genital HPV disease in U.S. Females 4,000 cervical cancer deaths 11,000 new cases of cervical cancer 330,000 new cases of HSIL: CIN2/3 (high grade cervical dysplasia) 500,000 cases of genital warts 1.4 million new cases ofLSIL: CIN1 (low grade cervical dysplasia) 2.25 million cases, costing $7 billion American Cancer Society. 2008; SchiffmanArch Pathol Lab Med. 2003; Koshiol Sex Transm Dis. 2004; Insinga, Pharmacoeconomics, 2005

  22. Correlation between HPV and cervical cancer is higher than that between smoking and lung cancer

  23. Annual Report to the Nation on the Status of Cancer: HPV-Associated Cancers • 2000 to 2009 oral cancer rates increased • 1975-2009 Anal cancer rates doubled • Vulvar cancer rates rose for white and AA women • Penile cancer rates increased among Asian men Jemal A et al. J Natl Cancer Inst 2013;105:175-201

  24. Head & Neck Cancer Nose/Paranasal Sinuses Oral Cavity (mouth) Nasopharynx Oropharynx • soft palate or uvula • tonsil • base of tongue or lingual tonsil • posterior or lateral oropharyngeal wall Larynx (voicebox) Hypopharynx

  25. Oral HPV prevalence by age

  26. Epidemic of HPV Cancers in U.S. Men APC: +5% +5% +3% ~0% Oropharynx (tongue base) Oropharynx (tonsil) Anus Penis < 1/100,000

  27. Newly Diagnosed-Untreated CasesPresenting to MD Anderson Each Year Number of Cases

  28. Oropharyngeal CancerSEER Age-adjusted Incidence Males Chaturvedi AK, et al. JCO 2008.

  29. Oropharynx Cervix Median Age at Presentation: 45yo 55yo

  30. Oropharyngeal Cancer HPV(+) HPV(-)

  31. Anal Cancer

  32. Increased risk of anal cancer • HIV-positive men and women • Men who have sex with men • Iatrogenic immunosuppression (eg, solid organ transplant recipients, long term oral corticosteroids) • Women with a history of high-grade cervical, vulvar, vaginal dysplasia or cancer • Individuals with a history of anal warts

  33. Anal Dysplasia and Anal Cancer Dysplasia (anal intraepithelial neoplasia (AIN)) • Low-grade AIN (AIN1 or low-grade anal SIL): • often goes away without treatment-low chance of turning into cancer • High-grade AIN (AIN2 or AIN3, or high-grade anal SIL): • less likely to go away without treatment and could eventually become cancer, so it needs to be watched closely or treated • Carcinoma in situ • Most advanced pre cancer • Anal cancer • Most anal cancers in the United States are squamous cell carcinomas

  34. CIN: cervical intraepithelial neoplasia; AIN: anal intraepithelial neoplasia. Adapted from: Bonnez W. Papilloma virus. In: Clinical Virology, 2009, page 623.

  35. External Genital Lesions (N=2,545) AIN or worse (N=255 MSM) placebo qHPV vaccine placebo qHPV vaccine

  36. Penile Cancer

  37. Penile Cancer Risk Factors • Age: 50 to 70 years old, 1/3 under 50 • Tobacco use • HPV • Lack of circumcision • Phimosis: • AIDS

  38. Vulvar Cancer

  39. Annual Deaths HPV-Related Cancers CDC, National Meningitis Angels, and Texas DSHS

  40. Healthy People 2020 goal is 80%. Markowitz L et al, JID 2013 Markowitz L et al, Vaccine2012 Ali H et al, BMJ 2013 MMWR, July 25, 2014 38% United States 13- to 17-year old girls in 2013 1 dose = 57% 3 dose = 38% 13- to 17-year old boys in 2013 1 dose = 35% 3 dose = 14% Texas 56% 39% 34% 15% Houston 62% 34% 40% 18%

  41. HPV Moon Shot$5 million (+ Platform Support) for Year 1: September, 2015 Cancer Prevention and Control Platform: Health Policy Government Relations Professional Education Public Education Policy & Education (Lois M. Ramondetta) Flagship #1 Prevention & Screening Screening (Kathleen M. Schmeler) Platforms: Cancer Genomics Lab Institute for Applied Cancer Sciences Genomics (Curtis R. Pickering) Flagship #2 Discovery Target Discovery (Faye M. Johnson) Platforms: Center for Co-Clinical Trials Immunotherapy Rare Tumors (Cathy Eng) Flagship #3 Immunotherapy & Novel Trials GYN (Michael M. Frumovitz) Head & Neck (William N. William)

  42. NCI-designated Cancer Centers Urge HPV Vaccination for the Prevention of Cancer Approximately 79 million people in the United States are currently infected with a human papillomavirus (HPV) according to the Centers for Disease Control and Prevention (CDC), and 14 million new infections occur each year. Several types of high-risk HPV are responsible for the vast majority of cervical, anal, oropharyngeal (middle throat) and other genital cancers. The CDC also reports that each year in the U.S., 27,000 men and women are diagnosed with an HPV-related cancer, which amounts to a new case every 20 minutes. Even though many of these HPV-related cancers are preventable with a safe and effective vaccine, HPV vaccination rates across the U.S. remain low. AbramsonCancerCenter Together we, the National Cancer Institute (NCI)-designated Cancer Centers, recognize these low rates of HPV vaccination as a serious public health threat. HPV vaccination represents a rare opportunity to prevent many cases of cancer that is tragically underused. As national leaders in cancer research and clinical care, we are compelled to jointly issue this call to action. According to a 2015 CDC report, only 40 percent of girls and 21 percent of boys in the U.S. are receiving the recommended three doses of the HPV vaccine. This falls far short of the goal of 80 percent by the end of this decade, set forth by the U.S. Department of Health and Human Service’s Healthy People 2020 mission. Furthermore, U.S. rates are significantly lower than those of countries such as Australia (75 percent), the United Kingdom (84-92 percent) and Rwanda (93 percent), which have shown that high vaccination rates are currently achievable. The HPV vaccines, like all vaccines used in the U.S., passed extensive safety testing before and after being approved by the U.S. Food and Drug Administration (FDA). The vaccines have a safety profile similar to that of other vaccines approved for adolescents in the U.S. Internationally, the safety of HPV vaccines has been tested and approved by the World Health Organization’s Global Advisory Committee on Vaccine Safety. CDC recommends that boys and girls receive three doses of HPV vaccine at ages 11 or 12 years. The HPV vaccine series can be started in preteens as early as age 9 and should be completed before the 13th birthday. The HPV vaccine is more effective the earlier it is given; however, it is also recommended for young women until age 26 and young men until age 21. The low vaccination rates are alarming given our current ability to safely and effectively save lives by preventing HPV infection and its associated cancers. Therefore, the 69 NCI-designated Cancer Centers urge parents and health care providers to protect the health of our children through a number of actions: • We encourage all parents and guardians to have their sons and daughters complete the 3-dose HPV vaccine series before the 13th birthday, and complete the series as soon as possible in children aged 13 to 17. Parents and guardians should talk to their health care provider to learn more about HPV vaccines and their benefits. Georgetown University receives income from its licensing of the HPV vaccine technology for commercialization. • We encourage young men (up to age 21) and young women (up to age 26), who were not vaccinated as preteens or teens, to complete the 3-dose HPV vaccine series to protect themselves against HPV. • We encourage all health care providers to be advocates for cancer prevention by making strong recommendations for childhood HPV vaccination. We ask providers to join forces to educate parents/guardians and colleagues about the importance and benefits of HPV vaccination. HPV vaccination is our best defense in stopping HPV infection in our youth and preventing HPV-related cancers in our communities. The HPV vaccine is CANCER PREVENTION. More information is available from the CDC.

  43. Legislation: Senate Bill 200DSHS Sunset -Amendment The Health and Human Services Commission shall develop a strategic plan to significantly reduce morbidity and mortality from HPV-associated cancer. In developing the strategic plan, the Health and Human Services Commission shall collaborate with the DSHS and the CPRIT and may convene any necessary workgroups.

  44. Acknowledgments Dr. Lewis Foxhall – Office of Health Policy Dr. Ernest Hawk –Cancer Prevention and Population Sciences Mark Moreno – Government Relations Wesley Duncan – Government Relations The HPV Vaccine Team (Office of Health Policy) • Rosalind Bello • Lori Stevens • Melissa Mims • MehwishJavaid • Dana Ashrawi • Rachel Harris • ZeenaShelal Leadership • Dr. Ronald DePinho

  45. Questions Lois Ramondetta, MD Professor, Department of Gynecologic Oncology and Reproductive Medicine The University of Texas MD Anderson Cancer Center Chief, Division of Gynecologic Oncology Lyndon Baines Johnson General Hospital Harris Health System lramonde@mdanderson.org

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