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Anal Cancer
What’s the Bottom Line on Vaccination,
Screening, and Treatment
Yosef Nasseri M.D.
The Surgery Group of Los An...
No Relevant
Disclosures
Overview
• Anal Cancer
– Incidence
– Risk Factors
• Prevention
– Risk stratification
– Vaccination
– Screening
• Treatment...
Anatomy
Anatomy
Anal Cancer
Anal Cancer
• Incidence
– 2012 NCCN Anal Cancer Data
• 6230 new cases of anal cancer per year
– Women 3,980
– Men 2,250
• ...
Anal Cancer: Risk Factors
• 95% associated with HPV
– Human Papiloma Virus, a papovavirus, 8 kb genome
– Most common viral...
Anal Cancer: Risk Factors
• High Risk HPV Serotypes
– HPV-16, HPV-18
– detected in > 80% of anal cancer specimens
– CDC: e...
Anal Cancer: Terminology
• Condyloma
– AIN I
– LSIL
• Dysplasia
– Bowen’s Disease
– Anal SCC in situ
– AIN II
– AIN III
– ...
Anal Cancer:
Similar HPV Pathway as Cervical Cancer
Progression of persistent HPV infection in the cervix
Ortoski R A , an...
Anal Cancer: Terminology
• Condyloma
– AIN I
– LSIL
• Dysplasia
– Bowen’s Disease
– Anal SCC in situ
– AIN II
– AIN III
– ...
Anal Cancer
Prevention
Prevention
• Vaccination
– Recombinant HPV Quadrivalent Vaccine, HPV4
(Gardasil®)
• FDA Approved 12/23/2010 for anal cance...
Prevention
• Vaccination
– Recombinant HPV Quadrivalent Vaccine, HPV4
(Gardasil®)
• FDA Approved 12/23/2010 for anal cance...
Prevention
• Vaccination
– Bivalent HPV Vaccine against HPV-16 and 18, HPV2
(Cervarix®)
– Efficacy in anal lesions pending...
Prevention
• Vaccination
– Recombinant HPV Quadrivalent Vaccine, HPV4 (Gardasil®)
• FDA Approved 12/23/2010 for anal cance...
Prevention
• There is No Effective Barrier Protection
– HPV pools at the base of the penis, scrotum, and
vaginal introitus...
Prevention
• Routine Screening for High Risk Patient
Populations
– HIV +, Male, CD4 counts < 500 x 106 cells / L
– HIV +, ...
Prevention & Screening
Who? What? When? Where?
Screening Methods
• Physical Examination
– Anal Exam
– DRE
– Anoscopy
• Ana...
Prevention & Screening
Who? What? When? Where?
• ANAL Lesions
– Lesions that are not visible or
are incompletely visible w...
Prevention & Screening
Who? What? When? Where?
• High Resolution
Anoscopy
– H&P, HRA every 6
months
– Surgical ablation of...
Prevention & Screening
Who? What? When? Where?
• High Resolution
Anoscopy
– Rate of progression to
cancer 1.2%
– Complicat...
Prevention & Screening
Who? What? When? Where?
• Who? – high risk individuals
– HIV +, Male, CD4 counts < 500 x 106 cells ...
Treatment
HPV Dysplasia
LSIL = low grade = condyloma
HSIS = high grade = carcinoma in situ
Treatment: HPV LSIL, HSIL
• Surgical Methods:
– Excision
– Cryotherapy
– Fulguration
– Electrodesication
• Topical Treatme...
Treatment: HPV LSIL, HSIL
Goal: destruction or removal of all obvious disease while minimizing morbidity
Method of
Action
...
Treatment
Anal Cancer
Anal Cancer Treatment
Prognosis
• Independent Poor Prognostic Indicators for
Survival and Local Control
– Positive lymph n...
Treatment: Anal Cancer
• Anal Cancer Staging
– H&P, DRE, Anoscopy, colonoscopy, Inguinal LN exam
– X-sectional imaging Che...
Treatment: Anal Cancer
• Traditional Protocol - APR
• APR 5 year survival 40-70%
• High local recurrence rates
• Permanent...
Anal Cancer
Location, Location, Location
• ANAL Lesions
– “Anal Canal”
– Lesions that are not visible or
are incompletely ...
Treatment:
Anal Canal Cancer
• Combined Modality Therapy (CMT)
– Primary treatment for non-metastatic anal canal
cancer
– ...
Treatment:
Anal Margin Cancer
• Either local excision or CMT depending on the
clinical stage
– Local Excision: T1 & T2 tum...
Treatment: Anal Cancer
• Post-treatment Surveillance
• H&P, DRE, Anoscopy 8 – 12 weeks after CMT
– 29% of patients without...
Review• Anal Cancer
– Incidence:
– Risk Factors:
• HPV Prevention
– Risk stratification
– Vaccination
– Screening
• Treatm...
Anal Cancer:
Prevention and Screening
“Working Where the Sun
Don’t Shine”
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Anal Cancer - What's the Bottom Line on Vaccination, Screenings, and Treatment

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Presentation by Yossef Nasseri, M.D.

Yosef Nasseri, M.D., is a founding member of The Surgery Group of Los Angeles, a Los Angeles based physician group providing a comprehensive approach to surgical care through advanced technology, long-term patient follow-up, and direct physician access. Dr. Nasseri is double board-certified in general and colorectal surgery and specializes in cutting-edge robotic and minimally invasive techniques for the treatment of colon and rectal cancers, inflammatory bowel disease, benign anorectal diseases, a variety of hernias, and general surgery.

Published in: Health & Medicine
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Anal Cancer - What's the Bottom Line on Vaccination, Screenings, and Treatment

  1. 1. Anal Cancer What’s the Bottom Line on Vaccination, Screening, and Treatment Yosef Nasseri M.D. The Surgery Group of Los Angeles
  2. 2. No Relevant Disclosures
  3. 3. Overview • Anal Cancer – Incidence – Risk Factors • Prevention – Risk stratification – Vaccination – Screening • Treatment – HPV – Anal Cancer
  4. 4. Anatomy
  5. 5. Anatomy
  6. 6. Anal Cancer
  7. 7. Anal Cancer • Incidence – 2012 NCCN Anal Cancer Data • 6230 new cases of anal cancer per year – Women 3,980 – Men 2,250 • 780 Deaths – 2.2% of GI Cancers • Increased incidence 1979 - 2000 – 1.5 increase in women – 1.9 increase in men http://www.nccn.org
  8. 8. Anal Cancer: Risk Factors • 95% associated with HPV – Human Papiloma Virus, a papovavirus, 8 kb genome – Most common viral sexually transmitted disease • HPV: Necessary, but not sufficient – Cell-Mediated Immunity Dysfunction – Immunosuppression • Solid OrganTransplantation • Anti-TNF therapy • HIV • Hematologic Malignancies – Smoking – Autoimmune Disorders NCCN, CDC, NCI, ACA, ASCRS Databases
  9. 9. Anal Cancer: Risk Factors • High Risk HPV Serotypes – HPV-16, HPV-18 – detected in > 80% of anal cancer specimens – CDC: estimates 86-97% of cancers of the anus are attributed to HPV infection – Other Oncogenic HPV strains: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 66 • Immunosuppression facilitates persistence of HPV infection – HIV+, MSM incidence 131 / 100,000 persons – Solid Organ Transplant – Anti-TNF Therapy
  10. 10. Anal Cancer: Terminology • Condyloma – AIN I – LSIL • Dysplasia – Bowen’s Disease – Anal SCC in situ – AIN II – AIN III – HSIL • Anal Cancer – Invasive Squamous Cell Carcinoma of the Anus – SCC Anus
  11. 11. Anal Cancer: Similar HPV Pathway as Cervical Cancer Progression of persistent HPV infection in the cervix Ortoski R A , and Kell C S J Am Osteopath Assoc 2011;111:S35-S43
  12. 12. Anal Cancer: Terminology • Condyloma – AIN I – LSIL • Dysplasia – Bowen’s Disease – Anal SCC in situ – AIN II – AIN III – HSIL • Anal Cancer – Invasive Squamous Cell Carcinoma of the Anus – SCC Anus Whew!
  13. 13. Anal Cancer Prevention
  14. 14. Prevention • Vaccination – Recombinant HPV Quadrivalent Vaccine, HPV4 (Gardasil®) • FDA Approved 12/23/2010 for anal cancer prevention • HPV types 6, 11, 16, 18 • Ages 9 – 26 • 3 shots over 6 months – Efficacy 78% • RCT: 602 healthy MSM, age 16 – 26 years – 3 year observational study – No anal cancer – Placebo: HSIL 24 cases – Vaccine: HSIL 5 cases Palefsky JM et al HPV Vaccine against Anal HPV and AIN NEJM 2011;365:1576-1585
  15. 15. Prevention • Vaccination – Recombinant HPV Quadrivalent Vaccine, HPV4 (Gardasil®) • FDA Approved 12/23/2010 for anal cancer prevention • HPV types 6, 11, 16, 18 • Ages 9 – 26 – Practice Guidelines • Advisory Committee on Immunization Practices (ACIP) – Routine use of vaccine • Female age 11 – 26 • Male age 11-21 • American Academy of Pediatrics (AAP) – Agree with Above, plus MSM up to age 26 ACIP MMWR Morb Mortal Wkly Rep 2010;59:626-629 & 2011;60:1705-1708 Pediatrics 2012:129:602-605
  16. 16. Prevention • Vaccination – Bivalent HPV Vaccine against HPV-16 and 18, HPV2 (Cervarix®) – Efficacy in anal lesions pending – Data only currently for cervical HPV and Dysplasia: • Efficacy in preventing initial HPV infection 84% • Reduced high-grade CIN in young women Efficacy of a bivalent HPV 16/18 vaccine Lancet Oncol 2011;12:862-870 PATRICIA trial. Lancet Oncology 2011;13:69-99
  17. 17. Prevention • Vaccination – Recombinant HPV Quadrivalent Vaccine, HPV4 (Gardasil®) • FDA Approved 12/23/2010 for anal cancer prevention – HPV types 6, 11, 16, 18 – Ages 9 – 26 • Practice Guidelines – ACIP • Female age 11 – 26 • Male age 11 – 21 – AAP • plus MSM up to age 26 ACIP MMWR Morb Mortal Wkly Rep 2010;59:626-629 & 2011;60:1705-1708 Pediatrics 2012:129:602-605 Female: 9 … 11 – 26 Male: 9 … 11 – 21 … 26
  18. 18. Prevention • There is No Effective Barrier Protection – HPV pools at the base of the penis, scrotum, and vaginal introitus – Only preventative method is abstinence – Anal HPV can be present without ARI
  19. 19. Prevention • Routine Screening for High Risk Patient Populations – HIV +, Male, CD4 counts < 500 x 106 cells / L – HIV +, MSM – HSIL – high grade anal intraepithelial neoplasm – Immunosuppression • Solid organ transplantation • Multi-modal immunosuppressive therapy • Screening Methods? • What time interval is routine?
  20. 20. Prevention & Screening Who? What? When? Where? Screening Methods • Physical Examination – Anal Exam – DRE – Anoscopy • Anal pap smears • High resolution anoscopy – 5% acetic acid
  21. 21. Prevention & Screening Who? What? When? Where? • ANAL Lesions – Lesions that are not visible or are incompletely visible with gentle traction to spread the buttocks • Peri-Anal Lesions – Lesions that are completely visible with gentle traction to spread butocks • SCC Skin Cancer
  22. 22. Prevention & Screening Who? What? When? Where? • High Resolution Anoscopy – H&P, HRA every 6 months – Surgical ablation of persistent lesions • Expectant Management – H&P, DRE, Anoscopy every 6 months – Surgical ablation of a new or ulcerative lesions Welton et al Hi Res Anoscopy DCR 2008;51:829-35Cosman B. , UCSD, Unpublished data
  23. 23. Prevention & Screening Who? What? When? Where? • High Resolution Anoscopy – Rate of progression to cancer 1.2% – Complications 4% – 57% recurrence rate, average 19 months • Expectant Management – Rate of progression of HSIL to invasive cancer: 1% per year – The cancers that arise are curable – Patients who progress to cancer often do so more than once Welton et al Hi Res Anoscopy DCR 2008;51:829-35 Cosman B. , UCSD, Unpublished data
  24. 24. Prevention & Screening Who? What? When? Where? • Who? – high risk individuals – HIV +, Male, CD4 counts < 500 x 106 cells / L – HIV +, MSM – HSIL – high grade anal intraepithelial neoplasm – Immunosuppression • What? – at minimum, H&P, DRE, Anoscopy – Refer to specialty clinic if available – Ongoing HIV testing • When? – HSIL: Every 3 months x 1 year if, then every 6 months – Evaluate any new or ulcerative lesion when it arises
  25. 25. Treatment HPV Dysplasia LSIL = low grade = condyloma HSIS = high grade = carcinoma in situ
  26. 26. Treatment: HPV LSIL, HSIL • Surgical Methods: – Excision – Cryotherapy – Fulguration – Electrodesication • Topical Treatments: (not approved for use in anal canal) – Podofilox 0.5% gel • Purified product of antimitotic plant resin podophyllin • BID x 3 days, off 4 days repeat x 1 month – Imiquimod (Aldera) • 3x per week, apply at bedtime (6-8 hr) x 16 weeks – Trichloracetic acid – Less common: topical 5-FU, Cidofovir Goal: destruction or removal of all obvious disease while minimizing morbidity
  27. 27. Treatment: HPV LSIL, HSIL Goal: destruction or removal of all obvious disease while minimizing morbidity Method of Action Clearance Rate Recurrence Rate Podofilox 0.5% gel, soln Anti-mitotic 35-80% 10 – 20% Imiquimod (Aldera) Immune response modifier ( IFN-α) 50% 11% Surgery Excision, Destruction 60 – 90% 20 – 30%
  28. 28. Treatment Anal Cancer
  29. 29. Anal Cancer Treatment Prognosis • Independent Poor Prognostic Indicators for Survival and Local Control – Positive lymph nodes, tumor size > 5 cm, male sex, skin ulceration • Staging – T1 < 2 cm; T2 2 – 5 cm – T3 > 5 cm – T4 invades adj organs – N 1 peri rectal LN – N2 unilateral ilac or inguinal LN – N3 = N1+ N2 http://www.nccn.org Stage 5-year Survival Rate I (T1N0) 71% II (T2-T3, N0) 64% III B (T1-3, N1, T4N0) 48% III B (T4N1, T1-4N2-3) 43% IV (Metastasis) 21%
  30. 30. Treatment: Anal Cancer • Anal Cancer Staging – H&P, DRE, Anoscopy, colonoscopy, Inguinal LN exam – X-sectional imaging Chest/Abd/Pelvis (PET CT) – HIV testing, CD4 levels when positive – Cervical cancer screening in women http://www.nccn.org
  31. 31. Treatment: Anal Cancer • Traditional Protocol - APR • APR 5 year survival 40-70% • High local recurrence rates • Permanent colostomy • Nigro Protocol – 1974 complete tumor regression in patients treated with combined radiation and chemotherapy (CMT) – Changed management from APR to CMT • 70% Survival • Low local recurrence rates • Sphincter preservation http://www.nccn.org
  32. 32. Anal Cancer Location, Location, Location • ANAL Lesions – “Anal Canal” – Lesions that are not visible or are incompletely visible with gentle traction to spread the buttocks • Peri-Anal Lesions – “Anal Margin” – Lesions that are completely visible with gentle traction to spread buttocksSkin Cancer
  33. 33. Treatment: Anal Canal Cancer • Combined Modality Therapy (CMT) – Primary treatment for non-metastatic anal canal cancer – Chemotherapy 1st and 5th week • Mitomycin day 1 or 2 of 1st & 5th week • 5-FU 96 – 120 hour infusion during 1st & 5th weeks – Radiation Therapy for 5 weeks • Minimum of 45 Gy to primary cancer http://www.nccn.org
  34. 34. Treatment: Anal Margin Cancer • Either local excision or CMT depending on the clinical stage – Local Excision: T1 & T2 tumors with 1 cm margin – CMT +/- APR: T3 &T4 tumors • Combined Modality Therapy (CMT) – Chemotherapy 1st and 5th week • Mitomycin C, 5-FU – Radiation Therapy for 5 weeks • 45 Gy to primary cancer http://www.nccn.org
  35. 35. Treatment: Anal Cancer • Post-treatment Surveillance • H&P, DRE, Anoscopy 8 – 12 weeks after CMT – 29% of patients without complete response at 11 weeks achieved complete response by 26 weeks • Complete Remission – Follow up every 3 – 6 months for 5 years – DRE, anoscopy, inguinal LN evaluation – Annual Chest/Abd/Pelvis Imaging x 3 years • Recurrence, Incomplete Response – APR ASCO Meeting Abstracts 2012;30:4004; NCCN Quidelines
  36. 36. Review• Anal Cancer – Incidence: – Risk Factors: • HPV Prevention – Risk stratification – Vaccination – Screening • Treatment – HPV Dysplasia – Anal Cancer Rare, but incidence on the rise HPV, HIV, MSM, Immunosuppression (IS) HIV+, CD4 < 500 , MSM, HSIL, IS HPV 6, 11, 16, 18 Vaccine (Gardasil®) – M / F: Ages 9…11 – 21 / 26 (…26 MSM) H&P, DRE, Anoscopy – Biopsy all new or ulcerative lesions – Get Path on all high risk patients Topical (Podofilox, Aldera), Surgery Refer to a specialist
  37. 37. Anal Cancer: Prevention and Screening “Working Where the Sun Don’t Shine”

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