New Guidelines for the Management of Abnormal Pap Smears by Z73xC3Uh

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									  New Guidelines for the
      Management of
  Abnormal Pap Smears:
Applications in Family PACT

  Michael S. Policar, MD, MPH
   UCSF School of Medicine

                Sponsored by
          Office of Family Planning         1
   California Department of Public Health
        Pap Smear Frequency
      1989 Consensus Statement
• All women who are, or who have been, sexually
  active, or who have reached 18 years old,
  should have annual Pap smears
  After at least 3 consecutive annual negative
  smears, Pap testing may be done less frequently
• No upper age limit on screening
• After hysterectomy, vaginal Paps every 3-5
  years
• Most guidelines used risk factors to define
  screening intervals
                                                2
       2001 Bethesda System:
         Goal of Screening
• The central purpose of screening is to detect high
  grade lesions
   – Most LSIL, especially in young women, is due
     to acute HPV infection, which itself is not
     dangerous
   – >90% LSIL lesions resolve without treatment
   – Evaluate ASC, LSIL Paps because HSIL may
     exist
   – Focus on high grade lesions as progression to
     cancer is more likely, regression is less likely
   – Detect glandular lesions likely to progress
                                                   3
     Designing Pap Smear Intervals

• Screening interval depends upon
   – Error rate of screening test
   – Progression rate of disease
• Cervical cancer risk factors don’t impact interval
   – (Slow) rate of growth is the same, irrespective
     of behavioral risk factors
   – If rapid growth is more likely (HIV positive,
     immunocompromised), screen more often
• With improved accuracy of screening test (LBC),
  longer screening intervals justifiable
                                                  4
       American Cancer Society
    Pap Smear Intervals: Made Easy
• Start screening
   – 3 years after first intercourse or 21 years old
   – Counsel virginal women re: benefits, risks
• Stop screening after
   – Total hysterectomy for benign condition, or
   – 3 negative Paps if hysterectomy for CIN 3, or
   – 65 yo, if 3 consecutive benign Paps in prior 10 yrs
• While screening
   – If LBC, every 2 years till 30, then every 2-3 years
   – If glass, annually till 30, then every 2-3 years
   – If immunocompromised, repeat annually
                                                       5
     Screening Interval in
  Immunecompromised Women
           ACS, USPSTF 2002; ACOG 2003

Recommendation
Perform Pap every 6 months x 2, then yearly if
• HIV seropositive
• Immunocompromised by organ transplant,
  chemotherapy, chronic steroid use
Rationale
• Progression rates from HSIL to cancer more
  rapid in immunocompromised women

                                                 6
           Adolescents:
     Why Wait 3 Years to Screen?
• High grade lesions take years to develop
  – Earliest HSILS are 3 years after sexual debut
• High grade lesions are rare
  – CIN 3 annual incidence 15-19 yo: 3/10,000
  – 4 years after HPV infection, CIN 2/3 in <5%
• Low grade lesions typically resolve spontaneously
  – At 3 years, 91% LSIL regress; only 3%
    progress to HSIL
• CIN 2 lesions often act like CIN 1; usually regress

                                                   7
    Common Questions About
        Pap Intervals
• Are the intervals any different for women
   – With multiple sexual partners?
   – Who have sex only with other women?
   – Who are pregnant?
   – Using hormonal contraceptives or hormone
     therapy?
• If a Pap is not scheduled or necessary, what
  about a bimanual pelvic exam?


                                                 8
       2004 WHO Selected Practice
            Recommendations
          for Contraceptive Use
• Not recommended as “contributing substantially
  to safe and effective use of contraceptive
  method”
   – Breast or genital tract examination
   – Cervical cancer screening
   – STI assessment or lab test screening
   – Hemoglobin determination
   – Other routine lab tests
• Blood pressure measurement before initiation of
   – OCs, POPs, DMPA, and implants               9
      Implications of 2002 Pap
        Interval Guidelines

•   Far fewer Paps for women less than 21 yo
•   Far fewer Paps for women older than 65-70 yo
•   One-half as many Paps if LBC smears used
•   No Paps if total hysterectomy for benign disease
•   No need for two Pap smears (antepartum and
    postpartum) in pregnant women
     – Illogical to do Paps in pregnant women < 21 yo

                                                  10
Management of Non-SIL
Pap Smear Abnormalities




                          11
         Pap Specimen Adequacy
     Cytology Finding                        Action
Unsatisfactory             • Repeat cytology in 2-4 months
Satisfactory, negative for • Repeat cytology within 6 months if
SIL, but limited by…few        • Unable to clearly visualize the
(scant) endocervical cells        cervix or sample the endocervical
                                  canal
                               • the client is immunosuppressed,
                               • there was a previously abnormal
                                  Pap without adequate follow up
                               • A positive HPV-DNA test within
                                  the past year,
                               • 3 or more years since the last
                                  normal cytology
                           • Otherwise, repeat in one year
                           • If practice-wide rate is > 15%, discuss
                             remediation with cytopathologist
                                                                 12
                        Organisms
   Cytology Finding                        Action
Trichomonas vaginalis • If recently treated, no further evaluation is
                        necessary
                      • If not, notify patient and offer either
                        presumptive treatment or confirmatory
                        testing
                      • Finding may indicate presence of other
                        STIs, although long term colonization also
                        is possible.
                      • Unless unsatisfactory, repeat cytology at
                        scheduled screening interval
Fungal organisms      • Usually due to asymptomatic Candidal
morphologically         colonization
consistent with       • No action is necessary; patient
Candida spp.            notification is optional
                      • Unless unsatisfactory, repeat cytology at
                        scheduled screening interval             13
                         Organisms
Cytology Finding                           Action
Shift in flora        Poor correlation with diagnosis of BV.
suggestive of         If recently treated, no further evaluation is
bacterial              necessary.
vaginosis (BV)             If not, patient notification is optional. If
                            notified, offer confirmatory evaluation
                      Repeat cytology at scheduled screening
                       interval.
Bacteria              In IUC user, rarely associated with pelvic
consistent with        actinomycosis.
Actinomyces           To evaluate, perform pelvic exam or refer for
                       gynecologic consultation.
                      If negative pelvic exam, IUC removal is not
                       required and there is no evidence of benefit
                       of antibiotic therapy
                                                                       14
                    Organisms
     Cytology                            Action
      Finding
Cellular changes   • Strongly suggestive of HSV shedding
consistent with    • If herpes diagnosis is in medical record,
herpes simplex       patient notification is optional
virus                 • If not, notify patient of result. Direct tests
                         for herpes virus (culture, DFA) are not
                         indicated
                      • If the patient requests confirmation, a
                         positive HSV type-specific serology will
                         confirm prior infection (not a Family PACT
                         benefit)
                   • Finding may indicate presence of other STIs,
                     although long standing HSV infection also is
                     possible.
                   • Repeat cytology at scheduled interval
                                                                   15
       Other Non-Neoplastic Findings
 Cytology Finding                            Action
Reactive changes    • May be due to GC, Ct, trichomonas, viruses,
associated with         irritants, (very rarely) cancer
(severe)            •   If recent GC, Ct tests were negative, no further
inflammation3           STD evaluation is necessary
                    •   If not recently screened, notify patient and offer
                        GC, Ct testing
                    •   Do not presumptively treat with topical or oral
                        antibiotics
                    •   If unexplained inflammation, repeat cytology in 6-
                        12 months
                    •   If persistent unexplained inflammation, consider
                        colposcopic evaluation
Reactive changes    • No action is necessary
associated with     • Patient notification is unnecessary
intrauterine        • Repeat cytology at scheduled screening interval
contraception
                                                                       16
     Other Non-Neoplastic Findings
Cytology Finding                     Action
Atrophy            • No action is necessary
                   • Patient notification is unnecessary
                   • Repeat cytology at scheduled screening
                     interval

Benign            • For post-menopausal women, endometrial
endometrial cells   assessment is recommended (not a Family
(including          PACT benefit)
stromal cells or • For premenopausal women
histiocytes)         • No action is necessary
                     • Patient notification is unnecessary
                     • Repeat cytology at scheduled screening
                       interval

                                                              17
    2006 ASCCP Cervical Cytology
       Management Guidelines

• http://www.asccp.org/consensus/cytological.shtml
• Guidelines on Management of Women with
  Cytological Abnormalities
   – How to manage abnormal Pap results
• Guidelines on Management of Women with
  Histological Abnormalities
   – How to manage abnormal biopsy results


                                               18
       What Are Indications for
          Colposcopy?-1

• Cytology result with ASC-H, HSIL or suspicion
  of cancer
• Cytology with LSIL in a women >21 years old
  (unless pregnant or post-menopausal)
• Cytology with atypical glandular cells (AGC),
  unless AGC-atypical endometrial cells and
  positive endometrial sampling



                                              19
       What Are Indications for
          Colposcopy?-2
• Cytology showing ASC-US in the following
  circumstances
   – Women who are unlikely or unwilling to return
     for follow-up
   – Repeat cytology test with ASC-US or worse
     performed during observation period (except
     adolescents)
   – High-risk HPV DNA present at initial or
     subsequent testing (except adolescents)

                                               20
       What Are Indications for
          Colposcopy?-3

• Cervical leukoplakia (visible white lesion) or
  other unexplained cervical lesion regardless of
  cytology result
• Unexplained or persistent cervical bleeding
  regardless of cytology result




                                                    21
            ASCCP 2006:
     Managing Women with ASC-US

 2001 Guideline                  2006 Guideline
•A program of repeat          A program of repeat
cervical cytology, or         cervical cytological
colposcopy, or DNA            testing, colposcopy, or
testing for high-risk types   DNA testing for high-risk
of HPV are all acceptable     types of HPV are all
methods for managing          acceptable methods for
women with ASC-US.            managing women over the
(AI)                          age of 20 with ASC-US.
                              (AI)
                                                     22
   Managing Women with ASC-US
 No Major Changes from 2001 Guideline

• Acceptable post-colposcopy management options for
women who are positive for high-risk types of HPV,
but in whom CIN is not identified, are HPV DNA
testing at 12 months or repeat cytological testing at 6
and 12 months. (BII)
• It is recommended that HPV DNA testing not be
performed at intervals less than 12 months. (EIII)


                                                     23
ASC-US: Women > 21 Years Old




                           24
    Management of ASC-US

Special groups of women
 Postmenopausal women
 Immunosuppressed women
 Adolescents (9-19 years of age)


                                    25
      Management of ASC-US
      Postmenopausal Women

 2001 Guideline                2006 Guideline
• Providing a course of       Postmenopausal
intravaginal estrogen        women with ASC-US
followed by a repeat         should be managed in
cervical cytology obtained
                             the same manner as
approximately a week
after completing the
                             women in the general
regimen. (CIII)              population. (BII)


                                                26
     Management of ASC-US
   Immunosuppressed Women

  2001 Guideline                2006 Guideline
• Referral for colposcopy is
recommended for all             Immunosuppressed
immunosuppressed               women with ASC-US
patients with ASC-US.          should be managed in
(BII)                          the same manner as
• Includes all HIV-infected    women in the general
women, irrespective of CD4     population. (BII)
count, HIV viral load, or
antiretroviral therapy.
                                                 27
       Management of ASC-US
Adolescent Women (20 yrs and younger)

   HPV DNA testing and colposcopy are
  unacceptable for adolescents with ASC-
  US. (EII)
   If HPV testing is inadvertently
  performed, the results should not influence
  management                                  2006


                                              28
ASC-US+ LSIL: Adolescents




                            29
      Summary: ASC-US and LSIL
        in Adolescent Women
                        ASCCP 2006

• ASC-US and LSIL are managed identically
• Colposcopy and (reflex) HPV triage are no longer
  recommended as initial options
• If a follow-up Pap in one year is less than HSIL,
  perform a second Pap one year later
   – If result is ASC-US or worse, refer for
     colposcopy
• Follow patients with biopsy proven CIN I or
  CIN II for at least 2 years to allow for regression
                                                  30
ASC-H: Women of All Ages




                           31
         Management of LSIL


 Key Changes for 2006
 Less importance is given as to whether the
  colposcopic examination is satisfactory and CIN 1
  is found
 Adolescents are managed less aggressively and in
  the same fashion as those with ASC-US, i.e. repeat
  cytology


                                                  32
LSIL: Women > 21 years Old




                         33
LSIL: Pregnant Women




                       34
        Management of LSIL
      Postmenopausal Women
• Acceptable options for the management of LSIL in
  postmenopausal women include "reflex" HPV DNA
  testing (BII) or colposcopy (BII)
• If the HPV DNA test is negative or if colposcopy is
  negative, repeat cytology in 12 months is
  recommended
   – If the HPV DNA test is positive colposcopy is
      recommended (AII)

                                                  35
       Management of HSIL

Key changes for 2006
• Either a diagnostic excisional procedure or
  colposcopy with endocervical assessment are
  acceptable for initial management
• If no CIN 2+ is identified on colposcopy either a
  diagnostic excisional procedure or follow-up are
  acceptable (not limited to adolescents)


                                                      36
     Management of HSIL
Except Adolescents and Young Women




                                 37
  Management of HSIL
Adolescents and Young Women




                              38
   Should HPV Testing or Repeat
     Pap Be Used in the Initial
       Evaluation of AGC?

• A program of repeat cervical cytology     is
unacceptable in the initial triage of all
subcategories of AGC or AIS

• HPV DNA testing alone is unacceptable in the
initial triage of all subcategories of AGC or AIS


                                                 39
  Management of AGC
Initial Workup (All Ages)




                            40
Management of AGC
Subsequent Workup




                    41
          Management of
         Cervical Biopsies
• Biopsy CIN 1
  – Pap ASC-US, ASC-H, LSIL
  – Pap HSIL, AGC-NOS
  – Adolescents
• Biopsy CIN 2, 3
  – Adolescents and Young Women
  – Adults Excluding Adolescents, Young
    Women
• Adenocarcinoma in Situ (AIS)
                                          42
     Biopsy CIN 1
Pap ASC-US, ASC-H, LSIL




                          43
   Biopsy CIN 1
Pap HSIL, AGC-NOS




                    44
Biopsy CIN 1
Adolescents




               45
          Biopsy CIN 2, 3
(excluding Adolescents and Young Women)




                                    46
      Biopsy CIN 2 or 3
Adolescents and Young Women




                          47
Adenocarcinoma in Situ (AIS)




                               48
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