Disclosures. Learning objectives. George F. Sawaya, MD. I have nothing to disclose.

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Well Woman Visits in 2018: How Should We Approach Cervical Cancer Screening and Routine Pelvic Examinations? George F. Sawaya, MD Disclosures I have nothing to disclose.

1 Well Woman Visits in 2018: How Should We Approach Cervical Cancer Screening and Routine Pelvic Examinations? George F. Sawaya, MD Disclosures I have nothing to disclose. Professor, Obstetrics, Gynecology and Reproductive Sciences Epidemiology & Biostatistics University of California, San Francisco The Robert B. Domush Chair in Obstetrics and Gynecology Education Director, The Colposcopy Clinic at Zuckerberg San Francisco General Hospital Education Lead, UCSF Center for Healthcare Value Learning objectives Current cervical cancer screening recommendations, average risk women 2012: USPSTF, ACS/ASCCP/ASCP, ACOG To understand 3 current recommendations for cervical cancer screening in the US: ACOG (2016), ACS/ASCCP/ASCP (2012), USPSTF (2012, draft 2017) To understand the 3 current recommendations for screening pelvic examinations in the US: ACOG (2012, 2016), American College of Physicians (2014), USPSTF (2017) Sawaya et al Ann Intern Med. 2015;162:

2 Which women are not average risk? Immunocompromised due to HIV infection Exposure to diethylstilbestrol in utero Prior cervical intraepithelial lesion grade 2 or cancer it is reasonable to extrapolate the recommendations for women with HIV infection to [women immunocompromised due to non HIV causes]. Annual cervical cytology screening is reasonable for women exposed to diethylstilbestrol in utero. Screening immunocompromised women, ACOG 2016 Age to begin: within 1 year of onset of sexual activity or, if already sexually active, within the first year after HIV diagnosis but no later than age 21 Age to end: no ending age Ages <30: cytology every year but can extend to every 3 years after 3 normal tests Ages 30+: same as above OR cytology plus HPV testing (co testing) every 3 years ACOG Bulletin No. 168, October 2016 ACOG Bulletin No. 168, October 2016 More specific recommendations American Cancer Society/ASCCP/ASCP, 2012 Aged <30: HPV testing should not be used in this age group. Ages 30 65: screening by HPV testing alone is not recommended in most clinical settings US Preventive Services Task Force, 2012 Aged <30: Recommend against screening for cervical cancer with HPV testing (alone or in combination with cytology) 2015 FDA approves HPV alone strategy for women aged 25+ years Cobas test (14 hrhpv types) If negative, routine screening ( not more often than 3 years ) If positive, do type specific testing (HPV 16/18) if 16/18 positive > colposcopy if 16/18 negative > cytology > if ASC+ > colposcopy if normal > follow up in 12 months Huh et al Use of primary high risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance [from SGO] Gynecol Oncol 2015

3 ACOG Update, 2016 In women 25 years and older, the FDA approved primary HPV screening test can be considered as an alternative to current cytology based cervical cancer screening methods. If screening with primary HPV testing is used, it should be performed as per the ASCCP and SGO interim guidance. Cytology alone and co testing remain the options specifically recommended in current major society guidelines. UCSF and ZSFG Tables From screening, to colposcopy to treatment all in 2, post able pages! In your syllabus ACOG Bulletin No. 168, October 2016 USPSTF Draft Recommendations 2017 No longer recommending co testing (Pap plus HPV) Recommending either cytology alone every 3 years or HPV testing alone every 5 years (women aged 30+ only) D recommendation against HPV testing for women under age 30: removed But no specific recommendation for how to manage HPV+ women (16/18 triage? Cytology?) Screening pelvic examinations: Background Three components: external genitalia; internal visualization of vagina and cervix (speculum); bimanual examination with or without rectovaginal examination Screening: asymptomatic women Excludes: cervical cancer screening, STI screening (GC, CT) Foundation of gynecologic care: Over 62 million performed in 2010

I lay much stress with reference to local examination on the superiority of the information yielded by

Pozzi, 1893 Audience Question #1: In which asymptomatic woman would you feel most strongly about

35 year old, no new partners for 5 years 3.

4 I lay much stress with reference to local examination on the superiority of the information yielded by touch and bi manual palpation over that yielded by the speculum. Pozzi, 1893 Audience Question #1: In which asymptomatic woman would you feel most strongly about performing a routine bimanual examination? year old, sexually active for one month year old, no new partners for 5 years year old, prior removal of the entire uterus and ovaries year old, not sexually active for 10 years 5. Feel equally strongly about all of the above 6. None of the above OB/GYN s practices: Bimanual exams

OB/GYN s practices: Bimanual exam reasons OB/GYN s practices: External genital inspection and speculum exams Hsu, Henderson, Harper, Sawaya J Am Geriatr Soc 2016.

Annual pelvic examination of patients 21 years of age or older is recommended by the College.

5 OB/GYN s practices: Bimanual exam reasons OB/GYN s practices: External genital inspection and speculum exams Hsu, Henderson, Harper, Sawaya J Am Geriatr Soc American College of Obstetricians and Gynecologists, 2012 What do professional groups recommend? Annual pelvic examination of patients 21 years of age or older is recommended by the College. At this time, this recommendation is based on expert opinion, and limitations of the internal pelvic examination should be recognized. No evidence supports or refutes the annual pelvic examination or speculum and bimanual examination for the asymptomatic, low risk patient. An annual examination seems logical ACOG Committee Opinion No. 534, Well Woman Visits, August 2012

American College of Obstetricians and Gynecologists, 2012 The decision whether or not to perform a pelvic examination for the asymptomatic patient should be a shared decision after a discussion

After total hysterectomy and BSO for benign indications: the decision to receive an internal examination can be left to the patient *no history of VIN; CIN2, 3 or cancer; no HIV or immunocompromise;

6 American College of Obstetricians and Gynecologists, 2012 The decision whether or not to perform a pelvic examination for the asymptomatic patient should be a shared decision after a discussion between the patient and her health care provider. After total hysterectomy and BSO for benign indications: the decision to receive an internal examination can be left to the patient *no history of VIN; CIN2, 3 or cancer; no HIV or immunocompromise; not exposed to DES in utero. ACOG Committee Opinion No. 534, Well Woman Visits, August 2012 American College of Obstetricians and Gynecologists, 2012 Annual examination of the external genitalia should continue. Also, it would be reasonable to stop performing pelvic examinations when a woman s age or other health issues reach a point where the woman would not choose to intervene on conditions detected during the routine examination, particularly if she is discontinuing her other routine health care maintenance assessments. ACOG Committee Opinion No. 534, Well Woman Visits, August 2012 American College of Physicians, 2014 American College of Physicians, 2014 ACP recommends against performing screening pelvic exams in asymptomatic, nonpregnant adult women.

7 ACOG response to ACP: 2014 continues to firmly believe in the clinical value of pelvic examinations, through which gynecologists can recognize issues such as incontinence and sexual dysfunction. allow gynecologists to explain a patient s anatomy, reassure her of normalcy, and answer her specific questions, thus establishing open communication between patient and physician. While not evidence based, the use of pelvic exams is supported by the clinical experiences of gynecologists treating their patients. ACOG response to ACP: Washington Post ACOG s Vice President for Health Policy said she believes the pelvic exam can be a bonding experience. It opens the door and is a time of intimacy between the patient and care provider, encouraging patients to discuss sexual concerns, urinary incontinence and other issues they might otherwise avoid. "An absence of evidence isn't an absence of value. We all know there is value to laying on of hands ACOG/News Room/Statements and Advisories/2014/ACOG Practice Advisoryon Annual Pelvic Examination Recommendations US Preventive Services Task Force: 2017 Insufficient evidence (I statement) Studies evaluating the accuracy and effectiveness of screening pelvic examination to detect conditions other than ovarian cancer, bacterial vaginosis, genital herpes, and trichomoniasis are lacking. clinicians are encouraged to consider the patient s risk factors for various gynecologic conditions and the patient s values and preferences, and engage in shared decisionmaking with the patient to determine whether to perform a pelvic examination. Evidence Review: Focus Bacterial vaginosis, genital herpes, trichomoniasis: No screening studies solely in asymptomatic primary care populations. Ovarian cancer

8 Evidence Review: Ovarian cancer USPSTF Recommendations Studies mainly in post menopausal women Sensitivity ranged from 0 100%; false positive testing ranged from % Surgery rates resulting from an abnormal screening pelvic examination for ovarian cancer ranged from 5% to 36% at 1 year, with the largest study reporting an 11% surgery rate and 1% complication rate within 1 year of a screening pelvic examination with abnormal findings. Certainty of Magnitude of Net Benefit Net Benefit Substantial Moderate Small Zero/Negat ive High A B C D Moderate B B C D Low I statement (insufficient evidence) ACOG Response to USPSTF: 2017 Reaffirmed the 2012 Committee Opinion recommending annual pelvic examinations in women aged 21 and older Revoked the 2014 Practice Advisory: No longer state possible benefits: recognition of incontinence, sexual dysfunction and reassurance of normalcy No current statement on potential benefits ACOG Response to USPSTF: New York Times USPSTF: This is not a recommendation against doing the exam. This is a recommendation to call for more research to figure out the benefits and harms associated with screening pelvic exams. That s the big message here. [ACOG s VP of Health Policy] said the call for more research is impractical. Exams are part of preventive care that is tricky to evaluate or assess, she said, and such studies are unlikely to get funded. Looking for evidence based answers to centuries old processes and procedures doesn t always make sense. exams may not prolong life a taskforce says/

9 ACP Response to USPSTF: 2017 we believe that the [USPSTF] missed the mark by issuing an I statement (insufficient evidence) rather than a D recommendation against the screening pelvic examination. The only purported benefit of the screening pelvic examination: establish and maintain a patientphysician relationship. we are at a loss to see how the pelvic examination, which is invasive, can be justified to establish a patient physician relationship. What do patients think? Interviews with 262 women, ZSFG and MZ Shown an illustration of an exam, asked if they knew why it was performed and if it reassured them of their health About half (56%) stated that they knew the exam s purpose. Most frequently cited: assurance of normalcy. 82% believed the examination reassured them of their health. Qaseem et al. JAMA (3): 300 Norrell, Kuppermann, Moghadassi, Sawaya. Am J Obstet Gynecol 2016 Women s opinions: San Francisco women randomized to: a summary of the ACP recommendation against the examination (no benefit and evidence of harm) a summary of the ACOG recommendation for the examination (expert opinion) Given a choice, would you want to have this examination even if you were having no problems? Total Yes No or Don t know Univariable Multivariable* No guideline (79) 54 (21) reference reference Sawaya GF, Smith McCune KK, Gregorich SE, Moghadassi M, Kuppermann M. Am J Obstet Gynecol Sep;217(3):338.

10 Given a choice, would you want to have this examination even if you were having no problems? Given a choice, would you want to have this examination even if you were having no problems? Total Yes No or Don t Univariable Multivariable* Total Yes No or Don t Univariable Multivariable* know know No guideline (79) 54 (21) reference reference ACOG (82) 17 (18) 1.22 ( ) 1.37 ( ) No guideline (79) 54 (21) reference reference ACOG (82) 17 (18) 1.22 ( ) 1.37 ( ) ACP (39) 57 (61) 0.16 ( ) 0.12 ( ) Sawaya GF, Smith McCune KK, Gregorich SE, Moghadassi M, Kuppermann M. Am J Obstet Gynecol Sep;217(3):338. Sawaya GF, Smith McCune KK, Gregorich SE, Moghadassi M, Kuppermann M. Am J Obstet Gynecol Sep;217(3):338. Do you think this examination helps establish open communication between you and your health care provider? Do you believe that women with no health problems should discuss the potential benefits and harms of this examination with their provider before deciding to have one? Total Yes No or Don t know Univariable Multivariable* No guideline (62) 99 (38) reference reference ACOG (63) 36 (37) 1.03 ( ) 1.09 ( ) ACP (53) 43 (47) 0.68 ( ) 0.70 ( ) Sawaya GF, Smith McCune KK, Gregorich SE, Moghadassi M, Kuppermann M. Am J Obstet Gynecol Sep;217(3):338. Total Yes No or Don t know Univariable ACOG (93) 7 (7) reference ACP (96) 4 (4) 1.73 ( ) Sawaya GF, Smith McCune KK, Gregorich SE, Moghadassi M, Kuppermann M. Am J Obstet Gynecol Sep;217(3):338.

11 The path forward Bridging evidence gaps: averting torsion of benign ovarian masses? Screening for vulvar intraepithelial neoplasia (VIN)? Is there an intangible, un measurable benefit? Is the need for reassurance of normalcy simply a consequence of decades long public health messaging about the need for an annual examination? Should we continue to consider the female pelvis a ticking time bomb that can only be defused by a clinician at an annual visit? Shared decision making: should it be more about the lack of consensus from these 3 groups? Summary Three different recommendations ACOG: ACP: USPSTF: We think we know: Do it. But discuss first. We know: Don t do it. We don t know, but you may want to discuss it. Research path forward unclear Clinical path forward: Scripted ways to discuss this with patients may be useful. Sawaya JAMA Int Med 2017 Screening Pelvic Examinations. The Emperor s New Clothes, Now in 3 Sizes? Audience Question #2: Which recommendation will you follow? 1. ACOG (do it) 2. ACP (don t do it) 3. USPSTF (don t know) Questions, comments, discussion

12 Possible script I know that you have had pelvic exams as part of your annual visits in the past, but you should be aware that there is now a lot of uncertainty about whether we should do these in women with no problems. In fact, 3 professional groups now have 3 somewhat different recommendations. All agree that there is no scientific evidence that the examination provides benefits, but 2 acknowledge there are harms, including false alarms that lead to further testing and unnecessary surgery. One of the professional groups believes screening pelvic exams are more harmful than beneficial, and strongly recommends against them. Since you have no problems, I don't recommend you have the examination today, but let s discuss any concerns you may have about not having it. OR I recommend you have the examination today, but let s discuss any concerns you may have about having it.

13 Table 1: Cervical cancer screening* Age to begin 21 Method and intervals, by age Ages 21-65: cytology every 3 years or Ages 21-29: cytology every 3 years, then Ages 30-65: cytology plus hrhpv testing every 5 years (co-testing) Co-testing is reserved for women ages wanting to lengthen their screening interval to every 5 years. Age to end 65 These are 2012 recommendations by the USPSTF, ACOG and ACS. hrhpv indicates high-risk human papillomavirus. *Recommendations apply to women with no prior diagnosis of cervical intraepithelial neoplasia grade 2 or a more severe lesion or cervical cancer, women who are not immunocompromised (e.g., HIV infected) and women with no in utero exposure to diethylstilbestrol. only among women with 3 consecutive negative cytology results or 2 consecutive negative cytology plus hrhpv tests within 10 years before cessation of screening, with the most recent test performed within the last 5 years. Screening should not resume after cessation even if a woman acquires new sexual partners. Routine screening should continue for at least 20 years after treatment of CIN2 or CIN3, even if this extends screening past age 65. Special populations Pregnant women After total hysterectomy Women with HIV infection or immunocompromise After diagnosis and treatment of cervical cancer Screen as above If no prior CIN2, 2/3 or 3 Screening should not be performed. If prior CIN2, 2/3 or 3 End screening after 3 normal annual vaginal cytology tests (2003 ACOG recommendation)* Annual screening after 2 normal cytology tests 6 months apart in the year following initial HIV diagnosis or immunocompromised state Surveillance as per gynecologic oncology protocols CIN indicates cervical intraepithelial neoplasia. *2012 ACOG recommends cytology every 3 years for 20 years after the initial CIN2+ treatment and post-treatment surveillance Sawaya & Smith-McCune, SFGH/UCSF/SFDPH,

14 Table 2. Management of initial screening test results Unsatisfactory cytology Satisfactory cytology, but no endocervical cells Atypical squamous cells, undetermined significance (ASC- US), hrhpv negative Benign-appearing endometrial cells ASC-US, hrhpv unknown Normal cytology, hrhpv positive, HPV 16/18 negative Low-grade squamous intraepithelial lesion (LSIL), hrhpv negative ASC-US, hrhpv positive Normal cytology, hrhpv positive on 2 consecutive tests Normal cytology, hrhpv positive, HPV 16/18 positive LSIL, hrhpv positive or unknown High-grade squamous intraepithelial lesion (HSIL) Atypical squamous cells, cannot exclude HSIL (ASC-H) Atypical glandular cells (AGC) Adenocarcinoma in situ Repeat cytology in 2-4 months Repeat cytology in 3 years* Routine screening in 3 years Pre-menopausal: No action. Post-menopausal: Endometrial biopsy. Cytology in 12 months. Colposcopy for any abnormality. If normal, resume routine screening. Cytology plus HPV testing in 12 months. Colposcopy for any abnormality. If both normal, repeat cytology plus HPV testing in 3 years. Ages 21-24: Cytology in 12 months (colposcopy for ASC-H or HSIL+) and at 24 months (colposcopy for any abnormality). If all normal, routine screening. Age 25+: Colposcopy Colposcopy Colposcopy with endocervical curettage; endometrial biopsy if abnormal bleeding, chronic anovulation or age 35+ hrhpv indicates high-risk human papillomavirus. HSIL+ indicates HSIL, AGC, AIS or cancer. *2012 ACOG/ASCCP: cytology plus hrhpv testing preferred over repeat cytology alone Colposcopy should be performed even if hrhpv is negative. Endocervical curettage should not be performed in pregnancy. If atypical glandular cells are specified as endometrial, endometrial biopsy is indicated. Pregnant women ASC-US Age 21-24, manage as per non-pregnant women. Age 25+, if colposcopy indicated, may defer to 6 weeks post-partum. LSIL Age 21-24, manage as per non-pregnant women. Age 25+, colposcopy is recommended but may be deferred to 6 weeks post-partum. Women with HIV infection: manage as per average-risk women (as per ASCCP 2012) All patients should be advised about smoking cessation and HIV testing should be offered. Sawaya & Smith-McCune, SFGH/UCSF/SFDPH,

15 Table 3. Management after initial colposcopy Indication for initial colposcopy Normal cytology, hrhpv positive on 2 consecutive tests Normal cytology, hrhpv positive, HPV 16/18 positive Atypical squamous cells of undetermined significance (ASC-US) on 2 consecutive tests ASC-US, hrhpv positive Low-grade SIL (LSIL) Atypical glandular cells (AGC), not otherwise specified High-grade SIL (HSIL) Atypical squamous cells, cannot exclude HSIL (ASC-H) Findings at colposcopy No lesion, normal biopsy or CIN1 Age 25+: Cytology plus hrhpv testing in 12 months; colposcopy for any abnormality. If both normal, routine screening. Ages 21-24: Cytology alone in 12 months (colposcopy for ASC-H or HSIL+) and at 24 months (colposcopy for any abnormality). If all normal, routine screening.^ Cytology plus hrhpv testing in 12 and 24 months; colposcopy for any abnormality. If all normal, routine screening.^ Colposcopy and cytology at 6 and 12 months, if colposcopy adequate and endocervical curettage negative.* If all normal, routine screening. Diagnostic excisional procedure, if colposcopy inadequate CIN2, 2/3, 3 see Table 4 Atypical glandular cell, favor neoplasia Adenocarcinoma in situ Diagnostic excisional procedure CIN indicates cervical intraepithelial neoplasia. hrhpv indicates high-risk human papillomavirus testing. SIL indicates squamous intraepithelial lesion. HSIL+ indicates HSIL, AGC, AIS or cancer. *2012 ACOG/ASCCP: for women aged 25+, cytology plus hrhpv testing in 12 and 24 months; colposcopy for any abnormality. If all normal, repeat cytology plus hrhpv testing in 3 years. If cytology and HPV testing at 3 years normal, routine screening. Review of prior cytology, histology and colposcopic findings may be warranted, especially when potential risks of excision may exceed benefit. Excisional procedures are deferred in pregnant women to the postpartum period unless cancer is suspected. ^2012 ACOG/ASCCP: If all normal, cytology alone (women under 30) or cytology plus hrhpv testing (women 30+) in 3 years. If testing at 3 years normal, resume routine screening. All patients should be advised about smoking cessation and HIV testing should be offered. Sawaya & Smith-McCune, SFGH/UCSF/SFDPH,

16 Table 4. Choosing treatments for CIN2*, CIN2/3* and CIN3 Ablation Cryotherapy Use if the following criteria met: adequate colposcopy lesion(s) completely visible, not covering more than 75% of the ectocervix and can be covered entirely with the cryoprobe under age 40 Laser Use as for cryotherapy and for large ( 2 cm) and/or multifocal lesions, with or without vaginal involvement. Excision Loop excision Use if criteria for ablation not met. Cone biopsy Use if criteria for ablation not met and instead of loop excision if: suspicion for malignancy or cervical architecture distorted (e.g., prior cervical treatments, severely atrophic cervix). *In women of childbearing potential with CIN2 and CIN2/3 (but not CIN3), colposcopy and cytology every 6 months for up to 24 months is acceptable if colposcopy is adequate. Routine screening may resume after 2 normal cytology tests and colposcopies and a normal cytology plus hrhpv test a year later. We recommend ablation in women under age 40 when criteria are met. Cryotherapy failure rates increase with age and exceed 30% over a 6-year period in women aged 40+ treated for CIN3. Table 5. Follow-up after treatment of CIN2, CIN2/3 and CIN3 Hysterectomy Screening may end after 3 normal annual vaginal cytology tests (2003 ACOG recommendation)* Cryotherapy or laser ablation; loop Cytology with or without colposcopy at 6 months, followed by cytology at 12 months and then annual excision or cone biopsy with negative cytology for at least 20 years margins Loop excision or cone biopsy with Cytology and endocervical curettage (non-pregnant women) with or without colposcopy at 6 months, positive margins followed by cytology at 12 months and then annual cytology for at least 20 years *2012 ACOG/ASCCP recommendation: cytology alone every 3 years for 20 years after the initial CIN treatment and post-treatment surveillance 2012 ACOG/ASCCP recommendation: cytology plus hrhpv testing in 12 and 24 months; colposcopy for any abnormality. If all normal, cytology plus hrhpv testing in 3 years. If cytology and HPV testing at 3 years normal, routine screening. Table 6. Follow-up after treatment of adenocarcinoma in situ Hysterectomy Annual cytology. After 3 consecutive, normal tests, cytology may be performed every 3 years. Cone biopsy Colposcopy with cytology, HPV testing and ECC in 6 months, then cytology and ECC 12 and 18 months later followed by cytology and ECC every year until hysterectomy. Colposcopy for ASC+. All patients should be advised about smoking cessation and HIV testing should be offered. Sawaya & Smith-McCune, SFGH/UCSF/SFDPH,

I have no financial interests in any product I will discuss today.

I have no financial interests in any product I will discuss today. Cervical Cancer Screening Update and Implications for Annual Exams George F. Sawaya, MD Professor Department of Obstetrics, Gynecology and Reproductive Sciences Department of Epidemiology and Biostatistics