Disclosures Cancer Screening for Women What works? I have no - PDF document

Disclosures Cancer Screening for Women What works? • I have no conflicts of interest What doesn’t? Judith M.E. Walsh, MD, MPH Division of General Internal Medicine Women’s Health Center of Excellence University of California, San Francisco Topics for today But what about? • Colorectal Cancer • Breast cancer screening – What test – How often? – Later this morning • Lung Cancer • Cervical cancer screening – Why not Chest X Ray? – Tomorrow – Who should we screen? • Ovarian cancer – Screening pelvic examination – CA-125 and ultrasound

Principles of screening USPSTF • Detection while patient is asymptomatic • Rigorous review of existing peer ‐ reviewed – High sensitivity evidence • Early detection reduces the risk of death from the cancer – randomized trials • Ratings reflect the strength of the evidence on the benefits and harms of a • The number of false positives is preventive service acceptably low – High specificity • No consideration of costs – Reasonably high prevalence of disease • ACA: Must cover A or B ratings • Ideally few harms USPSTF Grades Grade Evidence Recommendation A High certainty of substantial net benefit Provide B High certainty of moderate net benefit Provide Lung Cancer Screening Moderate certainty of moderate/substantial net benefit C Moderate certainty that net benefit is small Selectively offer/provide D No net benefit or harms outweigh benefits Do not provide I Insufficient evidence regarding balance of benefits and harms

Lung Cancer • In the U.S., lung cancer is the leading cause of cancer death in women • Smoking is biggest risk factor in women – Among non-smokers, the age adjusted incidence is higher in women than in men What’s in your shopping cart? Question? • Ms. Virginia Slim is a 69 year old woman with a 50 pack-year history of smoking and COPD. You have previously been unsuccessful in encouraging her to quit smoking. She comes in for a check-up, is worried about developing lung cancer and wants to know what test you think he should have. What do you recommend? – Chest X ray – Sputum cytology – LDCT – None of these tests

Lung Cancer Screening: PLCO: Lung Cancer Screening Systematic Review of Chest X-rays • 7 trials of lung cancer screening • PCLO randomly assigned 154,901 adults • Frequent screening with chest x-rays was aged 55 through 74 to annual CXR for 4 associated with an increase in mortality years vs. usual care – RR 1.11 (95% C.I. 1.00-1.23) • Followed for 13 years • No difference in chest X-ray plus • Cumulative lung cancer mortality cytology versus chest X-ray alone – 14.0/10,000 py screening group vs. 14.2/10,000 py control group – Rate ratio: 0.99 (95% CI 0.87 ‐ 1.22) Manser, Thorax, 2003 Oken MM. JAMA 2011;306:1865 The National Lung Screening Trial (NLST) Low Dose Spiral Computed Tomography • Scans lung in < 20 seconds (single breath) 53,454 participants randomized to CT or CXR - Current or former heavy smokers: ≥ 30 pack-years • No IV contrast - Ages 55 to 74 • More radiation exposure than CXR but - Annual CT scans x 3 years. 6.5 years follow-up less than conventional CT RR (95% CI) • Can detect much smaller lesions than Lung cancer death .80 (.73-.93) chest X-ray Any death .93 (.86-.98) 20% reduction in lung cancer death; 7% all deaths!

Number needed to invite to screen Summary from NLST • NNI to prevent one lung cancer death in 6.5 years = 320 • NNI to prevent one death from any cause in 6.5 years = 218 NLST Harms • False positives – At least 1 positive test in 39% CT • Possible over diagnosis – Higher cancer incidence with CT • 1060 vs. 941 cancers • Rate ratio 1.13 (95% CI 1.03 ‐ 1.23) • Radiation exposure • Incidental findings

Guidelines and recommendations The NLST Setting • Recommend for those meeting NLST • 76% of sites were NCI designated cancer centers entry criteria at specialized centers • 82% were large academic medical centers – ACCP / ASCP / ATS • All likely to have specialized thoracic – ACS radiologists and board certified thoracic – ALA surgeons on site – NCCN • CT scanners extensive quality control – AATS • Nodule management algorithm but not mandated USPSTF Recommendation USPSTF • USPSTF recommends annual • Age screening for lung cancer with low- – 55-79 dose computed tomography (LDCT) • Total exposure to tobacco smoke in persons at high risk for lung – 30 pack years or more cancer based on age and smoking • Years since quitting history – Those who have smoked within the past 15 – Grade B recommendation years are at highest risk – Published December 31, 2013 • Consider other comorbidities

Primary Prevention Of Medicare Coverage Decision Lung Cancer • Annual lung cancer screening with • Smoking cessation LDCT for age 55-77, asymptomatic, at • Smoking cessation least 30 pack year history and currently smoking or quit within past 15 years • Smoking cessation • Written order for lung cancer screening • Smoking cessation written during lung cancer screening • Smoking cessation shared decision making visit furnished by physician or certified non-physician • Smoking cessation practitioner • Smoking cessation!!!!! – February, 2015 Implications • Smoking cessation Colorectal Cancer • Strict adherence to guidelines – 55-79 years, 30+ pack years • Use experienced centers / demonstration projects to ensure quality and effectiveness

Question • What do you most commonly recommend for colorectal cancer screening? Guidelines – Fecal occult blood test (FOBT) – Fecal immunochemical Test (FIT) – Sigmoidoscopy Guidelines, Guidelines – Colonoscopy – Virtual Colonoscopy – Fecal DNA Joint Guideline: ACS, ACR, Multi-Society Task Force Joint Guidelines • FOBT annually • Discuss the menu of options • Fecal immunochemical test annually • Offer a test that is effective at both • Flexible sigmoidoscopy every 5 years cancer prevention and detcetion and • DCBE every 5 years not just detection • CT colonography every 5 years • CRC prevention should be the • Colonoscopy every 10 years primary goal of screening • Stool DNA testing (interval uncertain) Levin, Gastroenterology, 2008

New Multi-Society Guidelines Multi-Society Guidelines • American College of Gastroenterology, • First tier tests American Gastroenterological Association, – Colonoscopy or FIT Society for Gastrointestinal Endoscopy – Offer colonoscopy first • New guidelines include three “tiers” of tesing – A risk stratified approach is also appropriate » July, 2017 • Second tier tests – CT colonography every 5 years – FIT-fecal DNA every 3 years – Sigmoidoscopy every 5-10 years Multi-Society Guidelines American College of Gastroenterology • Third tier • American College of Gastroenterology – Capsule colonoscopy every 5 years guidelines for colorectal cancer • Septin 9 is not recommended screening (Rex DK. Am J Gastroenterol 2009;104:739) • Start screening at age 50 in average risk – Colonoscopy… remains the preferred individuals CRC screening strategy – Limited evidence supports screening African Americans starting at age 45 • Consider discontinuing screening at age 75 or less than 10 years life expectancy

American College of Physicians 2015 USPSTF 2016 • Annual high sensitivity gFOBT or FIT • USPSTF: “ A ” recommendation (2016) • Flex sigmoidoscopy every 5 years – Routine screening from age 50 until 75 • High sensitivity gFOBT or FIT every • USPSTF “C” recommendation (2016) 4 years plus flex sigmoidoscopy Individualized decisions age 76 to 85 every 5 years • Greater benefit in those not previously screened • Colonoscopy every 10 years • No screening after 85 » Ann Int Med 2015 USPSTF JAMA 2016 USPSTF 2016 Colonoscopy: RCTs in progress • VA • Screening for CRC in average risk patients age 50 ‐ 75 is of substantial net benefit – Colonoscopy versus fecal immunochemical test in reducing mortality from colorectal cancer • Multiple screening strategies available • Spain – Different levels of evidence – Colorectal cancer screening in average ‐ risk – Strategies reviewed include colonoscopy, population: immunochemical fecal occult blood FOBT, FIT, flex sig, CT colonography, fecal DNA testing versus colonoscopy and methylated SEPT9DNA test • Netherlands – No evidence that any strategy provides greater – Colonoscopy or colonography for screening net benefit USPSTF JAMA 2016

Computed Tomographic Colonography Newer Tests (Virtual Colonoscopy) • Non-invasive radiological technique • Virtual Colonoscopy – Radiation dose similar to barium enema • Stool based molecular testing • Bowel preparation similar to colonoscopy – Fecal DNA – Prep-less technique is being evaluated • Does not require sedation • Combined FIT and Stool DNA • Colon distended with carbon dioxide or air • Septin-9 • Breath holding for 20-50 seconds • Colonoscopy to remove polyps Laxative-Free CT Colonography Potential Harms • Radiation Exposure • Low fiber diet, orally ingested contrast material and specialized processing software – 1/1000 could develop solid cancer or “electronic cleansing” leukemia • 605 adults underwent CTC and OC • Procedure related harms • CTC was more accurate in detecting – Perforation rate low adenomas 10 mm or larger and less so for • Extra-colonic findings smaller lesions – 91% sensitivity vs 70% for adenoma 8 mm or larger • Patients preferred it » Zalis, Ann Intern Med, 2012