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Screening leaders outreach lecture
- 1. Breast Cancer Screening ACRBreast Cancer Screening Leaders March 2019
- 2. Preview/Introduction • The Riskof Breast Cancer to Women • Does Mammography Save Lives? • When to Start and How Often Should Women Screen? • Risks Versus Benefits of Mammography
- 3. Breast Cancer: The Impacton Women
- 4. Breast Cancer Stats:2019 • Most common cancer diagnosed in women • 12.8% of women will be diagnosed during lifetime • More than 331,000 new cases anticipated (268,600 invasive) • 30% of all new cancer cases in women • 41,760 women expected to die from breast cancer • 3,477,866 women are living with breast cancer (based on 2016 data) Source: https://seer.cancer.gov/statfacts/html/breast.html
- 5. Has Mammography Reduced BreastCancer Death?
- 6. Women aged 40–84by year 1969–2015 42% mortality Age-adjusted U.S. breast cancer mortality rates (per 100,000) Hendrick RE, Baker JA, and Helvie MA. Breast Cancer Deaths Averted Over 3 Decades. Cancer 2019;0:1-7. Mammography ~ 384,000-614,500 Lives saved YES - MAMMOGRAPHY HAS REDUCED BREAST CANCER DEATHS
- 7.
- 8. Decades of EvidenceProve Mammography Saves Lives • Randomized controlled trials of women ages 40–74 show at least a 20% reduction in breast cancer deaths • Observational studies: show a mortality reduction of about 40% • Observational studies show benefits for women over 74, as well as the 40–74 age group Note: RCTs test only the “invitation to screening” Note: test actual mammogram use
- 9. Evidence of Benefit: RandomizedControlled Trials (RCT)
- 10. 24% mortality reduction DuffySW, Tabár L, Smith RA. CA Cancer J Clin. 2002 Mar-Apr;52(2):68-71.
- 11.
- 12. Evidence of Benefit: ObservationalTrials (Europe) • Why observational data matters • Randomized controlled trials UNDERESTIMATE benefit of screening • What European observational data shows1 • Magnitude of mortality reduction from screening mammography is greater than RCTs suggest, 38–49% 1Broeders et al J Med Sci 2012
- 13. Case-Control Studies (Ages40–75) 49% ↓ Mortality Cancer Epidemiol Biomarkers Prev 2012
- 14. Evidence of Benefit: ObservationalTrials (Europe) Broeders et al J Med Sci 2012 38% mortality reduction
- 15. Evidence of Benefit: ThePan-Canadian Study
- 16. Pan-Canadian Study • 1990–2009 •2.8 million women • Compared breast cancer deaths in women who had screening mammograms to those who did not
- 17. Results Average breast cancer mortalityreduction among all participants was 40% 40% Mortality (95% CI, 0.33-0.48)
- 18. 40 to 49years 44% Mortality 50 to 59 years 40% Mortality 60 to 69 years 42% Mortality 70 to 79 years 35% Mortality Results by Age
- 19. Benefits of Screening: AdditionalConsiderations
- 20. Benefits of Screening •40% drop in breast cancer death • Less extensive surgery for screening detected cancers • Less chemotherapy for screening detected cancers • Chemotherapy is MORE EFFECTIVE for screened women Tabar, et al. Cancer 2018 125: 515-523
- 21. Tabar, et al.Cancer 2018 November Using the same available treatments, SCREENED women had 60% LOWER mortality at 10 yrs follow up and 47% LOWER mortality at 20 yrs follow up than UNSCREENED women • 58 years of follow up • All women had either 10 or 20 years of follow up
- 22. Why Start Screeningat 40?
- 23. Breast cancer isa serious problem for women in their 40s • 1 in 6 breast cancers are found in women ages 40–49 • The 10-year risk for being diagnosed with breast cancer in a 40 year old woman is 1 in 69 • About 1/3rd of the years of life lost from breast cancer are in women in their 40s • >70% of the women dying from breast cancer in their 40’s belong to the 20% not being screened
- 24. Beginning screening atage 40 saves most lives • Starting yearly mammograms at age 40 has cut breast cancer deaths by 40% • Yearly screening starting at age 40 versus every other year age 50–74 saves approximately 13,770 more lives each year • Over 40% of years-of-life to breast cancer are lost to women diagnosed under age 50
- 25. How do alternativescreening guidelines compare to the American College of Radiology®?
- 26. American Cancer Societyand USPSTF • USPSTF uses limited and older data that underestimates the mortality reduction gained from screening mammography • Both the ACS and USPSTF count only ONE benefit: mortality reduction, and ignore all of the other benefits of screening, yet include all risks, all of which are NON-lethal • All acknowledge that screening mammography does reduce mortality in women 40–74 AND that screening every year starting at age 40 would save the most lives • REMEMBER: The goal of screening is to find cancer as early as possible to save as many lives as possible! • There is evidence that women understand the risks of mammography and believe they are worth the benefit.
- 27. Comparison: Screening RecommendationOutcomes Screening regimen, patient age (y) Reduction in risk of dying of breast cancer1 Number of women whose lives will be saved (per 100,000)1 Number of life-years gained (per 100,000)1 Yearly, 40-84* 40% 1190 18,900 (+72%)* Yearly, 45-54; every other year, 55- 79˜ 31% 925 14,900 (+35%)* Every other year, 50- 74ˠ 23% 695 11,000 * % increase in life-years gained compared to biennial 50-74
- 28. Distribution of Yearsof Life Lost due to Death from Breast Cancer by Age at Diagnosis 0% 0% 2% 5% 9% 12% 15% 15% 13% 10% 7% 5% 4% 2% 2% 0% 2% 4% 6% 8% 10% 12% 14% 16% 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-89 80-84 85+ % of total YLL due to BC Age at diagnosis Distribution of YLL from breast cancer by age at diagnosis ACS report JAMA 2015
- 29. Risks: Recall andBiopsy
- 30. Recall is uncommon = only10% Biopsy is rare = 1-2% per year
- 31. Risks: Recall &Biopsy • “False Positives” and anxiety are commonly presented as risks • Risks from recall and biopsy must be compared to the 40% reduction in breast cancer deaths due to screening mammography • Short-term anxiety from screening resolves, and women have no long term anxiety nor adverse health effects
- 32.
- 33. Overdiagnosis • Defined asbreast cancer that would not kill a women in her lifetime • Can’t be measured directly; not possible to know which breast cancers are overdiagnosed without leaving cancer untreated • Is rare! Estimated at 1–10% of all breast cancers • Underdiagnosis is NOT ideal
- 34. Summary for AverageRisk Women • Screening mammography is a proven life-saver • 40% reduction in breast cancer death with regular screening • Most lives are saved with ANNUAL SCREENING at AGE 40
- 35. Summary for AverageRisk Women • Modern treatments are most effective in saving lives when cancers are caught early on screening mammograms • Risks, such as recall for additional imaging, needle biopsy, anxiety and overdiagnosis – all NON-lethal – need to be considered against lives saved from breast cancer death
- 36. Breast Cancer Screeningof Women at Higher Than Average Risk Recommendations from the American College of Radiology
- 37. All women, especiallyblack women and women of Ashkenazi Jewish descent should be evaluated for breast cancer risk by age 30 to: • Identify those at higher risk than average • Benefit from supplemental screening
- 38. Higher risk womenneed supplemental and earlier screening Risk DM +/- DBT MRI+ Known genetic mutation or lifetime risk ≥20% Annually starting at age 30 Annually starting at age 25–30 Breast cancer history and dense breasts at any age or breast cancer diagnosed <age 50 Annually starting at time of diagnosis Annually starting at time of diagnosis History of chest radiation therapy before age 30 Annually starting at age 25 or 8yrs after therapy (whichever is later) Annually starting at age 25–30 History of ADH, ALH, LCIS or personal breast cancer history other than above Annually starting at time of diagnosis Consider annually starting at time of diagnosis +Ultrasound may be considered if women cannot undergo MRI. Monticciolo DL et al, J Am Coll Radiol 2018;15:408-414
- 39.
- 40. Contributors KELLY W. BIGGS,MD, Committee Chair VILERT LOVING, MD, MMM CATHERINE M. APPLETON, MD DEBRA MONTICCIOLO, MD, FACR, FSBI LORA BARKE, DO, FACR MARY S. NEWELL, MD, FACR, FSBI PRAGYA DANG, MD ELISSA R. PRICE, MD FRCPC FSBI STAMATIA DESTOUNIS MD, FACR, FSBI, FAIUM JOCELYN RAPELYEA, MD, FSBI DIPTI GUPTA, MD KIMBERLY RAY, MD, FSBI JIYON LEE, MD SHADI AMINOLOLAMA-SHAKERI, MD JESSICA W. T. LEUNG, MD, FACR, FSBI
Editor's Notes
- #5 Breast cancer is the most commonly diagnosed cancer in women in the US. In fact, in 2019, it is estimated that over 331,000 will be diagnosed. Stated differently, about 12-13% of women will be diagnosed with breast cancer during their lifetime. That is approximately 1:8 women. We know that better outcomes are directly linked to breast cancer screening – early detection results in improved outcomes and fewer deaths from breast cancer.
- #7 Since 1989, hundreds of thousands of lives have been saved by the use of screening mammography and new developments in breast cancer treatment. This graph shows that, prior to the widespread availability of screening mammography, the breast cancer death rate was fairly constant. Since the late 1980s, the breast cancer death rate has decreased by more than 40%
- #8 References: Hendrick RE, et al. Benefit of screening mammography in women aged 40-49: a new meta-analysis of randomized controlled trials, J Natl Cancer Inst Monogr; 1997;(22):87-92 Smith R, et al. The randomized trials of breast cancer screening: what have we learned? Radiol Clin North Am 2004; 52(5):793-806 Tabar L, et al. The incidence of fatal breast cancer measures the increased effectiveness of therapy in women participating in mammography screening. Cancer 2019; 125(4):515-523 Hendrick RE, et al. Breast cancer deaths averted over 3 decades. Cancer 2019; Feb 11. [Epub ahead of print] Walter LC, Schonberg MA. Screening mammography in older women: a review. JAMA. 2014; 311(13):1336-1347. Sanderson M, Levine RS, Fadden MK, et al. Mammography screening among the elderly: a research challenge. Am J Med. 2015;128(12):1362.e7-e14.
- #9 Randomized controlled trials (RCTs), conducted in the 1960s, 1970s, and 1980s, represent the highest order of study category. RCTs are designed to minimize biases, and are therefore subject to strict criteria. Because of these restrictions, RCTs underestimate the true benefit of screening, as discussed later. Observational studies can compare women who are getting screening mammograms to those who are not. These studies confirm the benefits of mammography. They are less likely to account for all selection biases. For example, what other lifestyle or environmental factors affect the screened group compared to the control group that might affect the outcome? For women who are not at higher than typical risk for developing breast cancer, the benefit of screening under age 40 is not well researched. In general, younger women have denser tissue, which reduces the sensitivity of mammography. There are significantly fewer breast cancer diagnoses in women younger than 40. For women older than 74, it is more difficult to prove benefit in terms of reduced mortality. Older women may die from complications related to other comorbidities, which complicates analysis. Still, observational studies and Medicare claims data demonstrate screening mammography reduces breast cancer deaths in women up to age 84.
- #11 The combined results of the RCTs show a 24% reduction in mortality in the “Invited to Screen” (ITS) arms, and this includes two studies that actually showed a higher rate of death in the ITS arms, related to severe methodological issues with these studies. It is vital to remember, however, that the RCT’s tend to underestimate the mortality benefit due to many causes: Non-compliance (those in the screening arm being invited to but not partaking of screening); contamination (those in the control arm getting screening outside of the trial); inadequate follow up period; suboptimal technology. The Canadian National Breast Screening Studies (noted by arrows) are outliers among the RCTs. Poor quality imaging and poor patient grouping compromised study results. For example, women already suffering from symptoms of breast cancer were included in the screening mammography group, and a greater number of symptomatic women were placed in the mammography group compared to the non-mammogram group. Note, the meta-analysis benefit of screening is conclusive, even when incorporating negative results of the Canadian NBSS.
- #13 RCTs prove that screening mammography decreases mortality from breast cancer. However, the magnitude of that mortality reduction is underestimated by RCTs, as discussed previously. Observational studies compare women in a given population who had screening mammograms to those who did not. Since observational studies are not bound by the same strict criteria as RCTs, they can be used to assess the impact on women who actually received a screening mammogram rather than those who were invited to screen. While less strict parameters leave room for selection bias, the results may nonetheless be more practical for assessing efficacy of screening. This concept is important, because some institutions have used statistics associated with the invitation to screen to devalue screening. Observational studies for breast cancer screening are predominantly service screening programs, as exist in many European countries. Service screening refers to centrally-organized, large scale screening programs with standardized screening protocols, centralized databases and reliable outcome monitoring with tumor registries. Boreders et al estimate the mortality reduction from screening mammography is 25–31% for women invited for screening, and 38–48% for women actually screened.
- #14 13
- #15 Broeders 2012 J Med Sci Europe Service Screening shows impressive reduction is breast cancer deaths. Summary data from 7 countries involved in service screening demonstrates an overall 38% mortality reduction in women screened compared to women not screened.
- #16 Coldman, Phillips, Wilson, et al. “Pan-Canadian Study of Mammography Screening and Mortality from Breast Cancer” Journal of the National Cancer Institute 2014
- #17 The Pan-Canadian Study is a particularly important observational study because of its recent completion (2014), very large population, and length. It further substantiates the life saving value of screening mammography. Each province linked its screening program database to its provincial cancer registry and provincial mortality database to identify cases and deaths from breast cancer that occurred before the end of the study. Standardized mortality ratio (SMR) calculated by comparing observed mortality in participants to expected mortality based on non-participant rates.
- #18 2,796,472 women participants 20.2 million person-years of observation
- #19 A more in-depth view (Standardized Mortality Ratios broken down by age and then by region) Forest plots of SMRs by province for ages at entry: 40 to 49 years (A), 50-59 years (B), 60-69 years (C), and 70-79 years (D).
- #20 Mortality reduction is the main benefit of screening but it is not the only benefit.
- #21 Benefits of Screening amount to more than just mortality reduction – although this is an extremely important benefit. Other benefits of being screened include less extensive surgery and less toxic chemotherapy for women whose tumors are found by screening. And chemotherapy is MORE EFFECTIVE for screened women. This is extremely important.
- #22 Tabar and colleagues published a landmark study in November 2018 showing the interaction between screening and chemotherapy. Some try to argue that chemotherapy has improved so much that we don’t need to screen, but this is simply untrue. Chemotherapy HAS gotten better over the years but it is MOST effective when tumors are smaller – as screening detected tumors are. In Tabar’s study, which covers nearly 6 decades of follow up, all women had either 10 or 20 years of follow up (958,000 had 20years of follow up; approx. 1.5 million had 10 years follow up). These are very large numbers and the follow up is extremely long – giving much more credibility to the results. Using the SAME available treatments, Screened women had 60% lower mortality at 10yr follow up and 47% lower mortality at 20yrs. This shows that chemotheraphy is much, much more effective in women whose tumors are found by screening.
- #23 References: 1. Oeffinger KC, Fontham ETH, Etzioni R, et al. Breast Cancer Screening for Women at Average Risk: 2015 Guideline Update From the American Cancer Society. JAMA. 2015;314(15):1599–1614. doi:10.1001/jama.2015.1278 2. Webb ML, Cady B, Michaelson JS, et al. A failure analysis of invasive breast cancer: Most deaths from disease occur in women not regularly screened. Cancer. 2014; 120 (18): 2781-2938. 3. Hendrick RE, Helvie MA. United States Preventive Services Task Force Screening Mammography Recommendations: Science Ignored. American Journal of Roentgenology. 2011;196: W112-W116. 4. Yaffe M, Mitmann N, Lee, P. et al. Clinical outcomes of modelling mammography screening strategies. Health Rep. 2015 Dec;26(12):9-15.
- #24 Breast cancer is a big issue in women in their 40s. Women in their 40s have more years of life ahead of them and develop more aggressive cancers The Randomized Controlled Trials prove that screening mammography saves lives for women ages 40-74. The breast cancer incidence rate for ages 40-44 is twice that for ages 35-39 (122.5 vs 59.5 per 100,000 women). For ages 45-49, it is 188.6 per 100,000 women; and continues to increase until age 80 (http://seer.cancer.gov).
- #25 Annual screening starting at age 40 saves most lives and life years Based on decades of evidence, all societies including ACS, SBI, ACR, ACOG, and USPSTF agree that most lives are saved and most life years gained when screening begins at age 40 and is performed every year. All of the computer models in the National Cancer Institute's Cancer Intervention and Surveillance Network (CISNET) agree that the most lives are saved by annual screening beginning at the age of 40. If women now in their thirties were to delay screening until the age of 50, and then participate only every two years, the models show that as many as 100,000 lives would be lost that could have been saved by annual screening beginning at the age of 40 [3] There is no medical evidence or physiologic change (such as menopause) to support screening beginning at age 50 instead of 40. The cancer rate increase is gradual as a woman ages, with only slightly more women diagnosed in their 50s compared to their 40s.
- #26 Based on decades of evidence, the ACR advocates women of average risk undergo screening annually beginning at age 40, and continue for as long as they are healthy. Some organizations have recently issued guidelines promoting less frequent screening over a shorter period of life. They also weighed less data and made judgments on behalf of women about how benefits and risks should be valued. In 2019, the American Society of Breast Surgeons released its screening recommendations, which are similar to the recommendations of the American College of Radiology. It also supports annual screening beginning at age 40 for women of average risk for breast cancer. References: Monticciolo DL, Newell MS, Hendrick, RE, et. al. Breast Cancer Screening for Average-Risk Women: Recommendations From the ACR Commission on Breast Imaging. J Am Coll Radiol 2017;14:1137-1143. Oeffinger KC, Fontham ET, Etzioni R, et al. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA 2015; 314: 1599-1614. Siu AL; U.S. Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2016; 164: 279-296. Munoz D, Near AM, van Ravesteyn NT, et al. Effects of screening and systemic adjuvant therapy on ER-specific US breast cancer mortality. J Natl Cancer Inst 2014; 106:dju289. Schwartz LM, Woloshin S, Sox HC, Fischhoff B, Welch HG. US women’s attitudes to false positive mammography results and detection of ductal carcinoma in situ: cross sectional survey. BMJ 2000; 320: 1635-1640.
- #27 Recall that Randomized Controlled Trials underestimate the true benefit of screening by comparing breast cancers deaths in groups divided into those invited to screen and those not invited to screen, not those who actually underwent screening. USPSTF guideline authors focused on “number needed to invite” to screening in generating statistics for the number of mammograms need to save one life. This was arguably intended to trivialize the benefit of screening. Underestimation of mortality reduction ranges from 5-15% depending on referenced study. As the ACS and USPSTF refer to the “harms” outweighing the benefits of screening – it is important to understand the woman’s point of view. Schwartz et al found that “women were highly tolerant of false positives: 63% thought that 500 or more false positives per life saved was reasonable and 37% would tolerate 10,000 or more.” For annual screening starting at age 40, CISNET models estimated that 1 life-year would be saved for each benign biopsy experienced. One does not need an attitudinal survey to conclude that almost all women would be willing to undergo a benign biopsy to extend their life by 1 year.
- #28 Arleo EK, Hendrick RE, Helvie MA, Sickles EA. Comparison of Recommendations for Screening Mammography Using CISNET Models. Cancer 2017; 3673-3680. *American College of Radiology, Society of Breast Imaging and National Comprehensive Cancer Network ˜American Cancer Society ˠUnited States Preventive Services Task Force ^Percentage increase in number of life-years gained compared to screening every other year age 50-74.
- #29 This graph highlights years of life lost to breast cancer segregated by age. In discouraging screening for the 40-49 age group, the USPSTF and the ACP guidelines deprive some of the most vulnerable women of the benefits of screening.
- #30 References 1. Tosteson A, et al. Consequences of false-positive screening mammograms. JAMA Intern Med. 2014; 174:954-961. 2. Schwartz L, et al. Enthusiasm for cancer screening in the United States. JAMA. 2004;291:71-78. 3. For recall and biopsy numbers, reference = the BI-RADS Atlas, mammography audit 4. Skaane P, Bandos AI, Gullien R, et al. Comparison of Digital Mammography Alone and Digital Mammography Plus Tomosynthesis in a Population-based Screening Program. Radiology 2013, Apr; 267(1): 47-56.
- #32 “False positives” are often touted as a risk of screening mammograms. The term is misleading for the general public, since it seemingly suggests that some mammograms falsely indicate cancer when there is no cancer. This conclusion is wrong. Recalls do not falsely diagnose cancer. They merely indicate that more information is needed. Most women simply require extra images to resolve. Anxiety of screening is further touted as a risk of screening. Published studies indicate that false positive mammograms do increase short term anxiety. However, this anxiety is transient with no long term anxiety and no detrimental long term health effects (1). Furthermore, a national survey showed that the US population heavily favors cancer screening. 96% of women who received a false positive mammogram were glad they had the screening test, and they truly wanted to know their test results (2). Decreasing access to screening would prevent women from obtaining this personal health knowledge that they desire. Digital Breast Tomosynthesis (DBT), now widely available in the United States, reduces false positive results during screening by 15% (4). Because the breast is imaged in layers rather than as a whole (as in conventional mammography), artifact caused by superimposed tissues is less common.
- #33 1. Bleyer A, Welch HG. Effect of three decades of screening mammography on breast-cancer incidence. N Engl J Med 2012;367:1998-2005. 2. Puliti D, Duffy SW, Miccinesi G, et al. Overdiagnosis in mammographic screening for breast cancer in Europe: a literature review. J Med Screen 2012; 19(suppl 1):42-56. 3. Monticciolo DL, Helvie MA, Hendrick RE. Current issues in the overdiagnosis and overtreatment of breast cancer. AJR 2018; 210:1-7.
- #34 We cannot directly measure the rate of overdiagnosis, because in order to do so we would have to withhold treatment and observe which cancers fail to progress. Rates of overdiagnosis can be estimated from screening studies, but estimates vary widely in the literature. Some authors overestimated the degree of overdiagnosis in the United States by declaring the background incidence of breast cancer to be close to zero over time.[1]. Epidemiological data in the U.S. and Europe have clearly shown an increase in this baseline incidence of more than 1% annually. Reliable literature estimates overdiagnosis to be less than 10% [2]. Practically speaking, older women with competing causes of death are much more likely than young healthy women to be affected by overdiagnosis. Overdiagnosis will not be affected by either the age that screening is begun or the screening interval. An overdiagnosed cancer that is not detected at age 40 will not go away- therefore it will still be detected at age 50. And the same overdiagnosed cancer will be detected whether you screen every year or every other year. This is important because reducing overdiagnosis is cited as a justification for USPSTF guidelines.
- #39 DM = digital mammography DBT = Digital Breast Tomosynthesis