From: Subject: JAMA -- Rethinking Screening for Breast Cancer and Prostate Cancer, October 21, 2009, Esserman et al. 302 (15): 1685 Date: Fri, 30 Oct 2009 06:25:37 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01CA5929.CB5F1DA0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.5579 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01CA5929.CB5F1DA0 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://jama.ama-assn.org/cgi/content/full/302/15/1685 JAMA -- Rethinking Screening for Breast Cancer and = Prostate Cancer, October 21, 2009, Esserman et al. 302 (15): = 1685

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3D" 3D" Vol. 302 No. 15, = October 21,=20 2009 3D" 3D"
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CLINICIAN'S=20 CORNER
Rethinking=20 Screening for Breast Cancer and Prostate = Cancer

<= NOBR>Laura=20 Esserman, MD, MBA; Yiwey Shieh, AB; = Ian=20 Thompson, MD

JAMA. 2009;302(15):1685-1692.=20

ABSTRACT=20
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After 20 = years of=20 screening for breast and prostate cancer, several = observations can be made. First, the incidence of these = cancers increased after the introduction of screening = but=20 has never returned to prescreening levels. = Second, the=20 increase in the relative fraction of early stage = cancers=20 has increased. Third, the incidence of regional = cancers=20 has not decreased at a commensurate rate. One = possible=20 explanation is that screening may be increasing = the=20 burden of low-risk cancers without significantly = reducing=20 the burden of more aggressively growing cancers and=20 therefore not resulting in the anticipated reduction = in=20 cancer mortality. To reduce morbidity and = mortality from=20 prostate cancer and breast cancer, new approaches = for=20 screening, early detection, and prevention for = both=20 diseases should be considered.



INTRODUCTION=20
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 =95 Top
 =95 Introduction
 =95 Effec= t=20 of = population-based...
 =95 A=20 shift in strategy:...
 =95 Concl= usion
 =95 Autho= r=20 information
 =95 Refer= ences
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Breast=20 cancer and prostate cancer account for 26% of all = cancers=20 in the United States, with an estimated 386 560=20 patients diagnosed annually: 194 280 for = breast=20 cancer and 192 280 for prostate = cancer1=20 For both, there are remarkable differences = between=20 outcomes of localized vs advanced disease (breast = cancer:=20 5-year relative survival rates of 98.1% vs 27.1%; = prostate=20 cancer: 100% vs 31.7%).2=20 As a result, screening for both cancers has been = promoted=20 on the assumption that early detection and treatment = is=20 the best way to reduce disease-associated morbidity and=20 mortality.


Effect=20 of Population-Based Screening
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 =95 Top
 =95 Introd= uction
 =95 Effect of=20 = population-based...
 =95 A=20 shift in strategy:...
 =95 Concl= usion
 =95 Autho= r=20 information
 =95 Refer= ences
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A large=20 fraction of the US population participates in screening = for prostate cancer and for breast cancer. About 50% = of=20 at-risk men have a routine prostate-specific = antigen=20 (PSA) test and 75% have previously had a PSA = test.3-4=20 About 70% of women older than 40 years reported = having a=20 recent mammogram.5=20 Two decades of screening have resulted in a = significant=20 increase in detection of early cancers. = Prostate-specific=20 antigen testing has nearly doubled the chance = that a man=20 will be diagnosed with prostate cancer in his = lifetime:=20 In 1980, a white man's lifetime risk of prostate = cancer=20 was 1 in 116;=20 today it is 1 in 6.1=20 A woman's lifetime risk of breast cancer was 1 in = 12 in=20 1980; today it is 1 in 8.1=20 If ductal carcinoma in situ (DCIS) is included, = the risk=20 of being diagnosed with breast cancer, like prostate=20 cancer, has almost doubled as well.

The increase in early cancers as a fraction of total = cancers=20 detected is not necessarily beneficial. The=20 introduction of an optimal screening test should be followed = by an=20 increase in the rate of early disease followed by a decrease = in=20 regional disease while the overall detection rate remains=20 constant.7=20 Figure=20 1 illustrates hypothetical optimal, worst-case, and=20 intermediate-case scenarios, using 1980 breast = cancer=20 incidence rates as a starting point. In the worst = case,=20 screening leads to an increase in local disease = detection=20 without a corresponding decrease in regional = disease,=20 thereby increasing costs and morbidity due to=20 overdetection and overtreatment of = non=96life-threatening=20 cancers. Although the scenarios are quite different, = the=20 percentage of early cancers detected, as a = fraction of=20 total cancers identified, increases from 50% to = almost=20 70% in each case. This type of intermediate = metric, often=20 cited as evidence of success for screening = programs, is=20 potentially misleading.



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Figure=20 1. Hypothetical Screening Scenarios

Three hypothetical scenarios of changes = over=20 time in stage-specific incidence rates = associated=20 with widespread screening usage are = presented. The=20 dotted lines indicate the point of = screening=20 initiation. The fraction of localized and = regional=20 disease before and after screening is = shown for=20 each scenario. A, Screening leads to an = increase=20 in localized cancers, a decrease in = regional=20 cancers, and stable rates of overall = invasive=20 cancer (after an initial increase = following=20 introduction of screening). B, Screening = leads to=20 an increase in the detection of total and = early=20 stage cancers but without a decrease in = the rate=20 of regional cancers. C, Screening results = in an=20 increase in early and overall cancer = rates, with=20 some decrease in regional stage disease. = This=20 outcome is intermediate between A and B. = D, The=20 incidence of localized and regional = cancers is=20 shown for the prescreening period and for = each of=20 the scenarios. The height of the bars = represents=20 total incidence. E, The relative = percentage of=20 localized vs regional cancers is shown. = Note that=20 all 3 scenarios lead to the same increase = in the=20 percentage of detection of localized = cancers. =


How do breast and prostate cancer screening compare with=20 these hypothetical scenarios? The data for breast = cancer=20 and prostate cancer (Figure=20 2) resemble the intermediate-case scenario at = best.=20 The incidence of invasive breast cancer (excluding in=20 situ lesions) has increased substantially and remains=20 higher than prescreening rates. SEER data8=20 show that localized (node negative, no skin or = chest wall=20 involvement) and regional (node positive, skin or = chest=20 wall involvement) breast cancer has declined = slightly but=20 far less than the increase in localized disease. = The=20 reported rate of advanced disease has decreased=20 substantially for prostate cancer; however, about=20 one-third of patients currently classified as = having=20 localized cancer are found to have extraprostatic = disease=20 at the time of surgical resection.11=20 It is disappointing that the absolute numbers of = more=20 advanced disease have not decreased nearly as much as = hoped=20 for either cancer. Thus, neither screening test is=20 optimal. Although the incidence of high-grade = cancer has=20 dropped as a fraction of all cancers detected, = the=20 absolute numbers have not decreased as much as = hoped (Figure=20 2B).



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Figure=20 2. Age-Adjusted Incidence Rates of = Breast and=20 Prostate Cancer Over Time and by Prescreen = and=20 Postscreen Snapshot

A, Age-adjusted incidence rate by stage = of=20 invasive female breast cancers for all = ages, SEER=20 1973-2006.8=20 Mammography was introduced in 1983 and = more widely=20 used beginning in 1986.9=20 The incidence per 100 000 women of = localized,=20 regional, and metastatic breast cancer is = shown=20 over time (left), and for the period prior = to the=20 uptake of screening (1982) and 16 years = after=20 (1998) (middle). Local disease, as a = fraction of=20 all cancers reported, is shown on the = right. B,=20 Age-adjusted incidence rate of = adenocarcinoma of=20 the prostate for men older than 24 years, = SEER,=20 1973-2006. Prostate cancer screening began = in 1986=20 and was more widely used beginning in = 1989-1990.=20 Given the degree of missing data for = prostate=20 cancer TNM stage in SEER, we chose to show = the=20 change in Gleason grade, a significant = predictor=20 of outcome since the introduction of = screening.=20 The middle panel shows the incidence per=20 100 000 men of tumors with Gleason = grades=20 that were low- and intermediate-grade = (2-7) vs=20 high-grade (8-10) tumors, for the period = prior to=20 the uptake of screening (1988) and 16 = years after=20 (2004). The low- and intermediate-grade = tumors as=20 a fraction of all cancers is shown in the = panel on=20 the right.10 =


Mortality has decreased for both cancers over the past 2=20 decades but the contribution from screening is = uncertain.=20 A comparison of prostate cancer incidence rates = in the=20 United States and the United Kingdom found that = intensive=20 PSA screening in the United States along with = dramatic=20 increases in incidence did not result in = significant=20 differences in mortality compared with the United = Kingdom, where PSA screening was not widely=20 adopted.12=20 The 2 prostate cancer screening trials have mixed=20 results: the European trial11=20 showed a 20% relative decrease in mortality and = the US=20 trial13=20 found no effect on mortality. For breast cancer, = the=20 relative reduction in mortality from screening in = 7=20 randomized trials ranged from 20% to 30%13;=20 meta-analyses estimate the reduction to range = from 0% to=20 20%.14=20 The observed decrease in mortality is = attributable to=20 both screening and adjuvant therapy, with an = estimated=20 decrease of 7% to 23%, and 12% to 21%,=20 respectively.15=20

Screening's Limited Effect on Mortality and = Significant=20 Effect on Incidence. There are several = reasons that=20 may help to explain why screening has not led to = a more=20 significant reduction in deaths from these 2 = diseases in=20 the United States. First, screening increases the = detection of indolent cancers. Second, screening = likely=20 misses the most aggressive cancers. In other = words, tumor=20 biology dictates and trumps stage, so the basic assumption = of these=20 screening programs that finding and treating early stage = disease=20 will prevent late stage or metastatic disease may not always = be=20 correct.

Periodic screening risks detection of slower growing and=20 potentially indolent tumors (Figure=20 3A and B, length bias), finds some progressive = cancer=20 early (Figure=20 3C) but does not screen patients often enough = to=20 detect lethal tumors (Figure=20 3D) in time to prevent death. Without the = ability to=20 distinguish cancers that pose minimal risk from = those=20 posing substantial risk and with highly sensitive = screening tests, there is an increased risk that the=20 population will be overtreated. This phenomenon was = noted=20 in a study comparing prostate cancer incidence = and=20 mortality in 2 US sites, Connecticut (low rate of = PSA=20 screening) and Seattle, Washington16=20 (high rates). Significantly higher prostate cancer=20 incidence and treatment rates in Seattle were = unrelated to=20 mortality rates.17-18=20 The rate of overdiagnosis in national breast cancer=20 screening programs may be as high as 1 in 3 for = invasive=20 cancers,19=20 and it is possible that some screen-detected cancers = might=20 even regress.20=20 The observed increase in the fraction of molecularly=20 low-risk cancers in a screened population supports = this=20 observation.21=20 Screening with a focus on high sensitivity will = increase=20 cancer detection rates, which has been = demonstrated for=20 other cancers in the setting of population-based=20 screening, including neuroblastoma22-23=20 and now likely lung cancer with the introduction of=20 computed tomographic (CT)=96based = screening.24=20



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Figure=20 3. Screen Detection Capability Based = on Tumor=20 Biology and Growth Rates

Growth rates of 4 tumors are displayed = from the=20 time the first tumor cells appear while = the tumor=20 is not yet detectable (microscopic); when = it can=20 be detected as localized (confined to the = organ)=20 and most likely to be curable; regional = (after the=20 tumor spreads beyond the organ) where it = may not=20 be curable; and to the point when = metastases and=20 death occur. Tumor A remains undetectable = and=20 without morbidity during the patient's = lifetime.=20 Tumor B grows until it becomes detectable = but=20 never causes symptoms or leads to death. = Both=20 tumors A and B represent low-risk indolent = or IDLE=20 (indolent lesions of epithelial origin) = tumors.=20 Tumor C is destined to become metastatic = and fatal=20 but can be detected while still curable. = Tumor D=20 is destined to become metastatic but grows = so=20 quickly that by the time it can be = detected, it=20 may no longer be curable. Among these 4 = tumors,=20 only the patient with tumor C benefits = from=20 screening. =


Early detection may not be the solution for aggressive=20 cancers because many may not be detected early = enough for=20 cure. Some small "curable" breast cancers, = categorized as=20 low risk by National Institutes of Health = criteria, have=20 a high mortality risk when analyzed using = prognostic=20 molecular profiles such as the NKI 70 gene = test.25=20 Biologically aggressive cancers present with a = higher=20 stage despite screening. Interval = cancers, those=20 that present clinically between routine screens, have a = higher=20 growth fraction and are more likely to be lethal compared = with=20 screen detected cancers.26=20 In the neoadjuvant I-SPY (Investigation of Serial = Studies=20 to Predict Your Therapeutic Response With Imaging = and=20 Molecular Analysis) trial, in which the mean = tumor size=20 was 6 cm (accrual 2003-2006 in the United = States), 91%=20 had poor prognosis biology27=20 (using the NKI 70 gene test), which is much higher = than=20 the 33% poor prognosis proportion in women = undergoing=20 routine screening.21=20 Of women undergoing routine screening in the I-SPY = TRIAL,=20 85% of the malignancies were interval cancers and = only=20 15% were screen detected,28=20 suggesting that locally advanced cancers reflect = the=20 growth curve of line D in Figure=20 3. Similarly, the most lethal prostate = cancers are=20 those with rapidly increasing PSA levels. =

Screening is most successful when = premalignant lesions=20 can be detected and eliminated as in the case of adenomatous = polyp=20 removal during colonoscopy screening29=20 or cervical intraepithelial neoplasia ablation by=20 colposcopy after detection by pap smear.30=20 Perhaps most important is that screening for = cervical and=20 colon cancer and the removal of preneoplastic = lesions=20 have been accompanied by a significant decrease in = their=20 invasive cancer counterparts; this has not been seen = in=20 breast and prostate cancer. Ductal carcinoma = in situ,=20 rare prior to widespread screening, now = represents 25% to=20 30% of all breast cancer diagnoses = (>60 000 new=20 case-diagnoses annually are not included in the = invasive=20 cancer statistics),1=20 the majority of these lesions are low and = intermediate=20 grade.31=20 Ductal carcinoma in situ is considered to be a=20 precancerous lesion and standard of care is = excision and=20 adjuvant treatment. However, after 2 decades of = detecting=20 and treating DCIS, there is no convincing = evidence of=20 substantial reduction in invasive breast cancer=20 incidence. The 2002 decrease in incidence leveled off = in=20 2005 and is attributed to a reduction in = postmenopausal=20 hormone therapy use, not DCIS removal.32=20

The current quandary stems from the focus of screening=20 programs on improving test sensitivity, leading = to=20 potential tumor overdetection and overtreatment. = In the=20 Prostate Cancer Prevention Trial,33=20 biopsy of all men in this study found that there was = no=20 level of PSA below which cancer was not found.=20 Additionally, at the current 4.0 ng/mL cutoff of = PSA=20 values, almost 30% of cancers were already = potentially=20 incurable. Although lowering the PSA threshold = reduced=20 the number of incurable tumors, the risk of = detection of=20 insignificant disease increased substantially. = That the=20 bulk of tumors found across all levels of risk in the=20 trial33=20 met current criteria of "significant cancer" is a = testimonial=20 to the inability to discriminate between = inconsequential=20 disease and disease that will cause serious = illness and=20 death.34=20 The European Randomized Study of Prostate = Cancer35=20 screening showed that a very large number of men = had been=20 screened to find many prostate cancers, the = majority of=20 which will not cause harm during intermediate=20 follow-up.

Surgical and radiation interventions are associated with=20 morbidities that are sometime significant in many = men. In=20 the US Prostate, Lung, Colorectal, and Ovarian = Cancer=20 study, a large number of excess tumors were = detected in=20 the screening group but without a reduction in=20 mortality.36=20 Even in breast cancer, for which there is = evidence and=20 agreement that screening saves lives, the Table=20 illustrates that for every breast cancer death averted, = even in the age group for which screening is least=20 controversial (age 50-70 years), 838 women must = undergo=20 screening for 6 years, generating thousands of = screens,=20 hundreds of biopsies, and many cancers treated as = if they=20 were life threatening when they are not. Even in = the=20 centrally organized European screening programs, = where=20 the emphasis on greater specificity has led to fewer=20 interventions,38=20 the problem remains.


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Table.=20 Benefit and Burden of Mammographic = Screening and=20 Prostate-Specific Antigen Screening in the = United=20 States and Europe =


After 23D1/2=20 decades of = screening=20 for breast and prostate cancer, conclusions are=20 troubling: Overall cancer rates are higher, many = more=20 patients are being treated, and the absolute incidence = of=20 aggressive or later-stage disease has not been = significantly=20 decreased. Screening has had some effect, but it comes = at=20 significant cost, including overdiagnosis, = overtreatment,=20 and complications of therapy, problems likely to = be=20 exacerbated as the US population ages. Additional = gains=20 are unlikely with the current approach and may=20 inadvertently add to the burden of treatment and = diagnosis=20 for relatively indolent disease.


A Shift=20 in Strategy: Options for the Future
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 Jump=20 to Section
 =95 Top
 =95 Introd= uction
 =95 Effec= t=20 of = population-based...
 =95 A shift in=20 strategy:...
 =95 Concl= usion
 =95 Autho= r=20 information
 =95 Refer= ences
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To=20 significantly reduce death and morbidity from breast = and=20 prostate cancer, a new focus and approach is proposed = for=20 early detection and prevention: (1) focus on = development=20 and validation of markers that identify and = differentiate=20 significant- and minimal-risk cancers; (2) reduce = treatment for minimal-risk disease; (3) develop = clinical=20 and patient tools to support informed decisions = about=20 prevention, screening, biopsy, and treatment and = offer=20 treatments tailored to tumor biology; and (4) work = to=20 identify the highest-risk patients and target = preventive=20 interventions. To accomplish these goals, = demonstration=20 projects, that drive innovation in prevention, = screening,=20 and management in breast and prostate cancer are=20 needed.

Develop and Validate Biomarkers to Differentiate=20 Significant- and Minimal-Risk Cancers. To = help move=20 toward a more effective solution, the first step = is a=20 change in mindset in scientific discovery efforts = and=20 clinical practice. The approach to screening = should=20 follow a multidecision path such as the one shown in = Figure=20 4. Beyond merely identifying those most at risk for=20 developing cancer (Figure=20 4, point 1), individuals at the highest likelihood = of=20 having substantial risk disease (Figure=20 4, point 3) must be identified. Treatment = success or=20 failure (point 4) should inform prevention (point = 5) and=20 screening (point 6). This will require models to = predict=20 those individuals who are likely to develop = high-risk=20 cancers and focus studies on this population.



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Figure=20 4. Framework for Advancing Screening = and=20 Detection

At point 1, it would be optimal to find = a=20 biomarker for susceptibility (eg, breast = density,=20 risk models, gene polymorphisms, immune = function)=20 to tailor recommendations for screening. = At point=20 2, higher-risk patients would undergo = detection=20 screening with imaging, biomarkers, or = both. When=20 a cancer is detected, point 3, molecular = profiling=20 determines tumor type, and risk for = progression.=20 Minimal-risk disease can be treated less=20 aggressively, and patients with = significant risk=20 of metastatic disease should receive = tailored=20 interventions, point 4. Biomarkers that = predict=20 good response to therapy with targeted = agents=20 should provide opportunities to develop = tailored=20 prevention interventions with potential = biomarkers=20 for measuring response, point 5. Patients = with=20 poor response to therapy should provide = clues for=20 identifying markers of risk and = susceptibility and=20 research should be directed to identify = those=20 susceptible (point 6) to aggressive = disease that=20 is difficult to treat. Tailored screening = might=20 include susceptibility biomarkers or more=20 intensive detection strategies (eg, = magnetic=20 resonance imaging for BRCA = carriers).=20 Biomarkers that characterize tumor type = and=20 response should inform prevention and = screening=20 efforts (pathways shown in blue). =


Reduce Treatment Burden for Minimal-Risk Disease. = Many=20 diagnosed tumors will follow an indolent course = for the=20 patient's lifetime42=20 or are probably cured with surgical excision alone.=20 However, the inability to distinguish the most = aggressive=20 from the least aggressive cancers promotes = interventions=20 for all patients. For both breast and prostate = cancer,=20 methods exist to identify low- and high-risk=20 cancers.43-44=20 Tests for prognosis25,=20 44=20 and prediction45=20 of breast cancer are available and provide better=20 discriminatory information than clinical features=20 alone.25,=20 45-46=20 These and other emerging tools should be used and=20 validated as classifiers at the time of = diagnosis.=20 Minimal-risk lesions should not be called cancer. = A more=20 appropriate term, such as indolent lesions of=20 epithelial origin (IDLE) tumors would help = focus on=20 systematically studying how to reduce or eliminate=20 therapeutic interventions while achieving a good = outcome.=20 For substantial-risk tumors the focus must be on=20 developing optimal multimodal therapies while=20 concurrently developing preventive = strategies.=20

For prostate cancer, low-volume lesions with low Gleason=20 scores have a low risk of causing death within an = intermediate period.47=20 A large US-based trial that randomized men to surgery = vs=20 no therapy is nearing completion, a National = Cancer=20 Institute (US and Canada)=96sponsored trial is = beginning to=20 compare immediate vs delayed therapy, and a = prospective=20 study of patients on surveillance for prostate = cancer is=20 enabling the collection of clinical data and = biomarkers=20 to correlate with outcomes.48-49=20 These and other studies will improve the ability = to=20 classify lesions as minimal risk. The community = should=20 reclassify these low-risk lesions as IDLE tumors = and not=20 refer to them as cancer. The in situ precursors = of IDLE=20 tumors (IDLE in situ) would then not need to be = treated.=20 The scientific community should target the development = of=20 classifiers to distinguish IDLE in situ from precursors = of=20 more significant lesions, which can then be referred = to by=20 the emerging terms, ductal intraepithelial=20 neoplasia (DIN) and prostate = intraepithelial=20 neoplasia (PIN). By doing so and reliably = categorizing=20 these lesions with low risk of morbidity or mortality, = the=20 burden of therapy can be eliminated in many = cases.=20

Develop Tools to Support Informed Decisions. = Information=20 about risks of screening and biopsy should be = shared with=20 patients before screening. At the time of cancer=20 detection, risks and benefits of treatment for = specific=20 biological subtypes should be shared. Decision = support=20 tools should be designed to assist patients and=20 clinicians and facilitate introduction of new data. = As=20 risk factors for biologically aggressive cancers are=20 identified, recommendations regarding tools and = frequency=20 of screening will need to be tailored to the = patient, as=20 in the example of BRCA carriers. =

Women recalled after mammography screening are assigned a = Breast Imaging Reporting and Data System (BIRADS) = classification. BIRADS 4 is considered suspicious = but=20 corresponds to a risk that ranges from 3% to 75% = for=20 developing cancer.50=20 Less aggressive interventions for women with = lowest-risk=20 lesions (BIRADS 4a or <20% risk of cancer) = should be=20 developed.51=20 For prostate cancer, a risk calculator can = integrate=20 multiple risk factors to provide a composite risk = estimate that is often more informative than PSA = level=20 alone.52=20 This enables the clinician to recommend biopsies = to men=20 at highest risk and avoid biopsies for the lower-risk=20 patients. The risk calculator has the advantage of=20 assessing risk of cancer and risk of high-grade = disease;=20 because the latter poses the primary risk of = morbidity=20 and death, this level of risk may be most = informative as=20 patients decide whether to have a biopsy or a = preventive=20 intervention.

Focus on Prevention for the Highest-Risk Patients. = Ultimately, prevention is preferable to screening = by=20 reducing the risk that a patient will have a = diagnosis,=20 experience undesirable effects of treatment, and = confront=20 the specter of recurrence. For both breast and = prostate=20 cancer, available agents are proven to reduce = cancer=20 risk: finasteride53=20 and tamoxifen or raloxifene.54=20 In the case of prostate cancer, finasteride has = been=20 demonstrated to be safe and effective in reducing = the=20 risk of cancer regardless of risk stratum.55=20 Finasteride does not increase and may reduce risk = of=20 high-grade cancer.56-58=20 For breast cancer, focus should be on prevention = efforts=20 for women for whom the risk and the benefits of=20 intervention have been shown to be highest, eg, = in the=20 setting of atypia at a young age (for which = chemoprevention=20 may reduce relative risk by 85%),59-60=20 or breast cancer (BRCA) gene=96mutation = carriers at=20 a young age (for which surgical prophylaxis = reduces=20 absolute risk by more than 40%-70%).61-63=20 Chemoprevention may also be an alternative to surgical = excision and radiation for minimal-risk = cancers.64=20

The timing of progression of cancer is rarely considered = but=20 should be a part of decision making and the design of=20 preventive interventions. Premalignant lesions, = which are=20 likely to take years to progress, should be seen = as an=20 opportunity to study preventive = interventions65=20 rather than merely as an opportunity to treat. A = high=20 national priority must be to find innovative ways = to=20 initiate prevention trials, especially for = aggressive=20 disease.

Three barriers hinder the acceptance of prevention: = failure=20 of physicians to make clear to patients (and patients = to=20 understand) their individual risk of cancer, the = belief=20 that early detection and "cure" are ensured with=20 screening, and organized medicine's focus on = treatment=20 rather than prevention. It is critical to develop = tools=20 to assess the benefit of current preventive = interventions=20 for an individual patient (Figure=20 3, point 2). Preventive interventions will be = used if=20 they have few adverse effects, if they are not = costly,=20 and if biomarkers identify the patients most likely = to=20 benefit and whether the intervention is having an = effect.66=20 The human and financial savings of not becoming a = cancer=20 survivor for the person's lifetime makes = prevention a=20 better option than treatment.55=20 When risk can be determined with accuracy, patients=20 choose preventive interventions: For BRCA1 and=20 BRCA2 gene mutation carriers, prophylactic = surgery=20 is cost-effective, lifesaving,67=20 and increasingly selected as reconstruction options=20 improve.68=20

Demonstration Projects: Tactics for the New = Strategy. To=20 reduce morbidity and mortality from breast cancer = and=20 prostate cancer and to execute the proposed = strategy, a=20 comprehensive approach, using large demonstration = projects to create a learning system, integrating = both=20 clinical care and research is needed. By spanning = the=20 spectrum from screening to treatment and survivorship, = learning=20 from diagnosis, treatment, and outcomes can be applied = to=20 developing tailored strategies for screening and=20 prevention. Critical elements include structured = data=20 collection as a byproduct of care and patient = engagement=20 in screening and treatment; a database that = includes=20 known and proposed risk factors, exposures, and = comorbidities,=20 diagnostic interventions, molecular classification of=20 tumors at the time of diagnosis, treatment = decisions,=20 short- and long-term outcomes; collection and = storage of=20 blood and tissue for research; comparative = effectiveness;=20 tools for automated risk assessment; and = democratized=20 access to identity-protected information. With = this=20 infrastructure, biomarkers to identify minimal-risk = cancers=20 can be tested and applied; options can be provided to=20 reduce treatment; shared decision-making tools = can be=20 used to update information; and risk assessment = tools can=20 be automated, using risk information gathered at = the time=20 of screening and diagnostic evaluation to = systematically=20 identify, target risk reduction, and track men = and women=20 predisposed to developing significant-risk = cancers.=20

Optimizing interventions and tracking outcomes will=20 accelerate the ability to refine treatment and = screening=20 strategies, predict risk for specific biological = tumor=20 types, and ultimately develop tailored prevention = strategies. This is clearly a superior strategy = to the=20 fragmented, inefficient, underpowered approach of = developing=20 small disease cohorts for each proposed new marker. = The=20 demonstration project concept provides = opportunity but=20 will require new types of collaborations among = industry,=20 academia, government, health care payers, = clinicians, and=20 patients. The ATHENA Breast Health Network, an = innovative=20 project across the University of California = campuses, is=20 an example.69=20


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Screening=20 for breast and prostate cancer has increased the number = of cancers detected generating expense and morbidity = from=20 detection and treatment of cancers that pose = minimal=20 risk. To improve screening, a new focus is = recommended for=20 research and care to identify markers that discriminate = minimal-risk=20 from high-risk disease; identify less aggressive = interventions for=20 minimal-risk disease to reduce treatment burden for patients = and=20 society; develop decision support tools to integrate current = and=20 emerging knowledge into routine care; and develop effective=20 prevention, screening, and treatment strategies for = high-risk=20 disease. About $20 billion is spent to screen = for=20 breast cancer and prostate cancer in the United=20 States.70=20 Highly innovative businesses typically invest 10% = to 20%=20 of their sales into research and development for = the next=20 new product.71=20 A similar investment is needed to improve = screening,=20 accelerate prevention research, and reduce harm = from=20 breast cancer and prostate cancer deaths.


AUTHOR=20 INFORMATION
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Corresponding=20 Author: Laura Esserman, MD, MBA, Carol Franc Buck=20 Cancer Center, University of California, San = Francisco,=20 1600 Divisadero St, Box 1710, San Francisco, CA = 94115=20 (laura.esserman{at}ucsfmedctr.org ).

Author Contributions: Dr Esserman and Mr Shieh had = full=20 access to all of the data in the study and take=20 responsibility for the integrity of the data and = the=20 accuracy of the data analysis.

Study concept and design: Esserman, Thompson. =

Acquisition of data: Esserman, Shieh.

Analysis and interpretation of data: Esserman, = Shieh,=20 Thompson.

Drafting of the manuscript: Esserman, Shieh,=20 Thompson.

Critical revision of the manuscript for important=20 intellectual content: Esserman, Shieh, = Thompson.=20

Statistical analysis: Esserman.

Administrative, technical, or material support: = Esserman,=20 Shieh.

Study supervision: Esserman.

Financial Disclosures: None reported.

Funding/Support: This article grew out of = collaboration=20 initiated within the Early Detection Research = Network and=20 was supported by grants U01CA111234 and = U01CA086402.=20

Additional Contributions: We are indebted to Karen = Sepucha, PhD, senior scientist, Decision = Sciences, and=20 Elissa Ozanne, PhD, associate professor, = Institute for=20 Technology Assessment, Massachusetts General = Hospital,=20 Boston; and Virginia Ernster, PhD, professor = emeritus,=20 Epidemiology, University of California, San = Francisco,=20 for reviewing the manuscript and providing excellent=20 editorial advice, none of whom received = compensation.=20

Author=20 Affiliations: Department of Surgery and Radiology (Dr = Esserman)=20 and School of Medicine (Mr Shieh), University of California, = San=20 Francisco, and Department of Urology, University of Texas = Health=20 Science Center, San Antonio (Dr Thompson).


REFERENCES=20
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PADDING-BOTTOM: 12px; PADDING-LEFT: = 12px; PADDING-RIGHT: 12px; FONT-FAMILY: = verdana,arial,helvetica,sans-serif; FLOAT: left; COLOR: #000; FONT-SIZE: = 13px; PADDING-TOP: 12px } .leftmargin { MARGIN-LEFT: 10px } DIV.ifora .listcols { WIDTH: 32%; FLOAT: left } DIV.ifora UL { LIST-STYLE-TYPE: none } DIV.ifora LI.level2 { FONT-WEIGHT: bold } DIV.ifora LI.level3 { MARGIN-LEFT: 1em } DIV.ifora LI.level4 { MARGIN-LEFT: 2em } DIV.ifora H2 { COLOR: #003366; CLEAR: left; FONT-SIZE: 1em } DIV.ifora { FONT-FAMILY: verdana,arial,helvetica,sans-serif; FONT-SIZE: 13px } DIV.ifora P.toplink { FONT-SIZE: 0.7em } DIV.ifora .medline A { TEXT-TRANSFORM: uppercase; MARGIN-LEFT: 5px; FONT-SIZE: 0.7em } DIV.ifora HR { BORDER-BOTTOM: medium none; BORDER-LEFT: medium none; BACKGROUND-COLOR: = #9db6c7; WIDTH: 90%; DISPLAY: block; HEIGHT: 1px; COLOR: #9db6c7; CLEAR: = left; BORDER-TOP: medium none; BORDER-RIGHT: medium none } ------=_NextPart_000_0000_01CA5929.CB5F1DA0--