JAMA - Archives Internal Medicine - Radiation Breast Cancer Jul 2012

SPECIAL ARTICLE

Environmental Causes of Breast Cancerand Radiation From Medical Imaging

Findings From the Institute of Medicine Report

Rebecca Smith-Bindman, MD

S usan G. Komen for the Cure asked the Institute of Medicine (IOM) to perform a com-prehensive review of environmental causes and risk factors for breast cancer. Interest-ingly, none of the consumer products (ie, bisphenol A, phthalates), industrial chemi-cals (ie, benzene, ethylene oxide), or pesticides (ie, DDT/DDE) considered could beconclusively linked to an increased risk of breast cancer, although the IOM acknowledged that theavailable evidence was insufficient to draw firm conclusions for many of these exposures, callingfor more research in these areas. The IOM found sufficient evidence to conclude that the 2 envi-ronmental factors most strongly associated with breast cancer were exposure to ionizing radiationand to combined postmenopausal hormone therapy. The IOMs conclusion of a causal relation be-tween radiation exposure and cancer is consistent with a large and varied literature showing thatexposure to radiation in the same range as used for computed tomography will increase the risk ofcancer. It is the responsibility of individual health care providers who order medical imaging tounderstand and weigh the risk of any medical procedures against the expected benefit.

Arch Intern Med. 2012;172(13):1023-1027.Published online June 11, 2012.

doi:10.1001/archinternmed.2012.2329

Susan G. Komen for the Cure, the largestgrassroots network of breast cancer sur-vivors and activists in the United States,asked the Institute of Medicine (IOM) toperform a comprehensive and evidence-based review of environmental causes andrisk factors for breast cancer, with a fo-cus on identifying evidence-based ac-tions that women can take to reduce theirrisk.1 Environmental exposures were de-fined broadly to include all factors not ge-netically inherited, and the IOM commit-tee appointed towrite this report includedacademicians and chairs from depart-ments of environmental health, toxicol-ogy, cancer epidemiology, preventivemedicine, and biostatistics in addition toadvocates for patients with breast cancer.Committeemembers conducted their own

reviews of the peer-reviewed epidemio-logical and basic science literature, com-missioned several papers specifically fortheir report, and drew on evidence-basedreviews already completed by organiza-tions such as the Agency for Research on

Cancer and the World Cancer ResearchFund International. The publicationBreastCancer and the Environment: A Life CourseApproach was released online in Decem-ber 2011.1

IOMs CONCLUSIONS

Interestingly, none of the consumer prod-ucts (ie, bisphenol A, phthalates), indus-trial chemicals (ie, benzene, ethyleneoxide), or pesticides (ie, DDT/DDE) con-

For editorial commentsee page 982

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Author Affiliations: Departments of Radiology and Biomedical Imaging,Epidemiology and Biostatistics, and Obstetrics and Gynecology and ReproductiveSciences, University of California, San Francisco.

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sidered could be conclusively linkedto an increased risk of breast can-cer, although the IOM acknowl-edged that the available evidencewasinsufficient to draw firm conclu-sions for many of these exposures,calling for more research in theseareas. The IOM found sufficient evi-dence to conclude that the 2 envi-ronmental factors most strongly as-sociated with breast cancer wereexposure to ionizing radiation andto combined postmenopausal hor-mone therapy.1 Since the WomensHealth Initiative reported that com-bined estrogen and progestin hor-mone therapy increases a womansrisk of breast cancer,2 there has beena steep decline in hormone therapyuse, followed by small decline inbreast cancer incidence.3 Thus, themost significant conclusion of theIOM report is that to reduce her riskof breast cancer, a woman shouldavoid inappropriate radiation expo-sure. In particular, because the ra-diation doses delivered by com-puted tomographic (CT) imaging arehigh, women should reduce any un-necessary exposure to CT. The IOMalso concluded that several lifestylefactorsmaymodestly reduce awom-ans risk of breast cancer, such aslimiting alcohol consumption,main-taining a healthy body weight, andreducing active smoking, all ofwhich have health benefits beyondlowering a risk womans risk ofbreast cancer.

The IOMs conclusion of a causalrelation between radiation expo-sure and cancer is consistent with alarge and varied literature showingthat exposure to radiation in thesame range as used for CT will in-crease the risk of cancer.4-6Many na-tional and international organiza-tions such as the National CouncilonRadiationProtection (NCRP), theInternational Council on RadiationProtection (ICRP), and the Interna-tionalAtomicEnergyAgency (IAEA)were established in part to promoteradiation protection, given its car-cinogenic properties. What is sur-prising is the IOMs focus on theavoidance ofmedical imaging as oneof the most important and concretesteps that women can take to re-duce their risk of breast cancer, re-flecting the growing awareness thatCT is overused and that a reduc-

tion in unnecessary use would leadto health improvement. Further-more, the IOM highlighted that ex-cess radiation exposure is aggra-vated by the large variation in CTdoses for the same imaging test con-ducted among different institu-tions, as well as dosing errors by in-adequately trained or supervisedtechnologists and poorly designedequipment. A reduction in varia-tion in doses across patients and in-stitutions and elimination of over-dosing errorswould greatly improvethe safety of CT and reduce its po-tential for causing cancer. The IOMestimated that 2800 future breastcancers would result from 1 year ofmedical radiation exposure amongthe entire US female population,with two-thirds of those cases re-sulting from CT radiation expo-sures.While these represent a smallproportion of all breast cancers,1,7,8

they are important because they canpotentially be reduced.

CT OVERUSE

The use of CT has increased nearly5-fold over the last 2 decades.9-14

Currently, 75 million CT scans areperformed annually in the UnitedStates,15 around half in women, re-flecting the large number of indi-viduals who are exposed to thissource of radiation. Thought lead-ers in radiology are often quoted asestimating that 30% or more of ad-vanced imaging tests may be unnec-essary,8,16 andwhile there are few sci-entific data to precisely estimate theamount of overuse, many radiolo-gists believe the proportion may beeven higher.

The reasons for overuse of CT aremany16 and include the ease of con-ducting this examination and theclear diagnostic images made pos-sible through advances in technol-ogy. Intense marketing focusing onprofit leads to the rapid purchase ofmachines prior to completely un-derstanding how this technologyshould be used to improve healthoutcomes has created excess capac-ity, complicated by few evidence-based guidelines for its use.17 Strongfinancial incentives,18 reflectedby thegrowing ownership of CT scannersby nonradiologists for use in theirprivatemedical offices,19,20 strong pa-

tient demand (in part resulting fromdirect-to-consumer advertisementsthat do not mention untoward ef-fects21), and medical malpracticeconcerns leading to defensive test or-dering,22 have all further contrib-uted to high excess use. Thus, whileCT is clearly indicated and valu-able inmany casesfor example, forpatients with acute appendicitis andpulmonary embolismCT is fre-quently used in the absence of evi-dence.17 The threshold for using CTfor imaging has dropped dramati-cally,23 and thus it is not surprisingthat the IOM suggested curtailingunnecessary radiation exposure frommedical imaging to reduce cancerrisks.

Outside the medical world, suchas the nuclear power industry, themilitary, or homeland security, ra-diation use must be carefully justi-fied. The concern for limiting radia-tion exposures in occupational andindustrial settings where the per-son exposed does not receive directbenefit from that exposure should bethe same for medical use. We canlearn fromEurope, where very clearjustification for CT is required. Thereferral guidelines for imaging pub-lished by the European Commis-sion state24(p23):

in view of the potential high doses, CTshould only be carried out after properclinical justification by an experiencedradiologist. Examinations on children re-quire a higher level of justification, sincesuch patients are at greater risk fromradiation.

Justification in the United States formedical imaging that delivers radia-tion was present in the earlier yearsof its use, but ironically, as the dosesof radiation used inmedical imaginghave increasedwith thewider use ofCT, and the development of higher-dose CT scanning protocols, the re-quirement for justification for its usehas declined. Recently, and surpris-ingly, its known harms have evenbeen trivialized by some25 in con-trast to the large literature that hasclearly documented the potential forradiation doses in the same range asused in CT for causing cancer.




WEIGHING THE RISKS OF CT

To reduce inappropriate medicalimaging, individual patients, healthcare providers, and patient advo-cacy organizations all have a role toplay, and the IOM highlights stepsthat can be taken to limit unneces-sary exposures. Individual patientsand their families should expect thattheir health care providers will dis-cuss both the expected health ben-efits and potential harms of anyimaging test that has been orderedparticularly if the test involves ex-posure to radiationand patientsshould directly question any healthcare provider who does not pro-vide a complete picture. This pic-ture should be appropriate for theclinical contextthe likely ben-efit, the potential risk if imaging isnot performed, as well as the radia-tion the test is likely to deliver. Ause-ful rule of thumb is that patientsshould ask if a test is likely to altertheir clinical management or addconfidence to their clinicians diag-nosis, which would not be possiblewithout the test.

It is the responsibility of indi-vidual health care providers who or-der medical imaging to understandand weigh the risk of any medicalprocedures against the expected ben-efit. New imaging technologies aredelivering vastly larger radiationdoses than conventional x-rays. Forexample, a chest CT may deliver adose 100- to 500-fold higher than aconventional chest radiograph (con-ventional x-ray)26 With radio-graphs, the radiation dose is rela-tively small, so decisions aboutwhether to order radiographs can bemade based on less careful weigh-ing of these risks. New imaging andcomplex scanning protocols devel-oped for CT generate much largerdoses, in the range where increasedrates of cancer can bemeasured andwhere the doses have gotten so highthat accidents such as hair loss or ra-diation burns can result.27 Many or-dering physicians are insufficientlyinformed about radiation doses andthe cancer risks attributable tomedi-cal images,28 and yet this informa-tion is crucial toweigh risks andben-efits and provide appropriatejustification for the use of CT andother high-dose imaging studies to

patients and families. Brook29 re-cently hypothesized that showingclinicians the cost of a medical testevery time they ordered one for theirpatient might lead to the more ju-dicious and cost-effective use ofmedical care. Similarly, if clini-cianswere providedwith detailed in-formation about the expected radia-tion exposure of a procedure, aswellas about a patients cumulative ex-posure to medical radiation at thetime a test is ordered, they mightchoose the tests more judiciously.Current electronic medical recordsand test ordering platforms can beadopted to include this informa-tion, as well as information on thelikely benefit of any imaging exami-nation, and this would help to ful-fill the Centers for Medicare andMedicaid Services (CMS) require-ments formeaningful use of these in-formation systems. There is a press-ing need for educational informationfor the broad medical community(ie, not just medical physicists) toenhance understanding of the dosesof radiation involved in diagnosticimaging tests and the health risks as-sociated with those doses.

A CALL FOR OUTCOMESRESEARCH FOR IMAGING

Outcomes research for imaging issorely needed. Health care advo-cates, such as the National Partner-ship for Patients, should lobby forresearch that quantifies the risks andthe benefits of medical imaging,given how important advancedimaging is to medical care. Cur-rently, the National Institute of Bio-medical Imaging (the National In-stitutes of Health institute taskedwith medical imaging related re-search) has spent the majority of itsresearch dollars on the develop-ment of new imaging modalitiesrather than on quantifying the risksand benefits of existing imagingtechnology. Lastly, Congress and theCMS, as well as other payers, havealready enacted payment reformstargeted to reducing the expendi-tures on imaging and to removingsome of the financial incentives thathave led to the rapid rise in imaging.These measures have slowed thegrowth rate of imaging over the lastfew years.9,30 The recently released

White House health care budgetspecifically calls for an additional$820 million dollar reduction inpayments for imaging and intro-duces prior authorization to fur-ther reduce utilization, althoughthese specific recommendationsmay not be incorporated into thefinal approved budget. Since priorauthorization adds costs, complexi-ties, and time delays into the medi-cal care process, it is in the self-interest of both payers and healthcare providers to develop alterna-tive approaches to improving theappropriateness of imaging orders.There are some promising initia-tives in that regard,31 including theimplementation of clinical deci-sion support in the electronicmedi-cal record of several large healthsystems.32,33

STEPS TOWARD REDUCINGRADIATION EXPOSURE

The first step toward lowering ex-posures to unnecessary radiation isto reduce unnecessary testing. A sec-ond, and equally important, strat-egy for reducing inappropriate ex-posures to radiation from medicalradiation is to lower the doses de-livered for each imaging examina-tion. This can be done through thedevelopment of greater oversight ofCT. Patient demands for improve-ment can help speed such over-sight. Patients should ask their phy-sicians about the radiation dosesinvolved in their examinations, andrequest a record of the doses towhich they are exposed. The Na-tional Quality Forum recently ad-opted a quality measure focused onCT radiation dose that calls for fa-cilities who conduct CT to recordtheir doses.34 Consumers and phy-sicians should ask the facilities theyuse and the health plans to whichthey belong to adopt this measureand to publically report dose infor-mation. This would rapidly im-prove a facilitys knowledge of thedoses they use, as well as motivatethem to do whatever they can tolower and standardize radiationdose. Furthermore, this would al-low patients and health care provid-ers to use this information in theirdecision-making regardingwhere togo for imaging.




The US Food and Drug Admin-istration (FDA) created a road mapfor reducing and standardizing thedoses patients are exposed to whenthey undergo CT; they called for thecreation of benchmarks (standarddosing levels), recording doses inthe medical record and creatingevidence-based guidelines forimaging.35 However, they have notmoved these efforts forward, in-stead asking medical societies andprofessional groups to take the lead.Unfortunately, there has been littleprogress in these areas since the FDAinitially made these recommenda-tions in early 2010. Radiology pro-fessional organizations could takethe lead in creating concrete dosebenchmarks, working closely withthe FDA to do so, as this could re-sult in a marked reduction in thevariation in radiation doses ob-served for CT. Legislators could getinvolved as well, as was done to-ward the standardizing of doses usedinmammography through theMam-mography Quality Standards Act(MQSA); this successful effort canbe a model for how legislation canoptimize use of radiation in medi-cal imaging.36 At aminimum, theUSCongress should pass the CARE Bill(HR 2104, The Consistency, Accu-racy, Responsibility and Excel-lence in Medical Imaging and Ra-diation Therapy37) that is currentlyunder consideration. It would im-prove the training of those who or-der and conduct imaging examina-tions.California has recently enactedlegislation that goes into effect in July2012 (SB 1237) requiring the doseused for CT examinations be re-corded in every patientsmedical rec-ord and further requires inadver-tent CT radiation overdoses to beimmediately reported to the state.38

This will inform patients and refer-ring health care providers about doseand will further encourage facili-ties to begin assessing and reduc-ing the doses they are delivering totheir patients. The California legis-lation provides a template for con-sideration of national legislation.

Lastly, while manufacturers aredeveloping and marketing devicesthat can create diagnostic imagesusing considerably lower doses of ra-diation, itmay take decades for thesedevices to replace those currently in

operation. Thus, the manufactur-ers should work closely with all fa-cilities who use their equipment toprovide existing software upgradesto immediately reduce the doses towhich patients are exposed. Cur-rently, the costs of these software up-grades are marketed at prices out-side the reach of many facilities thatconduct CT. Furthermore, as theIOMsuggested,manufacturers couldadopt uniformdesign standardsashas been successfully done in otherareas of medicine (such as anesthe-sia) and outside of medicine (suchas the airline industry)that wouldmake it easier for technologists tomove between different manufac-turers and machines to improvesafety. For example, the differentmanufacturers have developed dif-ferent techniques to modulate thetube current for patients of differ-ent sizes to reduce the doses pa-tients receive. GEhas defined amea-sure known as the noise index, andthe higher values in the noise indexresult in lower dose. Siemens has de-fined reference milliampere sec-onds (mAs)higher values in the ef-fectivemAs resulting in higher dose.Thus, if a technologist has a smallpatient andwould like to reduce thedose, they need to turn the noise in-dex up on a GE machine, whereasthey need to turn the effective mAsdown on a Siemans machineseemingly opposite directions tolower the dose.

CONCLUSIONS

Computed tomography is a highlyvaluable tool, but unnecessary usemay lead to a small but real in-crease in a patients risk of cancer,and patients should be appropri-ately involved in the decision to un-dergo imaging.39 Many imaging en-thusiasts believe patients cannot betold about the radiation exposure as-sociated with medical imaging, be-lieving they will make poor choicesand refuse indicated imaging.40,41 Thisfear has not been substantiated.When given balanced informationabout both risks and benefits, pa-tients usually have made informedand appropriate decisions regard-ing medical imaging for themselvesor their families. For example, in onestudy of caregivers informed of the

radiation risk associated with a di-agnostic CT for their child, they pre-ferred the lower-risk option of ob-servation if the physician believed itwould be equally effective and chosein favor of CT if it was preferred andrecommended by their physician.42

Now we need to develop the evi-denceneededbybothphysicians andpatients so they can take advantageof this tool in the situations when itwill be most important to do so.

The IOM conclusion is that cur-rent evidence-based options forwomen to reduce their risk of breastcancer are limited. Most of theknown risks factors for breast can-cer, such as the age of menarche orfamily history, cannot be con-trolled. Avoiding and reducing ex-posure to medical radiation is oneof the primary evidence-based ac-tions that could reduce breast can-cer risk, and the medical commu-nity should do everything in ourpower to reduce unnecessary expo-sures as quickly as possible.

Accepted for Publication:April 17,2012.PublishedOnline: June11, 2012.doi:10.1001/archinternmed.2012.2329Correspondence: Rebecca Smith-Bindman, MD, Department of Ra-diology and Biomedical Imaging,University of California, San Fran-cisco, 350 Parnassus Ave, Ste 307,San Francisco, CA 94143 ([email protected]).Financial Disclosure: None re-ported.Additional Contributions: DianaMiglioretti, PhD, Per F. Peterson,PhD, and Leif Solberg, MD, pro-vided helpful comments on an ear-lier version of the manuscript.Online-OnlyMaterial:An audio au-thor interview is available at http://www.archinternmed.com.

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