1144 Rapid Communication First Epidemiological Analysis of Breast Cancer Incidence and Tumor Characteristics after Implementation of Population-Based Digital Mammo- graphy Screening Erste epidemiologische Analyse der Brustkrebsinzidenz und der Tumorcharakteristika nach Implementierung des populationsbezogenen digitalen Mammografie-Screening-Programms Autoren S. Weigel1, W. U. Batzler2, T. Decker3, H. W. Hense4, W. Heindel1 Institute 1 Institut für Klinische Radiologie und Referenzzentrum Mammographie Münster, Universitätsklinikum Münster 2 Epidemiologisches Krebsregister, NRW 3 Gerhard-Domagk-Institut für Pathologie und Brust-Screening-Referenzpathologie, Universitätsklinikum Münster 4 Institut für Epidemiologie und Sozialmedizin, Universität Münster Key words Zusammenfassung Abstract ●▶ breast ! ! ●▶ mammography Ziel: Epidemiologische Evaluation des digitalen Purpose: To epidemiologically evaluate the im- ●▶ digital mammography Mammografie-Screenings hinsichtlich Brustkrebs- pact of digital mammography screening on inci- screening ●▶ breast cancer incidence rate inzidenz und Tumorcharakteristika. dence rates and tumor characteristics for breast ●▶ cancer registry Material und Methoden: Mit Daten des Krebs- cancer. registers wurde die Implementierungsphase der Materials and Methods: The first German digital beiden ersten digitalen Screening-Einheiten screening units in the clinical routine were evalu- Deutschlands in der Regelversorgung hinsichtlich ated during the implementation period by using Inzidenzraten und Tumorcharakteristik analy- data from the cancer registry to compare the inci- siert. In der Region Münster/Coesfeld/Warendorf dence rate of breast cancers and prognostic char- wurden von 10/2005 – 12/2007 74% der 50 – 69- acteristics. 74% of women aged 50 – 69 within the Jährigen erstmals zum Screening eingeladen region of Muenster/Coesfeld/Warendorf were in- (Teilnahmerate 55%, n = 35961). vited between 10/2005 and 12/2007 for initial Ergebnisse: 2002 – 2004 lag die mittlere Brust- screening; 55% participated (n = 35961). krebsinzidenz (pro 100000) bei 297,9. Seit Pro- Results: In 2002 – 2004 the average breast cancer grammetablierung stieg die Rate auf 532,9 (2007). incidence rate (per 100000) was 297.9. During the Von 349 eingeschlossenen Screeningkarzinomen implementation of screening, the rate rose to 532.9 waren 76% invasiv (265/349), außerhalb des Pro- in 2007. Of the 349 cancers detected with screen- gramms im gleichen Zeitraum 90% (546/608). ing, 76% (265/349) were invasive compared to 37% der invasiven Screeningkarzinome (97/265) 90% (546/608) of cases not detected with screen- waren ≤ 10 mm, 75% (198/265) waren nodal nega- ing during the same period. 37% (97/265) of can- eingereicht 29.7.2009 akzeptiert 18.9.2009 tiv, außerhalb des Screenings lagen diese Raten bei cers detected in the screening program had a dia- 15% (79/546) bzw. bei 64% (322/503). Die Vertei- meter of ≤ 10 mm and 75% (198/265) were node- Bibliografie lung der invasiven Tumorgrößen (pT-Kategorien) negative compared to 15% (79/546) and 64% DOI http://dx.doi.org/10.1055/ und des Nodalstatus unterschieden sich statistisch (322/503), respectively, in cancers detected out- s-0028-1109831 signifikant zwischen in und außerhalb des Screen- side the screening program. The distribution of in- Online-Publikation: 26.10.2009 Fortschr Röntgenstr 2009; 181: ings detektierten Karzinomen (p = 0,005 bzw. vasive tumor size (pT categories) and the nodal sta- 1144 –1150 © Georg Thieme p = 0,004). tus differed with statistical significance between Verlag KG Stuttgart ∙ New York ∙ Schlussfolgerung: Es konnte epidemiologisch cancers detected in and outside the program ISSN 1438-9029 belegt werden, dass die Einführung eines popu- (p = 0.005 and p = 0.004, respectively). lationsbezogenen Mammografie-Screening-Pro- Conclusion: Epidemiological data shows that the Korrespondenzadresse Dr. Stefanie Weigel gramms zu einem deutlichen Anstieg der alters- implementation of a population-based screening Univ.-Prof. Dr. Walter Heindel spezifischen Brustkrebsinzidenz führt. Die program led to a relevant increase in the age-spe- Institut für Klinische Radiologie, Charakteristika der Screeningkarzinome erfüllen cific breast cancer incidence rate. The characteris- Universitätsklinikum Münster die Vorgaben der Europäischen Leitlinien und tics of breast cancers detected in the screening Albert-Schweitzer-Straße 33 sind prognostisch günstiger als Mammakarzi- program comply with the requirements of the 48129 Münster nome, die außerhalb des Screening-Programms European guidelines and are significantly favor- Germany diagnostiziert wurden. Damit bietet das digitale able compared to tumors diagnosed outside the Tel.: ++ 49/2 51/8 34 56 50 Fax: ++ 49/2 51/8 34 56 60 Mammografie-Screening die Voraussetzungen program. These findings indicate that digital [email protected] für eine effektive Früherkennung. mammography screening fulfills the require- [email protected] ments for an early tumor detection tool. Weigel S et al. First Epidemiological Analysis… Fortschr Röntgenstr 2009; 181: 1144 –1150 Rapid Communication 1145 Introduction total target population), 35961 women attended the screening ! examination (participation rate 55%). The expected benefits of breast cancer screening in certain age Both screening units performed mammography exclusively groups are the early detection of breast cancer and the subse- with digital techniques (MicroDosis Mammography, MDM, quent reduction in mortality rates while reducing the negative Sectra Medical Systems; Mammomat 3000 Nova, Siemens side-effects of treatment by detecting cancer at earlier stages Healthcare, DirectView CR975 EHR-M2, Carestream Health; when it is more responsive to less aggressive treatment [1]. Mammomat 3000 Nova, Siemens Healthcare, FCR Profect CS, Studies on the impact of mammography screening programs Fuji and Senographe DMR + , General Electric with DirectView revealed that the breast cancer mortality reductions observed CR975, Carestream Health). All devices fulfill the national re- for these routine services were consistent with those observed quirements (PAS 1054) as well as the requirements for con- in previous randomized trials, confirming a 25 – 39% decrease trast resolution of EPQC (European Protocol for the Quality in breast cancer deaths in women over age 50 [2 –4]. An ob- Control of the Physical and Technical Aspects of Mammogra- served decline in the rate of death from breast cancer could phy Screening) [8]. be explained by a combination of screening and improved The mammograms were double read (softcopy reading). To re- therapy not by either alone [5]. solve discrepancies between the interpretations of the two To accomplish these goals, quality assured programs define a readers review by consensus including a third reader was priori surrogate parameters serving as indicators for the targe- mandatory. The assessment was organized in a centralized ted reduction in breast cancer mortality rates. Performance way by the screening units [7]. Before undergoing mammogra- parameters, like the proportion of small invasive cancers as phy, the participating women gave written informed consent well as the stage distribution of screening detected cancers, to the management of their personal data for internal quality are useful right from the start of a program and should be assurance procedures of the screening units. provided by screening units. Death rates, despite being the pri- The Epidemiological Cancer Registry for the State of North mary endpoint of an evaluation of the effect of early cancer Rhine-Westphalia (EKR NRW) comprises the geographic re- detection, delay the availability of program evaluation results gions of Muenster, Coesfeld and Warendorf. Breast cancer re- by years because extended time periods are required for their ports reach the EKR NRW from pathology institutes in the re- conclusive assessment. gion and from hospitals treating breast cancer patients. The In 2002, the German Parliament decided to implement a na- EKR NRW receives notifications only by electronic means and tional population-based mammography screening program. stores all data exclusively under pseudonyms, i.e., as doubly The German Radiation Protection Council agreed to the use of encrypted personal identifying data. The EKR NRW has been both digital and analog mammography technologies, but it re- certified by the national Robert-Koch Institute as providing quired the specific evaluation of screening units using digital complete registration of breast cancer cases in the Muenster technology to make sure that the quality of digital mammo- region since the late 1990 s. For the purpose of this report, all graphy is not inferior to film mammography screening. personal data from the screening units were transformed into In October 2005, the first two digital screening units in Ger- pseudonyms which were then used for record linkage within many began operation. We previously reported on the perfor- the EKR [9]. Cases of breast cancer originating from the two mance indicators after one year of digital screening and screening units were specifically tagged in the registry data- showed that the parameters of the European guidelines were base. Record linkage identified cases detected in the screening met at lower radiation levels than in screen film mammogra- program for which additional notifications from other sources phy [6]. existed but we used only the data provided by the screening The purpose of the present study was to evaluate