Diagnostic Service Effectiveness During the First Year of Breast Cancer Screening in the Region of Lower Silesia

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1 ORIGINAL PAPERS Adv Clin Exp Med 2008, 17, 6, ISSN X Copyright by Silesian Piasts University of Medicine in Wrocław BARTŁOMIEJ SZYNGLAREWICZ 1, RAFAŁ MATKOWSKI 1,2, PIOTR KASPRZAK 3, MAŁGORZATA STRYCHALSKA 3, PIOTR KUPCZAK 3, JOLANTA KOTOWSKA 4, JÓZEF FORGACZ 1, MAREK PUDEŁKO 1, JAN KORNAFEL 2 Diagnostic Service Effectiveness During the First Year of Breast Cancer Screening in the Region of Lower Silesia Jakość diagnostyki raka piersi w pierwszym roku badań przesiewowych na Dolnym Śląsku 1 2 nd Department of Surgical Oncology, Lower Silesian Oncology Center, Wrocław, Poland 2 Silesian Piasts University of Medicine in Wrocław, Chair of Oncology and Department of Gynecological Oncology, Poland 3 Breast Imaging and Minimal Invasive Biopsy Unit, Lower Silesian Oncology Center, Wrocław, Poland 4 Regional Coordinating Center for Screening Programs, Wrocław, Poland Abstract Background. The Polish Government and the National Health Fund introduced population based breast cancer screening in 2007 aimed to reduce breast cancer mortality. Objectives. To evaluate the diagnostic quality of the program during its initial year in the region of Lower Silesia. Material and Methods. This nation wide program targets women aged 50 69, excluding females undergoing treat ment or being followed up due to breast cancer. Biennial two view screen film mammography is used as the standard screening test. A significant reduction in breast cancer mortality requires measurement of long term screening. Some early performance indicators are therefore widely used and accepted in monitoring the effectiveness of a screening program. These parameters were calculated and compared with those recommended by the European Union. Results. In 2007, 79,143 women were screened in the region of Lower Silesia. Only 0.26% of them were re exam ined for technical reasons. The recall for reassessment, short term recall, and invasive examination rates were 6.85, 0.91, and 0.39%, respectively. Pathologically confirmed breast cancer was found in 460 women, giving a detection rate 5.8/1000. The ratio of cancer detection rate to expected incidence was There were only 17 (3.7%) duc tal carcinoma in situ found among all the cancers. Three hundred twenty five cancers were histologically verified by open biopsy, giving a non operative biopsy rate for malignancy as low as 29%. Conclusions. The effectiveness of the diagnostic service for cancer detection during the initial phase of the breast cancer screening program corresponds to the parameters specified by the European guidelines for quality assess ment of initial screening examinations. The main disadvantage is the rate of minimal invasive biopsy for malig nancy, one third of that recommended. Another challenge is the low incidence of DCIS. This needs to be careful ly evaluated in the future together with the time interval and false negative cancers. Acceptable but not ideal rates of recall for reassessment and short term recall should be decreased in the coming years and kept at the lowest pos sible levels thereafter (Adv Clin Exp Med 2008, 17, 6, ). Key words: breast cancer, screening program, mammography. Streszczenie Wprowadzenie. W celu obniżenia śmiertelności na raka piersi rząd RP i Narodowy Fundusz Zdrowia wprowadzi ły od 2007 roku populacyjny program badań przesiewowych (skryning) tego nowotworu. Cel pracy. Ocena jakości prowadzonej w programie skryningowym diagnostyki na Dolnym Śląsku podczas pierw szego roku jego działania. Materiał i metody. Program jest adresowany do kobiet w wieku lat, które nie chorowały na raka piersi. Te stem skryningowym jest mammografia rentgenowska wykonywana w dwóch projekcjach co dwa lata. Znamienne

2 662 B. SZYNGLAREWICZ et al. zmniejszenie śmiertelności na raka piersi można ocenić dopiero po kilkunastu latach trwania skryningu. Dlatego wprowadzono określone wskaźniki będące wczesnymi wykładnikami skuteczności programu i służące do monito rowania jego jakości. W pracy dokonano oceny tych parametrów w aspekcie rekomendacji Unii Europejskiej. Wyniki. W 2007 roku na Dolnym Śląsku kobiety wzięły udział w programie. 0,26% z nich poddano bada niu powtórnemu z przyczyn technicznych. Odsetek wezwań powtórnych celem oceny radiologicznej, odsetek kon troli przyspieszonej (w terminie krótszym niż interwał skryningu) i odsetek kobiet poddanych diagnostyce inwa zyjnej wyniosły odpowiednio: 6,85; 0,91 i 0,39%. Potwierdzonego histologicznie raka piersi wykryto u czterystu sześćdziesięciu kobiet, co daje współczynnik wykrywalności 5,8 na Iloraz współczynnika wykrywalności do oczekiwanego współczynnika zapadalności wyniósł 3,54. Wśród tych nowotworów tylko siedemnaście (3,7%) by ło rakiem wewnątrzprzewodowym. Trzysta dwadzieścia pięć raków zostało zweryfikowanych w biopsji otwartej. W wyniku tego odsetek raków rozpoznanych za pomocą technik minimalnie inwazyjnych był mały, ponieważ wy nosił zaledwie 29%. Wnioski. Skuteczność diagnostyki prowadzonej w pierwszym roku skryningu mammograficznego w odniesieniu do wykrywalności raka piersi była na wysokim poziomie, osiągając wyszczególnione w rekomendacjach europej skich wartości zalecane. Głównym czynnikiem obniżającym jakość diagnostyki był ponad 3 krotnie za mały odse tek raków wykrytych metodami minimalnie inwazyjnymi. Częstość wykrywania raków wewnątrzprzewodowych była stosunkowo niewielka, co wymaga dokładnej analizy w przyszłości, także w aspekcie występowania raków interwałowych i błędnie ujemnych. Odsetek wezwań powtórnych w celu oceny radiologicznej i odsetek kobiet skierowanych do przyspieszonych badań kontrolnych były na poziomie dopuszczalnym. Muszą zostać zmniejszo ne i utrzymane na jak najniższym poziomie w następnych latach prowadzenia programu, aby osiągnąć zalecane wartości (Adv Clin Exp Med 2008, 17, 6, ). Słowa kluczowe: rak piersi, skryning, mammografia. The cornerstone screening program of the Health Insurance Plan (HIP) of Greater New York was successfully introduced over forty years ago [1, 2]. Since then, the critical role of periodic screening in reducing breast cancer mortality has been well established. Controlled randomized tri als and systematic overviews clearly showed that population based mammographic screening pro gram can significantly reduce breast cancer mor tality by up to 40% [3 10]. Published reduction rates vary, probably depending on the type and intensity of intervention, the length of the screen ing interval, awareness of the disease, and the quality of screening. Nevertheless, the favorable results reported have led to the introduction of breast cancer screening programs for well defined populations in over twenty countries [11]. However, changes in mortality rates take a long time to become evident, and this is compounded by factors outside the screening program, such as more effective treatment. Early indicators that can be used to monitor the management of the pro gram and to measure its effectiveness have been identified [12]. Many of these parameters involve the imaging and invasive diagnostic service. If these operational objectives are met, the program will be able to replicate the mortality reduction achieved in randomized trials. The aim of this study was to evaluate the qual ity of the diagnostic service performed in the region of Lower Silesia for the breast cancer screening program during its initial year. Material and Methods Breast Screening Program The Polish National Health Fund introduced population based breast cancer screening in Poland on January 1, This nation wide pro gram targets women aged 50 69, excluding females undergoing treatment or being followed up because of breast cancer. Invitations are issued centrally by the National Health Fund based on its population register. Because information about screening is a complex task, the media, general practitioners and other health professionals, adver tising, web sites, phone hot lines, texting (via mobile phone), and s are employed in the invitation process. Screening Test Two view screen film mammography, cranio caudal and oblique, without clinical examination is used as the standard screening test. The routine round length of the program is two years. Because of the limited budget, mammography is evaluated with a single reading. Further Assessment All women with radiological findings catego rized as R3 R5 according to the radiological guidelines specified in the European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis were recalled for reassessment [12]. The second level diagnostic tools were clinical

3 Diagnostic Effectiveness of Breast Cancer Screening 663 breast examination and additional imaging (mam mography and ultrasound). Following reassess ment, the women were referred for examination at the routine round length of the program or at a shorter interval (short term recall) or for biopsy procedures. Biopsy Women requiring biopsy were referred for open surgical excision or minimally invasive per cutaneous biopsy, i.e. fine needle aspiration, 14 gauge core needle biopsy, or 11 gauge vacuum assisted biopsy. For non palpable lesions the pro cedures were performed under radiological guid ance. Statistical Analysis Data were collected in a prospective manner using SIMP (the official electronic system for monitoring prophylaxis) and the database of the regional branch of the National Health Fund. The detection rate was calculated as the number of women with histologically confirmed primary breast carcinomas per one thousand screened women. The expected incidence rate (164 per 100,000 women) was calculated based on data from the Polish National Cancer Registry, being defined as the crude morbidity rate for breast can cer among women aged in Poland in 2005 [13]. The values and rates of the early indi cators of screening effectiveness were calculated. Quality assessment was performed by comparing the parameters of screening effectiveness with the levels recommended by the European Union (fourth edition) [12]. Results During 2007, 79,143 women were screened in Lower Silesia. Only 206 of them (0.26%) were re examined for technical reasons. Reassessment was necessary for 5421 women (6.85%) and 719 were referred for the next examination at an interval less than the routine round length, giving a short term recall rate of 0.95%. Pathologically confirmed breast cancer was diagnosed in 460 women, giving a detection rate 5.8 per The ratio of the can cer detection rate to the expected incidence was There were only 17 (3.7%) cases of ductal carcinoma in situ found among all cancers. Three hundred twenty five cancers were histologically verified by open surgical biopsy. Only 135 women with cancer underwent minimally invasive biopsy with or without radiological guidance, giving a non operative diagnosis rate for malignancy as low as 29%. The data are shown and compared with the performance indicators recommended by the European Breast Cancer Network (EBCN) in Table 1. Table 1. Early indicators of diagnostic effectiveness compared with European guidelines recommended for initial breast cancer screening Tabela 1. Wczesne wskaźniki skuteczności diagnostyki w aspekcie rekomendacji europejskich dla pierwszej rundy badań przesiewowych raka piersi Parameter Result Acceptable level Expected level (Wskaźnik) (Wynik) (Wartość dopuszczalna) (Wartość zalecana) Repeat examination for technical reasons 0.26% < 3% < 1% (Wezwania powtórne z przyczyn technicznych) Recall for reassessment rate 6.85% < 7% < 5% (Wezwania powtórne w celu oceny) Short term recall rate 0.91% < 1% none (Przyspieszone badania kontrolne) Cancer detection rate 5.8/1000 (Współczynnik wykrywalności raka) Ratio of cancer detection rate to expected incidence > 3.0 (Iloraz współczynnika wykrywalności do oczekiwanego współczynnika zapadalności) Ductal carcinoma in situ rate 3.7% 10% > 15% (Odsetek raków wewnątrzprzewodowych) Non operative biopsy rate (for cancer) 29% 90% > 90% (Odsetek raków zweryfikowanych metodami minimalnie inwazyjnymi)

4 664 Discussion Systematic early detection with the use of screening may result in decreasing the current breast cancer mortality rate and reducing the bur den of this disease in the population. To obtain these benefits, high quality service is essential. This may be achieved through the underlying prin ciples of training, specialization, volume levels, multidisciplinary team work, and the use of set tar gets and performance indicators. The examination was repeated (same view) because of technical inadequacy in only 0.26% of the women screened. This result is favorable, showing the high quality of mammography offered for the screening program in the present authors institution. Image quality is influenced by the X ray equipment as well as the image produc tion line, the training, experience, and motivation of the radiographer, and the friendly ambience in the mammography unit. The role of the radiogra pher is central to the success of a breast screening program because high quality mammograms are crucial for the early diagnosis of breast cancer. The rate of recall for reassessment observed in this analysis appears acceptable, but not ideal. Rates of up to 6.7% have been obtained in initial screen ing rounds in Italy, Scandinavia, and Western Europe [14 19]. The high incidence of re examina tion in present study can be partially explained by mammography evaluation with a single reading. A double reading can increase the sensitivity of mammography by up to 15% and is strongly recom mended, particularly for the first screening round [20 22]. In cases of discordant opinions, excellent results can be obtained using consensus discussion or arbitration by a third radiologist. An incidence of screen detected cancers of up to 12/1000 has been reported, which is two times higher than that found in subsequent screening rounds and yields a ratio of the cancer detection rate to the expected incidence of up to 4.7 [14 19, 23 26]. In described series, these rates, though slightly lower, are still at the expected level. Considering the detection rate during the initial round, presented findings indicate a good perfor mance of the program. Reported rates of DCIS vary from 14% [14] to 4.8% [26], compared with which presented results are unfavorable. It is believed that removing DCIS (particularly of the high grade type) contributes to the reduction in long term mortality. Its detection is also an impor tant indicator of the adequacy of image quality and the radiologist s prediction and assessment [12]. In the future this should be carefully evaluated B. SZYNGLAREWICZ et al. together with an assessment of the interval cancer incidence with regard to further assessment and invasive investigation rates. The short term recall rate is acceptable, but not ideal. Short term recall has a low predictive value for malignancy. It creates anxiety and pro motes benign biopsies, and can also falsely reas sure a woman. Some programs therefore operate without short term recalls [14]. This non cost effective procedure should never be used to mask insufficient mammogram evaluation or as a means of avoiding a skilled radiological decision. Special effort must be made to restrict its use to an absolute minimum during the coming years. The main disadvantage of the diagnostic ser vice in this region is the low incidence of non operative diagnoses. It is less than a third of the recommended level [12], which is poor compared with others [19]. Diagnostic open excision should be minimized, as non operative methods are the norm in evaluating breast lesions. Its role in malig nancy is to attempt to provide a definitive diagno sis allowing rapid referral for treatment, ideally in one procedure. Definitive non operative diagnosis for benign lesions is also fundamental, avoiding surgery and allowing a return to routine recall. Therefore, the proportion of women with a non operative diagnosis of malignancy is a valid indi cator of quality assessment, related to the high pre dictive value for malignancy in referral for open biopsy [12]. For lesions imaged with both mam mography and ultrasonography, biopsy under ultrasound guidance was the preferred option in this institution because of its considerable advan tages over stereotactic techniques. It is performed in real time and direct needle visualization allows sampling accuracy to be assessed [27]. The time of the procedure is shorter, it causes less patient dis comfort, it is less expensive, it does not involve ionizing radiation, and its sensitivity is higher than stereotactic biopsy [28, 29]. Regarding cancer detection in the first year of mammographic screening, the breast imaging and biopsy service this institute provides is in general of high quality, with a favorable profile of the per formance indicators. However, special effort has to be made to greatly increase the incidence of non operative minimal invasive diagnoses. Ano ther challenge is the low incidence of DCIS. This needs to be carefully evaluated in the future together with the interval and false negative can cers. Furthermore, the assessment rate and short term recall rate should be decreased to improve cost effectiveness, reduce women s anxiety, and avoid benign biopsies.

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