Report in English with a Dutch summary (KCE reports 63A)

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12 Breast Cancer KCE reports 63 3.2 POPULATION SCREENING A previous KCE report already formulated recommendations on mass screening for breast cancer [3]. This report was taken as a starting point for the present literature search. The report concluded that there were insufficient arguments against the present breast cancer screening programme by mammography for women aged 50 – 69 years [3]. However, the advantages of extension of the programme to women aged < 50 years or > 69 years were found to be unsure. Above this, no hard evidence was found to recommend other screening methods than two-view mammography, such as ultrasonography, MRI or self-examination [3]. Our search did not identify good-quality CPGs on population screening published after 2003. However, 3 systematic reviews and 1 pooled analysis of 3 RCTs were identified [4-7] (see evidence tables). In a recent systematic review of Gotzsche et al. 7 RCTs were identified, of which one was excluded because of bias [4]. The authors calculated a relative risk (RR) for breast cancer mortality of 0.80 (95% confidence interval [CI] 0.73 – 0.88) in favour of screening, and a number-needed-to-screen of 2000 women to throughout 10 years to prevent 1 death. However, the authors also pointed at the inevitable overdiagnosis associated with screening [4]. Indeed, it was calculated that for every 2000 women invited for screening throughout 10 years, 10 healthy women who would not have been diagnosed if there had not been screening, would be diagnosed as breast cancer patients and would be treated unnecessarily. In a pooled analysis of 3 RCTs, a shift to earlier stages was found in breast cancers detected by screening mammography [7]. Patients with interval cancers were found to have a 53% (95%CI 17% – 100%) greater hazard of death from breast cancer than patients with screen-detected cancers, and patients with cancer in the control groups had a 36% (95%CI 10% – 68%) greater hazard of death than patients with screendetected cancer. Kösters et al. identified 2 population-based studies that compared breast selfexamination with no intervention in more than 388.000 women [6]. No statistically significant difference was found in breast cancer mortality (RR 1.05, 95%CI 0.90 – 1.24). Finally, Irwig et al. reported on a systematic review of the accuracy of ultrasonography (US), magnetic resonance imaging (MRI), full-field digital mammography and computeraided detection for breast cancer screening [5]. All identified studies had an observational design. No hard data were found to support the use of these imaging techniques for population breast cancer screening. The recommendations formulated in the present guideline are in line with the recent European guidelines on breast cancer screening and diagnosis [8], which were not identified through our literature search. 1. Based on the literature, the present breast cancer screening programme by mammography for women aged 50 – 69 years remains justified (2A evidence) [3, 4, 7]. 2. There is no hard evidence to recommend other screening methods (e.g. ultrasonography, MRI, self-examination) than two-view mammography (1C evidence) [3, 5, 6].
KCE reports 63 Breast Cancer 13 3.3 MANAGEMENT OF HIGH-RISK WOMEN 3.3.1 Definition of high-risk A distinction should be made between genetic and familial risk for developing breast cancer: • Women with a proven mutation of the BRCA1, BRCA2 or TP53 gene are considered to be at genetic risk. • For the calculation of the familial risk, several models are available. Recently, Amir et al. compared four of these models [9], and concluded the Tyrer-Cuzick model to be the most consistently accurate model for the prediction of breast cancer (rate of expected to observed number of breast cancers = 0.81). This model incorporates the BRCA genes, a low penetrance gene and personal risk factors, such as age at menarche, parity, height, etc [10]. The model has been computerised and an interactive program is available from the authors on request [10]. Women with a lifetime risk of 20% or greater of developing breast cancer are considered to be at high risk. 3.3.2 Breast cancer susceptibility gene testing Two CPGs of good quality were found on breast cancer susceptibility gene testing [11, 12]. No additional evidence was identified. The recommendations from these CPGs were only slightly rephrased and adapted to the local Belgian context. We refer to the original CPGs for the evidence base. 3. Routine referral for genetic counselling or routine breast cancer susceptibility gene (BRCA) testing for women whose family or personal history is not associated with an increased risk for deleterious mutations in breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2) is not recommended (1B evidence) [12]. 4. Women whose family or personal history is associated with an increased risk for: • deleterious mutations in BRCA 1 or BRCA 2 gene (early-age-onset breast cancer, two primary breast cancers and/or breast and ovarian cancers in the same individual or close relatives on the same side of the family, known mutation in a family member, Ashkenazi Jewish decent with breast cancer in women < 50 years or ovarian cancer, male breast cancer, more than one ovarian cancer on the same side of the family); • Li-Fraumeni and Cowden Syndrome (thyroid cancer, sarcoma, adrenocortical cancer, endometrium cancer, pancreatic cancer, brain tumors, dermatologic manifestations, leukemia/lymphoma) should be referred for genetic counselling (1B evidence) [11, 12]. 5. All high-risk women should have access to information on genetic tests aimed at mutation finding (1C evidence) [11]. 6. Pre-test counselling (preferably two sessions) should be undertaken (1A evidence) [11]. 7. Discussion of genetic testing (predictive and mutation finding) should be undertaken by someone with appropriate training (1A evidence) [11]. 8. High-risk women and their affected relatives should be informed about the likely informativeness of the test (the meaning of a positive and a negative test) and the likely timescale of being given the results (1A evidence) [11].
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KCE reports 1. Effectiviteit en kos
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