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NSGC Comments on Breast Cancer Screening with MRI Recommendations
ACS Guideline for Breast Cancer Screening with MRI: Clarifications on the Italian Study
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Nancie Petrucelli, MS, CGC, Co-Chair National Society of Genetic Counselors (NSGC) Familial Cancer Risk Counseling Special Interest Group, Joy Larsen Haidle, MS, CGC and Catherine Wicklund, MS, CGC
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nsgc{at}nsgc.org Nancie Petrucelli, MS, CGC, et al.
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Dear Editor, On behalf of the National Society of Genetic Counselors (NSGC) Familial Cancer Risk Counseling Special Interest Group, we would like to commend the American Cancer Society’s efforts to convene a panel of experts to review the evidence and develop new recommendations for breast cancer screening with MRI. In reviewing Dr. Debbie Saslow’s recent article, American Cancer Society Guidelines for Breast Screening with MRI as an Adjunct to Mammography, there were two points which deserve clarification and further comment. 1) When discussing BRCA1 and BRCA2 mutations, the author states that, “These mutations follow an autosomal dominant pattern of transmission, which means that the sister, mother, or daughter of a woman with a BRCA mutation has a 50% chance of having the same mutation” (1). Autosomal dominant actually means that first-degree relatives (i.e., offspring, siblings, parents) of an individual with a mutation have a 50% chance of having the same mutation and is not gender dependant. This means both men and women can carry and transmit BRCA mutations and, thus, sons and daughters, brothers and sisters, and fathers and mothers of an individual with a mutation are at risk of having the same mutation. It is true that male mutation carriers have a lower risk of actually developing cancer as a result of a BRCA mutation and since the focus of these guidelines is on women at increased risk for breast cancer this may have been why it concentrated on females in the family. However, we are concerned that this statement is misleading and gives the impression that men are not at risk to carry or transmit BRCA mutations. 2) The author further states that, “Genetic testing for BRCA1 or BRCA2 mutations are generally offered to adult members of families with a known BRCA mutation, or to women with at least a 10% likelihood of carrying such a mutation, based on either validated family history criteria or one of the above-mentioned models.” When the American Society of Clinical Oncology (ASCO) updated their policy statement on genetic testing for cancer susceptibility in 2003, they stated, “Given the known limitations and wide variations inherent in models for estimating mutation probability in a given family or individual, and the lack of such models for many cancer predisposition syndromes, it is neither feasible nor practical to set numerical thresholds for recommending genetic risk assessment services. ASCO therefore recommends that evaluation by a health care professional experienced in cancer genetics should be relied on in making interpretations of pedigree information and determinations of the appropriateness of genetic testing, including determinations of appropriateness for reimbursement” (2). There are many reasons as to why an individual may have less than a 10% likelihood of carrying a BRCA mutation, such as small family size, predominantly male relatives, and/or limited family history information, and yet still benefit from genetic testing. Thus, the appropriateness of genetic testing should be based on clinical judgment and not numerical thresholds. Again, we congratulate the American Cancer Society on providing such a thorough review of the literature and discussion of the issues surrounding breast MRI. We are compelled, however, to dispel the misconception that hereditary risk cannot come from the father as this myth is still clinically prevalent. Sincerely, Nancie Petrucelli, M.S., C.G.C. Joy Larsen Haidle, M.S., C.G.C. Catherine Wicklund, M.S., C.G.C. References 1. Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin 2007;57:75-89. 2. American Cancer Society of Clinical Oncology. American Society of Clinical Oncology policy statement update: genetic testing for cancer susceptibility. J Clin Oncol 2003;21:2397-2406. |
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Franca Podo, Research Director and Head of the Section Molecular and Cellular Imaging Istituto Superiore di Sanità, Rome, Italy, and Francesco Sardanelli
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franca.podo{at}iss.it Franca Podo, et al.
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The recently reviewed ACS guideline on the use of MRI as an adjunct to mammography for screening women at significantly increased risk of breast cancer (1) will certainly facilitate the adoption of more effective strategies of secondary prevention by health authorities and health care providers in different Countries. Since 1998, the Istituto Superiore di Sanità (Rome, Italy) has been one of the first public health institutes to address specific efforts to coordinate a national multicenter study (HIBCRIT) to evaluate the effectiveness of integrating MRI with conventional imaging modalities, for early detection of breast cancer in women with hereditary predisposition for this disease (2-4). We were pleased that our study was considered among the contributions in favor of the issue of the new ACS guideline. However, we had to note some inexactness in reporting the results of our work, which may lead the reader to erroneous conclusions. In particular, in our first publication (2) on preliminary results on 105 women enrolled in 9 Italian Centers (proven carriers of germ-line pathogenetic BRCA1 or BRCA2 mutations or untested first-degree relatives of proven BRCA1 or BRCA2 mutation carrier) after a median of 1.13 rounds of screening, 8 cancers (5 invasive) were reported. MRI had one false positive case, mammography and ultrasound none. We had sensitivity values of 100% for MRI, 13% for mammography and 13% for ultrasound. Moreover, under the assumption that the remaining 97 women for whom no modality detected cancer lesions were all “true negatives”, the specificity of MRI, mammography and ultrasound would have been 94%, 98% and 91% respectively (5), differently from some of the data reported in Table 2 (last column) of the ACS guideline article (1). Our subsequent report, referring to the interim results obtained in the period June 2000-March 2004 (3,4), was on 278 women enrolled in 17 Centers (rather than 9 as quoted in the ACS article, page 80); 63% (and not 27%) carried a BRCA mutation or had a first-degree relative with a BRCA mutation, with a MRI sensitivity of 94%, compared to 59% for mammography, 65% for ultrasound, and 50% for clinical breast examination. While we still wait for the end of our seven-year study before definitely estimating the specificity of each modality, it may be worth noting that these interim results gave a positive predictive value of 82% for clinical breast examination, 77% for mammography, 65% for ultrasound, and 63% for MRI. Comparison of these values with those obtained in other similar studies is reported in our review article (4). We are convinced that the guideline panel will appreciate that, once correctly reported, our data are more consistent with those of other published studies on the matter and more effectively reinforce the relevant conclusions and recommendations expressed in the ACS article. Franca Podo, Istituto Superiore di Sanità, Rome, Italy and Francesco Sardanelli, University of Milan School of Medicine, Department of Medical and Surgical Sciences, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy References 1. Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin 2007;57:75-89. 2. Podo F, Sardanelli F, Canese R, et al. The Italian multi-centre project on evaluation of MRI and other imaging modalities in early detection of breast cancer in subjects at high genetic risk. J Exp Clin Cancer Res 2002;21:115-124. 3. Sardanelli F, Podo F, D’Agnolo G, et al. Multicenter comparative multimodality surveillance of women at genetic-familial high risk for breast cancer (HIBCRIT study): Interim results. Radiology 2007;242:698-715 (Epub 2007 Jan 23). 4. Sardanelli F and Podo F. Breast MR imaging in women at high-risk of breast cancer. Is something changing in early breast cancer detection? Eur Radiol 2007;17:873-887 (Epub 2006 Sep 29). 5. Liberman L. Breast cancer screening with MRI – What are the data for patients at high risk? N Engl J Med 2004;351:497-500. |
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