Publications by authors named "Marc B I Lobbes"

42 Publications

Supplemental Breast MRI for Women with Extremely Dense Breasts: Results of the Second Screening Round of the DENSE Trial.

Radiology 2021 Mar 16:203633. Epub 2021 Mar 16.

From the Julius Center for Health Sciences and Primary Care (S.G.A.V., S.V.d.L., M.F.B., E.M.M., C.H.v.G.), Department of Radiology (S.V.d.L., R.M.P., M.J.E., W.P.T.M.M., M.A.A.J.v.d.B., W.B.V.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands; Dutch Expert Centre for Screening, Nijmegen, the Netherlands (R.M.P.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M., N.K.); Department of Radiology, the Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (P.K.d.K.D.); Department of Radiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands (R.H.C.B.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands (M.B.I.L.); Department of Medical Imaging, Zuyderland Medical Centre, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands (M.D.F.d.J.); Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology, Hospital Group Twente (ZGT), Almelo, the Netherlands (J.V.); and Department of Public Health, Erasmus Medical Center, Rotterdam, the Netherlands (H.J.d.K.).

Background In the first (prevalent) supplemental MRI screening round of the Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial, a considerable number of breast cancers were found at the cost of an increased false-positive rate (FPR). In incident screening rounds, a lower cancer detection rate (CDR) is expected due to a smaller pool of prevalent cancers, and a reduced FPR, due to the availability of prior MRI examinations. Purpose To investigate screening performance indicators of the second round (incidence round) of the DENSE trial. Materials and Methods The DENSE trial (ClinicalTrials.gov: NCT01315015) is embedded within the Dutch population-based biennial mammography screening program for women aged 50-75 years. MRI examinations were performed between December 2011 and January 2016. Women were eligible for the second round when they again had a negative screening mammogram 2 years after their first MRI. The recall rate, biopsy rate, CDR, FPR, positive predictive values, and distributions of tumor characteristics were calculated and compared with results of the first round using 95% CIs and χ tests. Results A total of 3436 women (median age, 56 years; interquartile range, 48-64 years) underwent a second MRI screening. The CDR was 5.8 per 1000 screening examinations (95% CI: 3.8, 9.0) compared with 16.5 per 1000 screening examinations (95% CI: 13.3, 20.5) in the first round. The FPR was 26.3 per 1000 screening examinations (95% CI: 21.5, 32.3) in the second round versus 79.8 per 1000 screening examinations (95% CI: 72.4, 87.9) in the first round. The positive predictive value for recall was 18% (20 of 110 participants recalled; 95% CI: 12.1, 26.4), and the positive predictive value for biopsy was 24% (20 of 84 participants who underwent biopsy; 95% CI: 16.0, 33.9), both comparable to that of the first round. All tumors in the second round were stage 0-I and node negative. Conclusion The incremental cancer detection rate in the second round was 5.8 per 1000 screening examinations-compared with 16.5 per 1000 screening examinations in the first round. This was accompanied by a strong reduction in the number of false-positive results. © RSNA, 2021 See also the editorial by Moy and Gao in this issue.
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http://dx.doi.org/10.1148/radiol.2021203633DOI Listing
March 2021

Dedicated Axillary MRI-Based Radiomics Analysis for the Prediction of Axillary Lymph Node Metastasis in Breast Cancer.

Cancers (Basel) 2021 Feb 12;13(4). Epub 2021 Feb 12.

Department of Surgery, Maastricht University Medical Center+, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands.

Radiomics features may contribute to increased diagnostic performance of MRI in the prediction of axillary lymph node metastasis. The objective of the study was to predict preoperative axillary lymph node metastasis in breast cancer using clinical models and radiomics models based on T2-weighted (T2W) dedicated axillary MRI features with node-by-node analysis. From August 2012 until October 2014, all women who had undergone dedicated axillary 3.0T T2W MRI, followed by axillary surgery, were retrospectively identified, and available clinical data were collected. All axillary lymph nodes were manually delineated on the T2W MR images, and quantitative radiomics features were extracted from the delineated regions. Data were partitioned patient-wise to train 100 models using different splits for the training and validation cohorts to account for multiple lymph nodes per patient and class imbalance. Features were selected in the training cohorts using recursive feature elimination with repeated 5-fold cross-validation, followed by the development of random forest models. The performance of the models was assessed using the area under the curve (AUC). A total of 75 women (median age, 61 years; interquartile range, 51-68 years) with 511 axillary lymph nodes were included. On final pathology, 36 (7%) of the lymph nodes had metastasis. A total of 105 original radiomics features were extracted from the T2W MR images. Each cohort split resulted in a different number of lymph nodes in the training cohorts and a different set of selected features. Performance of the 100 clinical and radiomics models showed a wide range of AUC values between 0.41-0.74 and 0.48-0.89 in the training cohorts, respectively, and between 0.30-0.98 and 0.37-0.99 in the validation cohorts, respectively. With these results, it was not possible to obtain a final prediction model. Clinical characteristics and dedicated axillary MRI-based radiomics with node-by-node analysis did not contribute to the prediction of axillary lymph node metastasis in breast cancer based on data where variations in acquisition and reconstruction parameters were not addressed.
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http://dx.doi.org/10.3390/cancers13040757DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7917661PMC
February 2021

Contrast-enhanced Mammography: State of the Art.

Radiology 2021 Apr 2;299(1):36-48. Epub 2021 Mar 2.

From the Department of Radiology, Breast Imaging Service, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10065 (M.S.J.); Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands (M.B.I.L.); and GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht, the Netherlands (M.B.I.L.).

Contrast-enhanced mammography (CEM) has emerged as a viable alternative to contrast-enhanced breast MRI, and it may increase access to vascular imaging while reducing examination cost. Intravenous iodinated contrast materials are used in CEM to enhance the visualization of tumor neovascularity. After injection, imaging is performed with dual-energy digital mammography, which helps provide a low-energy image and a recombined or iodine image that depict enhancing lesions in the breast. CEM has been demonstrated to help improve accuracy compared with digital mammography and US in women with abnormal screening mammographic findings or symptoms of breast cancer. It has also been demonstrated to approach the accuracy of breast MRI in preoperative staging of patients with breast cancer and in monitoring response after neoadjuvant chemotherapy. There are early encouraging results from trials evaluating CEM in the screening of women who are at an increased risk of breast cancer. Although CEM is a promising tool, it slightly increases radiation dose and carries a small risk of adverse reactions to contrast materials. This review details the CEM technique, diagnostic and screening uses, and future applications, including artificial intelligence and radiomics.
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http://dx.doi.org/10.1148/radiol.2021201948DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7997616PMC
April 2021

Clinical Assessment of Breast Volume: Can 3D Imaging Be the Gold Standard?

Plast Reconstr Surg Glob Open 2020 Nov 25;8(11):e3236. Epub 2020 Nov 25.

Department of Plastic and Reconstructive Surgery, Maastricht University Medical Centre+, Maastricht, the Netherlands.

Three-dimensional (3D) camera systems are increasingly used for computerized volume calculations. In this study we investigate whether the Vectra XT 3D imaging system is a reliable tool for determination of breast volume in clinical practice. It is compared with the current gold standard in literature, magnetic resonance imaging (MRI), and current clinical practice (plastic surgeon's clinical estimation).

Methods: Breast volumes of 29 patients (53 breasts) were evaluated. 3D images were acquired by Vectra XT 3D imaging system. Pre-existing breast MRI images were collected. Both imaging techniques were used for volume analyses, calculated by two independent investigators. Breast volume estimations were done by plastic surgeons during outpatient consultations. All volume measurements were compared using paired samples -test, intra-class correlation coefficient, Pearson's correlation, and Bland-Altman analysis.

Results: Two 3D breast volume measurements showed an excellent reliability (intra-class correlation coefficient: 0.991), which was comparable to the reliability of MRI measurements (intra-class correlation coefficient: 0.990). Mean (SD) breast volume measured with 3D breast volume was 454 cm (157) and with MRI was 687 cm (312). These volumes were significantly different, but a linear association could be found: y(MRI) = 1.58 × (3D) - 40. Three-dimensional breast volume was not significantly different from volume estimation made by plastic surgeons (472 cm (69), = 0.323).

Conclusions: The 3D imaging system measures lower volumes for breasts than MRI. However, 3D measurements show a linear association with MRI and have excellent reliability, making them an objective and reproducible measuring method suitable for clinical practice.
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http://dx.doi.org/10.1097/GOX.0000000000003236DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722547PMC
November 2020

Diagnostic Performance of Noninvasive Imaging for Assessment of Axillary Response After Neoadjuvant Systemic Therapy in Clinically Node-positive Breast Cancer: A Systematic Review and Meta-analysis.

Ann Surg 2021 04;273(4):694-700

Department of Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands.

Objective: The purpose of this study was to perform a systematic review and meta-analysis to determine the diagnostic performance of current noninvasive imaging modalities for assessment of axillary response after neoadjuvant systemic therapy (NST) in clinically node-positive breast cancer patients.

Summary Of Background Data: NST can lead to downstaging of axillary lymph node disease. Imaging can potentially provide information about the axillary response to NST and, consequently, tailor the surgical management.

Methods: PubMed and Embase were searched for studies that compared noninvasive imaging after NST with axillary surgery outcome to identify axillary response in patients with initial pathologically proven axillary lymph node metastasis. Two reviewers independently screened the studies and extracted the data. A meta-analysis was performed by computing the pooled sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

Results: Thirteen studies describing 2380 patients were included for final analysis. Of these patients, 1322 had undergone axillary ultrasound, 849 breast MRI, and 209 whole-body 18F-FDG PET-CT. The overall axillary pathologic complete response rate was 39.5% (941/2380). For axillary ultrasound, the pooled sensitivity, specificity, PPV, and NPV were 65%, 69%, 77%, 50%, respectively. For breast MRI, the pooled sensitivity, specificity, PPV, and NPV were 60%, 76%, 78%, 58%, respectively. For whole-body 18F-FDG PET-CT, the pooled sensitivity, specificity, PPV, and NPV were 38%, 86%, 78%, 49%, respectively.

Conclusions: The diagnostic performance of current noninvasive imaging modalities is limited to accurately assess axillary response after NST in clinically node-positive breast cancer patients.
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http://dx.doi.org/10.1097/SLA.0000000000004356DOI Listing
April 2021

Cost-effectiveness of Breast Cancer Screening With Magnetic Resonance Imaging for Women at Familial Risk.

JAMA Oncol 2020 09;6(9):1381-1389

Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands.

Importance: For women with a 20% or more familial risk of breast cancer without a known BRCA1/2 (BRCA1, OMIM 113705; and BRCA2, OMIM 114480) or TP53 (OMIM 151623) variant, screening guidelines vary substantially, and cost-effectiveness analyses are scarce.

Objective: To assess the cost-effectiveness of magnetic resonance imaging (MRI) screening strategies for women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant.

Design, Setting, And Participants: In this economic evaluation, conducted from February 1, 2019, to May 25, 2020, microsimulation modeling was used to estimate costs and effectiveness on a lifetime horizon from age 25 years until death of MRI screening among a cohort of 10 million Dutch women with a 20% or more familial risk for breast cancer without a known BRCA1/2 or TP53 variant. A Dutch screening setting was modeled. Most data were obtained from the randomized Familial MRI Screening (FaMRIsc) trial, which included Dutch women aged 30 to 55 years. A health care payer perspective was applied.

Interventions: Several screening protocols with varying ages and intervals including those of the randomized FaMRIsc trial, consisting of the mammography (Mx) protocol (annual mammography and clinical breast examination) and the MRI protocol (annual MRI and clinical breast examination plus biennial mammography).

Main Outcomes And Measures: Costs, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated and discounted by 3%. A threshold of €22 000 (US $24 795.87) per QALY was applied.

Results: This economic evaluation modeling study estimated that, on a lifetime horizon per 1000 women with the Mx protocol of the FaMRIsc trial, 346 breast cancers would be detected, and 49 women were estimated to die from breast cancer, resulting in 22 885 QALYs and total costs of €7 084 767 (US $7 985 134.61). The MRI protocol resulted in 79 additional QALYs and additional €2 657 266 (US $2 994 964.65). Magnetic resonance imaging performed only every 18 months between the ages of 35 and 60 years followed by the national screening program was considered optimal, with an ICER of €21 380 (US $24 097.08) compared with the previous nondominated strategy in the ranking, when applying the National Institute for Health and Care Excellence threshold. Annual screening alternating MRI and mammography between the ages of 35 and 60 years, followed by the national screening program, gave similar outcomes. Higher thresholds would favor annual MRI screening. The ICER was most sensitive to the unit cost of MRI and the utility value for ductal carcinoma in situ and localized breast cancer.

Conclusions And Relevance: This study suggests that MRI screening every 18 months between the ages of 35 and 60 years for women with a family history of breast cancer is cost-effective within the National Institute for Health and Care Excellence threshold for all densities. Higher thresholds would favor annual MRI screening. These outcomes support a change of current screening guidelines for this specific risk group and support MRI screening.
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http://dx.doi.org/10.1001/jamaoncol.2020.2922DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7393584PMC
September 2020

A systematic review of magnetic resonance lymphography for the evaluation of peripheral lymphedema.

J Vasc Surg Venous Lymphat Disord 2020 09 13;8(5):882-892.e2. Epub 2020 May 13.

Department of Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. Electronic address:

Objective: Visualization of the lymphatic system is necessary for both early diagnosis and associated treatments. A promising imaging modality is magnetic resonance lymphography (MRL). The aim of this review was to summarize different MRL protocols, to assess the clinical value in patients with peripheral lymphedema, and to define minimal requirements necessary for visualization of lymphatics.

Methods: A systematic literature search was conducted in PubMed, Embase, and the Cochrane Library in December 2018. Studies performing MRL in patients with peripheral lymphedema or healthy participants were included. Study design, population, etiology, duration of lymphedema, clinical staging, contrast agent, dose, injection site, and technical magnetic resonance imaging details were analyzed. No meta-analyses were performed because of different study aims and heterogeneity of the study populations.

Results: Twenty-five studies involving 1609 patients with both primary lymphedema (n = 669) and secondary lymphedema (n = 657) were included. Upper and lower limbs were examined in 296 and 602 patients, respectively. Twenty-two studies used a gadolinium-based contrast agent that was injected intracutaneously or subcutaneously in the interdigital web spaces. Contrast-enhanced T1-weighted combined with T2-weighted protocols were most frequently used. T1-weighted images showed lymphatics in 63.3% to 100%, even in vessels with a diameter of ≥0.5 mm. Dermal backflow and a honeycomb pattern were clearly recognized.

Conclusions: MRL identifies superficial lymphatic vessels with a diameter of ≥0.5 mm with high sensitivity and specificity and accurately shows abnormal lymphatics and lymphatic drainage patterns. Therefore, MRL could be of clinical value in both early and advanced stages of peripheral lymphedema. Minimum requirements of an MRL protocol should consist of a gadolinium-based contrast-enhanced T1-weighted gradient-recalled echo sequence combined with T2-weighted magnetic resonance imaging, with acquisition at least 30 minutes after injection of contrast material.
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http://dx.doi.org/10.1016/j.jvsv.2020.03.007DOI Listing
September 2020

Solving the preoperative breast MRI conundrum: design and protocol of the MIPA study.

Eur Radiol 2020 Oct 6;30(10):5427-5436. Epub 2020 May 6.

Unit of Radiology, IRCCS Policlinico San Donato, Via Morandi 30, 20097, San Donato Milanese, Italy.

Despite its high diagnostic performance, the use of breast MRI in the preoperative setting is controversial. It has the potential for personalized surgical management in breast cancer patients, but two of three randomized controlled trials did not show results in favor of its introduction for assessing the disease extent before surgery. Meta-analyses showed a higher mastectomy rate in women undergoing preoperative MRI compared to those who do not. Nevertheless, preoperative breast MRI is increasingly used and a survey from the American Society of Breast Surgeons showed that 41% of respondents ask for it in daily practice. In this context, a large-scale observational multicenter international prospective analysis (MIPA study) was proposed under the guidance of the European Network for the Assessment of Imaging in Medicine (EuroAIM). The aims were (1) to prospectively and systematically collect data on consecutive women with a newly diagnosed breast cancer, not candidates for neoadjuvant therapy, who are offered or not offered breast MRI before surgery according to local practice; (2) to compare these two groups in terms of surgical and clinical endpoints, adjusting for covariates. The underlying hypotheses are that MRI does not cause additional mastectomies compared to conventional imaging, while reducing the reoperation rate in all or in subgroups of patients. Ninety-six centers applied to a web-based call; 36 were initially selected based on volume and quality standards; 27 were active for enrollment. On November 2018, the target of 7000 enrolled patients was reached. The MIPA study is presently at the analytic phase. Key Points • Breast MRI has a high diagnostic performance but its utility in the preoperative setting is controversial. • A large-scale observational multicenter prospective study was launched to compare women receiving with those not receiving preoperative MRI. • Twenty-seven centers enrolled more than 7000 patients. The study is presently at the analytic phase.
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http://dx.doi.org/10.1007/s00330-020-06824-7DOI Listing
October 2020

Diagnostic performance of standard breast MRI compared to dedicated axillary MRI for assessment of node-negative and node-positive breast cancer.

Eur Radiol 2020 Aug 27;30(8):4212-4222. Epub 2020 Mar 27.

Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+, Maastricht, The Netherlands.

Objectives: To investigate whether breast MRI has comparable diagnostic performance as dedicated axillary MRI regarding assessment of node-negative and node-positive breast cancer.

Methods: Forty-seven patients were included. All had undergone both breast MRI and dedicated axillary MRI, followed by surgery. All included breast MRI exams had complete field of view (FOV) of the axillary region. First, unenhanced T2-weighted (T2W) and subsequent diffusion-weighted (DW) images of both MRI exams were independently analyzed by two breast radiologists using a confidence scale and compared to histopathology. ADC values were measured by two researchers independently. Diagnostic performance parameters were calculated on a patient-by-patient basis.

Results: T2W breast MRI had the following diagnostic performance: sensitivity of 50.0% and 62.5%, specificity of 92.3%, PPV of 57.1% and 62.5%, NPV of 90.0% and 92.3%, and AUC of 0.72 for reader 1 and 0.78 for reader 2. T2W dedicated axillary MRI had the following diagnostic performance: sensitivity of 37.5% and 62.5%, specificity of 82.1% and 92.3%, PPV of 44.6% and 50.0%, NPV of 87.8% and 91.4%, and AUC of 0.65 for reader 1 and 0.73 for reader 2. In both evaluations, addition of DW images resulted in comparable diagnostic performance. For both breast MRI and dedicated axillary MRI, there was no significant difference between mean ADC values of benign and malignant lymph nodes.

Conclusions: T2W breast MRI with complete FOV of the axillary region has comparable diagnostic performance as T2W dedicated axillary MRI regarding assessment of node-negative and node-positive breast cancer. Optimization of T2W breast MRI protocol by including a complete FOV of the axillary region can, therefore, be recommended in clinical practice.

Key Points: • Breast MRI with complete field of view of the axillary region has comparable diagnostic performance as dedicated axillary MRI regarding assessment of node-negative and node-positive breast cancer. • Optimization of breast MRI protocol by including a complete field of view of the axillary region is recommended in clinical practice. • For both breast MRI and dedicated axillary MRI, DW imaging (including ADC measurements) is of no added value.
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http://dx.doi.org/10.1007/s00330-020-06760-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7338810PMC
August 2020

Image-guided breast biopsy and localisation: recommendations for information to women and referring physicians by the European Society of Breast Imaging.

Insights Imaging 2020 Feb 5;11(1):12. Epub 2020 Feb 5.

Unit of Radiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

We summarise here the information to be provided to women and referring physicians about percutaneous breast biopsy and lesion localisation under imaging guidance. After explaining why a preoperative diagnosis with a percutaneous biopsy is preferred to surgical biopsy, we illustrate the criteria used by radiologists for choosing the most appropriate combination of device type for sampling and imaging technique for guidance. Then, we describe the commonly used devices, from fine-needle sampling to tissue biopsy with larger needles, namely core needle biopsy and vacuum-assisted biopsy, and how mammography, digital breast tomosynthesis, ultrasound, or magnetic resonance imaging work for targeting the lesion for sampling or localisation. The differences among the techniques available for localisation (carbon marking, metallic wire, radiotracer injection, radioactive seed, and magnetic seed localisation) are illustrated. Type and rate of possible complications are described and the issue of concomitant antiplatelet or anticoagulant therapy is also addressed. The importance of pathological-radiological correlation is highlighted: when evaluating the results of any needle sampling, the radiologist must check the concordance between the cytology/pathology report of the sample and the radiological appearance of the biopsied lesion. We recommend that special attention is paid to a proper and tactful approach when communicating to the woman the need for tissue sampling as well as the possibility of cancer diagnosis, repeat tissue sampling, and or even surgery when tissue sampling shows a lesion with uncertain malignant potential (also referred to as "high-risk" or B3 lesions). Finally, seven frequently asked questions are answered.
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http://dx.doi.org/10.1186/s13244-019-0803-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7002629PMC
February 2020

Supplemental MRI Screening for Women with Extremely Dense Breast Tissue.

N Engl J Med 2019 11;381(22):2091-2102

From the Julius Center for Health Sciences and Primary Care (M.F.B., S.V.L., P.H.M.P., E.M.M., C.H.G.) and the Departments of Radiology (S.V.L., R.M.P., M.J.E., W.P.T.M.M., M.A.A.J.B., W.B.V.) and Pathology (P.J.D.), University Medical Center Utrecht, Utrecht University, Utrecht, the Dutch Expert Center for Screening (R.M.P.) and the Department of Radiology, Radboud University Nijmegen Medical Center (R.M.M., N.K.), Nijmegen, the Department of Radiology, Antoni van Leeuwenhoek Hospital (C.E.L.), and the Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam (K.M.D.), Amsterdam, the Department of Radiology, Albert Schweitzer Hospital, Dordrecht (R.H.C.B.), the Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and the Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen (M.B.I.L.), the Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch (M.D.F.J.), the Department of Radiology, Hospital Group Twente, Almelo (J.V.), and the Department of Public Health, Erasmus Medical Center, Rotterdam (H.J.K.) - all in the Netherlands; and the Department of Epidemiology and Biostatistics, School of Public Health, Faculty of Medicine, Imperial College London, London (P.H.M.P.).

Background: Extremely dense breast tissue is a risk factor for breast cancer and limits the detection of cancer with mammography. Data are needed on the use of supplemental magnetic resonance imaging (MRI) to improve early detection and reduce interval breast cancers in such patients.

Methods: In this multicenter, randomized, controlled trial in the Netherlands, we assigned 40,373 women between the ages of 50 and 75 years with extremely dense breast tissue and normal results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The groups were assigned in a 1:4 ratio, with 8061 in the MRI-invitation group and 32,312 in the mammography-only group. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period.

Results: The interval-cancer rate was 2.5 per 1000 screenings in the MRI-invitation group and 5.0 per 1000 screenings in the mammography-only group, for a difference of 2.5 per 1000 screenings (95% confidence interval [CI], 1.0 to 3.7; P<0.001). Of the women who were invited to undergo MRI, 59% accepted the invitation. Of the 20 interval cancers that were diagnosed in the MRI-invitation group, 4 were diagnosed in the women who actually underwent MRI (0.8 per 1000 screenings) and 16 in those who did not accept the invitation (4.9 per 1000 screenings). The MRI cancer-detection rate among the women who actually underwent MRI screening was 16.5 per 1000 screenings (95% CI, 13.3 to 20.5). The positive predictive value was 17.4% (95% CI, 14.2 to 21.2) for recall for additional testing and 26.3% (95% CI, 21.7 to 31.6) for biopsy. The false positive rate was 79.8 per 1000 screenings. Among the women who underwent MRI, 0.1% had either an adverse event or a serious adverse event during or immediately after the screening.

Conclusions: The use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography resulted in the diagnosis of significantly fewer interval cancers than mammography alone during a 2-year screening period. (Funded by the University Medical Center Utrecht and others; DENSE ClinicalTrials.gov number, NCT01315015.).
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http://dx.doi.org/10.1056/NEJMoa1903986DOI Listing
November 2019

Reversal of the hanging protocol of Contrast Enhanced Mammography leads to similar diagnostic performance yet decreased reading times.

Eur J Radiol 2019 Aug 15;117:62-68. Epub 2019 May 15.

Department of Radiology, Maastricht University Medical Center, PO box 5800, 6202, AZ, Maastricht, the Netherlands; Maastricht University, School for Oncology and Developmental Biology (GROW), Universiteitssingel 40, 6229, ER, Maastricht, the Netherlands.

Objectives: Contrast-enhanced mammography (CEM) was found superior to Full-Field Digital Mammography (FFDM) for breast cancer detection. Current hanging protocols show low-energy (LE, similar to FFDM) images first, followed by recombined (RC) images. However, evidence regarding which hanging protocol leads to the most efficient reading process and highest diagnostic performance is lacking. This study investigates the effects of hanging-protocol ordering on the reading process and diagnostic performance of breast radiologists using eye-tracking methodology. Furthermore, it investigates differences in reading processes and diagnostic performance between LE, RC and FFDM images.

Materials And Methods: Twenty-seven breast radiologists were randomized into three reading groups: LE-RC (commonly used hangings), RC-LE (reversed hangings) and FFDM. Thirty cases (nine malignant) were used. Fixation count, net dwell time and time-to-first fixation on malignancies as visual search measures were registered by the eye-tracker. Reading time per image was measured. Participants clicked on suspicious lesions to determine sensitivity and specificity. Area-under-the-ROC-curve (AUC) values were calculated.

Results: RC-LE scored identical on visual search measures, t(16)= -1.45, p =  .17 or higher-p values, decreased reading time with 31%, t(16)= -2.20, p = .04, while scoring similar diagnostic performance compared to LE-RC, t(13.2) = -1.39, p - .20 or higher p-values. The reading process was more efficient on RC compared to LE. Diagnostic performance of CEM was superior to FFDM; F (2,26) = 16.1, p <  .001. Average reading time did not differ between the three groups, F (2,25) = 3.15, p =  .06.

Conclusion: The reversed CEM hanging protocol (RC-LE) scored similar on diagnostic performance compared to LE-RC, while reading time was a third faster. Abnormalities were interpreted quicker on RC images. A RC-LE hanging protocol is therefore recommended for clinical practice and training. Diagnostic performance of CEM was (again) superior to FFDM.
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http://dx.doi.org/10.1016/j.ejrad.2019.05.013DOI Listing
August 2019

Breast Implant Prevalence in the Dutch Female Population Assessed by Chest Radiographs.

Aesthet Surg J 2020 01;40(2):156-164

Division of Epidemiology of the Netherlands Cancer Institute, Amsterdam, Netherlands.

Background: Breast implant-related health problems are a subject of fierce debate. Reliable population-based estimates of implant prevalence rates are not available, however, due to a lack of historical registries and incomplete sales data, precluding absolute risk assessments.

Objectives: This study aimed to describe the methodology of a novel procedure to determine Dutch breast implant prevalence based on the evaluation of routine chest radiographs.

Methods: The validity of the new method was first examined in a separate study. Eight reviewers examined a series of 180 chest radiographs with (n = 60) or without (n = 120) a breast implant confirmed by a computed tomography or magnetic resonance imaging scan. After a consensus meeting with best-performing expert reviewers, we reviewed 3000 chest radiographs of women aged 20 to 70 years in 2 large regional hospitals in the Netherlands in 2015. To calculate the national breast implant prevalence, regional prevalence variations were corrected utilizing the National Breast Cancer Screening Program.

Results: Eight reviewers scored with a median sensitivity of 71.7% (range, 41.7%-85.0%) and a median specificity of 94.6% (range, 73.4%-97.5%). After a consensus meeting and a reevaluation by best-performing expert reviewers, sensitivity was 79.9% and specificity was 99.2%. The estimated national prevalence of breast implants among women between 20 and 70 years was 3.0%, ranging from 1.7% at 21 to 30 years to 3.9% between 51 and 60 years.

Conclusions: The novel method in this study was validated with a high sensitivity and specificity, resulting in accurate prevalence estimates and providing the opportunity to conduct absolute risk assessment studies on the health consequences of breast implants.

Level Of Evidence: 2:
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http://dx.doi.org/10.1093/asj/sjz136DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006872PMC
January 2020

MRI versus mammography for breast cancer screening in women with familial risk (FaMRIsc): a multicentre, randomised, controlled trial.

Lancet Oncol 2019 08 17;20(8):1136-1147. Epub 2019 Jun 17.

Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. Electronic address:

Background: Approximately 15% of all breast cancers occur in women with a family history of breast cancer, but for whom no causative hereditary gene mutation has been found. Screening guidelines for women with familial risk of breast cancer differ between countries. We did a randomised controlled trial (FaMRIsc) to compare MRI screening with mammography in women with familial risk.

Methods: In this multicentre, randomised, controlled trial done in 12 hospitals in the Netherlands, women were eligible to participate if they were aged 30-55 years and had a cumulative lifetime breast cancer risk of at least 20% because of a familial predisposition, but were BRCA1, BRCA2, and TP53 wild-type. Participants who were breast-feeding, pregnant, had a previous breast cancer screen, or had a previous a diagnosis of ductal carcinoma in situ were eligible, but those with a previously diagnosed invasive carcinoma were excluded. Participants were randomly allocated (1:1) to receive either annual MRI and clinical breast examination plus biennial mammography (MRI group) or annual mammography and clinical breast examination (mammography group). Randomisation was done via a web-based system and stratified by centre. Women who did not provide consent for randomisation could give consent for registration if they followed either the mammography group protocol or the MRI group protocol in a joint decision with their physician. Results from the registration group were only used in the analyses stratified by breast density. Primary outcomes were number, size, and nodal status of detected breast cancers. Analyses were done by intention to treat. This trial is registered with the Netherlands Trial Register, number NL2661.

Findings: Between Jan 1, 2011, and Dec 31, 2017, 1355 women provided consent for randomisation and 231 for registration. 675 of 1355 women were randomly allocated to the MRI group and 680 to the mammography group. 218 of 231 women opting to be in a registration group were in the mammography registration group and 13 were in the MRI registration group. The mean number of screening rounds per woman was 4·3 (SD 1·76). More breast cancers were detected in the MRI group than in the mammography group (40 vs 15; p=0·0017). Invasive cancers (24 in the MRI group and eight in the mammography group) were smaller in the MRI group than in the mammography group (median size 9 mm [5-14] vs 17 mm [13-22]; p=0·010) and less frequently node positive (four [17%] of 24 vs five [63%] of eight; p=0·023). Tumour stages of the cancers detected at incident rounds were significantly earlier in the MRI group (12 [48%] of 25 in the MRI group vs one [7%] of 15 in the mammography group were stage T1a and T1b cancers; one (4%) of 25 in the MRI group and two (13%) of 15 in the mammography group were stage T2 or higher; p=0·035) and node-positive tumours were less frequent (two [11%] of 18 in the MRI group vs five [63%] of eight in the mammography group; p=0·014). All seven tumours stage T2 or higher were in the two highest breast density categories (breast imaging reporting and data system categories C and D; p=0·0077) One patient died from breast cancer during follow-up (mammography registration group).

Interpretation: MRI screening detected cancers at an earlier stage than mammography. The lower number of late-stage cancers identified in incident rounds might reduce the use of adjuvant chemotherapy and decrease breast cancer-related mortality. However, the advantages of the MRI screening approach might be at the cost of more false-positive results, especially at high breast density.

Funding: Dutch Government ZonMw, Dutch Cancer Society, A Sister's Hope, Pink Ribbon, Stichting Coolsingel, J&T Rijke Stichting.
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http://dx.doi.org/10.1016/S1470-2045(19)30275-XDOI Listing
August 2019

Correlation Between Pathologic Complete Response in the Breast and Absence of Axillary Lymph Node Metastases After Neoadjuvant Systemic Therapy.

Ann Surg 2020 03;271(3):574-580

Department of Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands.

Objective: The aim was to investigate whether pathologic complete response (pCR) in the breast is correlated with absence of axillary lymph node metastases at final pathology (ypN0) in patients treated with neoadjuvant systemic therapy (NST) for different breast cancer subtypes.

Background: Pathologic complete response rates have improved on account of more effective systemic treatment regimens. Promising results in feasibility trials with percutaneous image-guided tissue sampling for the identification of breast pCR after NST raise the question whether breast surgery is a redundant procedure. Thereby, the need for axillary surgery should be reconsidered as well.

Methods: Patients diagnosed with cT1-3N0-1 breast cancer and treated with NST, followed by surgery between 2010 and 2016, were selected from the Netherlands Cancer Registry. Patients were compared according to the pathologic response of the primary tumor with associated pathologic axillary outcome. Multivariable analysis was performed to determine clinicopathological variables correlated with ypN0.

Results: A total of 4084 patients were included for analyses, of whom 986 (24.1%) achieved breast pCR. In clinically node negative patients (cN0), 97.7% (432/442) with breast pCR had ypN0 compared with 71.6% (882/1232) without breast pCR (P < 0.001). In clinically node positive patients (cN1), 45.0% (245/544) with breast pCR had ypN0 compared with 9.4% (176/1866) without breast pCR (P < 0.001). The odds of ypN0 was decreased in case of clinical T3 stage (OR 0.59, 95% CI 0.40-0.87), cN1 (OR 0.03, 95% CI 0.02-0.04) and ER+HER2- subtype (OR 0.30, 95% CI 0.20-0.44), and increased in case of breast pCR (OR 4.53, 95% CI 3.27-6.28).

Conclusions: Breast pCR achieved after NST is strongly correlated with ypN0 in cN0 patients, especially in ER+HER2+, ER-HER2+, and triple negative subtypes. These results provide data to proceed with future clinical trials to investigate if axillary surgery can be safely omitted in these selected patients when image-guided tissue sampling identifies a breast pCR.
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http://dx.doi.org/10.1097/SLA.0000000000003126DOI Listing
March 2020

Multireader Study on the Diagnostic Accuracy of Ultrafast Breast Magnetic Resonance Imaging for Breast Cancer Screening.

Invest Radiol 2018 10;53(10):579-586

MeVis Medical Solutions, Bremen, Germany.

Objectives: Breast cancer screening using magnetic resonance imaging (MRI) has limited accessibility due to high costs of breast MRI. Ultrafast dynamic contrast-enhanced breast MRI can be acquired within 2 minutes. We aimed to assess whether screening performance of breast radiologist using an ultrafast breast MRI-only screening protocol is as good as performance using a full multiparametric diagnostic MRI protocol (FDP).

Materials And Methods: The institutional review board approved this study, and waived the need for informed consent. Between January 2012 and June 2014, 1791 consecutive breast cancer screening examinations from 954 women with a lifetime risk of more than 20% were prospectively collected. All women were scanned using a 3 T protocol interleaving ultrafast breast MRI acquisitions in a full multiparametric diagnostic MRI protocol consisting of standard dynamic contrast-enhanced sequences, diffusion-weighted imaging, and T2-weighted imaging. Subsequently, a case set was created including all biopsied screen-detected lesions in this period (31 malignant and 54 benign) and 116 randomly selected normal cases with more than 2 years of follow-up. Prior examinations were included when available. Seven dedicated breast radiologists read all 201 examinations and 153 available priors once using the FDP and once using ultrafast breast MRI only in 2 counterbalanced and crossed-over reading sessions.

Results: For reading the FDP versus ultrafast breast MRI alone, sensitivity was 0.86 (95% confidence interval [CI], 0.81-0.90) versus 0.84 (95% CI, 0.78-0.88) (P = 0.50), specificity was 0.76 (95% CI, 0.74-0.79) versus 0.82 (95% CI, 0.79-0.84) (P = 0.002), positive predictive value was 0.40 (95% CI, 0.36-0.45) versus 0.45 (95% CI, 0.41-0.50) (P = 0.14), and area under the receiver operating characteristics curve was 0.89 (95% CI, 0.82-0.96) versus 0.89 (95% CI, 0.82-0.96) (P = 0.83). Ultrafast breast MRI reading was 22.8% faster than reading FDP (P < 0.001). Interreader agreement is significantly better for ultrafast breast MRI (κ = 0.730; 95% CI, 0.699-0.761) than for the FDP (κ = 0.665; 95% CI, 0.633-0.696).

Conclusions: Breast MRI screening using only an ultrafast breast MRI protocol is noninferior to screening with an FDP and may result in significantly higher screening specificity and shorter reading time.
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http://dx.doi.org/10.1097/RLI.0000000000000494DOI Listing
October 2018

MRI-based response patterns during neoadjuvant chemotherapy can predict pathological (complete) response in patients with breast cancer.

Breast Cancer Res 2018 04 18;20(1):34. Epub 2018 Apr 18.

GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, the Netherlands.

Background: The main purpose was to investigate the correlation between magnetic resonance imaging (MRI)-based response patterns halfway through neoadjuvant chemotherapy and immunotherapy (NAC) and pathological tumor response in patients with breast cancer. Secondary purposes were to compare the predictive value of MRI-based response patterns measured halfway through NAC and after NAC and to measure interobserver variability.

Methods: All consecutive patients treated with NAC for primary invasive breast cancer from 2012 to 2015 and who underwent breast MRI before, halfway through (and after) NAC were included. All breast tumors were reassessed on MRI by two experienced breast radiologists and classified into six patterns: type 0 (complete radiologic response); type 1 (concentric shrinkage); type 2 (crumbling); type 3 (diffuse enhancement); type 4 (stable disease); type 5 (progressive disease). Percentages of tumors showing pathological complete response (pCR), > 50% tumor reduction and > 50% tumor diameter reduction per MRI-based response pattern were calculated. Correlation between MRI-based response patterns and pathological tumor reduction was studied with Pearson's correlation coefficient, and interobserver agreement was tested with Cohen's Kappa.

Results: Patients (n = 76; mean age 53, range 29-72 years) with 80 tumors (4 bilateral) were included. There was significant correlation between these MRI-based response patterns halfway through NAC and tumor reduction on pathology assessment (reader 1 r = 0.33; p = 0.003 and reader 2 r = 0.45; p < 0.001). Type-0, type-1 or type-2 patterns halfway through NAC showed highest tumor reduction rates on pathology assessment, with > 50% tumor reduction in 90%, 78% and 65% of cases, respectively. In 83% of tumors with type 0 halfway through NAC, pathology assessment showed pCR. There was no significant correlation between MRI-based response patterns after NAC and tumor reduction rates on pathology assessment (reader 1 r = - 0.17; p = 0.145 and reader 2 r = - 0.17; p = 0.146). In 41% of tumors with type 0 after NAC, pathology assessment showed pCR.

Conclusion: MRI-based response patterns halfway through NAC can predict pathologic response more accurately than MRI-based response patterns after NAC. Complete radiological response halfway NAC is associated with 83% pCR, while complete radiological response after NAC seems to be correct in only 41% of cases.
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http://dx.doi.org/10.1186/s13058-018-0950-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5907188PMC
April 2018

Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast.

JAMA Oncol 2018 Mar;4(3):335-341

Department of Pathology, VU University Medical Centre, Amsterdam, the Netherlands.

Importance: Breast implants are among the most commonly used medical devices. Since 2008, the number of women with breast implants diagnosed with anaplastic large-cell lymphoma in the breast (breast-ALCL) has increased, and several reports have suggested an association between breast implants and risk of breast-ALCL. However, relative and absolute risks of breast-ALCL in women with implants are still unknown, precluding evidence-based counseling about implants.

Objective: To determine relative and absolute risks of breast-ALCL in women with breast implants.

Design, Setting, And Participants: Through the population-based nationwide Dutch pathology registry we identified all patients diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016 and retrieved clinical data, including breast implant status, from the treating physicians. We estimated the odds ratio (OR) of ALCL associated with breast implants in a case-control design, comparing implant prevalence between women with breast-ALCL and women with other types of breast lymphoma. Cumulative risk of breast-ALCL was derived from the age-specific prevalence of breast implants in Dutch women, estimated from an examination of 3000 chest x-rays and time trends from implant sales.

Main Outcomes And Measures: Relative and absolute risks of breast-ALCL in women with breast implants.

Results: Among 43 patients with breast-ALCL (median age, 59 years), 32 had ipsilateral breast implants, compared with 1 among 146 women with other primary breast lymphomas (OR, 421.8; 95% CI, 52.6-3385.2). Implants among breast-ALCL cases were more often macrotextured (23 macrotextured of 28 total implants of known type, 82%) than expected (49 193 sold macrotextured implants of total sold 109 449 between 2010 and 2015, 45%) based on sales data (P < .001). The estimated prevalence of breast implants in women aged 20 to 70 years was 3.3%. Cumulative risks of breast-ALCL in women with implants were 29 per million at 50 years and 82 per million at 70 years. The number of women with implants needed to cause 1 breast-ALCL case before age 75 years was 6920.

Conclusions And Relevance: Breast implants are associated with increased risk of breast-ALCL, but the absolute risk remains small. Our results emphasize the need for increased awareness among the public, medical professionals, and regulatory bodies, promotion of alternative cosmetic procedures, and alertness to signs and symptoms of breast-ALCL in women with implants.
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http://dx.doi.org/10.1001/jamaoncol.2017.4510DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885827PMC
March 2018

Breast magnetic resonance imaging use in patients undergoing neoadjuvant chemotherapy is associated with less mastectomies in large ductal cancers but not in lobular cancers.

Eur J Cancer 2017 08 12;81:74-80. Epub 2017 Jun 12.

Division of Medical Oncology, GROW-School for Oncology and Developmental Biology, Maastricht University Medical Centre+, Maastricht, The Netherlands. Electronic address:

Background: To assess the impact of breast magnetic resonance imaging (MRI) use on surgical outcome per histological breast cancer subtype in patients treated with neoadjuvant chemotherapy.

Patients And Methods: All patients aged 18-70 years who underwent neoadjuvant chemotherapy for stage I-III invasive breast cancer in the Netherlands in the years 2011-2013 were identified from the Netherlands Cancer Registry. Patients with cT4 tumours were excluded from the analysis. Use of breast MRI and impact on surgical treatment, resection margins and detection of contralateral breast cancer were analysed by multivariable analyses.

Results: Breast MRI was performed in 2879 (83.9%) out of 3433 patients treated with neoadjuvant chemotherapy. Younger age (odds ratio [OR] 1.42; 95% confidence interval [CI] 1.17-1.71 for 18-50 years compared with 50-70 years), larger tumour stage (OR 1.46 [95% CI 1.15-1.86] for cT3, compared to cT1-2 tumours) and multifocality (OR 1.30; 95% CI 1.04-1.61, versus unifocality) were associated with increased breast MRI use. In ductal breast cancer, after stratification for cT-status, breast MRI use is associated with a significant lower OR for mastectomy as final surgery in cT3 tumours (OR 0.45, 95% CI 0.21-0.99). Resection margin involvement and detection of contralateral breast cancer were not associated with breast MRI use.

Conclusion: In patients treated with neoadjuvant chemotherapy, the use of breast MRI was associated with a reduced mastectomy rate, particularly in patients with large invasive ductal breast tumours but not in patients with lobular breast cancer.
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http://dx.doi.org/10.1016/j.ejca.2017.05.012DOI Listing
August 2017

Hybrid F-FDG PET/MRI might improve locoregional staging of breast cancer patients prior to neoadjuvant chemotherapy.

Eur J Nucl Med Mol Imaging 2017 Oct 10;44(11):1796-1805. Epub 2017 Jun 10.

GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, the Netherlands.

Purpose: Our purpose in this study was to assess the added clinical value of hybrid F-FDG-PET/MRI compared to conventional imaging for locoregional staging in breast cancer patients undergoing neoadjuvant chemotherapy (NAC).

Methods: In this prospective study, primary invasive cT2-4 N0 or cT1-4 N+ breast cancer patients undergoing NAC were included. A PET/MRI breast protocol was performed before treatment. MR images were evaluated by a breast radiologist, blinded for PET images. PET images were evaluated by a nuclear physician. Afterwards, a combined PET/MRI report was written. PET/MRI staging was compared to conventional imaging, i.e., mammography, ultrasound and MRI. The proportion of patients with a modified treatment plan based on PET/MRI findings was analyzed.

Results: A total of 40 patients was included. PET/MRI was of added clinical value in 20.0% (8/40) of patients, changing the treatment plan in 10% and confirming the malignancy of suspicious lesions on MRI in another 10%. In seven (17.5%) patients radiotherapy fields were extended because of additional or affirmative PET/MRI findings being lymph node metastases (n = 5) and sternal bone metastases (n = 2). In one (2.5%) patient radiotherapy fields were reduced because of fewer lymph node metastases on PET/MRI compared to conventional imaging. Interestingly, all treatment changes were based on differences in number of lymph nodes suspicious for metastasis or number of distant metastasis, whereas differences in intramammary tumor extent were not observed.

Conclusion: Prior to NAC, PET/MRI shows promising results for locoregional staging compared to conventional imaging, changing the treatment plan in 10% of patients and potentially replacing PET/CT or tissue sampling in another 10% of patients.
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http://dx.doi.org/10.1007/s00259-017-3745-xDOI Listing
October 2017

A Novel Less-invasive Approach for Axillary Staging After Neoadjuvant Chemotherapy in Patients With Axillary Node-positive Breast Cancer by Combining Radioactive Iodine Seed Localization in the Axilla With the Sentinel Node Procedure (RISAS): A Dutch Prospective Multicenter Validation Study.

Clin Breast Cancer 2017 08 19;17(5):399-402. Epub 2017 Apr 19.

Department of Surgery, Amphia Hospital Breda, Breda, The Netherlands. Electronic address:

Background: In 1 of 3 patients with initial lymph node-positive (cN) breast cancer, neoadjuvant chemotherapy (NAC) results in an axillary pathologic complete response (ax-pCR). This urges the need for a less-invasive axillary staging method. Recently introduced less-invasive procedures have been insufficient in accurately identifying ax-pCR. Therefore, we propose a novel less-invasive axillary staging procedure: the Radioactive Iodine Seed localization in the Axilla with the Sentinel node procedure (RISAS), a combination of the procedure of marking axillary lymph nodes with radioactive iodine seeds (MARI) and sentinel lymph node biopsy (SLNB).

Patients And Methods: In the present open single-arm multicenter validation study, 225 cN (biopsy-proven) patients will undergo the RISAS procedure, in which a positive lymph node is marked by an iodine-125 seed before NAC. After NAC completion, this iodine-125 seed-marked lymph node is removed, together with any additional sentinel lymph nodes. The RISAS procedure is subsequently followed by completion axillary lymph node dissection (ALND). The RISAS lymph nodes will be compared with the lymph nodes from the completion ALND specimen. The primary endpoint is accuracy of the RISAS procedure. The identification rate, false-negative rate, negative predictive value, and possible concordance between the MARI and SLNB will be reported.

Conclusion: The present prospective multicenter RISAS trial will enable us to validate the combination of MARI and SLNB for assessing the axillary response to NAC in cN patients. If RISAS proves to be an accurate axillary staging procedure, ALND could safely be abandoned in the case of ax-pCR confirmed using the RISAS procedure.
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http://dx.doi.org/10.1016/j.clbc.2017.04.006DOI Listing
August 2017

Contrast Media Administration in Coronary Computed Tomography Angiography - A Systematic Review.

Rofo 2017 Apr 6;189(4):312-325. Epub 2017 Mar 6.

Maastricht University Medical Center, Maastricht University CARIM School for Cardiovascular Diseases, Maastricht, Netherlands.

 Various different injection parameters influence enhancement of the coronary arteries. There is no consensus in the literature regarding the optimal contrast media (CM) injection protocol. The aim of this study is to provide an update on the effect of different CM injection parameters on the coronary attenuation in coronary computed tomographic angiography (CCTA).  Studies published between January 2001 and May 2014 identified by Pubmed, Embase and MEDLINE were evaluated. Using predefined inclusion criteria and a data extraction form, the content of each eligible study was assessed. Initially, 2551 potential studies were identified. After applying our criteria, 36 studies were found to be eligible. Studies were systematically assessed for quality based on the validated Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-II checklist.  Extracted data proved to be heterogeneous and often incomplete. The injection protocol and outcome of the included publications were very diverse and results are difficult to compare. Based on the extracted data, it remains unclear which of the injection parameters is the most important determinant for adequate attenuation. It is likely that one parameter which combines multiple parameters (e. g. IDR) will be the most suitable determinant of coronary attenuation in CCTA protocols.  Research should be directed towards determining the influence of different injection parameters and defining individualized optimal IDRs tailored to patient-related factors (ideally in large randomized trials).   · This systematic review provides insight into decisive factors on coronary attenuation.. · Different and contradicting outcomes are reported on coronary attenuation in CCTA.. · One parameter combining multiple parameters (IDR) is likely decisive in coronary attenuation.. · Research should aim at defining individualized optimal IDRs tailored to individual factors.. · Future directions should be tailored towards the influence of different injection parameters.. · Mihl C, Maas M, Turek J et al. Contrast Media Administration in Coronary Computed Tomography Angiography - A Systematic Review. Fortschr Röntgenstr 2017; 189: 312 - 325.
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http://dx.doi.org/10.1055/s-0042-121609DOI Listing
April 2017

Clinical tumor stage is the most important predictor of pathological complete response rate after neoadjuvant chemotherapy in breast cancer patients.

Breast Cancer Res Treat 2017 May 15;163(1):83-91. Epub 2017 Feb 15.

GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.

Background: Pathological complete response (pCR) is the ultimate response in breast cancer patients treated with neoadjuvant chemotherapy (NCT). It might be a surrogate outcome for disease-free survival (DFS) and overall survival (OS). We studied the effect of clinical tumor stage (cT-stage) on tumor pCR and the effect of pCR per cT-stage on 5-year OS and DFS.

Methods: Using the Netherlands Cancer Registry, all primary invasive breast cancer patients treated with NCT from 2005 until 2008 were identified. Univariable logistic regression analysis was performed to evaluate the effect of cT-stage on pCR, stepwise logistic regression analysis to correct for potential confounders and Kaplan-Meier survival analyses to calculate OS and DFS after five years.

Results: In 2366 patients, overall pCR rate was 21%. For cT1, cT2, cT3, and cT4, pCR rates were 31, 22, 18, and 17%, respectively. Lower cT-stage (cT1-2 vs cT3-4) was a significant independent predictor of higher pCR rate (p < 0.001, OR 3.15). Furthermore, positive HER2 status (p < 0.001, OR 2.30), negative estrogen receptor status (p = 0.062, OR 1.69), and negative progesterone receptor status (p = 0.008, OR 2.27) were independent predictors of pCR. OS and DFS were up to 20% higher in patients with cT2-4 tumors with pCR versus patients without pCR. DFS was also higher for cT1 tumors with pCR.

Conclusions: The most important predictor of pCR in breast cancer patients is cT-stage: lower cT-stages have significantly higher pCR rates than higher cT-stages. Patients with cT2-4 tumors achieving pCR have higher OS and DFS compared to patients not achieving pCR.
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http://dx.doi.org/10.1007/s10549-017-4155-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5387027PMC
May 2017

Breast MRI increases the number of mastectomies for ductal cancers, but decreases them for lobular cancers.

Breast Cancer Res Treat 2017 04 28;162(2):353-364. Epub 2017 Jan 28.

Maastricht University Medical Center, Department of Medical Oncology, Maastricht, The Netherlands.

Purpose: In this retrospective population-based cohort study, we analyzed breast MRI use and its impact on type of surgery, surgical margin involvement, and the diagnosis of contralateral breast cancer.

Methods: All Dutch patients with cTNM breast cancer diagnosed in 2011-2013 and treated with primary surgery were eligible for inclusion. Using multivariable analyses, we analyzed in different categories whether MRI use was related to surgery type, margin involvement, and diagnosis of contralateral breast cancer (CBC).

Results: MRI was performed in 10,740 out of 36,050 patients (29.8%). Patients with invasive ductal cancer undergoing MRI were more likely to undergo primary mastectomy than those without MRI (OR 1.30, 95% confidence interval (CI) 1.22-1.39, p < 0.0001). Patients with invasive lobular cancer undergoing MRI were less likely to undergo primary mastectomy than those without MRI (OR 0.86, 95% CI 0.76-0.99, p = 0.0303). A significantly lower risk of positive surgical margins after breast-conserving surgery was only seen in patients with lobular cancer who had undergone MRI as compared to those without MRI (OR 0.59, 95% CI 0.44-0.79, p = 0.0003) and, consequently, a lower risk of secondary mastectomy (OR 0.61, 95% CI 0.42-0.88, p = 0.0088). Patients who underwent MRI were almost four times more likely to be diagnosed with CBC (OR 3.55, 95% CI 3.01-4.17, p < 0.0001).

Conclusions: Breast MRI use was associated with a reduced number of mastectomies and less positive surgical margins in invasive lobular cancer, but with an increased number of mastectomies in ductal cancers. Breast MRI use was associated with a fourfold higher incidence of CBC.
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http://dx.doi.org/10.1007/s10549-017-4117-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5326630PMC
April 2017

Reply to Tagliafico AS, Bignotti B, Rossi F, et al.

Breast 2017 04 28;32:267. Epub 2016 Oct 28.

Breast Imaging Section, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, USA.

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http://dx.doi.org/10.1016/j.breast.2016.10.017DOI Listing
April 2017

Risk of regional recurrence in triple-negative breast cancer patients: a Dutch cohort study.

Breast Cancer Res Treat 2016 Apr 25;156(3):465-472. Epub 2016 Mar 25.

Department of Surgical Oncology, Maastricht University Medical Center, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands.

Triple-negative breast cancer is associated with early recurrence and low survival rates. Several trials investigate the safety of a more conservative approach of axillary treatment in clinically T1-2N0 breast cancer. Triple-negative breast cancer comprises only 15 % of newly diagnosed breast cancers, which might result in insufficient power for representative results for this subgroup. We aimed to provide a nationwide overview on the occurrence of (regional) recurrences in triple-negative breast cancer patients with a clinically T1-2N0 status. For this cohort study, 2548 women diagnosed between 2005 and 2008 with clinically T1-2N0 triple-negative breast cancer were selected from the Netherlands Cancer Registry. Follow-up data until 2014 were analyzed using Kaplan-Meier. Sentinel lymph node biopsy was performed in 2486 patients, and (completion) axillary lymph node dissection in 562 patients. Final pathologic nodal status was pN0 in 78.5 %, pN1mi in 4.5 %, pN1 in 12.3 %, pN2-3 in 3.6 %, and pNx in 1.1 %. During a follow-up of 5 years, regional recurrence occurred in 2.9 %, local recurrence in 4.2 % and distant recurrence in 12.2 %. Five-year disease-free survival was 78.7 %, distant disease-free survival 80.5 %, and 5-year overall survival 82.3 %. Triple-negative clinically T1-2N0 breast cancer patients rarely develop a regional recurrence. Their disease-free survival is more threatened by distant recurrence, affecting their overall survival. Consequently, it seems justified to include triple-negative breast cancer patients in randomized controlled trials investigating the safety of minimizing axillary staging and treatment.
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http://dx.doi.org/10.1007/s10549-016-3757-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4837212PMC
April 2016

Ultrasound is at least as good as magnetic resonance imaging in predicting tumour size post-neoadjuvant chemotherapy in breast cancer.

Eur J Cancer 2016 Jan 30;52:67-76. Epub 2015 Nov 30.

Department of Medical Oncology, GROW-School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands. Electronic address:

Background: The aim of this study was to evaluate the accuracy of clinical imaging of the primary breast tumour post-neoadjuvant chemotherapy (NAC) related to the post-neoadjuvant histological tumour size (gold standard) and whether this varies with breast cancer subtype. In this study, results of both magnetic resonance imaging (MRI) and ultrasound (US) were reported.

Methods: Patients with invasive breast cancer were enrolled in the INTENS study between 2006 and 2009. We included 182 patients, of whom data were available for post-NAC MRI (n=155), US (n=123), and histopathological tumour size.

Results: MRI estimated residual tumour size with <10-mm discordance in 54% of patients, overestimated size in 28% and underestimated size in 18% of patients. With US, this was 63%, 20% and 17%, respectively. The negative predictive value in hormone receptor-positive tumours for both MRI and US was low, 26% and 33%, respectively. The median deviation in clinical tumour size as percentage of pathological tumour was 63% (P25=26, P75=100) and 49% (P25=22, P75=100) for MRI and US, respectively (P=0.06).

Conclusions: In this study, US was at least as good as breast MRI in providing information on residual tumour size post-neoadjuvant chemotherapy. However, both modalities suffered from a substantial percentage of over- and underestimation of tumour size and in addition both showed a low negative predictive value of pathologic complete remission (Gov nr: NCT00314977).
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http://dx.doi.org/10.1016/j.ejca.2015.10.010DOI Listing
January 2016

[A woman with lumps in her breast].

Ned Tijdschr Geneeskd 2015 ;159:A9299

MAASTRO clinic, afd. Radiotherapie, Maastricht.

A 61-year-old woman was examined for multiple lumps and an ulcer in her breast, 23 years after breast-conserving therapy for breast cancer, including surgery, chemotherapy and radiation therapy. Clinical examination and imaging showed extensive calcifications as a late effect of irradiation, which was confirmed by the pathologist after surgery.
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August 2016

MR Imaging as an Additional Screening Modality for the Detection of Breast Cancer in Women Aged 50-75 Years with Extremely Dense Breasts: The DENSE Trial Study Design.

Radiology 2015 Nov 23;277(2):527-37. Epub 2015 Jun 23.

From the Julius Center for Health Sciences and Primary Care (M.J.E., M.F.B., P.H.M.P., E.M.M., C.H.v.G.) and Department of Radiology (R.M.P., M.A.A.J.v.d.B., W.P.Th.M.M., W.B.V.), Stratenum 6.131, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Epidemiology and Biostatistics, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom (P.H.M.P.); Department of Radiology, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (C.E.L.); Department of Radiology, Radboud University Medical Center, Nijmegen, the Netherlands (R.M.M., N.K.); Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands (M.D.F.d.J.); Department of Radiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands (R.H.C.B.); Department of Radiology, Hospital Group Twente (ZGT), Almelo and Hengelo, the Netherlands (J.V.); Department of Radiology, VU University Medical Center, Amsterdam, the Netherlands (K.M.D.); Department of Radiology, Maastricht University Medical Center, Maastricht, the Netherlands (M.B.I.L.); Dutch Reference Centre for Screening, Nijmegen, the Netherlands (R.M.P.); and Department of Public Health, Erasmus Medical Center, Rotterdam, the Netherlands (H.J.d.K.).

Women with extremely dense breasts have an increased risk of breast cancer and lower mammographic tumor detectability. Nevertheless, in most countries, these women are currently screened with mammography only. Magnetic resonance (MR) imaging has the potential to improve breast cancer detection at an early stage because of its higher sensitivity. However, MR imaging is more expensive and is expected to be accompanied by an increase in the number of false-positive results and, possibly, an increase in overdiagnosis. To study the additional value of MR imaging, a randomized controlled trial (RCT) design is needed in which one group undergoes mammography and the other group undergoes mammography and MR imaging. With this design, it is possible to determine the proportion of interval cancers within each study arm. For this to be an effective screening strategy, the additional cancers detected at MR imaging screening must be accompanied by a subsequent reduction in interval cancers. The Dense Tissue and Early Breast Neoplasm Screening, or DENSE, trial is a multicenter RCT performed in the Dutch biennial population-based screening program (subject age range, 50-75 years). The study was approved by the Dutch Minister of Health, Welfare and Sport. In this study, mammographic density is measured by using a fully automated volumetric method. Participants with extremely dense breasts (American College of Radiology breast density category 4) and a negative result at mammography (Breast Imaging Recording and Data System category 1 or 2) are randomly assigned to undergo additional MR imaging (n = 7237) or to be treated according to current practice (n = 28 948). Participants provide written informed consent before the MR imaging examination, which consists of dynamic breast MR imaging with gadolinium-based contrast medium and is intended to be performed for three consecutive screening rounds. The primary outcome is the difference in the proportions of interval cancers between the study arms. Secondary outcomes are the number of MR imaging screening-detected cancers, proportions of false-positive results, diagnostic yield of MR imaging, tumor characteristics, quality of life, and cost effectiveness.
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http://dx.doi.org/10.1148/radiol.2015141827DOI Listing
November 2015

Radiation exposure of digital breast tomosynthesis using an antiscatter grid compared with full-field digital mammography.

Invest Radiol 2015 Oct;50(10):679-85

From the *Departments of Radiology and Nuclear Medicine, †GROW, School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht; and ‡Dutch Reference Center for Screening, Nijmegen, the Netherlands.

Objectives: Our study aim was to assess the radiation dose of digital breast tomosynthesis (DBT) in comparison to full-field digital mammography (FFDM) in a clinical setting.

Materials And Methods: Two-hundred four patients were consecutively included, of which 236 complementary DBT and FFDM examinations were available. All acquisitions were performed on a single commercially available mammography system capable of FFDM and DBT acquisitions using an antiscatter grid. The average glandular dose (AGD) was calculated for each examination using the Dance method. For this, tube output and half-value layer were measured, and the required exposure parameters (target/filter material, tube voltage, tube load, compressed breast thickness) were retrieved from the DICOM metadata. The DBT and FFDM AGD values were pairwise tested, and a subanalysis with respect to breast thickness was performed.

Results: The mean (SD) AGD values for a single-view DBT and FFDM were 1.49 (0.36) mGy and 1.62 (0.55) mGy, respectively, which are small but statistically significant differences. This difference may be partially attributed to the small difference in the mean breast thickness between FFDM and DBT (3 mm). In this patient population, the AGD was lower for DBT than for FFDM in 61% of the patients. When patients were categorized according to breast thickness, the AGD of DBT was only significantly smaller than the AGD of FFDM for breast thickness categories larger than 50 mm, indicating that the dose reduction for DBT compared with FFDM was more pronounced in thick breasts.

Conclusions: The radiation dose of patients undergoing a single-view DBT was comparable to a single-view FFDM. For patients with thicker breasts, the radiation dose of DBT was slightly lower than FFDM.
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http://dx.doi.org/10.1097/RLI.0000000000000168DOI Listing
October 2015