The Lucerne Toolbox 3 initiative addresses the pressing need for evidence-based integration of digital health and artificial intelligence (AI) technologies in early breast cancer care. The multidisciplinary consortium identified and prioritised 15 crucial medical knowledge gaps across the patient journey, from diagnosis to treatment and survivorship, using a modified Delphi consensus process with 112 unique members from 27 countries and 16 medical societies, trial groups, and patient organisations. The knowledge gaps include AI-based mammography screening, personalised screening strategies, digital knowledge databases, AI-driven treatment optimisation, and digitally delivered monitoring and supportive care. The consortium developed 13 trial designs in the Population, Intervention, Comparison, and Outcome format to address these gaps, achieving consensus or majority vote in 98% of statements. The recommendations emphasise precision medicine, patient-centred care, and interdisciplinary collaboration to improve outcomes, efficiency, and equity in breast cancer care. By presenting a roadmap for actionable trials, Lucerne Toolbox 3 sets a foundation for advancing digital health in breast cancer care.

Clinical axillary lymph node management in early breast cancer has evolved from being merely an aspect of surgical management and now includes the entire multidisciplinary team. The second edition of the "Lucerne Toolbox", a multidisciplinary consortium of European cancer societies and patient representatives, addresses the challenges of clinical axillary lymph node management, from diagnosis to local therapy of the axilla. Five working packages were developed, following the patients' journey and addressing specific clinical scenarios. Panellists voted on 72 state-ments, reaching consensus (agreement of 75% or more) in 52.8%, majority (51%-74% agreement) in 43.1%, and no decision in 4.2%. Based on the votes, targeted imaging and standardized pathology of lymph nodes should be a prerequisite to planning local and systemic therapy, axillary lymph node dissection can be replaced by sentinel lymph node biopsy ( & PLUSMN; targeted approaches) in a majority of scenarios; and positive patient outcomes should be driven by both low recurrence risks and low rates of lymphoedema. Copyright & COPY; 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

AIM:Demand for nipple- and skin- sparing mastectomy (NSM/SSM) with immediate breast reconstruction (BR) has increased at the same time as indications for post-mastectomy radiation therapy (PMRT) have broadened. The aim of the Oncoplastic Breast Consortium initiative was to address relevant questions arising with this clinically challenging scenario.METHODS:A large global panel of oncologic, oncoplastic and reconstructive breast surgeons, patient advocates and radiation oncologists developed recommendations for clinical practice in an iterative process based on the principles of Delphi methodology.RESULTS:The panel agreed that surgical technique for NSM/SSM should not be formally modified when PMRT is planned with preference for autologous over implant-based BR due to lower risk of long-term complications and support for immediate and delayed-immediate reconstructive approaches. Nevertheless, it was strongly believed that PMRT is not an absolute contraindication for implant-based or other types of BR, but no specific recommendations regarding implant positioning, use of mesh or timing were made due to absence of high-quality evidence. The panel endorsed use of patient-reported outcomes in clinical practice. It was acknowledged that the shape and size of reconstructed breasts can hinder radiotherapy planning and attention to details of PMRT techniques is important in determining aesthetic outcomes after immediate BR.CONCLUSIONS:The panel endorsed the need for prospective, ideally randomised phase III studies and for surgical and radiation oncology teams to work together for determination of optimal sequencing and techniques for PMRT for each patient in the context of BR.

Primary systemic therapy is increasingly used in the treatment of patients with early-stage breast cancer, but few guidelines specifically address optimal locoregional therapies. Therefore, we established an international consortium to discuss clinical evidence and to provide expert advice on technical management of patients with early-stage breast cancer. The steering committee prepared six working packages to address all major clinical questions from diagnosis to surgery. During a consensus meeting that included members from European scientific oncology societies, clinical trial groups, and patient advocates, statements were discussed and voted on. A consensus was reached in 42% of statements, a majority in 38%, and no decision in 21%. Based on these findings, the panel developed clinical guidance recommendations and a toolbox to overcome many clinical and technical requirements associated with the diagnosis, response assessment, surgical planning, and surgery of patients with early-stage breast cancer. This guidance could convince clinicians and patients of the major clinical advancements purported by primary systemic therapy, the use of less extensive and more targeted surgery to improve the lives of patients with breast cancer.

PurposeIndications for nipple-sparing mastectomy(NSM) have broadened to include the risk reducing setting and locally advanced tumors, which resulted in a dramatic increase in the use of NSM. The Oncoplastic Breast Consortium consensus conference on NSM and immediate reconstruction was held to address a variety of questions in clinical practice and research based on published evidence and expert panel opinion.MethodsThe panel consisted of 44 breast surgeons from 14 countries across four continents with a background in gynecology, general or reconstructive surgery and a practice dedicated to breast cancer, as well as a patient advocate. Panelists presented evidence summaries relating to each topic for debate during the in-person consensus conference. The iterative process in question development, voting, and wording of the recommendations followed the modified Delphi methodology.ResultsConsensus recommendations were reached in 35, majority recommendations in 24, and no recommendations in the remaining 12 questions. The panel acknowledged the need for standardization of various aspects of NSM and immediate reconstruction. It endorsed several oncological contraindications to the preservation of the skin and nipple. Furthermore, it recommended inclusion of patients in prospective registries and routine assessment of patient-reported outcomes. Considerable heterogeneity in breast reconstruction practice became obvious during the conference.ConclusionsIn case of conflicting or missing evidence to guide treatment, the consensus conference revealed substantial disagreement in expert panel opinion, which, among others, supports the need for a randomized trial to evaluate the safest and most efficacious reconstruction techniques.

PURPOSE:To obtain consensus recommendations for the standardization of oncoplastic breast conserving surgery (OPS) from an international panel of experts in breast surgery including delegates from the German, Austrian and Swiss societies of senology.METHODS:A total of 52 questions were addressed by electronic voting. The panel's recommendations were put into context with current evidence and the report was circled in an iterative open email process until consensus was obtained.RESULTS:The panelists considered OPS safe and effective for improving aesthetic outcomes and broadening the indication for breast conserving surgery (BCS) towards larger tumors. A slim majority believed that OPS reduces the rate of positive margins; however, there was consensus that OPS is associated with an increased risk of complications compared to conventional BCS. The panel strongly endorsed patient-reported outcomes measurement, and recommended selected scales of the Breast-Q™-Breast Conserving Therapy Module for that purpose. The Clough bi-level classification was recommended for standard use in clinical practice for indicating, planning and performing OPS, and the Hoffmann classification for surgical reports and billing purposes. Mastopexy and reduction mammoplasty were the only two recognized OPS procedure categories supported by a majority of the panel. Finally, the experts unanimously supported the statement that every OPS procedure should be tailored to each individual patient.CONCLUSIONS:When implemented into clinical practice, the panel recommendations may improve safety and effectiveness of OPS. The attendees agreed that there is a need for prospective multicenter studies to optimize patient selection and for standardized criteria to qualify and accredit OPS training centers.

Within PrefHer ( NCT 01401166), patients and healthcare professionals ( HCP s) preferred subcutaneous ( SC ) over intravenous ( IV ) trastuzumab. We undertook a prospective, observational time and motion study to quantify patients’ time in infusion chairs and active HCP time in PrefHer. Patients with HER 2‐positive early breast cancer received four adjuvant cycles of SC trastuzumab (600 mg fixed dose via SC single‐use injection device [ SID , Cohort 1] or SC handheld syringe [ HHS , Cohort 2]) then four cycles of standard IV trastuzumab or the reverse sequence. Generic case report forms for IV and SC management, both in the treatment room and the drug preparation area, were tailored to reflect center practices. Patient chair time and active HCP time were recorded. We compared pooled Cohort 1 + 2 IV with Cohort 1 SC SID and Cohort 2 SC HHS mean times across eight countries and individually within them utilizing a random intercept generalized linear mixed‐effects model. Per session, the SC SID saved a mean of 57 min of patient chair time versus IV (range across countries: 47–86; P < 0.0001); the SC HHS saved 55 min (40–81; P < 0.0001). Active HCP time was reduced by a mean of 13 min per session with the SC SID (range across countries: 4–16; P < 0.0001) and 17 min with the SC HHS (5–28; P < 0.0001) versus IV . SC trastuzumab, delivered via SID or HHS , saved patient chair and active HCP times versus IV infusion, supporting a transition to either SC method.

Correspondence: Reply to ‘Quantitative evaluation of X-ray dark-field images for microcalcification analysis in mammography’

Phase contrast mammography using a grating interferometer is an emerging technology for breast imaging. It provides complementary information to the conventional absorption-based methods. Additional diagnostic values could be further obtained by retrieving quantitative information from the three physical signals (absorption, differential phase and small-angle scattering) yielded simultaneously. We report a non-parametric quantitative volumetric breast density estimation method by exploiting the ratio (dubbed the R value) of the absorption signal to the small-angle scattering signal. The R value is used to determine breast composition and the volumetric breast density (VBD) of the whole breast is obtained analytically by deducing the relationship between the R value and the pixel-wise breast density. The proposed method is tested by a phantom study and a group of 27 mastectomy samples. In the clinical evaluation, the estimated VBD values from both cranio-caudal (CC) and anterior-posterior (AP) views are compared with the ACR scores given by radiologists to the pre-surgical mammograms. The results show that the estimated VBD results using the proposed method are consistent with the pre-surgical ACR scores, indicating the effectiveness of this method in breast density estimation. A positive correlation is found between the estimated VBD and the diagnostic ACR score for both the CC view (p = 0.033) and AP view (p = 0.001). A linear regression between the results of the CC view and AP view showed a correlation coefficient γ = 0.77, which indicates the robustness of the proposed method and the quantitative character of the additional information obtained with our approach.

To compare the diagnostic accuracy of PET/MRI and PET/CT for staging and re-staging advanced gynaecological cancer patients as well as identify the potential benefits of each method in such a population.

Microcalcifications can be indicative in the diagnosis of early breast cancer. Here we report a non-invasive diagnostic method that may potentially distinguish between different types of microcalcifications using X-ray phase-contrast imaging. Our approach exploits the complementary nature of the absorption and small-angle scattering signals of microcalcifications, obtained simultaneously with an X-ray grating interferometer on a conventional X-ray tube. We demonstrate that the new approach has 100% sensitivity and specificity when applied to phantom data, and we provide evidence of the solidity of the technique by showing its discrimination power when applied to fixed biopsies, to non-fixed tissue specimens and to fresh, whole-breast samples. The proposed method might be further developed to improve early breast cancer diagnosis and has the potential to increase the diagnostic accuracy and reduce the number of uncomfortable breast biopsies, or, in case of widespread microcalcifications, to select the biopsy site before intervention.

Background Patients with HER2-positive early breast cancer (EBC) preferred subcutaneous (s.c.) trastuzumab, delivered via single-use injection device (SID), over the intravenous (i.v.) formulation (Cohort 1 of the PrefHer study: NCT01401166). Here, we report patient preference, healthcare professional satisfaction, and safety data pooled from Cohort 1 and also Cohort 2, where s.c. trastuzumab was delivered via hand-held syringe. Patients and methods Patients were randomized to receive four adjuvant cycles of 600 mg fixed-dose s.c. trastuzumab followed by four cycles of standard i.v. trastuzumab, or vice versa. The primary endpoint was overall preference proportions for s.c. or i.v., assessed by patient interviews in the evaluable ITT population. Results A total of 245 patients were randomized to receive s.c. followed by i.v. and 243 received i.v. followed …

OBJECTIVES:Differential phase contrast and scattering-based x-ray mammography has the potential to provide additional and complementary clinically relevant information compared with absorption-based mammography. The purpose of our study was to provide a first statistical evaluation of the imaging capabilities of the new technique compared with digital absorption mammography.MATERIALS AND METHODS:We investigated non-fixed mastectomy samples of 33 patients with invasive breast cancer, using grating-based differential phase contrast mammography (mammoDPC) with a conventional, low-brilliance x-ray tube. We simultaneously recorded absorption, differential phase contrast, and small-angle scattering signals that were combined into novel high-frequency-enhanced images with a dedicated image fusion algorithm. Six international, expert breast radiologists evaluated clinical digital and experimental mammograms in a 2-part blinded, prospective independent reader study. The results were statistically analyzed in terms of image quality and clinical relevance.RESULTS:The results of the comparison of mammoDPC with clinical digital mammography revealed the general quality of the images to be significantly superior (P < 0.001); sharpness, lesion delineation, as well as the general visibility of calcifications to be significantly more assessable (P < 0.001); and delineation of anatomic components of the specimens (surface structures) to be significantly sharper (P < 0.001). Spiculations were significantly better identified, and the overall clinically relevant information provided by mammoDPC was judged to be superior (P < 0.001).CONCLUSIONS:Our results demonstrate that complementary information provided by phase and scattering enhanced mammograms obtained with the mammoDPC approach deliver images of generally superior quality. This technique has the potential to improve radiological breast diagnostics.

With great interest we read the response to our article by Barranger and Ihrai, who stated that we lacked to discuss certain aspects of the magnetic sentinel lymph node (SLN) detection with the SentiMag® medical device. In detail Barranger and Ihrai identified five topics as potential drawbacks of the magnetic SLN detection and we want to discuss them in the following section.1)The tracer is not easy to use and requires a minimum learning curve. According to our experiences and with regard to the fact that many new users exchanged their experiences with us, we can state that the average learning curve of the magnetic technique is very steep and requires an average of three to four patients. We agree with Barranger and Ihrai and consider this amount of patients to get familiar with a new technique as minimal.2)The diameter of the handheld magnetometer is disadvantageous and requires an enlarged incision to insert the probe. Indeed, the diameter of the probe was somewhat larger than that of an average gamma probe. However, recently Sysmex Europe GmbH launched a device update that includes a longer and slimmer probe, which is now in the range of an average gamma probe.3)For detection the probe needs to be in contact with the SLN. The documented procedure of magnetic SLN detection starts with a transcutaneous measurement to localize the optimal incision site. After incision the detection is completed by a subcutaneous measurement and on the excised SLN. At no time it is necessary to make contact between SLN and probe otherwise the obligatory transcutaneous measurement would be senseless. All these aspects are part of the obligatory product training on the use of the SentiMag®.4)Non-magnetic surgical instruments are required. Ferrous or magnetic surgical instruments can influence the magnetic SLN detection. However, it is not necessary to replace all surgical instruments by non-magnetic instruments. The use of non-magnetic instruments is only necessary during detection measurements. Therefore, the required non-magnetic instruments are often limited to retractors. The use of other instruments (e.g. forceps or clamps) is up to the individual preference of the surgeon.5)The regular calibration of the SentiMag extends the duration of the surgery The hardware of the probe can be sensible for thermal changes of the environment. Therefore, the SentiMag® should be balanced before measurements. In the following we calculate the additional time consume to balance the SentiMag® device: For each SLN a total of three measurements is required (transcutaneous, subcutaneous and on the excised SLN). Our study showed that in average two SLN are excised per surgery. Each balance procedure on the SentiMag® requires five seconds after pressing the balance button or foot switch. Therefore, the average surgery time will be extended by about: 2 SLN/patient × 3 times balancing/SLN × 5 s = 30 s. We consider this time consume as minor and therefore did not include this topic into the discussion section of our article. After considering potential drawbacks of the magnetic sentinel lymph node detection mentioned by Barranger and Ihrai, we still arrive at the conclusion that the magnetic detection of SLN with the Sienna+/SentiMag® System has the potential to become standard of care. Response to the article by Thill et al.: “The Central-European SentiMag study: Sentinel lymph node biopsy with supermagnetic iron oxide (SPIO) vs. radioisotope”. The Breast 2014The BreastVol. 23Issue 3PreviewWe read with interest the recent published study by Thill et al. evaluating, in a multicentric non inferiority study including 150 patients, the performance of a new magnetic technique for SLNB [1]. In this large series of patients, the authors compared a magnetic tracer with the standard radioisotopic. The main results of this prospective study showed an excellent identification rate using the magnetic method (98%) vs. 97.3% for 99mTc with a similar average number of removed SLNs. The authors concluded that this technique is feasible for SLNB and equivalently well in comparison to the isotopic method. Full-Text PDF The Central-European SentiMag study: Sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotopeThe BreastVol. 23Issue 2PreviewSentinel lymph node biopsy (SLNB) is the standard surgical procedure for the axilla in early node-negative breast cancer. To date, the “gold standard” to localize the sentinel lymph node (SLN) is the radiotracer 99mTc with or without blue dye. The aim of this study was to evaluate potential equivalency of the new SentiMag® technique in comparison to the “gold standard”. Within this prospective, multicentric and multinational non-inferiority study including 150 patients 99mTc was compared with the magnetic technique, using superparamagnetic iron oxide particles (SPIOs, Sienna+®) for localization of SLNs. Full-Text PDF Open Access

Poster: ECR 2013 / C-1494 / Phase contrast mammography: a novel diagnostic tool for breast imaging by: Z. Wang 1, N. Hauser2, R. A. Kubik-Huch2, G. Singer2, E. Roessl3, N. Wieberneit3, I. Schulze-Wenck3, M. Stampanoni1; 1Villigen/CH, 2Baden/CH, 3Hamburg/DE

BACKGROUND: The aim of our study was to analyze diagnostic results, different treatment modalities, and the outcome of patients with breast abscesses treated at our institution in a multi-modality breast team, to determine whether minimally invasive treatments are successful. METHODS: 110 patients with mastitis and suspected breast abscesses at our institution between January 2000 and end of September 2007 were retrospectively analyzed. Abscesses were diagnosed using ultrasonography (US), and the material obtained using US-guided fine needle aspiration (FNA) was further examined. RESULTS: 29% of the patients were treated conservatively with antibiotics only, 51% were treated with US-guided FNA or drainage placement. 11% of the patients underwent additional surgery after minimally invasive treatment (i.e. conversion rate). 9% of the patients underwent primary surgery. Early complications occurred in 7% of patients treated minimally invasive but not in patients treated with surgery alone. Late complications occurred in 5% of patients who underwent minimally invasive treatments and in 30% of patients who underwent surgery. CONCLUSIONS: US-guided FNA as a minimally invasive therapy in combination with antibiotics was found to successfully treat most breast abscesses and, in cases where a larger volume of pus was involved, the placement of an additional drainage catheter was effective.

To prospectively compare the diagnostic performance of a non-Cartesian k-space sampling T2-weighted TSE BLADE sequence with a conventional T2-weighted TSE sequence in female pelvic organs.