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Background: In breast cancer patients, neoadjuvant chemotherapy (NAC) allows to obtain pathological complete response (pCR). In case of initially involved node before NAC, pCR after NAC could make it possible to avoid axillary surgery. The aim of our study was to address parameters to build a tool able to accurately select patients at a high probability of axillary pCR after NAC. Method: GANEA 3 was a French prospective multi institutional cohorts of breast cancer patients with a proven axillary involved node treated with NAC (NCT03630913). Initially involved node was clipped before treatment. Each patient received, before and after NAC, a bilateral mammography, a Magnetic Resonance Imaging (MRI), an axillary sonography. After NAC breast, conservative or radical, and axillary surgery, were performed. Breast surgery allowed to measure breast tumor residual and to perform a Sataloff classification. Targeted axillary detection (TAD) was defined as the combination of the resection of the clipped node and SLN dissection. Axillary clipped node, sentinel lymph node (SLN) and axillary lymph node dissection (ALND) were always performed. ALND allowed to assess the false negative rate (FNR) of axillary clipped node and SLN dissection. A total of 500 included patients is planned to close this still ongoing trial. Results : From January 2019 to March 2022, 405 patients were included from 18 institutions. We present here the results of the 260 first patients, who experienced a complete treatment with NAC courses and post NAC breast and axillary surgery. Among these patients, SBR grade was III in 52%, OR and PR were positive in 59% and 46% respectively, HER2 was overexpressed in 40%, 26% were triple negative and pCR was present in 28%. FNR of the SLN detection was 21.1%, 9% for the clipped node alone and 6% for the TAD. Histopronostic grading, progesteron receptors, HER2 expression, MRI results and Sataloff grading of breast residual tumor were indepently linked with global pCR (breast and axilla) in multivariate analysis. The Area Under the Curve (AUC) model was 0.91 with 82% correctly patients classified. The false negative rate of no pCR classified patients was 14%. Conclusion : Intermediate results of Ganea 3 trial showed that operable breast cancer patients with an initially involved axillary node treated with NAC, showed that TAD allows to reduce the FNR of axillary surgery. Patients with histopronostic grade 3, negative progesteron receptors, HER2 overexpression, a normal MRI after NAC and a breast Sataloff A, have a low risk of axillary tumour residual burden and could be safely spare from any axillary surgery. Large prospective trials are needed to confirm the safety of this surgical de-escalation. Citation Format: Céline Renaudeau, Pierre Gimbergues, Eugénie Guillot, Marie-Pierre Chauvet, Marian Gutowski, Eva Jouve, Philippe Rauch, Monique Cohen, Christelle Faure, Marie-Martine Padeano, Vivien Ceccato, Catherine Uzan, Anne-Sophie Bats, Hélène Charitansky, Pierre-François Dupré, Augustin Reynard, Séverine Alran, Cécile Bendavid-Athias, Loïc Campion, Isabelle Doutriaux, Jean-Marc Classe. Axillary surgery de-escalation after neoadjuvant chemotherapy in breast cancer patients with initially involved node: the GANEA 3 trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-09-01.

Purpose The purpose of this study was to create a deep learning algorithm to infer the benign or malignant nature of breast nodules using two-dimensional B-mode ultrasound data initially marked as BI-RADS 3 and 4. Materials and methods An ensemble of mask region-based convolutional neural networks (Mask-RCNN) combining nodule segmentation and classification were trained to explicitly localize the nodule and generate a probability of the nodule to be malignant on two-dimensional B-mode ultrasound. These probabilities were aggregated at test time to produce final results. Resulting inferences were assessed using area under the curve (AUC). Results A total of 460 ultrasound images of breast nodules classified as BI-RADS 3 or 4 were included. There were 295 benign and 165 malignant breast nodules used for training and validation, and another 137 breast nodules images used for testing. As a part of the challenge, the distribution of benign and malignant breast nodules in the test database remained unknown. The obtained AUC was 0.69 (95% CI: 0.57–0.82) on the training set and 0.67 on the test set. Conclusion The proposed deep learning solution helps classify benign and malignant breast nodules based solely on two-dimensional ultrasound images initially marked as BIRADS 3 and 4.

To evaluate the diagnostic accuracy of breast MRI in identifying lesions requiring excision for patients with suspicious nipple discharge but normal mammograms and ultrasounds. Between September 2013 and May 2019, 106 female participants (mean age 57.9 years) were consecutively included in this prospective multicenter study; 102 were retained for analysis. MRI was considered negative in the absence of suspicious enhancement and positive in cases of ipsilateral abnormal enhancement (BI-RADS 3 to 5). Final diagnoses were based on histological findings of surgical or percutaneous biopsies or at 1-year follow-up. We considered all lesions requiring excision found on pathology (papilloma, atypia, nipple adenomatosis, or cancer) as positive results. We considered spontaneous resolution of the discharge at 1 year as a negative result. MRI showed ipsilateral abnormal enhancement in 54 patients (53%) revealing 46 lesions requiring excision (31 benign papillomas, 5 papillomas with atypia, 2 nipple adenomatosis, and 8 cancers) and 8 benign lesions not requiring excision. No suspicious enhancement was found in the remaining 48 participants (47%). Forty-two were followed up at 1 year with spontaneous resolution of the discharge and six underwent surgery (revealing 2 benign papillomas). MRI diagnostic accuracy for the detection of a lesion requiring excision was as follows: sensitivity 96%, specificity 85%, positive predictive value 85%, and negative predictive value 96%. In patients with suspicious nipple discharge and normal mammogram and ultrasound, MRI demonstrates excellent performance to identify lesions for which excision is required. Normal MRI indicates it is safe to propose follow-up only management, thus avoiding unnecessary duct excision. ClinicalTrials.gov NCT02819362 • Breast MRI can be useful for the management of patients with suspicious nipple discharge and negative mammogram and ultrasound. • MRI detected a lesion requiring excision in 46 participants (45%) with unexplained discharge. • If breast MRI is negative, follow-up is a safe alternative for these patients.

BackgroundAlmost half of the patient with initially metastatic axillary node, treated with neoadjuvantchemotherapy (NAC) for a large operable breast cancer, has no axillary lymph node involvementat the time of surgery after NAC. Sentinel lymph node detection (SLND), performed after NAC,has a high false negative rate (FNR) when compared to FNR after primary surgery. GANEA 3 isa French prospective multi institutional ongoing trial, aimed at assessing the impact of targeting,before NAC, the initially positive node and removing it after NAC. The main objective of GANEA3 trial is the accuracy of this initially positive node to predict pathological status of the otheraxillary nodes after NAC. A total of 385 patients are required.ObjectiveThe current abstract assessed preliminary results of the detection rate of the clipped node and thedifferent methods to find it during axillary surgery based on the first 41 patients.Patients and MethodThis study is part of GANEA 3 Trial validated by scientific national board (clinicialtrials.gov:NCT03630913).Inclusion criteria: TNM stage T1-T3 N1 infiltrating breast carcinoma, indication of NAC, andsigned consent form,Exclusion criteria: more than 5 suspicious axillary nodes, inflammatory cancer, local relapse,mental disorder, pregnancy or no contraceptive method, contra-indication to NAC, NACinterrupted due to progressive disease.Design: Patients treated for an early breast cancer with NAC, axillary sonography with fine needlecytology before NAC to select patients with a proven lymph node involvement. Initially positive node identification warranted, for example with a clip. After NAC patients underwent the removalof the clipped node, a SLN detection with the combined method (patent blue and technetium) andan axillary lymph node dissection (ALND). In order to find the clipped node, during surgery thesurgeon attempted to find it with palpation and sonography. Each surgical specimen was then x-rayed before pathological examination.Studied parameters were clipped node and SLND detection rate, and the methods used to find theclipped node.ResultsFrom January 2019, to November 2019, 41 patients were enrolled, from 13 institutions, withinitially positive axillary node clipped, NAC courses and surgery after NAC.Median age was 53 (31-75), pathological subtype infiltrative ductal carcinoma (n=40) andinfiltrative lobular carcinoma (n=1), a median of 7 courses of NAC (1-16).SLN detection rate was 90% (37/41). A median number of 2 sentinel nodes were removed (1-7).The clipped node was removed in 100% of cases. The clipped node was identified by thesurgeon palpation (n=11), an axillary wire (n=13), per operative axillary sonography (n=4),surgical specimen radiography (n=11), the pathologist (n=2).The clipped node was part of SLN in 29 cases (70%). It was part of axillary lymphadenectomyspecimen in 6 cases (14.5%) and was find alone as an isolated node in 6 cases (14.5%).ConclusionThe clipped node was always found after NAC. It was mostly always part of SLN or ALNDspecimens. Further studies are needed in order to help the surgeon to remove only the clippednode. Citation Format: Celine Renaudeau, Roman Rouzier, Pierre Gimbergues, Marian Gutowski, Eva Jouve, Philippe Rauch, Charles Coutant, Christelle Faure, Catherine Uzan, Pierre-François Dupré, Vivien Ceccato, Charlotte N'go, Augustin Reynard, Isabelle Doutriaux, Loic Campion, Jean-Marc Classe. Axillary surgery after neoadjuvant chemotherapy in patients treated for an operable breast cancer with a proven initially positive axillary node: Preliminary results of identification and removal of the initially positive axillary node [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS1-43.

Second reading is an important part of breast cancer organized screening program. Image quality control and detection of non-diagnosed cancer by first reader are the two goals of this process. In France, 6 % of all screening cancer are diagnosed by second reading, actually done on screen film. With the technologic evolution (Digital breast tomosynthesis, Artificial intelligence) and societal digitalization, this process need to evolve. After some report about organization and results for second reading in France and outside, current and future shortcomings, proposition from professionals involved in breast cancer screening are made to improve this public health program.

INTRODUCTION: Organized and individual breast screening have been accompanied by an increase in the detection of "atypical breast lesions "(ABL). Recently, the NOMAT multicenter study proposed a predictive model of the risk of developing breast cancer after detection of an ABL in order to avoid surgical removal of "low-risk" lesions. It also aimed to provide information on psychological experience, in particularly anxiety, to assist in the shared medical decision process. METHODS: Three hundred women undergoing surgery for ABL were included between 2015 and 2018 at 18 French centers. Women completed questionnaires before and after surgery assessing their level of anxiety (STAI-State, STAI-Trait), their level of tolerance to uncertainty, their perceived risk of developing a breast cancer, and their satisfaction with the management care. RESULTS: One hundred nighty nine patients completed the STAI-Status before and after surgery. Overall, a decrease in anxiety level (35.4 vs 42.7, p

e12557 Background: Triple-negative breast cancer (TNBC) tends to exhibit aggressive behavior lacking from targeted therapies. Tumor-associated-macrophages (TAMs as M2 and M1 macrophages) are interest targets in TNBC to approach the tumor patient immunity. The mitochondrial translocator protein (TSPO), a sensitive marker for macrophages, could be interesting for TNBC micro-environment stratification. We performed a multicenter imaging pilot study (NCT04320030) using non-invasive [18F]DPA-714 (DPA), a TSPO PET radioligand, aiming at assessing immunity to define the immunotherapy possibilities in TNBC patients. Methods: All patients underwent TSPO genotyping (LAB: Low Affinity Binder, MAB: Mixed and HAB: High), [18F]FDG (FDG) and DPA PET-CT, macrophages immunochemistry and in vitro TSPO autoradiography using both tritiated PK11195 (PK) and DPA. Thorax PET-CT was acquired just after injection (DPA1) to 30 min, then from 45 min (DPA2) to 60 min, followed by a whole body PET-CT. Groups of interest (Macrophages immunochemistry and Genotype) were compared using Kruskal-Wallis test. Correlation between continuous parameters were determined using Spearman’s Rho. Results: A total of 13 TNBC patients were included. No adverse events occurred after DPA injection. For TSPO genotyping, 2/13 (15.5%) patients were LAB, 6/13 (46%) MAB and 5/13 (38.5%) HAB. All of them showed FDG and DPA uptake regardless of the patient's genotype without significant difference between the 3 groups. The DPA kinetics showed a tracer accumulation between DPA1 and DPA2, whatever patient genotypes, observed on SUVmax (p = 0.0015), SUVmean (p = 0.0015) and TL-DPA (p = 0.0024). A correlation between FDG and DPA1 either DPA2 tumor volume was shown, respectively (p = 0.0252 and 0.0067) as well as between the TLG (FDG) and the TL-DPA1 (p = 0.0346) regardless of the patient's genotype. Macrophages immunochemistry showed a tendency difference for M2 percentage (p = 0.09) between the 3 genotypes groups. In vitro binding ratio (PK/DPA), measured for both radioligands, on adjacent tumor slices, was 1.77 (1.35-2.21). A difference in this binding ratio was observed between MAB and HAB (Mean 1.68±0.36) compared to LAB 3.04±0.23 (p = 0.0367), suggesting that DPA binding is sensitive to TSPO genotype, unlike PK binding. Conclusions: Despite the limited population, all TNBC tumor patients were DPA positive with an accumulation over time. The total glycolysis and total DPA uptake in the tumor were correlated, which may link tumor aggressiveness and DPA uptake. These data were confirmed by a better sensitivity for HAB and MAB vs LAB. DPA seemed to be a promising tracer to explore non-invasively TNBC patient’s immunity. Clinical trial information: NCT04320030.

International audience; Background: Diagnosis of atypical breast lesions (ABLs) leads to unnecessary surgery in 75-90% of women. We have previously developed a model including age, complete radiological target excision after biopsy, and focus size that predicts the probability of cancer at surgery. The present study aimed to validate this model in a prospective multicenter setting.- methods: Women with a recently diagnosed ABL on image-guided biopsy were recruited in 18 centers, before wire-guided localized excisional lumpectomy. Primary outcome was the negative predictive value (NPV) of the model.Results: The NOMAT model could be used in 287 of the 300 patients included (195 with ADH). At surgery, 12 invasive (all grade 1), and 43 in situ carcinomas were identified (all ABL: 55/287, 19%; ADH only: 49/195, 25%). The area under the receiving operating characteristics curve of the model was 0.64 (95% CI 0.58-0.69) for all ABL, and 0.63 for ADH only (95% CI 0.56-0.70). For the pre-specified threshold of 20% predicted probability of cancer, NPV was 82% (77-87%) for all ABL, and 77% (95% CI 71-83%) for patients with ADH. At a 10% threshold, NPV was 89% (84-94%) for all ABL, and 85% (95% CI 78--92%) for the ADH. At this threshold, 58% of the whole ABL population (and 54% of ADH patients) could have avoided surgery with only 2 missed invasive cancers.Conclusion: The NOMAT model could be useful to avoid unnecessary surgery among women with ABL, including for patients with ADH.

Resume Traiter mieux tout en traitant moins tel est l’enjeu de la cancerologie mammaire. C’est dans ce contexte que s’inscrit le concept de desescalade du traitement locoregional dont l’objectif est de diminuer la morbidite due aux traitements et de developper des strategies therapeutiques specifiques optimisees. Les performances diagnostiques de l’IRM mammaire sont aujourd’hui largement validees au vu de son excellente valeur predictive negative superieure a 95 %. Les etudes de depistage de femmes a tres haut risque de cancer du sein ont egalement valide les excellentes performances de l’IRM, que ce soit pour la detection des carcinomes infiltrants comme des carcinomes in situ, avec une sensibilite de l’IRM superieure a celle du couple mammographie et echographie. La question posee est celle de la place de l’IRM comme outil d’aide a la desescalade therapeutique ou diagnostique. Autrement dit, l’IRM peut-elle contribuer a optimiser les strategies diagnostiques ou therapeutiques ? Nous essaierons de repondre a cette question selon le contexte clinique.

Resume La reactualisation des recommandations professionnelles de l’Institut national du cancer (INCa) sur les strategies de detection precoce des cancers du sein et de l’ovaire chez les femmes porteuses d’une mutation des genes BRCA1 ou BRCA2, valide la diminution du nombre d’incidence mammographique, limite a une seule incidence mammographique oblique externe par sein pour les femmes indemnes tant que l’IRM est realisee, l’arret du depistage par IRM a 65 ans, la poursuite d’un suivi mammographique annuel au-dela de 65 ans et l’arret d’un depistage echographique du cancer des annexes.

PURPOSE We evaluated the addition of breast magnetic resonance imaging (MRI) to standard radiologic evaluation on the re-intervention rate in women with ductal carcinoma in situ (DCIS) undergoing breast-conserving surgery. PATIENTS AND METHODS Women with biopsy-proven DCIS corresponding to a unifocal microcalcification cluster or a mass less than 30 mm were randomly assigned to undergo MRI or standard evaluation. The primary end point was the re-intervention rate for positive or close margins (< 2 mm) in the 6 months after randomization ( ClinicalTrials.gov identifier: NCT01112254). RESULTS A total of 360 patients from 10 hospitals in France were included in the study. Of the 352 analyzable patients, 178 were randomly assigned to the MRI arm, and 174 were assigned to the control arm. In the intent-to-treat analysis, 82 of 345 patients with the assessable end point were reoperated for positive or close margins within 6 months, resulting in a re-intervention rate of 20% (35 of 173) in the MRI arm and 27% (47 of 172) in the control arm. The absolute difference of 7% (95% CI, −2% to 16%) corresponded to a relative reduction of 26% (stratified odds ratio, 0.68; 95% CI, 0.41 to 1.1; P = .13). When considering only the per-protocol population with an assessable end point, the difference was 9% (stratified odds ratio, 0.59; 95% CI, 0.35 to 1.0; P = .05). Total mastectomy rates were 18% (31 of 176) in the MRI arm and 17% (30 of 173) in the control arm (stratified P = .93). For 100 lesions seen on MRI, nonmass-like enhancement was more predominant (82%) than mass enhancement (20%). Nevertheless, no specific morphologic and kinetic parameters for DCIS were identified. CONCLUSION The study did not show sufficient surgical improvement with the use of preoperative MRI to be clinically relevant in DCIS staging. However, this could be reconsidered with the improvement of new MRI sequences and new modalities in magnetic resonance techniques.

Radiation recall is a rare phenomenon, defined as an acute inflammatory reaction in a previously irradiated area, after administration of anti-tumor agents, including chemotherapy. It is most commonly reported to trigger skin reactions but internal organ involvement is possible, particularly with gemcitabine. We report here a unique case of a gemcitabine-induced radiation recall myelitis following spinal irradiation. A 53-year-old patient received analgesic irradiation of the seventh thoracic vertebra (T7) in the context of metastatic non-small cell lung cancer, at conventional radiotherapy dose and fractionation. She was subsequently treated with gemcitabine and developed myelitis whose chronology is compatible with a radiation recall reaction. Spinal MRI confirmed a T6–T7 spinal cord enhancement, with an associated spinal cord oedema. Corticosteroids and supportive care did not improve myelitis symptoms. The patient died within a year of the radiation recall, due to a metastatic progression of lung cancer. This is, to our knowledge, the first reported case of gemcitabine-induced radiation recall myelitis and only the third case involving the spinal cord. Radiation recall is a rare and poorly understood phenomenon and all cases should be reported.

Resume Apres traitement conservateur du cancer du sein, le statut des marges d’exerese constitue un facteur de risque independant de recidive locale homolaterale. S’il n’existe pas de consensus sur la definition d’une marge optimale, on peut dire qu’elle correspond au compromis entre passer tres a distance de la tumeur au risque d’enlever beaucoup de tissu et preserver un bon resultat cosmetique. Les reinterventions pour marges non saines ne sont pas sans consequence, augmentant les risques de complications locales, de retard des traitements adjuvants ou d’alteration du resultat esthetique et pesent egalement sur le plan economique. L’imagerie tient une place essentielle dans la decision de la strategie therapeutique. Peut-elle contribuer a diminuer le nombre de reinterventions pour marges non saines ? Dans cette presentation, nous aborderons tour a tour la place du bilan preoperatoire, du reperage preoperatoire et de la radiographie peroperatoire dans l’optimisation de la prise en charge chirurgicale. Enfin, nous verrons dans quelles circonstances l’imagerie postoperatoire precoce peut aider a evaluer la maladie residuelle.

Resume Dans cette presentation nous nous interesserons a la surveillance apres traitement d’un cancer du sein des femmes âgees, sous deux angles differents. Quelle surveillance au long terme des femmes âgees traitees jeunes d’un cancer du sein : l’adage « mammographie annuelle a vie » est-il toujours d’actualite ? Quelle surveillance apres traitement d’un cancer du sein de la femme âgee ?

International audience; Purpose To assess the rate of underestimation of atypical ductal hyperplasia (ADH) and ductal carcinoma in situ (DCIS) at magnetic resonance (MR) imaging-guided vacuum-assisted breast biopsy and to explore the imaging, demographic, and histologic characteristics associated with lesion upgrade after surgery. Materials and Methods This retrospective study had institutional review board approval, and the need to obtain informed patient consent was waived. A total of 1509 MR imaging-guided vacuum-assisted biopsy procedures were performed in nine centers. A diagnosis of ADH was obtained after biopsy in 72 cases, and a diagnosis of DCIS was obtained in 118 cases. Pearson χ2 and Fisher tests were used to assess the association between demographic, MR imaging, and biopsy features and lesion upgrade. Univariate statistical analyses were performed, and each significant parameter was entered into a multivariate logistic regression analysis. Results Surgical excision was performed in 66 of the 72 ADH cases and in 117 of 118 DCIS cases. The ADH and DCIS underestimation rates were 25.8% (17 of 66) and 23.1% (27 of 117), respectively. Underestimation was 5.6-fold (odds ratio [OR] = 5.6; 95% confidence interval [CI]: 1.7, 18.3) and 3.6-fold (OR = 3.6; 95% CI: 1.2, 10) more likely in mass (n = 20 for ADH and n = 20 for DCIS) than in non-mass (n = 46 for ADH and n = 97 for DCIS), compared with nonunderestimation, in ADH and DCIS respectively. At multivariate analysis, the use of a 9- or 10-gauge needle versus a 7- or 8-gauge needle was also an independently associated with underestimation when a diagnosis of ADH was made at MR imaging-guided biopsy. No other parameters were associated with of ADH or DCIS upgrade at surgery. Conclusion The rates of underestimation in ADH and DCIS diagnosed at MR imaging-guided vacuum-assisted biopsy were high, at around 25%, and were significantly associated with the presence of a mass at MR imaging. © RSNA, 2016.

Purpose This study aimed to assess prospectively the efficacy of sequential [18F]fluorodeoxyglucose positron emission tomography (FDG PET) to evaluate early response to neoadjuvant chemotherapy in stage II and III breast cancer patients. Patients and Methods Images were acquired with a PET/computed tomography scanner in 64 patients after administration of FDG (5 MBq/kg) at baseline and after the first, second, third, and sixth course of chemotherapy. Ultrasound and mammography were used to assess tumor size. Decrease in the standardized uptake value (SUV) with PET was compared with the pathologic response. Results Surgery was performed after six courses of chemotherapy and pathologic analysis revealed gross residual disease in 28 patients and minimal residual disease in 36 patients. Although SUV data did not vary much in nonresponders (based on pathology findings), they decreased markedly to background levels in 94% (34 of 36) of responders. When using 60% of SUV at baseline as the cutoff value, the sensitivity, specificity, and negative predictive value of FDG PET were 61%, 96%, and 68% after one course of chemotherapy, 89%, 95%, and 85% after two courses, and 88%, 73%, and 83% after three courses, respectively. The same parameters with ultrasound (US) and mammography were 64%, 43%, and 55%, and 31%, 56%, and 45%, respectively. Assessment of tumor response with US or mammography was never significant whatever the cutoff. Conclusion Pathologic response to neoadjuvant chemotherapy in stage II and III breast cancer can be predicted accurately by FDG PET after two courses of chemotherapy.