Early-Stage Breast Cancer Detection in Breast Milk.

Breast cancer occurring during pregnancy (PrBC) and postpartum (PPBC) is usually diagnosed at more advanced stages compared with other breast cancer, worsening its prognosis. PPBC is particularly aggressive, with increased metastatic risk and mortality. Thus, effective screening methods to detect early PrBC and PPBC are needed. We report for the first time that cell-free tumor DNA (ctDNA) is present in breast milk (BM) collected from patients with breast cancer. Analysis of ctDNA from BM detects tumor variants in 87% of the cases by droplet digital PCR, while variants remain undetected in 92% of matched plasma samples. Retrospective next-generation sequencing analysis in BM ctDNA recapitulates tumor variants, with an overall clinical sensitivity of 71.4% and specificity of 100%. In two cases, ctDNA was detectable in BM collected 18 and 6 months prior to standard diagnosis. Our results open up the potential use of BM as a new source for liquid biopsy for PPBC detection. SIGNIFICANCE: For the first time, we show that BM obtained from patients with breast cancer carries ctDNA, surpassing plasma-based liquid biopsy for detection and molecular profiling of early-stage breast cancer, even prior to diagnosis by image. See related commentary by Cunningham and Turner, p. 2125. This article is featured in Selected Articles from This Issue, p. 2109.

Application of segmented analysis via multivariate curve resolution with alternating least squares to 1H-nuclear magnetic resonance spectroscopy to identify different sugar sources.

The different types of sugar employed in the food industry exhibit chemical similarity and are mostly dominated by sucrose. Owing to the sugar origin of and differences in production, the presence of certain minor organic compounds differs. To differentiate between sugars based on their botanical source, geographical origin, or storage conditions, commercial brown sugars and sugar beet extracts were analyzed by 1H NMR spectroscopy applying a segmented analysis by means of multivariate curve resolution-alternating least squares (MCR-ALS). Principal component analysis and partial least squares-discriminant analysis yielded excellent differentiation between sugars from different sources after the application of this preprocessing strategy; without loss of chemical information and with direct interpretation of the results. By applying a segmented analysis via MCR-ALS to 1H NMR sugar data, similar spectroscopic profiles could be differentiated. This improved the selectivity of 1H NMR spectroscopy for sugar source differentiation which can be useful for industrial sugar authentication purposes.

Feasibility and safety of targeted axillary dissection guided by intraoperative ultrasound after neoadjuvant treatment.

BACKGROUND: Axillary management in cN + axillary nodes after neoadjuvant systemic therapy (NST) in breast cancer (BC) remains under research with the aim of de-escalation of axillary node dissection (ALND). Several axillary guided localization techniques have been reported. This study evaluates the safety of intraoperative ultrasound (IOUS) guided targeted axillary dissection (TAD) in a large sample after the results of ILINA trial. MATERIALS: Prospective data have been collected from October 2015 to June 2022 in patients with cT0-T4 and positive axillary lymph nodes (cN1) treated with NST. Before NST, an ultrasound visible marker was placed into the positive node. After NST, IOUS guided TAD was performed including sentinel node biopsy (SLN). Until December 2019, all patients underwent an ALND after TAD procedure. From January 2020, ALND was spared in those patients with an axillary pathological complete response (pCR). RESULTS: 235 patients were included. pCR (ypT0/is ypN0) was achieved in 29% patients. Identification rate (IR) of the clipped node by IOUS was 96% (95% IC, 92.5-98.1%) and IR of SLN was 95% (95% IC, 90.8-97.2%). False negative rate (FNR) for TAD procedure (SLN + clipped node) was 7.0% (95% IC, 2.3-15.7%), which decreased to 4.9% when a total of 3 or more nodes were removed. Axillary ultrasound before surgery assessed residual disease with an AUC of 0.5241. Residual axillary disease tend to be the most significant factor for axillary recurrences. CONCLUSIONS: This study confirms the feasibility, safety and accuracy of IOUS guided surgery for axillary staging after NST in node positive BC patients.

Clearance of ctDNA in triple-negative and HER2-positive breast cancer patients during neoadjuvant treatment is correlated with pathologic complete response.

Background: Although the standard of care is to perform surgery of primary breast cancer (BC) after neoadjuvant chemotherapy (NAC), for certain patients achieving clinical complete response (cCR) and pathologic complete response (pCR), omission of surgical treatment may be an option. Levels of circulating tumor DNA (ctDNA) during and after therapy could identify patients achieving minimal residual disease. In this study, we evaluated whether ctDNA clearance during NAC could be a correlate to effective response in human epidermal growth factor receptor 2 positive (HER2+) and triple-negative (TN) BC patients. Methods: A prospective study was conducted to identify patient-specific PIK3CA and TP53 mutations in tissue using next-generation sequencing, which could then be used to track the presence/absence of mutations prior to, during, and following NAC using Sysmex SafeSEQ technology. All patients underwent a surgical excision after NAC, and pCR was assessed. Results: A total of 29 TN and HER2+ BC patients were examined and 20 that carried mutations in the PIK3CA and/or TP53 genes were recruited. Overall, 19 of these 20 patients harbored at least one tumor-specific mutation in their plasma at baseline. After NAC, 15 patients (75.0%) achieved pCR according to the histopathologic evaluation of the surgical specimen, and 15 patients (75.0%) had a cCR; 18 of 20 patients (90.0%) had concordant pCR and cCR. The status of 'no mutation detected' (NMD) following NAC in cCR patients correctly identified the pCR in 14 of 15 patients (93.33%), as well as correctly ruled out pCR in three patients, with an accuracy of 89.47%. During the 12-month follow-up after surgery, 40 plasma samples collected from 15 patients all showed no detectable ctDNA (NMD), and no patient recurred. Conclusion: These findings prompt further research of the value of ctDNA for non-invasive prediction of clinical/pathological response, raising the possibility of sparing surgery following NAC in selected BC patients.

Overcoming Limitations in Decarboxylative Arylation via Ag-Ni Electrocatalysis.

A useful protocol for achieving decarboxylative cross-coupling (DCC) of redox-active esters (RAE, isolated or generated in situ) and halo(hetero)arenes is reported. This pragmatically focused study employs a unique Ag-Ni electrocatalytic platform to overcome numerous limitations that have plagued this strategically powerful transformation. In its optimized form, coupling partners can be combined in a surprisingly simple way: open to the air, using technical-grade solvents, an inexpensive ligand and Ni source, and substoichiometric AgNO3, proceeding at room temperature with a simple commercial potentiostat. Most importantly, all of the results are placed into context by benchmarking with state-of-the-art methods. Applications are presented that simplify synthesis and rapidly enable access to challenging chemical space. Finally, adaptation to multiple scale regimes, ranging from parallel milligram-based synthesis to decagram recirculating flow is presented.

Preclinical In Vivo Validation of the RAD51 Test for Identification of Homologous Recombination-Deficient Tumors and Patient Stratification.

PARP inhibitors (PARPi) are approved drugs for platinum-sensitive, high-grade serous ovarian cancer (HGSOC) and for breast, prostate, and pancreatic cancers (PaC) harboring genetic alterations impairing homologous recombination repair (HRR). Detection of nuclear RAD51 foci in tumor cells is a marker of HRR functionality, and we previously established a test to detect RAD51 nuclear foci. Here, we aimed to validate the RAD51 score cut off and compare the performance of this test to other HRR deficiency (HRD) detection methods. Laboratory models from BRCA1/BRCA2-associated breast cancer, HGSOC, and PaC were developed and evaluated for their response to PARPi and cisplatin. HRD in these models and patient samples was evaluated by DNA sequencing of HRR genes, genomic HRD tests, and RAD51 foci detection. We established patient-derived xenograft models from breast cancer (n = 103), HGSOC (n = 4), and PaC (n = 2) that recapitulated patient HRD status and treatment response. The RAD51 test showed higher accuracy than HRR gene mutations and genomic HRD analysis for predicting PARPi response (95%, 67%, and 71%, respectively). RAD51 detection captured dynamic changes in HRR status upon acquisition of PARPi resistance. The accuracy of the RAD51 test was similar to HRR gene mutations for predicting platinum response. The predefined RAD51 score cut off was validated, and the high predictive value of the RAD51 test in preclinical models was confirmed. These results collectively support pursuing clinical assessment of the RAD51 test in patient samples from randomized trials testing PARPi or platinum-based therapies. SIGNIFICANCE: This work demonstrates the high accuracy of a histopathology-based test based on the detection of RAD51 nuclear foci in predicting response to PARPi and cisplatin.

Prognostic value of ctDNA detection in patients with early breast cancer undergoing neoadjuvant therapy: A systematic review and meta-analysis.

Circulating tumor DNA (ctDNA) is increasingly being used as a biomarker in early breast cancer (EBC). We performed a systematic review and meta-analysis to investigate the prognostic value of ctDNA in patients with EBC treated with neoadjuvant therapy (NAT). We searched Medline, Web of Science and Embase for observational or interventional studies that included patients with EBC undergoing NAT, reported outcomes related to the predefined endpoints, and had full text articles available. Study selection followed the PRISMA guidelines and quality assessment the REMARK tool for biomarker studies. Primary endpoint was impact of ctDNA detection in different time points (baseline, on-treatment, and after NAT) on relapse-free survival (RFS) and overall survival (OS). Secondary endpoints included the association of ctDNA detection with pathologic complete response (pCR), and the positive and negative predictive value of ctDNA detection in predicting residual disease after NAT. From the 2908 studies initially identified, 11 met the eligibility criteria and were included in the meta-analysis. Detection of ctDNA, both at baseline and after completion of NAT, significantly associated to worse RFS (HR 4.22, 95% CI: 1.29-13.82 and HR 5.67, 95% CI: 2.73-11.75, respectively) and worse OS (HR 19.1, 95% CI: 6.9-53.04 and HR 4.00, 95% CI: 1.90-8.42, respectively). In contrast, detection of ctDNA did not associate with the probability of achieving a pCR. Our results suggest that ctDNA assessment during NAT for EBC merits further evaluation as a stratification risk factor in prospective trials, in order to better individualize patient's treatment.

Health-Related Quality of Life After Nipple-Sparing Mastectomy: Results From the INSPIRE Registry.

INTRODUCTION: Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is increasingly used for both breast cancer (TNSM) and risk reduction (RRNSM). The aim of the study is to report the results of the INSPIRE registry assessing health-related quality of life (HRQoL) comparing baseline and 1-year follow-up, regarding surgical indications and chemotherapy (CT) received. METHODS: INSPIRE is a prospective database including women undergoing NSM and IBR from 18 countries. HRQoL was measured using EORTC QLQC30 and QLQ-BR23 before surgery and after 1 year. RESULTS: A total of 677 women were included, of whom 537 (79.3%) underwent TNSM and 140 (21.6%) RRNSM: in total, 806 NSM (556 TNSM and 250 RRNSM). Nipple involvement was present in 7.73% of TNSM and incidental carcinoma in 1.2% of the RRNSM group. Out of the overall 537 patients with systemic treatment, 177 (32.96%) received neoadjuvant chemotherapy (NCT) and 118 (21.92%) adjuvant chemotherapy (CT). A total of 227 patients (28.16%) developed at least one complication postoperatively, 164 (29.5%) in the TNSM group and 63 (25.2%) in the RRNSM group. The TNSM group improved in global health status and emotional functioning after 1 year. No differences were found when comparing HRQoL at 1 year between patients who received NCT and those who received adjuvant CT. The RRNSM group showed improvement in HRQoL, with better emotional functioning and fatigue after 1 year. CONCLUSIONS: This registry reports HRQoL findings after NSM. The impact of CT on worse HRQoL is independent from its timing. Patients with RRNSM showed an improved HRQoL at 1-year follow-up. Discussion of HRQoL outcomes with patients will facilitate the informed decision-making when considering NSM.

Impact of COVID-19 on a brain damage unit.

AIM: To report on the impact of COVID-19 on a brain damage unit. METHODS: We reviewed the records of all patients admitted to our brain damage unit. The study included all the significant clinical events from the first positive qualitative real-time reverse-transcriptase-polymerase-chain-reaction assay (April 8th, 2020) for SARS-CoV-2 to the day all patients tested negative (June 8th, 2020). RESULTS: Of the 20 patients (14 men) (age 57.7 ± 14.9; 2-71 months after brain damage; all with a modified Rankin scale score > 4), 16 tested positive for SARS-CoV-2 and remained positive for a mean of 32.3 days (ranging from 26 to 61). One patient died from COVID-19, while 12 patients were asymptomatic and three suffered mild pneumonia without acute respiratory distress syndrome. All patients received prophylactic subcutaneous heparin. Intravenous methylprednisolone was prescribed for three patients with bilateral pneumonia with excellent results. CONCLUSIONS: Most positive cases (93.7%) were not severe. The good outcome was most likely due to the use of prophylactic anticoagulation therapy, the early use of methylprednisolone for pneumonia and the previously reported immunosuppression amid patients with brain damage. This study hopes to encourage further study into brain damage immunity.

SOLTI-1805 TOT-HER3 Study Concept: A Window-of-Opportunity Trial of Patritumab Deruxtecan, a HER3 Directed Antibody Drug Conjugate, in Patients With Early Breast Cancer.

Background: Preclinical data support a key role for the human epidermal growth factor receptor 3 (HER3) pathway in hormone receptor (HR)-positive breast cancer. Recently, new HER3 directed antibody drug conjugates have shown activity in breast cancer. Given the need to better understand the molecular biology, tumor microenvironment, and mechanisms of drug resistance in breast cancer, we designed this window-of-opportunity study with the HER3 directed antibody drug conjugate patritumab deruxtecan (HER3-DXd; U3-1402). Trial Design: Based on these data, a prospective, multicenter, single-arm, window-of-opportunity study was designed to evaluate the biological effect of patritumab deruxtecan in the treatment of naïve patients with HR-positive/HER2-negative early breast cancer whose primary tumors are ≥1 cm by ultrasound evaluation. Patients will be enrolled in four cohorts according to the mRNA-based ERBB3 expression by central assessment. The primary endpoint is a CelTIL score after one single dose. A translational research plan is also included to provide biological information and to evaluate secondary and exploratory objectives of the study. Trial Registration Number: EudraCT 2019-004964-23; NCT number: NCT04610528.

Leveraging the increased rates of pathologic complete response after neoadjuvant treatment in breast cancer to de-escalate surgical treatments.

INTRODUCTION: Breast conservative surgery (BCS) and sentinel lymph node biopsy (SLNB) after neoadjuvant treatment (NAT) is safe and effective for selected patients. This aim of this study is to evaluate the impact of anatomic site of response on outcomes and to assess the real population who may benefit from nonsurgical approaches after NAT. MATERIAL AND METHODS: From a prospectively maintained database, patients with T1-4 N0-2 breast cancer undergoing NAT were identified. Clinicopathological and survival rates were compared in relation to response and anatomic site of response. RESULTS: Six hundred and forty-six patients were included in the study. Pathologic complete response (pCR) was an independent factor for BCS and SLN. HER2 positive and TN tumors with cN0 achieving a breast pCR remain ypN0 (p = .002). Residual axillary disease was associated with breast residual tumor (p = .05) and subtype (p = .001). With a median follow up of 35.25 months, patients with any pCR had improved survival when compared with partial response, but not significant differences between pCR, axillary pCR, or breast pCR. CONCLUSION: Achieving a pCR increases BCS and SLN. In selected subgroups, sparing any axillary surgery after NAT maybe feasible. In cN+ patients, any pCR was associated with survival, but not the anatomic site of response.

Fracturas de la columna vertebral en pacientes con espondilitis anquilosante / Spine fractures in patients with ankylosing spondylitis

Introducción: La espondilitis anquilosante es un trastorno inflamatorio progresivo que afecta el esqueleto axial, inclusive las articulaciones sacroilíacas; el riesgo de sufrir una fractura se cuadruplica (10% a los 10 años de enfermedad), la tasa de demora del diagnóstico es alta. La rigidez y la osteoporosis son factores clave para sufrir estas lesiones. La tomografía computarizada y la resonancia magnética cumplen un rol diagnóstico fundamental. La descompresión y la fijación quirúrgica es el tratamiento de elección actual. Se presenta una serie de casos con el objetivo de considerar las dificultades diagnósticas, describir las lesiones y la decisión terapéutica, analizar la presentación de complicaciones y realizar una actualización bibliográfica. materiales y métodos: Estudio multicéntrico retrospectivo de una serie de casos con 6 pacientes. Resultados: Seis hombres, edad promedio 58.1 años. Cuatro habían sufrido una caída desde la posición de pie. El tiempo promedio hasta el diagnóstico fue de 12.8 días. Los sectores más afectados fueron el torácico y el lumbar, con un mecanismo predominante en hiperextensión. Cuatro pacientes recibieron tratamiento quirúrgico. Conclusiones: Los pacientes con espondilitis anquilosante tienen un riesgo más alto de sufrir una fractura por traumas de baja energía. La demora para llegar al diagnóstico fue de 12.8 días. La cirugía con fijaciones largas y liberación por vía posterior es el tratamiento más utilizado. No se observaron complicaciones después del tratamiento. Nivel de Evidencia: IV

Introduction: Ankylosing Spondylitis (AS) is a progressive inflammatory disorder that affects the axial skeleton including the sacroiliac joints. Patients are 4 times more likely to suffer a fracture (10% at 10 years of illness), and there is a high percentage of delay in diagnosis. Stiffness and osteoporosis are key to suffering these injuries. CT and MRI scannings play a fundamental role in diagnosis. The current choice for treatment is decompression and surgical fixation. A series of cases is presented in order to: consider diagnostic difficulties; describe the injuries and therapeutic decision; analyze the presentation of complications andcarry out a bibliographic update. Materials and Methods: This is a retrospective multicenter study of a case series of 6 patients. Results: Six males with an average age of 58.1 years. Four presented a fall from the standing position. The delay in diagnosis was 12.8 days on average. The most affected areas were thoracic and lumbar, with a predominant mechanism of hyperextension. Four patients underwent surgery. Discussion: Fractures in patients with AS are frequent complications related to osteoporosis. CT is the sensitive and specific method for diagnosing the lesion. The current literature supports the need for subsequent surgical treatment. Conclusions: AS carriers are more at risk of suffering a low-energy trauma fracture. A delay of 12.8 days in diagnosis. Surgical treatment, with long fixations and posterior release, is the most widely used treatment. We have not observed post treatment complications. Level of Evidence: IV

Case report of Chagas disease reactivation: new diagnosis tool by direct microscopic observation of biopsy specimen and its preservation fluid

Abstract Chagas Disease is caused by Trypanosoma cruzi. This infection is endemic in the Americas region. Neurological Chagas reactivation is diagnosed through the visualization of the parasite in the cerebrospinal fluid, blood, or tissue samples. Herein, we report the visualization of trypomastigotes by direct microscopic observation of a brain biopsy specimen and its preservation fluid (PF) in a paitient infected with VIH and T. cruzi. This easy and simple diagnostic method coupled with quantitative polymerase chain reaction can be used in all tissue biopsies and PF of T. cruzi seropositive patients, suspected of Chagas disease reactivation.

Case report of Chagas disease reactivation: new diagnosis tool by direct microscopic observation of biopsy specimen and its preservation fluid.

Chagas Disease is caused by Trypanosoma cruzi. This infection is endemic in the Americas region. Neurological Chagas reactivation is diagnosed through the visualization of the parasite in the cerebrospinal fluid, blood, or tissue samples. Herein, we report the visualization of trypomastigotes by direct microscopic observation of a brain biopsy specimen and its preservation fluid (PF) in a paitient infected with VIH and T. cruzi. This easy and simple diagnostic method coupled with quantitative polymerase chain reaction can be used in all tissue biopsies and PF of T. cruzi seropositive patients, suspected of Chagas disease reactivation.

Presence of Trichomonas spp. in oral ulcerations of a patient with kidney transplant. A case report.

Mucosal ulcerations are an oral complication that can often affect kidney transplant patients, mostly due to the effect of immunosuppression. It has been frequently reported drug-induced ulceration or lymphoproliferative disorders with buccal manifestations however, some unusual disorders should also be considered, such as fungal infections, viruses, as well as opportunistic infection by other microorganisms. Determining the etiology and differential diagnose from other causes of mouth ulcers is very important for the adequate treatment of said lesion. Dental health of patients should also be taken into the account prior to the transplant surgery, since periodontal pockets are the main niche of microbial reservoir. Moreover, mixed with oral microbiota, parasites such as Trichomonas spp. can be found in the dental plaque of patients with periodontal disease. Particularly, Trichomonas spp. are anaerobic motile-flagellated protozoa that can both induce tissue damage and exacerbate preexistent injuries in vaginal and oral mucosa. Parasitic infection in the oral cavity has not been well studied and it is thought to be underreported. In the present study we report the first case in literature of presence of Trichomonas spp. as a potential etiological factor of the oral ulcerations of a kidney transplanted patient that remitted after antibiotic treatment. Key words:Immunosuppression, protozoan, buccal lesion, oral mucosa, kidney transplant.

Five microRNAs in Serum Are Able to Differentiate Breast Cancer Patients From Healthy Individuals.

Breast cancer is the cancer with the most incidence and mortality in women. microRNAs are emerging as novel prognosis/diagnostic tools. Our aim was to identify a serum microRNA signature useful to predict cancer development. We focused on studying the expression levels of 30 microRNAs in the serum of 96 breast cancer patients vs. 92 control individuals. Bioinformatic studies provide a microRNA signature, designated as a predictor, based on the expression levels of five microRNAs. Then, we tested the predictor in a group of 60 randomly chosen women. Lastly, a proteomic study unveiled the overexpression and downregulation of proteins differently expressed in the serum of breast cancer patients vs. that of control individuals. Twenty-six microRNAs differentiate cancer tissue from healthy tissue, and 16 microRNAs differentiate the serum of cancer patients from that of the control group. The tissue expression of miR-99a, miR-497, miR-362, and miR-1274, and the serum levels of miR-141 correlated with patient survival. Moreover, the predictor consisting of miR-125b, miR-29c, miR-16, miR-1260, and miR-451 was able to differentiate breast cancer patients from controls. The predictor was validated in 20 new cases of breast cancer patients and tested in 60 volunteer women, assigning 11 out of 60 women to the cancer group. An association of low levels of miR-16 with a high content of CD44 protein in serum was found. Circulating microRNAs in serum can represent biomarkers for cancer prediction. Their clinical relevance and the potential use of the predictor here described are discussed.

Axillary staging based on molecular analysis: Results of the B-CLOSER-II study.

INTRODUCTION: Axillary staging (pN) is a strong predictor of outcome in early stage breast cancer yet following the publication of the Z0011 trial there has been an increasing tendency to spare lymph node dissection. Automated molecular detection of cytokeratin 19mRNA by one-step nucleic acid amplification (OSNA) has been demonstrated to be an accurate method to assess sentinel lymph node (SLN) metastasis. In this study we compare histological and molecular methods following complete axillary lymph node dissection (cALND), determine whether molecular axillary staging affects survival, and evaluate the predictive and prognostic value of total tumor load in ALND (AD-TTL) and in all positive nodes (G-TTL). MATERIAL AND METHODS: Axillary lymph nodes were collected from 102 patients with primary breast cancer with histological confirmation of axillary involvement (cN+) or positive SLN. The central 1-mm portion of each non-SLN was processed for hematoxylin-eosin staining and the remaining tissue was analyzed by OSNA. RESULTS: Non-SLNs were diagnosed as positive in 72 out of 102 patients (70.6 %) on OSNA compared with only 53 (52 %) on histology (p < 0.01). Thirteen patients would have changed staging if the diagnoses provided had been by molecular methods (p < 0.01), but without a change in prognosis. AD-TTL and G-TTL were predictive of recurrence and mortality. CONCLUSIONS: Compared to molecular detection, histological examination significantly underestimates the frequency of axillary node metastases. However, the increase in pN did not show a clinical effect on survival in those patients.

Breast cancer during pregnancy: matched study of diagnostic approach, tumor characteristics, and prognostic factors.

INTRODUCTION: Breast cancer is one of the most frequently occurring cancers during pregnancy and its incidence is increasing. Many studies have shown poor outcomes, the causes of which remain unclear. OBJECTIVES: To analyze radiologic characteristics, histology, and prognosis factors of breast cancer during pregnancy. METHODS: A total of 42 patients with breast cancer diagnosed during pregnancy (BCP) were matched with 84 patients with breast cancer of similar age who were not pregnant. Sensitivity of radiology, tumor characteristics, prognosis factors, disease-free survival, and overall survival were analyzed. RESULTS: The sensitivity of breast ultrasound was higher than that of mammography for both groups. Ultrasound sensitivity for cancer was 95.7% in patients with BCP versus 98% in the not pregnant group, with non-statistically significant differences. Mammography sensitivity for cancer was 56.5% in patients with BCP versus 61% in the not pregnant group, with non-statistically significant differences. The stage at diagnosis according to the TNM staging system was significantly higher in patients with BCP with stage IV cancer: 16.7% in patients with BCP versus 3.7% in the not pregnant group (p = 0.03). No statistically significant differences were observed in histologic grade, Ki-67 index, or molecular subtype. Disease-free survival and overall survival were significantly lower in patients with BCP (p = 0.002 and p = 0.04). Multivariate analysis showed no difference when adjusting for stage and surrogate molecular subtype. CONCLUSION: Breast ultrasound shows a high sensitivity to detect breast cancer during pregnancy. BCP is diagnosed at a higher stage than in nonpregnant women. In our series, patients with BCP had poorer outcomes than the not pregnant group. These results were not observed when adjusting for stage.

A randomized study comparing different doses of superparamagnetic iron oxide tracer for sentinel lymph node biopsy in breast cancer: The SUNRISE study.

INTRODUCTION: The non-radioactive method that uses the magnetic tracer (SPIO/Sienna) has shown to be a feasible technique for the SLN detection in breast cancer patients. The aim of this study is to assess the efficacy of different doses of a new magnetic tracer Sienna XP (Magtrace) compared to Tc-99 m and to evaluate its non-inferiority. METHODS: Patients diagnosed with early-stage breast cancer cT1-3 N0, from October 2016 to August 2018 were eligible and consecutively randomized to three different doses of new SPIO used: group 1 (1 mL), group 2 (1.5 mL) and group 3 (2 mL). RESULTS: A total of 135 patients were included in the study, 45 in each group. Detection of SLNs with the three doses of Sienna XP (1 mL, 1.5 mL and 2 mL) showed non-inferior rates compared to the conventional technique with radiotracer (p = 0.654). Concordance by patients with SLN positive was 100% for all groups. 83 (70.3%) patients reported skin staining at one month postoperatively, significantly lower in group 1 (p = 0.042). At 6 months follow up, group 1 remains with significantly lower skin discoloration (p = 0,01). In multivariate analysis, dose of 2 mL showed statistically significant for the skin staining. The majority of patients (70%) felt that skin discoloration does not represent a problem. CONCLUSION: The use of the Sienna XP magnetic tracer at 1 mL is not inferior to higher doses of magnetic tracer neither is inferior to radiotracer. 1 mL of magnetic tracer resulted in significantly less skin discoloration compared to higher doses.