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1.
Br J Surg ; 109(9): 857-863, 2022 08 16.
Artículo en Inglés | MEDLINE | ID: mdl-35766257

RESUMEN

BACKGROUND: There is no consensus on axillary management after neoadjuvant therapy (NAT) in patients with clinically node-positive (cN+) breast cancer. To investigate current clinical practice, an international survey was conducted among breast surgeons and radiation oncologists. The aim of the first part of the survey was to provide a snapshot of international discrepancies regarding axillary surgery in this context. METHODS: The European Breast Cancer Research Association of Surgical Trialists (EUBREAST) developed a web-based survey containing 39 questions describing clinical scenarios in the setting of axillary management in patients with cN1 disease converting to ycN0 after NAT. The survey was then distributed to breast surgeons and radiation oncologists via 14 breast cancer societies between April and October 2021. RESULTS: Responses from 349 physicians in 45 countries were recorded. The most common post-NAT axillary surgery in patients with cN1 disease converting to ycN0 was targeted axillary dissection (54.2 per cent), followed by sentinel lymph node biopsy (SLNB) alone (20.9 per cent), level 1-2 axillary lymph node dissection (ALND) (18.4 per cent), level 1-3 ALND (4 per cent), and targeted lymph node biopsy (2.5 per cent). For SLNB alone, dual tracers were most commonly used (62.3 per cent). Management varied widely in patients with ambiguous axillary status before initiation of treatment or a residual metastatic burden in the axilla after NAT. In patients with ycN+ tumours, ALND was the preferred surgical approach for 66.8 per cent of respondents. CONCLUSION: These results highlight the wide heterogeneity in surgical approaches to the axilla after NAT. To standardize the guidelines, further data from clinical research are urgently needed, which underlines the importance of the ongoing AXSANA (EUBREAST-3) study.


Asunto(s)
Neoplasias de la Mama , Terapia Neoadyuvante , Axila/patología , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/cirugía , Femenino , Humanos , Escisión del Ganglio Linfático/métodos , Ganglios Linfáticos/patología , Ganglios Linfáticos/cirugía , Terapia Neoadyuvante/métodos , Biopsia del Ganglio Linfático Centinela/métodos
2.
Oncologist ; 26(1): e66-e77, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33044007

RESUMEN

INTRODUCTION: The rapid spread of COVID-19 across the globe is forcing surgical oncologists to change their daily practice. We sought to evaluate how breast surgeons are adapting their surgical activity to limit viral spread and spare hospital resources. METHODS: A panel of 12 breast surgeons from the most affected regions of the world convened a virtual meeting on April 7, 2020, to discuss the changes in their local surgical practice during the COVID-19 pandemic. Similarly, a Web-based poll based was created to evaluate changes in surgical practice among breast surgeons from several countries. RESULTS: The virtual meeting showed that distinct countries and regions were experiencing different phases of the pandemic. Surgical priority was given to patients with aggressive disease not candidate for primary systemic therapy, those with progressive disease under neoadjuvant systemic therapy, and patients who have finished neoadjuvant therapy. One hundred breast surgeons filled out the poll. The trend showed reductions in operating room schedules, indications for surgery, and consultations, with an increasingly restrictive approach to elective surgery with worsening of the pandemic. CONCLUSION: The COVID-19 emergency should not compromise treatment of a potentially lethal disease such as breast cancer. Our results reveal that physicians are instinctively reluctant to abandon conventional standards of care when possible. However, as the situation deteriorates, alternative strategies of de-escalation are being adopted. IMPLICATIONS FOR PRACTICE: This study aimed to characterize how the COVID-19 pandemic is affecting breast cancer surgery and which strategies are being adopted to cope with the situation.


Asunto(s)
Neoplasias de la Mama/terapia , COVID-19/prevención & control , Mastectomía/tendencias , Pandemias/prevención & control , Pautas de la Práctica en Medicina/tendencias , Citas y Horarios , Neoplasias de la Mama/patología , COVID-19/epidemiología , COVID-19/transmisión , COVID-19/virología , Control de Enfermedades Transmisibles/organización & administración , Control de Enfermedades Transmisibles/normas , Progresión de la Enfermedad , Procedimientos Quirúrgicos Electivos/normas , Procedimientos Quirúrgicos Electivos/estadística & datos numéricos , Procedimientos Quirúrgicos Electivos/tendencias , Femenino , Carga Global de Enfermedades , Asignación de Recursos para la Atención de Salud/normas , Asignación de Recursos para la Atención de Salud/estadística & datos numéricos , Asignación de Recursos para la Atención de Salud/tendencias , Humanos , Mastectomía/economía , Mastectomía/normas , Mastectomía/estadística & datos numéricos , Terapia Neoadyuvante/estadística & datos numéricos , Quirófanos/economía , Quirófanos/estadística & datos numéricos , Quirófanos/tendencias , Selección de Paciente , Admisión y Programación de Personal/economía , Admisión y Programación de Personal/estadística & datos numéricos , Admisión y Programación de Personal/tendencias , Pautas de la Práctica en Medicina/economía , Pautas de la Práctica en Medicina/organización & administración , Pautas de la Práctica en Medicina/estadística & datos numéricos , Derivación y Consulta/estadística & datos numéricos , Derivación y Consulta/tendencias , SARS-CoV-2/patogenicidad , Cirujanos/estadística & datos numéricos , Encuestas y Cuestionarios/estadística & datos numéricos , Tiempo de Tratamiento
3.
Br J Surg ; 108(9): 1120-1125, 2021 09 27.
Artículo en Inglés | MEDLINE | ID: mdl-34089583

RESUMEN

BACKGROUND: Staging of the axilla is not routine in ductal cancer in situ (DCIS) although invasive cancer is observed in 20-25 per cent of patients at final pathology. Upfront sentinel lymph node dissection (SLND) is advocated in clinical practice guidelines in certain situations. These include expected challenges in subsequent SLN detection and when the risk for invasion is high. Clinical practice guidelines are, however, inconsistent and lead to considerable practice variability. METHODS: Clinical practice guidelines for upfront SLND in DCIS were identified and applied to patients included in the prospective SentiNot study. These patients were evaluated by six independent, blinded raters. Agreement statistics were performed to assess agreement and concordance. Receiver operating characteristic curves were constructed, to assess guideline accuracy in identifying patients with underlying invasion. RESULTS: Eight guidelines with relevant recommendations were identified. Interobserver agreement varied greatly (kappa: 0.23-0.9) and the interpretation as to whether SLND should be performed ranged from 40-90 per cent and with varying concordance (32-88 per cent). The diagnostic accuracy was low with area under the curve ranging from 0.45 to 0.55. Fifty to 90 per cent of patients with pure DCIS would undergo unnecessary SLNB, whereas 10-50 per cent of patients with invasion were not identified as 'high risk'. Agreement across guidelines was low (kappa = 0.24), meaning that different patients had a similar risk of being treated inaccurately. CONCLUSION: Available guidelines are inaccurate in identifying patients with DCIS who would benefit from upfront SLNB. Guideline refinement with detailed preoperative work-up and novel techniques for SLND identification could address this challenge and avoid overtreatment. LAY SUMMARY: The decision whether to operate on the axilla in women with a diagnosis of ductal cancer in situ (DCIS) is based on the risk of an undiagnosed underlying invasive cancer and on the concern that resection of the breast will not allow for accurate axillary mapping afterwards. Guidelines stem from older knowledge and are heterogeneous. In this study, different breast cancer guidelines were tested in a patient cohort from the SentiNot prospective trial for uniformity of interpretation and diagnostic accuracy. Results show that guidelines did not allow for easy and uniform interpretation and had the predictive ability of the toss of a coin. This suggests that guidelines regarding the need of axillary evaluation in patients operated for DCIS need to be revised and that techniques that will address the conundrum should be developed.


The decision whether to operate on the axilla in women with a diagnosis of ductal cancer in situ (DCIS) is based on the risk of an undiagnosed underlying invasive cancer and on the concern that resection of the breast will not allow for accurate axillary mapping afterwards. Guidelines stem from older knowledge and are heterogeneous. In this study, different breast cancer guidelines were tested in a patient cohort from the SentiNot prospective trial for uniformity of interpretation and diagnostic accuracy. Results show that guidelines did not allow for easy and uniform interpretation and had the predictive ability of the toss of a coin. This suggests that guidelines regarding the need of axillary evaluation in patients operated for DCIS need to be revised and that techniques that will address the conundrum should be developed.


Asunto(s)
Neoplasias de la Mama/diagnóstico , Carcinoma Intraductal no Infiltrante/secundario , Guías de Práctica Clínica como Asunto , Adulto , Anciano , Axila , Carcinoma Intraductal no Infiltrante/diagnóstico , Femenino , Humanos , Ganglios Linfáticos/patología , Metástasis Linfática , Persona de Mediana Edad , Estudios Prospectivos , Biopsia del Ganglio Linfático Centinela
4.
Oncologist ; 25(7): e1013-e1020, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32412693

RESUMEN

Northern Italy has been one of the European regions reporting the highest number of COVID-19 cases and deaths. The pandemic spread has challenged the National Health System, requiring reallocation of most of the available health care resources to treat COVID-19-positive patients, generating a competition with other health care needs, including cancer. Patients with cancer are at higher risk of developing critical illness after COVID-19 infection. Thus, mitigation strategies should be adopted to reduce the likelihood of infection in all patients with cancer. At the same time, suboptimal care and treatments may result in worse cancer-related outcome. In this article, we attempt to estimate the individual risk-benefit balance to define personalized strategies for optimal breast cancer management, avoiding as much as possible a general untailored approach. We discuss and report the strategies our Breast Unit adopted from the beginning of the COVID-19 outbreak to ensure the continuum of the best possible cancer care for our patients while mitigating the risk of infection, despite limited health care resources. IMPLICATIONS FOR PRACTICE: Managing patients with breast cancer during the COVID-19 outbreak is challenging. The present work highlights the need to estimate the individual patient risk of infection, which depends on both epidemiological considerations and individual clinical characteristics. The management of patients with breast cancer should be adapted and personalized according to the balance between COVID-19-related risk and the expected benefit of treatments. This work also provides useful suggestions on the modality of patient triage, the conduct of clinical trials, the management of an oncologic team, and the approach to patients' and health workers' psychological distress.


Asunto(s)
Betacoronavirus/patogenicidad , Neoplasias de la Mama/terapia , Infecciones por Coronavirus/prevención & control , Control de Infecciones/normas , Oncología Médica/organización & administración , Pandemias/prevención & control , Neumonía Viral/prevención & control , Adulto , Factores de Edad , Anciano , COVID-19 , Ensayos Clínicos como Asunto/organización & administración , Ensayos Clínicos como Asunto/normas , Continuidad de la Atención al Paciente/organización & administración , Continuidad de la Atención al Paciente/normas , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/transmisión , Infecciones por Coronavirus/virología , Femenino , Humanos , Control de Infecciones/organización & administración , Italia/epidemiología , Oncología Médica/normas , Persona de Mediana Edad , Neumonía Viral/epidemiología , Neumonía Viral/transmisión , Neumonía Viral/virología , Proyectos de Investigación/normas , Medición de Riesgo , Factores de Riesgo , SARS-CoV-2 , Telemedicina/organización & administración , Telemedicina/normas
5.
Ann Plast Surg ; 83(4): 384-387, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-31524728

RESUMEN

Throughout the last decade, aesthetic breast surgery has enormously spread in the outpatient clinic setting where plastic surgeons perform the vast majority of procedures under local anesthesia as day-case operations. The "tumescent anesthesia" is defined as the injection of a dilute solution of local anesthetic combined with epinephrine and sodium bicarbonate into subcutaneous tissue until it becomes firm and tense, which is "tumescent." The "cold tumescent anesthesia" (CTA) derives from Klein's solution with the introduction of a new concept, which is the low temperature (4°C) of the injected solution. This novelty adds further anesthetic and hemostatic power to the well-known benefits of tumescent anesthesia. The authors report their experience with CTA in the last 15 years in the setting of aesthetic breast surgery, describing in detail the anesthesia protocol, surgical outcomes, and patient satisfaction. A total of 1541 patients were operated on during the study period and were included in this retrospective analysis. The types of breast procedures were breast augmentation in 762 cases (49.4%), mastopexy with implants in 123 patients (8.0%), mastopexy without implants in 452 cases (29.3%), and breast reduction in 204 cases (13.3%). Patient mean age was 42.8 years (range, 18-67 years). The mean operating time was 37 ± 32 minutes for breast augmentation, 78 ± 24 minutes for mastopexy with implants, 58 ± 18 minutes for mastopexy without implants, and 95 ± 19 minutes for breast reduction. No major complications occurred, and no conversion to general anesthesia was required. The median recovery time was 150 minutes (range, 120-210 minutes), and all patients were discharged within 3 hours after surgery. Wound or implant infections occurred in 33 patients (2.1%), wound dehiscences in 21 (1.4%), and postoperative bleeding requiring return to theater in 2 cases (0.1%). Thirteen patients (0.8%) developed capsular contracture. Fifteen patients (1%) required reintervention due to implant rotation or rupture. The median visual analog scale score was 1.8 (interquartile range, 1-3) after discharge. Patient satisfaction was very high in 91.3% (n = 1407) of the cases. In experienced hands, CTA can shorten operating time with high patient satisfaction and a low complication rate. These preliminary data could be hypothesis generating for future multicenter prospective trials done to confirm the benefits of CTA in other surgical fields.


Asunto(s)
Anestesia Local/métodos , Anestésicos Locales/administración & dosificación , Frío , Mamoplastia/métodos , Satisfacción del Paciente/estadística & datos numéricos , Adulto , Procedimientos Quirúrgicos Ambulatorios/métodos , Implantación de Mama/efectos adversos , Implantación de Mama/métodos , Estudios de Cohortes , Estética , Estudios de Factibilidad , Femenino , Humanos , Mamoplastia/efectos adversos , Persona de Mediana Edad , Tempo Operativo , Dolor Postoperatorio/fisiopatología , Cuidados Preoperatorios/métodos , Estudios Retrospectivos , Cirugía Plástica/efectos adversos , Cirugía Plástica/métodos , Resultado del Tratamiento , Estados Unidos
6.
Medicina (Kaunas) ; 55(8)2019 Jul 29.
Artículo en Inglés | MEDLINE | ID: mdl-31362334

RESUMEN

Women carrying a BRCA mutation have an increased risk of developing breast and ovarian cancer. The most effective strategy to reduce this risk is the bilateral salpingo-oophorectomy, with or without additional risk-reducing mastectomy. Risk-reducing bilateral salpingo-oophorectomy (RRBSO) is recommended between age 35 and 40 and between age 40 and 45 years for women carriers of BRCA1 and BRCA2 mutations, respectively. Consequently, most BRCA mutation carriers undergo this procedure prior to a natural menopause and develop an anticipated lack of hormones. This condition has a detrimental impact on various systems, affecting both the quality of life and longevity; in particular, women carrying BRCA1 mutation, who are likely to have surgery earlier as compared to BRCA2. Hormonal replacement therapy (HRT) is the only effective strategy able to significantly compensate the hormonal deprivation and counteract menopausal symptoms, both in spontaneous and surgical menopause. Although recent evidence suggests that HRT does not diminish the protective effect of RRBSO in BRCA mutation carriers, concerns regarding the safety of estrogen and progesterone intake reduce the use in this setting. Furthermore, there is strong data demonstrating that the use of estrogen alone after RRBSO does not increase the risk of breast cancer among women with a BRCA1 mutation. The additional progesterone intake, mandatory for the protection of the endometrium during HRT, warrants further studies. However, when hysterectomy is performed at the time of RRBSO, the indication of progesterone addition decays and consequently its potential effect on breast cancer risk. Similarly, in patients conserving the uterus but undergoing risk-reducing mastectomy, the addition of progesterone should not raise significant concerns for breast cancer risk anymore. Therefore, BRCA mutation carriers require careful counselling about the scenarios following their RRBSO, menopausal symptoms or the fear associated with HRT use.


Asunto(s)
Terapia de Reemplazo de Hormonas/métodos , Salpingooforectomía/métodos , Adulto , Proteína BRCA1/análisis , Proteína BRCA1/sangre , Proteína BRCA2/análisis , Proteína BRCA2/sangre , Femenino , Predisposición Genética a la Enfermedad/genética , Predisposición Genética a la Enfermedad/prevención & control , Terapia de Reemplazo de Hormonas/normas , Humanos , Persona de Mediana Edad , Conducta de Reducción del Riesgo , Salpingooforectomía/rehabilitación
7.
Breast Cancer Res Treat ; 164(2): 385-393, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28447239

RESUMEN

PURPOSE: To establish whether objective measurements of symmetry of volume and shape using three-dimensional surface imaging (3D-SI) can be used as surrogate markers of aesthetic outcome in patients who have undergone breast conserving therapy (BCT). METHODS: Women who had undergone unilateral BCT in the preceding 1-6 years were invited to participate. Participants completed a satisfaction questionnaire (BREAST-Q) and underwent 3D-SI. Volume and surface symmetry were measured on the images. Assessment of aesthetic outcome was undertaken by a panel of clinicians. The Kruskal-Wallis test was used to assess the relationship between volume and shape symmetry measurements with the panel score. Spearman's rho correlations were used to assess the relationship between the measurements and patient satisfaction. RESULTS: 200 women participated. Median volume symmetry was 87% (IQR 78-93) and shape symmetry was 5.9 mm (IQR 4.2-8.0). The participants were grouped according to panel assessment of aesthetic outcome (poor, fair, good, excellent) and the median volume and shape symmetry was calculated for each group. Volume symmetry significantly differed between the groups. Post hoc pairwise comparisons demonstrated that these differences existed between panel scores of fair versus good and good versus excellent. Median shape symmetry also differed according to patient panel groups with four significant pairwise comparisons between poor versus good, poor versus excellent, fair versus good and fair versus excellent. There was a significant but weak correlation of both volume symmetry and surface asymmetry with BREAST-Q scores (correlation coefficients 0.187 and -0.229, respectively). CONCLUSION: Breast volume and shape symmetry are both associated with panel assessment scores and patient satisfaction. The objective volume and shape symmetry measures were strongly associated with panel assessment scores, such that a 3D-SI tool could replace panel assessment as a faster and more objective method of evaluating aesthetic outcomes.


Asunto(s)
Neoplasias de la Mama/cirugía , Imagenología Tridimensional/métodos , Mastectomía Segmentaria/psicología , Satisfacción del Paciente , Anciano , Neoplasias de la Mama/diagnóstico por imagen , Femenino , Humanos , Mamografía , Persona de Mediana Edad , Resultado del Tratamiento
8.
Aging Clin Exp Res ; 29(Suppl 1): 139-142, 2017 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-27878556

RESUMEN

AIM: Surgical treatment is still the cornerstone in the treatment of breast cancer, a very common neoplasia, particularly affecting the female elderly population. Axillary dissection is crucial in the treatment of some tumours, but variations in axillary vessels anatomy are poorly described in standard anatomy and surgical textbook. We aimed to describe anatomical variations in axillary vessels found in our institutional experience. PATIENTS AND METHODS: A prospective 3-year study was conducted in our institution from January 2012 to December 2014. Sixty-one consecutive axillary lymph node dissections (ALNDs) were performed in 61 patients who underwent surgery for stage II and III invasive breast cancer. Anatomical details of axillary vascular anatomy and its variations have been evaluated, described and stored in a prospective database. RESULTS: Sixty-one ALNDs have been performed in the study period. The anatomy of lateral thoracic vein, angular vein and axillary vein was studied and compared with standard anatomical description. Eighteen percentage of venous variations were found out of the 61 dissection performed. CONCLUSIONS: Vascular anatomy of axilla is complex and variable. A better knowledge of all possible variations might be helpful in preventing injuries during ALND.


Asunto(s)
Axila , Neoplasias de la Mama , Complicaciones Intraoperatorias/prevención & control , Escisión del Ganglio Linfático , Mastectomía/métodos , Malformaciones Vasculares , Lesiones del Sistema Vascular/prevención & control , Anciano , Axila/irrigación sanguínea , Axila/patología , Vena Axilar/anomalías , Vena Axilar/patología , Neoplasias de la Mama/patología , Neoplasias de la Mama/cirugía , Femenino , Humanos , Escisión del Ganglio Linfático/efectos adversos , Escisión del Ganglio Linfático/métodos , Metástasis Linfática , Persona de Mediana Edad , Estadificación de Neoplasias , Estudios Prospectivos , Malformaciones Vasculares/diagnóstico por imagen , Malformaciones Vasculares/patología , Lesiones del Sistema Vascular/etiología
11.
Eur J Cancer Prev ; 32(6): 544-547, 2023 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-37401512

RESUMEN

The present review intends to discuss the controversies and strengths in clinically node-positive patients with axillary nodal status ypN i+ / mi after neoadjuvant chemotherapy. Over the past 20 years, a de-escalation approach toward axillary surgery has been observed in patients with breast cancer. The worldwide use of sentinel node biopsy in the upfront setting and after primary systemic therapy substantially reduced surgical complications or late sequelae and eventually improving quality of life of patients. However, the role of axillary dissection is still unclear in patients with low residual disease post-chemotherapy, namely those with micrometastases in the sentinel node, and its prognostic role is still not very clear. The aim of the present narrative review is to report the available evidence on this topic, discussing the pros and cons of performing axillary lymph node dissection in the infrequent finding of micrometastases in the sentinel node after neoadjuvant chemotherapy. We will also describe the ongoing prospective studies which are expected to shed light and guide future decisions.


Asunto(s)
Neoplasias de la Mama , Terapia Neoadyuvante , Humanos , Femenino , Micrometástasis de Neoplasia/patología , Estudios Prospectivos , Calidad de Vida , Metástasis Linfática , Escisión del Ganglio Linfático , Biopsia del Ganglio Linfático Centinela , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/cirugía , Neoplasias de la Mama/patología
12.
PLoS One ; 18(8): e0289365, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37535564

RESUMEN

BACKGROUND: Breast cancer therapy improved significantly, allowing for different surgical approaches for the same disease stage, therefore offering patients different aesthetic outcomes with similar locoregional control. The purpose of the CINDERELLA trial is to evaluate an artificial-intelligence (AI) cloud-based platform (CINDERELLA platform) vs the standard approach for patient education prior to therapy. METHODS: A prospective randomized international multicentre trial comparing two methods for patient education prior to therapy. After institutional ethics approval and a written informed consent, patients planned for locoregional treatment will be randomized to the intervention (CINDERELLA platform) or controls. The patients in the intervention arm will use the newly designed web-application (CINDERELLA platform, CINDERELLA APProach) to access the information related to surgery and/or radiotherapy. Using an AI system, the platform will provide the patient with a picture of her own aesthetic outcome resulting from the surgical procedure she chooses, and an objective evaluation of this aesthetic outcome (e.g., good/fair). The control group will have access to the standard approach. The primary objectives of the trial will be i) to examine the differences between the treatment arms with regards to patients' pre-treatment expectations and the final aesthetic outcomes and ii) in the experimental arm only, the agreement of the pre-treatment AI-evaluation (output) and patient's post-therapy self-evaluation. DISCUSSION: The project aims to develop an easy-to-use cost-effective AI-powered tool that improves shared decision-making processes. We assume that the CINDERELLA APProach will lead to higher satisfaction, better psychosocial status, and wellbeing of breast cancer patients, and reduce the need for additional surgeries to improve aesthetic outcome.


Asunto(s)
Inteligencia Artificial , Neoplasias de la Mama , Femenino , Humanos , Neoplasias de la Mama/cirugía , Nube Computacional , Inteligencia , Satisfacción del Paciente , Estudios Prospectivos
13.
JAMA Oncol ; 9(11): 1557-1564, 2023 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-37733364

RESUMEN

Importance: Sentinel lymph node biopsy (SLNB) is the standard of care for axillary node staging of patients with early breast cancer (BC), but its necessity can be questioned since surgery for examination of axillary nodes is not performed with curative intent. Objective: To determine whether the omission of axillary surgery is noninferior to SLNB in patients with small BC and a negative result on preoperative axillary lymph node ultrasonography. Design, Setting, and Participants: The SOUND (Sentinel Node vs Observation After Axillary Ultra-Sound) trial was a prospective noninferiority phase 3 randomized clinical trial conducted in Italy, Switzerland, Spain, and Chile. A total of 1463 women of any age with BC up to 2 cm and a negative preoperative axillary ultrasonography result were enrolled and randomized between February 6, 2012, and June 30, 2017. Of those, 1405 were included in the intention-to-treat analysis. Data were analyzed from October 10, 2022, to January 13, 2023. Intervention: Eligible patients were randomized on a 1:1 ratio to receive SLNB (SLNB group) or no axillary surgery (no axillary surgery group). Main Outcomes and Measures: The primary end point of the study was distant disease-free survival (DDFS) at 5 years, analyzed as intention to treat. Secondary end points were the cumulative incidence of distant recurrences, the cumulative incidence of axillary recurrences, DFS, overall survival (OS), and the adjuvant treatment recommendations. Results: Among 1405 women (median [IQR] age, 60 [52-68] years) included in the intention-to-treat analysis, 708 were randomized to the SLNB group, and 697 were randomized to the no axillary surgery group. Overall, the median (IQR) tumor size was 1.1 (0.8-1.5) cm, and 1234 patients (87.8%) had estrogen receptor-positive ERBB2 (formerly HER2 or HER2/neu), nonoverexpressing BC. In the SLNB group, 97 patients (13.7%) had positive axillary nodes. The median (IQR) follow-up for disease assessment was 5.7 (5.0-6.8) years in the SLNB group and 5.7 (5.0-6.6) years in the no axillary surgery group. Five-year distant DDFS was 97.7% in the SLNB group and 98.0% in the no axillary surgery group (log-rank P = .67; hazard ratio, 0.84; 90% CI, 0.45-1.54; noninferiority P = .02). A total of 12 (1.7%) locoregional relapses, 13 (1.8%) distant metastases, and 21 (3.0%) deaths were observed in the SLNB group, and 11 (1.6%) locoregional relapses, 14 (2.0%) distant metastases, and 18 (2.6%) deaths were observed in the no axillary surgery group. Conclusions and Relevance: In this randomized clinical trial, omission of axillary surgery was noninferior to SLNB in patients with small BC and a negative result on ultrasonography of the axillary lymph nodes. These results suggest that patients with these features can be safely spared any axillary surgery whenever the lack of pathological information does not affect the postoperative treatment plan. Trial Registration: ClinicalTrials.gov Identifier: NCT02167490.


Asunto(s)
Neoplasias de la Mama , Biopsia del Ganglio Linfático Centinela , Humanos , Femenino , Persona de Mediana Edad , Biopsia del Ganglio Linfático Centinela/métodos , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/cirugía , Neoplasias de la Mama/mortalidad , Estudios Prospectivos , Resultados Negativos , Recurrencia Local de Neoplasia/patología , Ganglios Linfáticos/diagnóstico por imagen , Ganglios Linfáticos/cirugía , Ganglios Linfáticos/patología , Ultrasonografía , Recurrencia
14.
Cancers (Basel) ; 15(4)2023 Feb 12.
Artículo en Inglés | MEDLINE | ID: mdl-36831516

RESUMEN

BACKGROUND: Surgical excision of a non-palpable breast lesion requires a localization step. Among available techniques, wire-guided localization (WGL) is most commonly used. Other techniques (radioactive, magnetic, radar or radiofrequency-based, and intraoperative ultrasound) have been developed in the last two decades with the aim of improving outcomes and logistics. METHODS: We performed a systematic review on localization techniques for non-palpable breast cancer. RESULTS: For most techniques, oncological outcomes such as lesion identification and clear margin rate seem either comparable with or better than for WGL, but evidence is limited to small cohort studies for some of the devices. Intraoperative ultrasound is associated with significantly higher negative margin rates in meta-analyses of randomized clinical trials (RCTs). Radioactive techniques were studied in several RCTs and are non-inferior to WGL. Smaller studies show higher patient preference towards wire-free localization, but little is known about surgeons' and radiologists' attitudes towards these techniques. CONCLUSIONS: Large studies with an additional focus on patient, surgeon, and radiologist preference are necessary. This review aims to present the rationale for the MELODY (NCT05559411) study and to enable standardization of outcome measures for future studies.

15.
Cancer Treat Rev ; 117: 102556, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37126938

RESUMEN

The aims of this Oncoplastic Breast Consortium and European Breast Cancer Research Association of Surgical Trialists initiative were to identify uncertainties and controversies in axillary management of early breast cancer and to recommend appropriate strategies to address them. By use of Delphi methods, 15 questions were prioritized by more than 250 breast surgeons, patient advocates and radiation oncologists from 60 countries. Subsequently, a global virtual consensus panel considered available data, ongoing studies and resource utilization. It agreed that research should no longer be prioritized for standardization of axillary imaging, de-escalation of axillary surgery in node-positive cancer and risk evaluation of modern surgery and radiotherapy. Instead, expert consensus recommendations for clinical practice should be based on current evidence and updated once results from ongoing studies become available. Research on de-escalation of radiotherapy and identification of the most relevant endpoints in axillary management should encompass a meta-analysis to identify knowledge gaps, followed by a Delphi process to prioritize and a consensus conference to refine recommendations for specific trial designs. Finally, treatment of residual nodal disease after surgery was recommended to be assessed in a prospective register.


Asunto(s)
Neoplasias de la Mama , Humanos , Femenino , Neoplasias de la Mama/cirugía , Neoplasias de la Mama/radioterapia , Escisión del Ganglio Linfático/métodos , Metástasis Linfática , Biopsia del Ganglio Linfático Centinela
16.
Ann Ital Chir ; 83(5): 429-32, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-23064305

RESUMEN

Bariatric surgery procedures are more and more performed in women of reproductive age, whose fertility often increases after weight loss, so they frequently become pregnant. In this condition they require appropriate management, according to the type of procedure, malabsorptive or restrictive. If health risks related to obesity (gestational diabetes, pregnancy induced hypertension, pre-eclampsia) decrease after weight loss, other risks related to bariatric procedures could appear. LAGB is a safe and well-tolerated procedure, but some complications could appear more frequently during pregnancy; some symptoms could be suggestive for important complications, that if not treated in the best way could threaten mother and child's health. Emesis of the first trimester could favor slippage, thus influencing feeding and fetal growth. The slippage of the band is a common complication of LAGB, that usually does not lead to serious conditions, but in our case the pregnant risked a lot because of malnutrition. The purpose of this article is to present an obstetric case study of a woman who experienced this complication postbariatric surgery and the implications for mother and child. A correct diagnosis and management of the clinical case led to a positive conclusion, thus underlining bariatric surgery and its complications should be known and taken into account by every physician.


Asunto(s)
Gastroplastia , Hiperemesis Gravídica/complicaciones , Falla de Prótesis/etiología , Adulto , Femenino , Humanos , Embarazo
17.
EClinicalMedicine ; 31: 100708, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33490932

RESUMEN

In 2020, the American Society of Clinical Oncology (ASCO) annual meeting was held as a virtual conference. Overall, 461 abstracts focused on breast cancer management. As European Breast Cancer Association of Surgical Trialists (EUBREAST) we summarize and comment the results of these abstracts dealing with axillary management in breast cancer patients and offer an interpretation on how these findings may be incorporated into clinical practice and further research.

18.
Breast ; 60: 155-162, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34627117

RESUMEN

INTRODUCTION: Preliminary clinical evidence suggests a detrimental effect of pathogenic variants of BRCA1 and 2 genes on fertility outcome. This meta-analysis evaluates whether women carrying BRCA mutations (BRCAm) have decreased ovarian reserve, in terms of Anti-Muellerian Hormone (AMH), compared to women without BRCAm (wild-type). MATERIAL AND METHODS: Systematic searches of PubMed, Medline, Scopus, Embase, Science Direct and the Cochrane Library from inception until July 2020 were conducted. All studies comparing AMH level in fertile age women, with and without BRCA pathogenic variants were considered. Sub-analyses were performed according to age, presence of breast cancer, and type of mutation. RESULTS: Among 64 studies, 10 series were included. For the entire cohort, a trend of reduced AMH level were found between BRCAm carriers and women without pathogenic variants. BRCAm carriers aged 41-years or younger had lower AMH levels compared to 41-years or younger wild type women (OR: 0.73 [95%CI-1.12;-0.35]; p = 0.0002). This finding was confirmed for BRCA1m carriers (OR: 1 [95%CI-1.96;-0.05]; p = 0.004) whereas no difference was observed between BRCA2m carriers and wild type women. The same analysis on breast cancer patients with and without BRCAm achieved the same results. CONCLUSION: Young BRCA1m carriers seem to have lower AMH level compared with wild type women and therefore a potential decreased ovarian reserve.


Asunto(s)
Neoplasias de la Mama , Reserva Ovárica , Hormona Antimülleriana , Neoplasias de la Mama/genética , Femenino , Heterocigoto , Humanos , Mutación , Reserva Ovárica/genética
19.
Cancers (Basel) ; 13(9)2021 04 24.
Artículo en Inglés | MEDLINE | ID: mdl-33923153

RESUMEN

BACKGROUND: use of fibrin sealants following pelvic, paraaortic, and inguinal lymphadenectomy may reduce lymphatic morbidity. The aim of this meta-analysis is to evaluate if this finding applies to the axillary lymphadenectomy. METHODS: randomized trials evaluating the efficacy of fibrin sealants in reducing axillary lymphatic complications were included. Lymphocele, drainage output, surgical-site complications, and hospital stay were considered as outcomes. RESULTS: twenty-three randomized studies, including patients undergoing axillary lymphadenectomy for breast cancer, melanoma, and Hodgkin's disease, were included. Fibrin sealants did not affect axillary lymphocele incidence nor the surgical site complications. Drainage output, days with drainage, and hospital stay were reduced when fibrin sealants were applied (p < 0.0001, p < 0.005, p = 0.008). CONCLUSION: fibrin sealants after axillary dissection reduce the total axillary drainage output, the duration of drainage, and the hospital stay. No effects on the incidence of postoperative lymphocele and surgical site complications rate are found.

20.
Breast ; 57: 25-35, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-33711697

RESUMEN

INTRODUCTION: The potential advantages of oncoplastic breast conserving surgery (BCS) have not been validated in robust studies that constitute high levels of evidence, despite oncoplastic techniques being widely adopted around the globe. There is hence the need to define the precise role of oncoplastic BCS in the treatment of early breast cancer, with consensual recommendations for clinical practice. METHODS: A panel of world-renowned breast specialists was convened to evaluate evidence, express personal viewpoints and establish recommendations for the use of oncoplastic BCS as primary treatment of unifocal early stage breast cancers using the GRADE approach. RESULTS: According to the results of the systematic review of literature, the panelists were asked to comment on the recommendation for use of oncoplastic BCS for treatment of operable breast cancer that is suitable for breast conserving surgery, with the GRADE approach. Based on the voting outcome, the following recommendation emerged as a consensus statement: Oncoplastic breast conserving surgery should be recommended versus standard breast conserving surgery for the treatment of operable breast cancer in adult women who are suitable candidates for breast conserving surgery (with very low certainty of evidence). DISCUSSION: This review has revealed a low level of evidence for most of the important outcomes in oncoplastic surgery with lack of any randomized data and absence of standard tools for evaluation of clinical outcomes and especially patients' values. Despite areas of controversy, about one-third (36%) of panel members expressed a strong recommendation in support of oncoplastic BCS. Presumably, this reflects a synthesis of views on the relative complexity of these techniques, associated complications, impact on quality of life and costs.


Asunto(s)
Neoplasias de la Mama/cirugía , Mastectomía Segmentaria , Neoplasias de la Mama/patología , Estudios Transversales , Femenino , Enfoque GRADE , Humanos , Estudios Prospectivos , Calidad de Vida
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