Coexistence field trials between MON810 and conventional maize in Mallorca as a basis for a regional regulatory proposal based on scientific evidence in the times of genome editing.

This paper reports the first coexistence field trials between transgenic and conventional maize carried out under Mediterranean island conditions. Their purpose was to assess the local validity of pollen barriers and sowing delays as coexistence strategies as a basis for a regional regulation on the subject. Two field trials were performed in two agricultural states of Alcudia and Palma, in Mallorca (Spain). In the first one, two adjacent plots were synchronously sown with conventional and transgenic maize, respectively. In the second trial, the previous design was replicated, and two additional plots sown with GM maize were added, paired with their respective conventional recipient plots sown 2 and 4 weeks later. All conventional plots were located downwind from their respective GM plots. Of the two conventional plots in sowing synchrony, only one of them required a 2.25 m pollen barrier to meet the 0.9% labeling threshold. A 4-week sowing delay between GM and non-GM plots proved to be enough to keep the GM content of the recipient plots below the legal threshold. However, with a 2-week sowing delay additional coexistence measures such as pollen barriers might be needed, as suggested in the literature. Results are consistent with previous research conducted in the northeast of Spain, thus validating in the island's agroclimatic conditions a model successfully tested in that peninsular region which allows to accurately estimate the need and width of pollen barriers. The results presented here could perhaps be extrapolated to other islands, coastal areas, and regions with stable prevailing winds during the maize flowering season.

Sentinel lymph node biopsy before and after neoadjuvant chemotherapy in cN0 breast cancer patients: impact on axillary morbidity and survival-a propensity score cohort study.

PURPOSE: In patients with clinically lymph node-negative (cN0) breast cancer, performing sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) has been preferentially embraced in comparison to before NACT. However, survival outcomes associated with both strategies remain understudied. We aimed to compare the axillary lymphadenectomy (ALND) rate, disease-free survival (DFS), and overall survival (OS), between two strategies. METHODS: We included 310 patients in a retrospective observational study. SNLB was performed before NACT from December 2006 to April 2014 (107 cases) and after NACT from May 2014 to May 2020 (203 patients). An inverse probability of treatment weighting (IPTW) method was applied to homogenize both groups. Hazard ratios (HR) and odd ratios (OR) are reported with 95% confidence intervals (95%CI). RESULTS: The lymphadenectomy rate was 29.9% before NACT and 7.4% after NACT (p < 0.001), with an OR of 5.35 95%CI (2.7-10.4); p = .002. After 4 years of follow-up, SLNB after NACT was associated with lower risk for DFS, HR 0.42 95%CI (0.17-1.06); p = 0.066 and better OS, HR 0.21 CI 95% (0.07-0.67); p = 0.009 than SLNB before NACT. After multivariate analysis, independent adverse prognostic factors for OS included SLNB before NACT, HR 3.095 95%CI (2.323-4.123), clinical nonresponse to NACT, HR 1.702 95% CI (1.012-2.861), and small tumors (cT1) with high proliferation index, HR 1.889 95% (1.195-2.985). CONCLUSION: Performing SLNB before NACT results in more ALND and has no benefit for patient survival. These findings support discontinuing the practice of SLNB before NACT in patients with cN0 breast cancer.

Banff 2022 pancreas transplantation multidisciplinary report: Refinement of guidelines for T cell-mediated rejection, antibody-mediated rejection and islet pathology. Assessment of duodenal cuff biopsies and noninvasive diagnostic methods.

The Banff pancreas working schema for diagnosis and grading of rejection is widely used for treatment guidance and risk stratification in centers that perform pancreas allograft biopsies. Since the last update, various studies have provided additional insight regarding the application of the schema and enhanced our understanding of additional clinicopathologic entities. This update aims to clarify terminology and lesion description for T cell-mediated and antibody-mediated allograft rejections, in both active and chronic forms. In addition, morphologic and immunohistochemical tools are described to help distinguish rejection from nonrejection pathologies. For the first time, a clinicopathologic approach to islet pathology in the early and late posttransplant periods is discussed. This update also includes a discussion and recommendations on the utilization of endoscopic duodenal donor cuff biopsies as surrogates for pancreas biopsies in various clinical settings. Finally, an analysis and recommendations on the use of donor-derived cell-free DNA for monitoring pancreas graft recipients are provided. This multidisciplinary effort assesses the current role of pancreas allograft biopsies and offers practical guidelines that can be helpful to pancreas transplant practitioners as well as experienced pathologists and pathologists in training.

Primer consenso español sobre el uso de la radioterapia intraoperatoria en el cáncer de mama. Conclusiones del panel de expertos / First Spanish consensus on the use of intraoperative radiotherapy in breast cancer. Conclusions of the expert panel

Introducción: la publicación de ensayos aleatorizados con resultados a largo plazo ha demostrado que la radioterapia intraoperatoria (RIO) en cáncer de mama en estadio precoz puede ser una alternativa terapéutica en casos bien seleccionados. En el presente trabajo se presentan los resultados del Primer Consenso de Radioterapia Intraoperatoria en Cáncer de Mama realizado de manera multidisciplinar en España. Material y método: se hizo una revisión sistemática de la literatura y se invitó a todos los oncólogos radioterápicos y cirujanos expertos en RIO en cáncer de mama de España a participar en el consenso. Se aplico la siguiente metodología en 2 fases: a) la creación de un grupo de trabajo y la revisión de la evidencia; b) la realización de la encuesta y generación de recomendaciones consensuadas. Resultados: han participado un total 95,65% de los centros que actualmente utilizan esta técnica en cáncer de mama y que fueron invitados. Los expertos estuvieron de acuerdo en el uso de RIO exclusiva en cáncer de mama en aquellas pacientes mayores de 60 años y por encima de 50 años posmenopáusicas, con carcinoma ductal infiltrante o subtipos histológicos favorables, sin invasión linfovascular, tumores menores o iguales a 25 mm, márgenes de resección libres y receptores hormonales positivos. La utilización de RIO como rescate de recidiva local después de la irradiación externa alcanzó un nivel de consenso muy fuerte. Conclusión: el presente consenso pretende establecer las guías respecto a las indicaciones de RIO exclusiva o como sobreimpresión anticipada y ser una ayuda para la toma conjunta de decisiones. (AU)

Introduction: The publication of randomized trials with long-term results has demonstrated that intraoperative radiation therapy (IORT) in early-stage breast cancer can be a therapeutic alternative for well-selected cases. This paper present work presents the results of the first multidisciplinary consensus on IORT in breast cancer carried out in Spain. Materials and methods: A systematic literature review was conducted, and all radiation oncologists and surgeons with expertise in IORT for breast cancer in Spain were invited to participate in the consensus. The following methodology was employed in two phases: a) creation of a working group and review of the evidence; b) conduct of the survey and generation of consensus recommendations. Results: A total of 95.65% of the invited centers currently utilizing this technique in breast cancer participated. The experts agreed on the use of exclusive intraoperative radiation therapy in breast cancer for patients above 60 years of age and above 50 years postmenopausal, with invasive ductal carcinoma or favorable histological subtypes, no lymphovascular invasion, tumors less than or equal to 25 mm, clear surgical margins, and positive hormone receptor. The use of IORT as salvage surgery for local recurrence after external irradiation achieved a very strong consensus level. Conclusion: The present consensus aims to establish guidelines regarding the indications for exclusive IORT or as an early boost, and to serve as an aid for joint decision-making. (AU)

Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinel nodes after neoadjuvant therapy (ADARNAT trial).

Introduction: Breast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this has significantly reduced the incidence of lymphedema without worsening the prognosis. However, patients treated with neoadjuvant systemic treatment (NST) cannot benefit from this option despite the low incidence of residual disease in the armpit in most cases. Data regarding the use of radiotherapy instead of ALND in this population are lacking. This study will assess whether ART is non-inferior to ALND in terms of recurrence and overall survival in patients with positive SLN after NST, including whether it reduces surgery-related adverse effects. Methods and analyses: This multicenter, randomized, open-label, phase 3 trial will enroll 1660 patients with breast cancer and positive SLNs following NST in approximately 50 Spanish centers over 3 years. Patients will be stratified by NST regimen and nodal involvement (isolated tumoral cells or micrometastasis versus macrometastasis) and randomly assigned 1:1 to ART without ALND (study arm) or ALND alone (control arm). Level 3 and supraclavicular radiotherapy will be added in both arms. The primary outcome is the 5-year axillary recurrence determined by clinical and radiological examination. The secondary outcomes include lymphedema or arm dysfunction, quality of life based (EORTC QLQ-C30 and QLQ-BR23 questionnaires), disease-free survival, and overall survival. Discussion: This study aims to provide data to confirm the efficacy and safety of ART over ALND in patients with a positive SLN after NST, together with the impact on morbidity. Ethics and dissemination: The Research Ethics Committee of Bellvitge University Hospital approved this trial (Protocol Record PR148/21, version 3, 1/2/2022) and all patients must provide written informed consent. The involvement of around 50 centers across Spain will facilitate the dissemination of our results. Trial registration: ClinicalTrials.gov, identifier number NCT04889924.

Associations between Menopausal Hormone Therapy and Colorectal, Lung, or Melanoma Cancer Recurrence and Mortality: A Narrative Review.

Objective: to develop eligibility criteria for use in non-gynecological cancer patients. Methods: We searched all the articles published in peer-reviewed journals up to March 2021. We utilized the PICOS standards and the following selection criteria: menopausal women with a history of non-gynecological and non-breast cancer who underwent hormone replacement therapy (HRT) using various preparations (oestrogens alone or in combination with a progestogen, tibolone, or tissue selective oestrogen complex) and different routes of administration (including oral, transdermal, vaginal, or intra-nasal). We focused on randomized controlled trials as well as relevant extension studies or follow-up reports, specifically examining recurrence and mortality outcomes. Results: Women colorectal cancer survivors who use MHT have a lower risk of death from any cause than those survivors who do not use MHT. Women who are skin melanoma survivors using MHT have a longer survival rate than non-MHT survivors. There is no evidence that women lung cancer survivors who use MHT have a different survival rate than those who do not use MHT. Conclusions: MHT is safe for women who have a history of colorectal, lung, or skin melanoma cancers.

Evaluation of breast cancer screening indicators in the female population using the National Health System, Brazil, 2018-2019: a descriptive study.

OBJETIVE: to analyze breast cancer screening monitoring indicators in the female population using the Brazilian National Health System, from 2018 to 2019. METHODS: this was a descriptive study based on Cancer Information System (SISCAN) data; screening indicators were calculated following deterministic linkage of the mammography and histopathology databases. RESULTS: in 2018, 807,430 women aged 50 to 69 years were screened for breast cancer, 91% of whom had a benign result, 1.8% probably benign, 6.7% inconclusive results and 0.5% results suggestive of cancer; the positive mammogram rate was 9.0%; biopsy was estimated to be indicated for 1.6% of the women, 33.9% of whom had a malignant result, and the cancer confirmation rate was 5.4 per 1,000 women. CONCLUSION: high benign lesion loss to follow-up was identified; the positive mammogram rate was lower than the international parameter, but the cancer detection rate was adequate and the percentage of inconclusive mammograms was acceptable.

Management of the axilla in postmenopausal patients with cN0 hormone receptor-positive/HER2-negative breast cancer treated with neoadjuvant endocrine therapy and its prognostic impact.

PURPOSE: To evaluate the differences in nodal positivity if the sentinel lymph node biopsy (SLNB) is performed before or after neoadjuvant endocrine therapy (NET) in breast cancer patients, and its impact on prognosis. METHODS: A retrospective cohort study was performed in a single center including 91 postmenopausal cases with clinically node-negative and hormone receptor-positive/HER2-negative (HR + /HER2-) breast cancer, treated with NET and SLNB. SLNB was done pre-NET until 2014, and post-NET thereafter. Axillary lymph node dissection (ALND) was indicated only in SLNB macrometastasis, although in selected elderly patients, it was omitted. Kaplan-Meier survival curves were estimated in relation to the status of the axilla, and the differences assessed using the log-rank test. RESULTS: Between December 2006 and March 2022, SLNB was performed pre-NET in 14 cases and post-NET in 77. Both groups were similar in baseline tumor and patient characteristics. SLNB positivity was similar regardless of whether SLNB was performed before (5/14, 35.7%) or after NET (27/77, 37%), with 2/14 SLN macrometastases in the pre-NET cohort and 17/77 in the post-NET cohort. Only three patients (18.7%) with SLN macrometastasis had > 3 positive nodes following ALND. The 5-year overall survival and distant disease-free survival were 92.4% and 94.8%, respectively, with no significant differences according to SLNB status (p 0.5 and 0.8, respectively). CONCLUSION: SLN positivity did not differ according to its timing (before or after NET). Therefore, NET has no effect on lymph node clearance. Furthermore, the prognosis is good regardless of the axillary involvement. Therefore, factors other than axillary involvement may affect the prognosis in these patients.

valuation of breast cancer screening indicators in the female population assisted in the Unified Health System, Brazil, 2018-2019: descriptive study / Evaluación de indicadores de tamizaje de cáncer de mama en la población femenina atendida en el Sistema Único de Salud, Brasil, 2018-2019: estudio descriptivo / Avaliação dos indicadores de monitoramento do rastreamento do câncer de mama na população do sexo feminino atendida no Sistema Único de Saúde, Brasil, 2018-2019: estudo descritivo

Objetive: To analyze breast cancer screening monitoring indicators in the female population assisted by the Brazilian Unified Health System, from 2018 to 2019. Methods: Descriptive study based on the Cancer Information System (Siscan). Screening indicators were calculated through the deterministic linkage of the mammography and histopathological databases. Results: In 2018, 807,430 women, aged 50 to 69 years were screened for breast cancer. Of these, 91% had a benign result, 1.8% probably benign, 6.7% inconclusive results and 0.5% suggestive of cancer. The positive mammography rate was 9.0%. An indication for biopsy was estimated for 1.6% of the women, a malignant result for 33.9% of them and a cancer confirmation rate of 5.4 per 1,000 women. Conclusion: A high loss of follow-up of benign lesions was identified. The rate of positive mammograms was lower than the international parameter, but the cancer detection rate was adequate and the percentage of inconclusive mammograms acceptable.

Objetivo: Analizar indicadores del tamizaje de cáncer de mama en población femenina atendida por Sistema Único de Salud Brasileño, de 2018-2019. Métodos: Estudio descriptivo basado en Sistema de Información del Cáncer (Siscan). Los indicadores de detección se calcularon después de vinculación determinista de bases de datos de mamografía e histopatología. Resultados: En 2018, 807.430 mujeres de 50-69 años examinaram cáncer de mama. De estos, 91% tuvo resultado benigno, 1,8% probablemente benigno, 6,7% resultado no concluyente y 0,5% sugestivo de cáncer. La tasa de mamografías positivas fue 9,0%. Se estimó indicación de biopsia en 1,6% de las mujeres, resultado maligno en 33,9% y tasa de confirmación de cáncer de 5,4 por 1.000 mujeres. Conclusión: Se identificó alta pérdida de seguimiento de las lesiones benignas. La tasa de mamografías positivas fue inferior al parámetro internacional, pero la tasa de detección de cáncer fue adecuada y el porcentaje de mamografías no concluyentes aceptable.

Objetivo: analisar indicadores de monitoramento do rastreamento do câncer de mama na população feminina usuária do Sistema Único de Saúde, Brasil, no período 2018-2019. Métodos: estudo descritivo, a partir do Sistema de Informação do Câncer; foram calculados indicadores de rastreamento após relacionamento determinístico das bases de dados de mamografia e histopatologia. Resultados: em 2018, 807.430 mulheres na faixa etária de 50-69 anos foram rastreadas e dessas, 91% apresentaram resultado benigno, 1,8% provavelmente benigno, 6,7% inconclusivo e 0,5% sugestivo de câncer; a taxa de mamografia positiva foi de 9,0%; estimou-se indicação de biópsia para 1,6% das mulheres, resultado maligno para 33,9% delas, e taxa de confirmação de câncer de 5,4 por 1000 mulheres. Conclusão: identificou-se elevada perda de seguimento das lesões benignas; a taxa de mamografias positivas foi inferior ao parâmetro internacional; contudo, a taxa de detecção de câncer foi adequada, e o percentual de mamografias inconclusivas aceitável.

Ten-year experience of bone SBRT in breast cancer: analysis of predictive factors of effectiveness.

PURPOSE: Data on the benefit of stereotactic body radiation therapy (SBRT) in patients with breast cancer (BC) and bone metastases remain limited. The purpose of this study is to report our 10-year experience of bone SBRT, analyzing toxicity and prognostic factors for local control (LC); progression-free survival, and overall survival (OS). METHODS/PATIENTS: We analyzed all spine and non-spine bone SBRT performed in patients with BC during the 2012-2022 period at our institution. Treatments carried out with ablative intent in stereotactic conditions with dose/fraction ≥ 5 Gy in 5 or fewer sessions were considered. Demographic, treatment, and toxicity data were recorded according to CTCAEv4. Risk factors were assessed through univariate and multivariate analysis by Cox regression. RESULTS: 60 bone SBRT treatments were performed during the study period. 75% were spine SBRT and 25% were non-spine SBRT (median BED4Gy was 80 Gy4). The median age was 52.5 years (34-79). The median tumor volume was 2.9 cm3 (0.5-39.4). The median follow-up was 32.4 months (1.2-101.7). 1 and 2 years LC were 92.9 and 86.6%, respectively. 1 and 2 years OS were 100 and 90.6%, respectively. Multivariate analysis (MVA) associated volume of the treated lesion ≥ 13 cm3 with worse LC (p = 0.046; HR 12.1, 95%CI = 1.1-140.3). In addition, deferring SBRT > 3 months after lesion diagnosis to prioritize systemic treatment showed a significant benefit, improving the 2 years LC up to 96.8% vs. 67.5% for SBRT performed before this period (p = 0.031; HR 0.1, 95%CI = 0.01-0.8). Hormonal receptors, the total number of metastases, and CA15-3 value were significantly associated with OS in MVA. During follow-up, three non-spine fractures (5%) were observed. CONCLUSIONS: According to our data, bone SBRT is a safe and effective technique for BC. Upfront systemic treatment before SBRT offers a benefit in LC. Therefore, SBRT should be considered after prior systemic treatment in this population.

Avaliação de indicadores de monitoramento do rastreamento do câncer de mama na população do sexo feminino atendida no Sistema Único de Saúde, Brasil, 2018-2019: estudo descritivo / Evaluación de indicadores del tamizaje de cáncer de mama en la población femenina atendida en el Sistema Único de Salud, Brasil, 2018-2019: estudio descriptivo / Evaluation of breast cancer screening indicators in the female population using the National Health System, Brazil, 2018-2019: a descriptive study

Objetivo: analisar indicadores de monitoramento do rastreamento do câncer de mama na população feminina usuária do Sistema Único de Saúde, Brasil, no período 2018-2019. Métodos: estudo descritivo, a partir do Sistema de Informação do Câncer; foram calculados indicadores de rastreamento após relacionamento determinístico das bases de dados de mamografia e histopatologia. Resultados: em 2018, 807.430 mulheres na faixa etária de 50-69 anos foram rastreadas, e dessas, 91% apresentaram resultado benigno, 1,8% provavelmente benigno, 6,7% inconclusivo e 0,5% sugestivo de câncer; a taxa de mamografia positiva foi de 9,0%; estimou- -se indicação de biópsia para 1,6% das mulheres, resultado maligno para 33,9% delas, e taxa de confirmação de câncer de 5,4 por 1 mil mulheres. Conclusão: identificou-se elevada perda de seguimento das lesões benignas; a taxa de mamografias positivas foi inferior ao parâmetro internacional; contudo, a taxa de detecção de câncer foi adequada, e o percentual de mamografias inconclusivas, aceitável.

Objetivo: analizar indicadores del tamizaje de cáncer de mama en población femenina atendida por Sistema Único de Salud Brasileño, de 2018-2019. Métodos: estudio descriptivo basado en Sistema de Información del Cáncer (Siscan). Los indicadores de detección se calcularon después de vinculación determinista de bases de datos de mamografía e histopatología. Resultados: en 2018, 807.430 mujeres de 50-69 años examinaram cáncer de mama. De estos, 91% tuvo resultado benigno, 1,8% probablemente benigno, 6,7% resultado no concluyente y 0,5% sugestivo de cáncer. La tasa de mamografías positivas fue 9,0%. Se estimó indicación de biopsia en 1,6% de las mujeres, resultado maligno en 33,9% y tasa de confirmación de cáncer de 5,4 por 1.000 mujeres. Conclusión: se identificó alta pérdida de seguimiento de las lesiones benignas. La tasa de mamografías positivas fue inferior al parámetro internacional, pero la tasa de detección de cáncer fue adecuada y el porcentaje de mamografías no concluyentes aceptable.

Objetive: to analyze breast cancer screening monitoring indicators in the female population using the Brazilian National Health System, from 2018 to 2019. Methods: this was a descriptive study based on Cancer Information System (SISCAN) data; screening indicators were calculated following deterministic linkage of the mammography and histopathology databases. Results: in 2018, 807,430 women aged 50 to 69 years were screened for breast cancer, 91% of whom had a benign result, 1.8% probably benign, 6.7% inconclusive results and 0.5% results suggestive of cancer; the positive mammogram rate was 9.0%; biopsy was estimated to be indicated for 1.6% of the women, 33.9% of whom had a malignant result, and the cancer confirmation rate was 5.4 per 1,000 women. Conclusion: high benign lesion loss to follow-up was identified; the positive mammogram rate was lower than the international parameter, but the cancer detection rate was adequate and the percentage of inconclusive mammograms was acceptable.

Re-irradiation spine SBRT in oligoprogression breast cancer: A case report / Re-irradiación con SBRT vertebral en oligoprogresión de cancer de mama: caso clínico

Stereotactic body radiotherapy has experienced exponential development in recent years, as its ablative capacity has demonstrated a benefit in certain patients including oligometastatic and oligoprogressive patients. We present a case of a 59-year-old woman with a history of infiltrating metastatic ductal breast carcinoma with vertebral bone oligoprogression. After radical surgical treatment and re-irradiation SBRT, a complete response was achieved. After more than two years of follow-up the patient remains with neither local nor distant recurrence. Patients with oligometastatic or oligoprogressive breast cancer are candidates for radical treatment modalities. Stereotactic body radiotherapy has demonstrated promising local control, progression free survival and overall survival in these patients. In this context, there are currently ongoing phase III studies in order to provide stronger evidence. (AU)

La radioterapia estereotáctica corporal ha sufrido un desarrollo exponencial en los últimos años. Debido a su capacidad ablativa, esta técnica ha demostrado un beneficio en determinados pacientes incluyendo los pacientes oligometastásicos o con oligoprogresión. Se presenta el caso de una mujer de 59 años con antecedentes de carcinoma ductal de mama infiltrante con oligoprogresión ósea vertebral. Tras tratamiento quirúrgico y reirradiación del lecho con SBRT se obtuvo una respuesta completa a nivel local. Tras más de dos años de seguimiento, la paciente permanece sin recidiva local ni a distancia. Las pacientes con cáncer de mama oligometastásico o con oligoprogresión son candidatas a recibir un tratamiento radical. La radioterapia corporal estereotáctica ha demostrado unas cifras de control local, supervivencia libre de progresión y supervivencia global prometedoras en estas pacientes. En este contexto, se están desarrollando ensayos fase III que aportarán una evidencia más sólida en el tratamiento de estas pacientes. (AU)

Eligibility criteria for Menopausal Hormone Therapy (MHT): a position statement from a consortium of scientific societies for the use of MHT in women with medical conditions. MHT Eligibility Criteria Group.

This project aims to develop eligibility criteria for menopausal hormone therapy (MHT). The tool should be similar to those already established for contraception A consortium of scientific societies coordinated by the Spanish Menopause Society met to formulate recommendations for the use of MHT by women with medical conditions based on the best available evidence. The project was developed in two phases. As a first step, we conducted 14 systematic reviews and 32 metanalyses on the safety of MHT (in nine areas: age, time of menopause onset, treatment duration, women with thrombotic risk, women with a personal history of cardiovascular disease, women with metabolic syndrome, women with gastrointestinal diseases, survivors of breast cancer or of other cancers, and women who smoke) and on the most relevant pharmacological interactions with MHT. These systematic reviews and metanalyses helped inform a structured process in which a panel of experts defined the eligibility criteria according to a specific framework, which facilitated the discussion and development process. To unify the proposal, the following eligibility criteria have been defined in accordance with the WHO international nomenclature for the different alternatives for MHT (category 1, no restriction on the use of MHT; category 2, the benefits outweigh the risks; category 3, the risks generally outweigh the benefits; category 4, MHT should not be used). Quality was classified as high, moderate, low or very low, based on several factors (including risk of bias, inaccuracy, inconsistency, lack of directionality and publication bias). When no direct evidence was identified, but plausibility, clinical experience or indirect evidence were available, "Expert opinion" was categorized. For the first time, a set of eligibility criteria, based on clinical evidence and developed according to the most rigorous methodological tools, has been defined. This will provide health professionals with a powerful decision-making tool that can be used to manage menopausal symptoms.

Recomendaciones sobre el uso de la telemedicina aplicada a la patología nutricional / Recommendations on the use of telemedicine as applied to nutritional pathology

Introducción: la telemedicina puede mejorar la calidad asistencial y el uso de recursos. La pandemia de COVID-19 ha hecho necesaria su implementación en la práctica habitual. Por ello, un grupo de endocrinólogos de la Comunidad Valenciana, Murcia y Baleares creó un comité para su desarrollo. Objetivos: establecer unas recomendaciones para mejorar la calidad de la consulta de patología nutricional y diseñar unos indicadores para su gestión. Metodología: se siguió la metodología Delphi con participación de 13 profesionales con el fin de alcanzar el mayor consenso. Para ello se circuló un cuestionario de 16 puntos en 3 rondas: en la primera se estableció el grado de consenso; en la segunda, los participantes tuvieron acceso a los resultados de la primera y respondieron a las cuestiones planteadas. Se consideró que había acuerdo si el consenso era ≥ 75 % de los participantes, y que existía acuerdo fuerte si este era ≥ 90 %. Además, se estableció la temática de los indicadores de calidad. En la tercera se desarrollaron dichos indicadores. Resultados: tras 3 rondas y una reunión de revisión se establecieron los sobre aspectos organizativos 5 recomendaciones con acuerdo fuerte; sobre los aspectos administrativos, 6 recomendaciones con acuerdo fuerte y 4 con acuerdo. Se seleccionaron 8 indicadores de calidad que se desarrollaron en formato de fichas. Conclusiones: este documento recopila una serie de recomendaciones sobre cuestiones, necesidades y requisitos a tener en cuenta para una consulta telemática de calidad al paciente con patología nutricional. Así mismo, se han desarrollado unos indicadores para mejorar la calidad asistencial (AU)

Introduction: telemedicine can improve the standards of clinical care and use of resources. The COVID-19 pandemic has required its implementation in routine practice. For this reason, a group of endocrinologists from Valencia, Murcia and the Balearic Islands created a committee for its development. Objectives: to establish recommendations in order to improve the quality of consultation in nutritional disorders, and to create indicators for its management. Methodology: the Delphi methodology was followed with the participation of 13 professionals in order to reach the widest consensus. A 16-item questionnaire was distributed within 3 rounds: in the first round, the degree of consensus was established; in the second round, the participants responded to the posed questions after having access to the first-round results. Agreement was considered if ≥ 75 % participants reached consensus, while strong agreement was considered if consensus was reached by ≥ 90 %. In addition, quality indicators were established. In a third round, these indicators were developed. Results: after 3 rounds and a revision 5 recommendations with strong agreement were established based on organizational aspects. Regarding administrative aspects, 6 recommendations with strong agreement were established while 4 recommendations reached the level of agreement. Eight quality indicators were selected and developed. Conclusions this document compiles a list of recommendations about needs and requirements to be taken into account for a quality telematic consultation in patients with nutritional disorders. In addition, health care quality indicators have been created and developed (AU)

A real-life study of the medium to long-term effectiveness of a hypercaloric, hyperproteic enteral nutrition formula specifically for patients with diabetes on biochemical parameters of metabolic control and nutritional status.

INTRODUCTION: Although current recommendations suggest the use of specific formulas in enteral nutrition in people with diabetes, there is little evidence of their long-term effectiveness in glycemic control. The main objective of this study is to evaluate the long-term efficacy (24 weeks) of a specific high-protein hypercaloric enteral nutrition formula for people with diabetes in glycemic control and in their improvement in nutritional status. METHODOLOGY: This was a multicenter, prospective, observational, real-life study of patients with long-term enteral nutrition prescription through gastrostomy or nasogastric tube who received a high protein hypercaloric formula specific for diabetes. Once the participant's informed consent was obtained and the inclusion and exclusion criteria were verified, data relating to glycemic control, inflammation parameters, biochemical data, nutritional status and gastrointestinal tolerance at 0, 12 and 24 weeks were collected. RESULTS: 112 patients were recruited, 44.6% women, age 75.0 (12.0) years and a mean time of evolution of diabetes of 18.1 (9.5) years. The percentage of patients with malnutrition according to VGS decreased throughout the treatment from 78.6% to 29.9% (p < 0.001). Glycemic and HbA1c levels were significantly reduced at 12 and 24 weeks (Blood glucose 155.9-139.0-133.9 mg/dl, p < 0.001; HbA1c 7.7-7.3-7.1%, p < 0.001) while no significant changes were observed in cholesterol, triglycerides, creatinine, or glomerular filtration. A significant increase in variables related to nutritional status was observed: weight, the BMI, albumin, prealbumin and transferrin, and CRP levels were significantly reduced and the CRP/Albumin ratio decreased. Gastrointestinal tolerance was good, the number of patients with moderate-severe symptoms was small, and did not change throughout the follow-up. CONCLUSION: Our real-life study suggests that the use of a specific hyperprotein hypercaloric formula for diabetes during a 6-month nutritional treatment allows adequate glycemic control and nutritional evolution, with good gastrointestinal tolerance.

Aetiological diagnosis of hyponatraemia in non-critical patients on total parenteral nutrition: A prospective multicentre study.

BACKGROUND: In patients receiving total parenteral nutrition (TPN), the frequency of hyponatraemia is high. However, the causes of hyponatraemia in TPN have not been elucidated, although diagnosis is required for appropriate therapy. The aim of this study is to describe the aetiology of hyponatraemia in non-critical hospitalised patients receiving TPN. METHODS: Prospective multicentre study in 19 Spanish hospitals. Non-critically hyponatraemic patients receiving TPN and presenting hyponatraemia over a 9-month period were studied. Data collected included sex, age, previous comorbidities, and serum sodium levels (SNa) before and following TPN initiation. Parameters for study of hyponatraemia were also included: clinical volaemia, the presence of pain, nausea, gastrointestinal losses, diuretic use, oedema, renal function, plasma and urine osmolality, urinary electrolytes, cortisolaemia, and thyroid stimulating hormone. RESULTS: 162 patients were included, 53.7% males, age 66.4 (SD13.8) years. Volume status was evaluated in 142 (88%): 21 (14.8%) were hypovolaemic, 96 (67.6%) euvolaemic and 25 (17.6%) hypervolaemic. In 111/142 patients the analytical assessment of hyponatraemia was completed. Hypovolaemic hyponatraemia was secondary to GI losses in 10/111 (9%), and to diuretics in 3/111 (2.7%). Euvolaemic hyponatraemia was due to Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH) in 47/111 (42.4%), and to physiological stimuli of Arginine Vasopressin (AVP) secretion in 28/111 (25.2%). Hypervolaemic hyponatraemia was induced by heart failure in 19/111 (17.1%), cirrhosis of the liver in 4/111 (3.6%). CONCLUSIONS: SIADH was the most frequent cause of hyponatraemia in patients receiving TPN. The second most frequent cause was physiological stimuli of AVP secretion induced by pain/nausea.

[Recommendations on the use of telemedicine as applied to nutritional pathology]. / Recomendaciones sobre el uso de la telemedicina aplicada a la patología nutricional.

Introduction: Introduction: telemedicine can improve the standards of clinical care and use of resources. The COVID-19 pandemic has required its implementation in routine practice. For this reason, a group of endocrinologists from Valencia, Murcia and the Balearic Islands created a committee for its development. Objectives: to establish recommendations in order to improve the quality of consultation in nutritional disorders, and to create indicators for its management. Methodology: the Delphi methodology was followed with the participation of 13 professionals in order to reach the widest consensus. A 16-item questionnaire was distributed within 3 rounds: in the first round, the degree of consensus was established; in the second round, the participants responded to the posed questions after having access to the first-round results. Agreement was considered if ≥ 75 % participants reached consensus, while strong agreement was considered if consensus was reached by ≥ 90 %. In addition, quality indicators were established. In a third round, these indicators were developed. Results: after 3 rounds and a revision 5 recommendations with strong agreement were established based on organizational aspects. Regarding administrative aspects, 6 recommendations with strong agreement were established while 4 recommendations reached the level of agreement. Eight quality indicators were selected and developed. Conclusions: this document compiles a list of recommendations about needs and requirements to be taken into account for a quality telematic consultation in patients with nutritional disorders. In addition, health care quality indicators have been created and developed.

Introducción: Introducción: la telemedicina puede mejorar la calidad asistencial y el uso de recursos. La pandemia de COVID-19 ha hecho necesaria su implementación en la práctica habitual. Por ello, un grupo de endocrinólogos de la Comunidad Valenciana, Murcia y Baleares creó un comité para su desarrollo. Objetivos: establecer unas recomendaciones para mejorar la calidad de la consulta de patología nutricional y diseñar unos indicadores para su gestión. Metodología: se siguió la metodología Delphi con participación de 13 profesionales con el fin de alcanzar el mayor consenso. Para ello se circuló un cuestionario de 16 puntos en 3 rondas: en la primera se estableció el grado de consenso; en la segunda, los participantes tuvieron acceso a los resultados de la primera y respondieron a las cuestiones planteadas. Se consideró que había acuerdo si el consenso era ≥ 75 % de los participantes, y que existía acuerdo fuerte si este era ≥ 90 %. Además, se estableció la temática de los indicadores de calidad. En la tercera se desarrollaron dichos indicadores. Resultados: tras 3 rondas y una reunión de revisión se establecieron los sobre aspectos organizativos 5 recomendaciones con acuerdo fuerte; sobre los aspectos administrativos, 6 recomendaciones con acuerdo fuerte y 4 con acuerdo. Se seleccionaron 8 indicadores de calidad que se desarrollaron en formato de fichas. Conclusiones: este documento recopila una serie de recomendaciones sobre cuestiones, necesidades y requisitos a tener en cuenta para una consulta telemática de calidad al paciente con patología nutricional. Así mismo, se han desarrollado unos indicadores para mejorar la calidad asistencial.

Effectiveness and safety of intraoperative radiotherapy (IORT) with low-energy X-rays (INTRABEAM®) for accelerated partial breast irradiation (APBI).

PURPOSE: To evaluate treatment outcomes in patients with early-stage breast cancer (ESBC) treated with targeted intraoperative radiation therapy (IORT) administered as accelerated partial breast irradiation (APBI). METHODS: Between December 2014 and May 2019, 50 patients diagnosed with ESBC were treated with a 50 kilovoltage (kV) X-ray source with a single dose of 20 Gy using the Intrabeam® radiotherapy delivery system. All patients were followed prospectively to assess local control (LC), disease-free survival (DFS), cancer-specific survival (CSS), overall survival (OS), radiation-induced toxicity, and cosmetic outcomes. We also evaluated the prognostic implications of the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). RESULTS: Median follow-up was 53 months. Mean patient age was 70 years. The mean duration of radiation delivery was 22.25 min. Two patients developed a recurrence. One death was recorded. Elevated pretreatment NLR levels were a significant risk factor for mortality (p = 0.0026). The most common treatment-related toxicities were breast induration (30%) and seroma (18%). Five-year LC, DFS, CSS, and OS rates were 97.1%, 93.9%, 100%, and 94.4%, respectively. Cosmesis was excellent or good in most cases (94%). CONCLUSION: These findings confirm the effectiveness of a single dose of 20 Gy of IORT with the Intrabeam device as APBI. The toxicity profile was good with excellent cosmesis. These results provide further support for the clinical use of APBI in well-selected patients.

Mastitis granulomatosa asociada a eritema nudoso: estudio de 42 casos / Granulomatous mastitis associated with erythema nodosum: A case series of 42 patients

Introducción:La mastitis granulomatosa (MG) se define por la presencia de inflamación granulomatosa en el tejido mamario. El eritema nudoso (EN) es una paniculitis inflamatoria reactiva caracterizada por nódulos subcutáneos dolorosos en las extremidades inferiores. La asociación entre MG y EN ha sido descrita, pero está poco estudiada. Nuestro objetivo fue analizar las características clínicas de las pacientes diagnosticadas de MG en nuestro centro y su asociación con EN.Métodos:Se revisaron retrospectivamente los casos diagnosticados histológicamente de MG entre 1995 y 2020.Resultados:Cuarenta y dos mujeres fueron diagnosticadas de MG. La edad media al diagnóstico fue de 41,619años y el 59,5% tenían ascendencia sudamericana. El EN se asoció con MG en el 11,9% de las pacientes. Las pacientes con EN fueron diagnosticadas precozmente respecto a aquellas con MG aislada (0,4meses frente a 6,81; p<0,05). La ulceración en la MG fue más prevalente en pacientes con EN asociado (60% vs 14,7%; p<0,05).Conclusión:El EN en pacientes con GM puede facilitar el diagnóstico precoz de esta rara condición que imita el cáncer de mama.(AU)

Background:Granulomatous mastitis (GM) is defined by the formation of granulomatous inflammation in breast tissue. Erythema nodosum (EN) is a reactive inflammatory panniculitis characterized by erythematous subcutaneous nodules in the lower limbs. The association of GM with EN has been rarely reported. Our aim was to retrospectively review our series of patients with GM to better characterize their features and their association with EN.Methods:Cases histologically diagnosed as granulomatous inflammation in breast tissue between 1995 and 2020 were retrospectively reviewed.Results:Forty-two women were diagnosed with GM. The average age at diagnosis was 41.619years, and 59.5% were of South-American ethnicity. EN was associated with GM in 11.9% of the patients. Patients with EN were diagnosed earlier than isolated GM (0.4months vs 6.81months; P<.05). Ulceration in the GM was more prevalent in patients with associated EN (60% vs 14.7%; P<.05).Conclusion:EN in patients with GM may reduce the evolution time and may help to diagnose this rare condition that mimics breast carcinoma. (AU)

Aluminum can activate grapevine defense through actin remodeling.

In the current study, we used a grapevine cell line in which actin filaments are labeled by GFP to show that aluminum causes actin remodeling through activation of NADPH oxidase in the plasma membrane, followed by activation of phytoalexin synthesis genes. Elimination of actin filaments by latrunculin B disrupts gene activation and inhibition of MAPK signaling by the inhibitor PD98059. Interestingly, aluminum also induces the transcription of ISOCHORISMATE SYNTHASE, a key enzyme for the synthesis of salicylic acid, as well as PR1, a gene that is known to be responsive to salicylic acid. However, while salicylic acid responses are usually a hallmark of the hypersensitive response, aluminum-triggered defense is not accompanied by cell death. Both actin remodeling and gene activation in response to aluminum can be suppressed by the natural auxin indole acetic acid, suggesting that the actin response is not caused by nonspecific signaling. Further evidence for the specificity of the aluminum-triggered activation of phytoalexin synthesis genes comes from experiments in which plant peptide elicitors induce significant cellular mortality but do not evoke induction of these transcription. The response in grapevine cells can be recapitulated in grapevine leaf discs from two genotypes contrasting in stilbene inducibility. Here, aluminum can induce accumulation of the central grapevine phytoalexin, the stilbene aglycone trans-resveratrol; this is preceded by a rapid induction of transcription for RESVERATROL SYNTHASE and the regulating transcription factor MYB14. The amplitude of this induction reflects the general stilbene inducibility of these genotypes, indicating that the aluminum effect is not caused by nonspecific toxicity but by activation of specific signaling pathways. The findings are discussed in relation to a model in which actin filaments activate a specific branch of defense signaling, acting in concert with calcium-dependent PAMP-triggered immunity. This pathway links the apoplastic oxidative burst through MAPK signaling with the activation of defense-related transcription.