Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinelnodes 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

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

IntroductionBreast 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 analysesThis 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.DiscussionThis 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 disseminationThe 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 registrationClinicalTrials.gov, identifier number NCT04889924

Simultaneous quantification of 49 elements associated to e-waste in human blood by ICP-MS for routine analysis

Health risks concerns related to e-waste contamination are increasing all over the world, and especially in developing countries. We have developed an easy, quick, and robust method for the quantification of 49 elements associated to electronic consumer products and their e-wastes in human blood. An aliquot of blood (130 μL) is simply diluted using an alkaline solution, and the elements are simultaneously quantified at the picogram-per-milliliter level without the need of clean-up steps. The accuracy, precision, linearity and limit of quantification (LOQ) of the method were assessed. Recovery values at concentration levels between 0.010 and 5 ng mL−1 were studied. A range of 89–118% and a range of 87–128% for REE and toxic heavy elements was found respectively. The relative standard deviations (RSD) calculated were lower than 8% for the most elements. The limits of quantification (LOQ) were found to be lower than 0.04 ng mL−1 for toxic heavy elements and 0.06 ng mL−1 for the REE with some few exceptions in both cases. The validity of the proposed methodology was assessed by analyzing a certified human blood reference material with known concentrations of several elements. The proposed method is suitable for routine use in biomonitoring studies

Comparative analyses of pesticide residues, elemental composition and mycotoxin levels in Spanish traditional and novel ciders

The apple cultivar, known for its adaptability and diverse varieties, has been extensively utilized for cider production, particularly in climatically suitable regions. Cider, an age-old alcoholic beverage derived from fermenting apple juice, is gaining popularity, especially among younger generations. Despite this trend, comprehensive knowledge regarding the toxicological profile of ciders remains limited, leaving room for potential chemical contaminants from raw ingredients or production methods. To address this gap, we conducted an unprecedented study analyzing sixty-eight cider samples from the Spanish market, encompassing both traditional ciders and newly developed apple-based flavored drinks referred to as “ciders.” Our investigation focused on pesticide residues, elemental profiles, and mycotoxin residues. In a groundbreaking approach, our study integrated the analysis of 225 pesticide residues, 50 Persistent Organic Pollutants (POPs), 11 mycotoxins (AFB1, AFB2, AFG1, AFG2, DON, FB1, FB2, H-2, HT-2, OTA, PAT, and ZEN), and a total of 50 elements. Pesticide residues were identified using GCMSMS and LCMSMS, elemental composition determined via ICPMS, and mycotoxins analyzed using LCMSMS. The significance of our research lies in addressing the dearth of toxicological analyses of ciders, despite their burgeoning global consumption and production. For pesticide residues and elemental composition, our results underwent statistical processing, revealing distinct differences between the elemental profiles of traditional ciders and “ciders.” Additionally, disparities were observed between cider and other low-alcohol fermented beverages like wines and beers. Concentrations of most pesticide residues and elements in the cider samples were deemed non-toxic, falling below allowable limits established by international organizations for other beverages such as water or wine. However, certain elements, notably Br and Pb in traditional ciders, raised potential concerns. Our findings underscore the necessity of establishing regulatory limits for pesticide residues, potentially hazardous elements, and mycotoxins in cider, a regulatory framework currently lacking on a global scale.This research was supported by the Catalina Ruiz research staff training aid program of the Regional Ministry of Economy, Knowledge and Employment of the Canary Islands Government, granted to the University of Las Palmas de Gran Canaria through the European Social Fund, via a post-doctoral grant to the author Andrea Acosta-Dacal (APCR2022010003). This work was supported by the Spanish Plan for Innovation, Technical and Scientific Research 2017–Ramón y Cajal RYC2018-024025-I and the ACIISI project ProID2021010071 for Eva Parga-Dans.Peer reviewe

Revista española de drogodependencias

Resumen tomado de la publicaciónAntecedentes: Los trastornos por uso de sustancias (TUS) se pueden presentar en cualquier sociedad. En el país y en sus instituciones educativas son escasos los estudios epidemiológicos. Esta situación dificulta la comprensión epidemiológica, su prevención, planificación y evaluación. Objetivo: Determinar la prevalencia vital e incidencia del último año de TUS en estudiantes de la Universidad de Los Andes, Mérida -Venezuela. Método: Estudio observacional transversal en estudiantes seleccionados aleatoriamente en tres campus universitarios. La muestra representó el 5 por ciento del universo: n=1.018 y se evaluó mediante un instrumento autoadministrado, anónimo y validado para Venezuela con denominaciones genéricas/jerga y en concordancia a criterios diagnósticos de reconocida aceptación. Todos fueron informados del carácter voluntario y de retirarse, si lo manifestase. Se aplicaron tests bilaterales no paramétricos, ? 0, 05. Conclusiones: La prevención y vigilancia en la institución sobre TUS deberían programarse según los hallazgos y las diferencias detectadas en cada campus. Los resultados pueden orientar estudios toxicológicos no invasivas: cabellos. La separación social entre sustancias lícitas e ilícitas debería obviarse para las estrategias y objetivos de prevención integral.ValenciaUniversidad de Valladolid. Facultad de Educación y Trabajo Social. Biblioteca; Campus Miguel Delibes. Paseo de Belén, 1; 47011 Valladolid; +34983423435; +34983423436; [email protected]

Monitoring serum PCB levels in the adult population of the Canary Islands (Spain)

Polychlorinated biphenyls (PCBs) are persistent organic chemicals that have been detected in human serum or tissues all over the world. These pollutants could exert a number of deleterious effects on humans and wildlife, including carcinogenic processes. The Spanish population of the Canary Islands was evaluated with respect to PCB levels more than ten years ago showing lower levels than other Western populations. The objective of our study was to assess the current level of contamination by PCBs showed by this population. We measured serum PCBs in a sample of healthy adult subjects (206 serum samples from subjects with an average age of 66 years old) to evaluate the potential modification of PCB serum levels in this population during the last decade. PCB congeners (28, 52, 77, 81, 101, 105, 114, 118, 123, 126, 138, 153, 156, 157, 167, 169, 180, and 189) were measured by gas chromatography-mass spectrometry (GC/MS). Our results showed that PCB residues were found in 84% of serum samples analyzed, the congeners 28, 153 and 180 being the most frequently detected and at the highest median values (0.1 ng/mL). In addition, the median concentration of the sum of those PCBs considered as markers of environmental contamination by these chemicals (Marker-PCBs) was 0.6 ng/mL, reaching values as high as as 2.6 ng/mL in the 95th percentile. Levels of the sum of PCBs with toxic effects similar to dioxins (dioxin-like PCBs) reached median values of 0.4 ng/mL in the 95th percentile. The reported levels are similar to those described previously in this population more than ten years ago, in the sense that the inhabitants of the Canary Archipelago show levels of PCB contamination lower than the majority of populations from developed countries. These findings suggest that currently there is not any active source of these chemicals in this archipelago. Nevertheless, as foods seem to be a relevant source for these compounds, Public Health authorities should monitor the presence of PCB residues in foods available in the market of these Islands

Comparative analysis of mycotoxin, pesticide, and elemental content of Canarian craft and Spanish mainstream beers

The number of craft breweries and the volume of craft beer produced globally is growing exponentially. However, little is known about their differences with mainstream beers regarding mycotoxin profile, pesticide and pollutant residues and elemental composition. Given that beer is one of the most consumed beverages worldwide, it is important to shed light on its toxicological profile. In this study, samples of 23 craft beers and 19 mainstream Spanish beers were collected to perform a comparative analysis including 8 mycotoxins, 225 pesticide residues and 50 POPs, and 50 elements. Mycotoxins were not detected in craft beers, while 100% of mainstream beers presented at least one mycotoxin. In contrast, craft beers contained higher average pesticide residues than their mainstream counterparts, although significant differences were only found in Mepiquat and Metrafenone content. No persistent organic pollutants were detected in any sample. The elemental composition presented differences between the two groups both in the concentration of elements and their hierarchy. In conclusion, the toxicological profile of all beers was safe and is unlikely to constitute a hazard to consumer health. Craft beers present significant differences from their mainstream counterparts in all the dimensions explored.This research was supported by the Catalina Ruiz research staff training aid programme of the Regional Ministry of Economy, Knowledge and Employment of the Canary Islands Government, granted to the University of Las Palmas de Gran Canaria through the European Social Fund via a post-doctoral grant to the author Andrea Acosta-Dacal (APCR2022010003). This work was supported by the Spanish Plan for Innovation, Technical and Scientific Research 2017–Ramón y Cajal RYC2018–024025-I for Eva Parga-Dans. The manuscript was proof-edited by Guido Jones, currently funded by the Cabildo de Tenerife, under the TFinnova Programme supported by MEDI and FDCAN funds.Peer reviewe

Effects of Early Physical Therapy and Follow-Up in Acute Severe Coronavirus Disease 2019 Pneumonia: A Retrospective Observational Study

BackgroundRehabilitation in subjects with severe coronavirus disease 2019 (COVID-19) pneumonia has been widely recommended. However, data regarding the starting time of rehabilitation, subjects and healthcare workers' safety, as well as rehabilitation program features are limited. We aimed to assess the safety and characterize the effect of early and non-early physiotherapy on severe COVID-19 pneumonia subjects. MethodsA retrospective cohort study, including a consecutive sample of surviving subjects admitted to an acute care hospital due to severe COVID-19 pneumonia from March 13th to May 15th of 2020, is made. Subjects were separated into three groups: non-physical therapy, early physiotherapy (onset <7 days of admission), and non-early physiotherapy. Subject and therapist safety and length of hospital stay were the main evaluated outcomes. ResultsA total of 159 subjects were included (72% men; median age 62 years). Rehabilitation was performed on 108 subjects (32 early and 76 non-early physiotherapies). The length of hospital stay was 19 [interquartile range (IQR) 36.25] and 34 days (IQR 27.25) (p = 0.001) for early and non-early physiotherapy groups, respectively. No physiotherapist was infected and no subject adverse effect was identified. Multivariate analysis of subjects receiving physiotherapy during admission identified obesity [odds ratio (OR) 3.21; p-value 0.028], invasive mechanical ventilation (OR 6.25; p-value <0.001), and non-early physiotherapy (OR 3.54; p-value 0.017) as independent factors associated with a higher risk of prolonged hospital stay. Survivors' follow-up after hospital discharge at 8 weeks was completed by 54% of subjects. ConclusionRehabilitation in acute severe COVID-19 pneumonia is safe for subjects and healthcare workers and could reduce the length of hospitalization stay, especially in those that may start early