Baseline extracellular vesicle TGF-ß is a predictive biomarker for response to immune checkpoint inhibitors and survival in non-small cell lung cancer.

BACKGROUND: Immune-checkpoint inhibitors (ICIs) are an effective therapeutic strategy, improving the survival of patients with lung cancer compared with conventional treatments. However, novel predictive biomarkers are needed to stratify which patients derive clinical benefit because the currently used and highly heterogenic histological PD-L1 has shown low accuracy. Liquid biopsy is the analysis of biomarkers in body fluids and represents a minimally invasive tool that can be used to monitor tumor evolution and treatment effects, potentially reducing biases associated with tumor heterogeneity associated with tissue biopsies. In this context, cytokines, such as transforming growth factor-ß (TGF-ß), can be found free in circulation in the blood and packaged into extracellular vesicles (EVs), which have a specific delivery tropism and can affect in tumor/immune system interaction. TGF-ß is an immunosuppressive cytokine that plays a crucial role in tumor immune escape, treatment resistance, and metastasis. Thus, we aimed to evaluate the predictive value of circulating and EV TGF-ß in patients with non-small-cell lung cancer receiving ICIs. METHODS: Plasma samples were collected in 33 patients with advanced non-small-cell lung cancer before and during treatment with ICIs. EV were isolated from plasma by serial ultracentrifugation methods and circulating and EV TGF-ß expression levels were evaluated by enzyme-linked immunosorbent assay. RESULTS: Baseline high expression of TGF-ß in EVs was associated with nonresponse to ICIs as well as shorter progression-free survival and overall survival, outperforming circulating TGF-ß levels and tissue PD-L1 as a predictive biomarker. CONCLUSION: If validated, EV TGF-ß could be used to improve patient stratification, increasing the effectiveness of treatment with ICIs and potentially informing combinatory treatments with TGF-ß blockade. PLAIN LANGUAGE SUMMARY: Treatment with immune-checkpoint inhibitors (ICIs) has improved the survival of some patients with lung cancer. However, the majority of patients do not benefit from this treatment, making it essential to develop more reliable biomarkers to identify patients most likely to benefit. In this pilot study, the expression of transforming growth factor-ß (TGF-ß) in blood circulation and in extracellular vesicles was analyzed. The levels of extracellular vesicle TGF-ß before treatment were able to determine which patients would benefit from treatment with ICIs and have a longer survival with higher accuracy than circulating TGF-ß and tissue PD-L1, which is the currently used biomarker in clinical practice.

Psychosocial interventions and needs among individuals and families with Li-Fraumeni syndrome: A scoping review.

Li-Fraumeni syndrome (LFS), a rare cancer predisposition syndrome caused by germline mutations in the TP53 gene, is associated with significant lifetime risk of developing cancer and warrants extensive and long-term surveillance. There are psychosocial impacts on individuals and families living with this condition, from the initial diagnosis throughout multiple stages across the lifespan, but these impacts have not been systematically reviewed and organized. The objective of this scoping review was to synthesize and characterize the literature on psychosocial screening and outcomes, educational needs, support services, and available interventions for patients and families with LFS. A systematic search of six databases was most recently conducted in August 2020: (PubMed/MEDLINE (NLM), EMBASE (Elsevier), Cochrane Library (Wiley), CINAHL (EBSCO), PsycINFO (OVID), and Web of Science (Clarivate Analytics). A total of 15 757 titles were screened, and 24 articles included. Several important themes were identified across studies: factors associated with TP53 genetic testing, LFS surveillance, psychological outcomes, and communication. Findings related to these themes were organized into age-specific categories (age agnostic/across the lifespan, childhood, adolescence and young adulthood, and adulthood).

Guía de Práctica Clínica para el diagnóstico temprano y la referencia oportuna del cáncer de pulmón.

OBJETIVO: Proporcionar recomendaciones para la detección temprana de pacientes con alto riesgo de desarrollar cáncer de pulmón (CP) en el primer nivel de atención y su referencia oportuna. Material y métodos. Se realizó una búsqueda detallada de la evidencia científica disponible para responder las preguntas de investigación clínica y se utilizó el Panel Delphi modificado para lograr un consenso entre expertos. RESULTADOS: Se generaron 14 recomendaciones siguiendo los estándares de una GPC. Conclusión. El CP representa un problema de salud pública en México; por ello, esta guía establece recomendaciones que apoyan la toma de decisiones sobre la detección precoz y la referencia de pacientes con sospecha de CP en el primer nivel de atención.

Clinical Impact of the COVID-19 Pandemic in Mexican Patients with Thoracic Malignancies.

BACKGROUND: Accumulated evidence indicates that patients with lung cancer are a vulnerable population throughout the pandemic. Limited information is available in Latin America regarding the impact of the pandemic on medical care. The goal of this study was to describe the clinical and social effect of COVID-19 on patients with thoracic cancer and to ascertain outcomes in those with a confirmed diagnosis. MATERIALS AND METHODS: This cohort study included patients with thoracic neoplasms within a single institution between March 1, 2020, and February 28, 2021. All variables of interest were extracted from electronic medical records. During this period, the Depression Anxiety and Stress Scale 21 (DASS-2) was applied to evaluate and identify more common psychological disorders. RESULTS: The mean age for the total cohort (n = 548) was 61.5 ± 12.9 years; non-small cell lung cancer was the most frequent neoplasm (86.9%), advanced stages predominated (80%), and most patients were under active therapy (82.8%). Any change in treatment was reported in 23.9% of patients, of which 78.6% were due to the COVID-19 pandemic. Treatment delays (≥7 days) were the most frequent modifications in 41.9% of cases, followed by treatment suspension at 37.4%. Patients without treatment changes had a more prolonged progression-free survival and overall survival (hazard ratio [HR] 0.21, p < .001 and HR 0.28, p < .001, respectively). The mean DASS-21 score was 10.45 in 144 evaluated patients, with women being more affected than men (11.41 vs. 9.08, p < .001). Anxiety was reported in 30.5% of cases, followed by depression and distress in equal proportions (18%). Depressed and stressed patients had higher odds of experiencing delays in treatment than patients without depression (odds ratio [OR] 4.5, 95% confidence interval [CI] 1.53-13.23, p = .006 and OR 3.18, 95% CI 1.2-10.06, p = .006, respectively). CONCLUSION: Treatment adjustments in patients with thoracic malignancies often occurred to avoid COVID-19 contagion with detrimental effects on survival. Psychological disorders could have a role in adherence to the original treatment regimen. IMPLICATIONS FOR PRACTICE: The pandemic has placed an enormous strain on health care systems globally. Patients with thoracic cancers represent a vulnerable population, with increased morbidity and mortality rates. In Mexico, treatment modifications were common during the pandemic, and those who experienced delays had worse survival outcomes. Most treatment modifications were related to a patient decision rather than a lockdown of health care facilities in which mental health impairment plays an essential role. Moreover, the high case fatality rate highlights the importance of improving medical care access. Likewise, to develop strategies facing future threats that may compromise health care systems in non-developed countries.

Radiation-induced lung injury: current evidence.

Chemo-radiotherapy and systemic therapies have proven satisfactory outcomes as standard treatments for various thoracic malignancies; however, adverse pulmonary effects, like pneumonitis, can be life-threatening. Pneumonitis is caused by direct cytotoxic effect, oxidative stress, and immune-mediated injury. Radiotherapy Induced Lung Injury (RILI) encompasses two phases: an early phase known as Radiation Pneumonitis (RP), characterized by acute lung tissue inflammation as a result of exposure to radiation; and a late phase called Radiation Fibrosis (RF), a clinical syndrome that results from chronic pulmonary tissue damage. Currently, diagnoses are made by exclusion using clinical assessment and radiological findings. Pulmonary function tests have constituted a significant step in evaluating lung function status during radiotherapy and useful predictive tools to avoid complications or limit toxicity. Systemic corticosteroids are widely used to treat pneumonitis complications, but its use must be standardized, and consider in the prophylaxis setting given the fatal outcome of this adverse event. This review aims to discuss the clinicopathological features of pneumonitis and provide practical clinical recommendations for prevention, diagnosis, and management.

Dyadic Psychosocial eHealth Interventions: Systematic Scoping Review.

BACKGROUND: Dyadic psychosocial interventions have been found beneficial both for people coping with mental or physical health conditions as well as their family members and friends who provide them with support. Delivering these interventions via electronic health (eHealth) may help increase their scalability. OBJECTIVE: This scoping review aimed to provide the first comprehensive overview of dyadic eHealth interventions for individuals of all ages affected by mental or physical illness and their family members or friends who support them. The goal was to understand how dyadic eHealth interventions have been used and to highlight areas of research needed to advance dyadic eHealth intervention development and dissemination. METHODS: A comprehensive electronic literature search of PubMed, EMBASE, Cochrane, Cumulative Index to Nursing and Allied Health Literature, and PsycINFO was conducted for articles published in the English language through March 2019. Eligible records described a psychosocial eHealth intervention that intervened with both care recipients and their support person. RESULTS: A total of 7113 records were reviewed of which 101 met eligibility criteria. There were 52 unique dyadic eHealth interventions identified, which were tested across 73 different trials. Of the unique interventions, 33 were conducted among dyads of children and their supporting parent, 1 was conducted with an adolescent-young adult care recipient population, and the remaining 18 were conducted among adult dyads. Interventions targeting pediatric dyads most commonly addressed a mental health condition (n=10); interventions targeting adult dyads most commonly addressed cancer (n=9). More than three-fourths of interventions (n=40) required some human support from research staff or clinicians. Most studies (n=64) specified one or more primary outcomes for care recipients, whereas less than one-fourth (n=22) specified primary outcomes for support persons. Where specified, primary outcomes were most commonly self-reported psychosocial or health factors for both care recipients (n=43) and support persons (n=18). Results of the dyadic eHealth intervention tended to be positive for care recipients, but evidence of effects for support persons was limited because of few studies specifying primary outcomes for supporters. Trials of dyadic eHealth interventions were most commonly randomized controlled trials (RCTs; n=44), and RCTs most commonly compared the dyadic eHealth intervention to usual care alone (n=22). CONCLUSIONS: This first comprehensive review of dyadic eHealth interventions demonstrates that there is substantial, diverse, and growing literature supporting this interventional approach. However, several significant gaps were identified. Few studies were designed to evaluate the unique effects of dyadic interventions relative to individual interventions. There was also limited assessment and reporting of outcomes for support persons, and there were no interventions meeting our eligibility criteria specifically targeting the needs of older adult dyads. Findings highlight areas of research opportunities for developing dyadic eHealth interventions for novel populations and for increasing access to dyadic care.

[Lung-cancer screening program in Mexico]. / Detección temprana de cáncer de pulmón en México.

La detección temprana de cáncer pulmonar (CP) en población de alto riesgo tiene el potencial de diagnosticar la enfermedad en estadios tempranos y facilitar el tratamiento oportuno con el fin de disminuir la tasa de mortalidad. En México, como en otros países en vías de desarrollo, además del tabaquismo, la exposición al humo de leña se posiciona como uno de los principales factores de riesgo para desarrollar CP, lo cual no se ha considerado en estudios de tamizaje previamente publicados. Distintas interrogantes surgen en relación con quiénes son las personas que presentan un alto riesgo de desarrollar CP en América Latina, cuál es el costo-beneficio de poner en marcha un programa de detección oportuna de CP en México y cuáles son los obstáculos que los países de la región enfrentan para su implementación.

Lung cancer screening has the potential to be diagnosed at an early stage which increases the possibility of curative treatment in order to decrease the mortality rate. In Mexico, as in other developing nations, along with wood smoke exposure is one of the main risk factors for developing lung cancer, not considered in previously published screening trials. Different questions arise concerning the population at higher risk to develop lung cancer in Latin America, the cost-benefit of implementing a lung cancer screening program and the obstacles facing developing countries when implementing a detection program. To knowledge, there are no lung cancer screening trials in Mexico.

Herbal medicine for depression and anxiety: A systematic review with assessment of potential psycho-oncologic relevance.

Anxiety and depression are prevalent among cancer patients, with significant negative impact. Many patients prefer herbs for symptom relief to conventional medications which have limited efficacy/side effects. We identified single-herb medicines that may warrant further study in cancer patients. Our search included PubMed, Allied and Complementary Medicine, Embase, and Cochrane databases, selecting only single-herb randomized controlled trials between 1996 and 2016 in any population for data extraction, excluding herbs with known potential for interactions with cancer treatments. One hundred articles involving 38 botanicals met our criteria. Among herbs most studied (≥6 randomized controlled trials each), lavender, passionflower, and saffron produced benefits comparable to standard anxiolytics and antidepressants. Black cohosh, chamomile, and chasteberry are also promising. Anxiety or depressive symptoms were measured in all studies, but not always as primary endpoints. Overall, 45% of studies reported positive findings with fewer adverse effects compared with conventional medications. Based on available data, black cohosh, chamomile, chasteberry, lavender, passionflower, and saffron appear useful in mitigating anxiety or depression with favorable risk-benefit profiles compared to standard treatments. These may benefit cancer patients by minimizing medication load and accompanying side effects. However, well-designed larger clinical trials are needed before these herbs can be recommended and to further assess their psycho-oncologic relevance.

[Unilateral congenital pulmonary lymphangiectasia in a preterm infant]. / Linfangiectasia pulmonar congénita unilateral en un neonato prematuro.

Unilateral congenital pulmonary lymphangiectasia (CPL) is an extremely rare disease of the pulmo nary lymphatic vessels. OBJECTIVE: to present a case of CPL in a premature newborn. CLINICAL CASE: premature male newborn with severe respiratory failure at 2 hours of extrauterine life was treated with exogenous surfactant, catecholamines and high frequency oscillatory ventilation (HFOV). Chest computed tomography (CT) scan showed bullae and air trapping of the left lung; the histopathological study showed cystic dilation of the bronchoalveolar lymphatic channels. The diagnosis of secondary unilateral CPL was made. The clinical course up to 19 months of age was normal and the chest CT scan showed few emphysematous bullae. CONCLUSIONS: CPL must be one of the differential diagnoses in neonates with unexplained respiratory distress. The prognosis will depend on the type of CPL and lung involvement.

Evaluating the Impact of Mediated Literature Searches at a Comprehensive Cancer Center.

Research informationists at a comprehensive cancer center sought to evaluate the impact and value of mediated literature searches in support of their users' work activities. An assessment tool was identified in the literature and modified by the investigators to solicit feedback from library users and identify the major reason(s) why scientists and health care professionals request literature searches, how they use the resulting information, and the impact that the results may or may not have on their research or patient care/decision-making activities. Survey results were qualitatively analyzed, and future avenues of outreach and promotion of mediated literature search services were identified.

Impact of provider-patient communication on cancer screening adherence: A systematic review.

Cancer screening is critical for early detection and a lack of screening is associated with late-stage diagnosis and lower survival rates. The goal of this review was to analyze studies that focused on the role of provider-patient communication in screening behavior for cervical, breast, and colorectal cancer. A comprehensive search was conducted in four online databases between 1992 and 2016. Studies were included when the provider being studied was a primary care provider and the communication was face-to-face. The search resulted in 3252 records for review and 35 articles were included in the review. Studies were divided into three categories: studies comparing recommendation status to screening compliance; studies examining the relationship between communication quality and screening behavior; and intervention studies that used provider communication to improve screening behavior. There is overwhelming evidence that provider recommendation significantly improves screening rates. Studies examining quality of communication are heterogeneous in method, operationalization and results, but suggest giving information and shared decision making had a significant relationship with screening behavior. Intervention studies were similarly heterogeneous and showed positive results of communication interventions on screening behavior. Overall, results suggest that provider recommendation is necessary but not sufficient for optimal adherence to cancer screening guidelines. Quality studies suggest that provider-patient communication is more nuanced than just a simple recommendation. Discussions surrounding the recommendation may have an important bearing on a person's decision to get screened. Research needs to move beyond studies examining recommendations and adherence and focus more on the relationship between communication quality and screening adherence.

The level of association between functional performance status measures and patient-reported outcomes in cancer patients: a systematic review.

PURPOSE: The process of assessing patient symptoms and functionality using patient-reported outcomes (PROs) and functional performance status (FPS) is an essential aspect of patient-centered oncology research and care. However, PRO and FPS measures are often employed separately or inconsistently combined. Thus, the purpose of this study was to conduct a systematic review of the level of association between PRO and FPS measures to determine their differential or combined utility. METHODS: A systematic search was conducted using five databases (1966 to February 2014) to identify studies that described an association between PRO and FPS. Studies were excluded if they were non-cancer specific, did not include adults aged 18 or older, or were review articles. Publications were selected for review by consensus among two authors, with a third author arbitrating as needed. RESULTS: A total of 18 studies met inclusion criteria. FPS was primarily assessed by clinicians using the ECOG Performance Status or Karnofsky Performance Status measures. PROs were captured using a variety of measures, with numerous domains assessed (e.g., pain, fatigue, and general health status). Concordance between PROs and FPS measures was widely variable, falling in the low to moderate range (0.09-0.72). CONCLUSIONS: Despite consistency in the method of capture of PROs or FPS, domain capture varied considerably across reviewed studies. Irrespective of the method of capturing PROs or FPS, the quantified level of association between these two areas was moderate at best, providing evidence that FPS and PRO assessments offer unique information to assist clinicians in their decision-making.

Facing an un-met need in lung cancer screening: The never smokers.

Lung cancer (LC) is the leading cause of cancer-related deaths worldwide and the second most common cancer in both men and women. In addition to smoking, other risk factors, such as environmental tobacco smoke, air pollution, biomass combustion, radon gas, occupational exposure, lung disease, family history of cancer, geographic variability, and genetic factors, play an essential role in developing LC. Current screening guidelines and eligibility criteria have limited efficacy in identifying LC cases (50 %), as most screening programs primarily target subjects with a smoking history as the leading risk factor. Implementing LC screening programs in people who have never smoked (PNS) can significantly impact cancer-specific survival and early disease detection. However, the available evidence regarding the feasibility and effectiveness of such programs is limited. Therefore, further research on LC screening in PNS is warranted to determine the necessary techniques for accurately identifying individuals who should be included in screening programs.

Clinical practice guidelines for diagnostic and treatment of the chronic heart failure.

Chronic heart failure continues to be one of the main causes of impairment in the functioning and quality of life of people who suffer from it, as well as one of the main causes of mortality in our country and around the world. Mexico has a high prevalence of risk factors for developing heart failure, such as high blood pressure, diabetes, and obesity, which makes it essential to have an evidence-based document that provides recommendations to health professionals involved in the diagnosis and treatment of these patients. This document establishes the clinical practice guide (CPG) prepared at the initiative of the Mexican Society of Cardiology (SMC) in collaboration with the Iberic American Agency for the Development and Evaluation of Health Technologies, with the purpose of establishing recommendations based on the best available evidence and agreed upon by an interdisciplinary group of experts. This document complies with international quality standards, such as those described by the US Institute of Medicine (IOM), the National Institute of Clinical Excellence (NICE), the Intercollegiate Network for Scottish Guideline Development (SIGN) and the Guidelines International Network (G-I-N). The Guideline Development Group was integrated in a multi-collaborative and interdisciplinary manner with the support of methodologists with experience in systematic literature reviews and the development of CPG. A modified Delphi panel methodology was developed and conducted to achieve an adequate level of consensus in each of the recommendations contained in this CPG. We hope that this document contributes to better clinical decision making and becomes a reference point for clinicians who manage patients with chronic heart failure in all their clinical stages and in this way, we improve the quality of clinical care, improve their quality of life and reducing its complications.

La insuficiencia cardiaca crónica sigue siendo unas de las principales causas de afectación en el funcionamiento y en la calidad de vida de las personas que la presentan, así como una de las primeras causas de mortalidad en nuestro país y en todo el mundo. México tiene una alta prevalencia de factores de riesgo para desarrollar insuficiencia cardiaca, tales como hipertensión arterial, diabetes y obesidad, lo que hace imprescindible contar con un documento basado en la evidencia que brinde recomendaciones a los profesionales de la salud involucrados en el diagnóstico y el tratamiento de estos pacientes. Este documento establece la guía de práctica clínica (GPC) elaborada por iniciativa de la Sociedad Mexicana de Cardiología (SMC) en colaboración con la Agencia Iberoamericana de Desarrollo y Evaluación de Tecnologías en Salud, con la finalidad de establecer recomendaciones basadas en la mejor evidencia disponible y consensuadas por un grupo interdisciplinario y multicolaborativo de expertos. Cumple con estándares internacionales de calidad, como los descritos por el Institute of Medicine de los Estados Unidos de América (IOM), el National Institute of Clinical Excellence (NICE) del Reino Unido, la Intercollegiate Network for Scottish Guideline Development (SIGN) de Escocia y la Guidelines International Network (G-I-N). El grupo de desarrollo de la guía se integró de manera interdisciplinaria con el apoyo de metodólogos con experiencia en revisiones sistemáticas de la literatura y en el desarrollo de GPC. Se llevó a cabo y se condujo metodología de panel Delphi modificado para lograr un nivel de consenso adecuado en cada una de las recomendaciones contenidas en esta GPC. Esperamos que este documento contribuya para la mejor toma de decisiones clínicas y se convierta en un punto de referencia para los clínicos que manejan pacientes con insuficiencia cardiaca crónica en todas sus etapas clínicas, y de esta manera logremos mejorar la calidad en la atención clínica, aumentar la calidad de vida de los pacientes y disminuir las complicaciones de la enfermedad.

Coronary Revascularization in Patients With Diabetes: A Meta-Analysis of Randomized Controlled Trials and Propensity-Matched Studies.

OBJECTIVE: Patients with diabetes have poorer outcomes with coronary artery disease (CAD) and pose a unique clinical population for revascularization. We performed a pairwise meta-analysis of randomized trials (RCTs) and propensity-matched observational studies (PMS) to compare the clinical outcomes of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in patients with diabetes. METHODS: A comprehensive literature search was performed to identify RCT and PMS studies comparing CABG with PCI in patients with diabetes with concurrent CAD. Studies were pooled using the random-effects model to perform a pairwise meta-analysis. Primary outcomes included long-term all-cause mortality, cardiac mortality, myocardial infarction (MI), major adverse cardiac and cerebrovascular events (MACCE), and repeat revascularization. Meta-regression was used to explore the effects of baseline risk factors on primary outcomes with moderate to high heterogeneity. RESULTS: A total of 18 RCTs and 9 PMS with 28,846 patients were included. PCI was associated with increased long-term all-cause mortality (risk ratio [RR] = 1.34, P < 0.001), cardiac mortality (RR = 1.52, P < 0.001), MI (RR = 1.51, P = 0.009), MACCE (RR = 1.65, P < 0.001), and repeat revascularization (RR = 2.48, P < 0.001) compared with CABG. There was no difference in long-term stroke between the 2 groups (RR = 0.95, P = 0.82). At meta-regression, a greater proportion of female patients in studies was associated with a decreased protective benefit for CABG for long-term all-cause mortality but an increased protective benefit for long-term MI and repeat revascularization. CONCLUSIONS: Revascularization of patients with diabetes using CABG is associated with significantly reduced long-term mortality, MI, MACCE, and repeat revascularizations. Future studies exploring the influence of gender on revascularization outcomes are necessary to elucidate the ideal treatment modality in patients with diabetes.

Impact of Tyrosine Kinase Inhibitors on the Immune Response to SARS-CoV-2 Vaccination in Patients with Non-Small Cell Lung Cancer.

Immune dysregulation and cancer treatment may affect SARS-CoV-2 vaccination protection. Antibody production by B-cells play a vital role in the control and clearance of the SARS-CoV-2 virus. This study prospectively explores B-cell seroconversion following SARS-CoV-2 immunization in healthy individuals and non-small cell lung cancer (NSCLC) patients undergoing oncological treatment. 92 NSCLC patients and 27 healthy individuals' blood samples were collected after receiving any COVID-19 vaccine. Serum and mononuclear cells were isolated, and a serum surrogate virus neutralization test kit evaluated SARS-CoV-2 antibodies. B-cell subpopulations on mononuclear cells were characterized by flow cytometry. Patients were compared based on vaccination specifications and target mutation oncological treatment. A higher percentage of healthy individuals developed more SARS-CoV-2 neutralizing antibodies than NSCLC patients (63% vs. 54.3%; p = 0.03). NSCLC patients receiving chemotherapy (CTX) or tyrosine kinase inhibitors (TKIs) developed antibodies in 45.2% and 53.7%, of cases, respectively, showing an impaired antibody generation. CTX patients exhibited trends towards lower median antibody production than TKIs (1.0, IQR 83 vs. 38.23, IQR 89.22; p = 0.069). Patients receiving immunotherapy did not generate antibodies. A sub-analysis revealed that those with ALK mutations exhibited non-significant trends towards higher antibody titers (63.02, IQR 76.58 vs. 21.78, IQR 93.5; p = 0.1742) and B-cells quantification (10.80, IQR 7.52 vs. 7.22, IQR 3.32; p = 0.1382) against the SARS-CoV-2 spike protein than EGFR patients; nonetheless, these differences were not statistically significant. This study shows that antibodies against SARS-CoV-2 may be impaired in patients with NSCLC secondary to EGFR-targeted TKIs compared to ALK-directed treatment.

Best Practices for BREAST-Q Research: A Systematic Review of Study Methodology.

BACKGROUND: Data heterogeneity and methodologic errors hinder the ability to draw clinically meaningful conclusions from studies using the BREAST-Q Reconstruction Module patient-reported outcome measure. In this systematic review, the authors evaluate the quality of BREAST-Q Reconstruction Module administration in relation to the BREAST-Q version 2.0 user's guide and the reporting of key methodology characteristics. The authors also describe a framework for improving the quality of BREAST-Q data analysis and reporting. METHODS: The authors conducted a systematic search of PubMed, Embase, Cochrane CENTRAL, and Ovid HAPI databases to identify articles on the BREAST-Q Reconstruction Module to assess postmastectomy breast reconstruction outcomes. The authors registered the protocol before study implementation on Open Science Framework ( https://osf.io/c5236 ) and adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data on mode of BREAST-Q administration, time horizon justification, and sample size calculation were collected. RESULTS: The authors included 185 studies in the analysis. Errors in BREAST-Q administration were identified in 36 studies (19.5 percent). Appropriate administration of the BREAST-Q could not be determined in 63 studies (34.1 percent) because of insufficient reporting. Time horizon for the primary outcome was reported in 71 studies (38.4 percent), with only 17 (9.2 percent) reporting a sample size calculation. CONCLUSIONS: The authors identified important yet actionable shortcomings in the BREAST-Q literature. Researchers are encouraged to review the BREAST-Q user's guide in the study design phase to mitigate errors in patient-reported outcome measure administration and reporting for future trials using the BREAST-Q Reconstruction Module. Adhering to these guidelines will allow for greater clinical utility and generalizability of BREAST-Q research.

[Perinatal complications in patients with chronic renal failure]. / Complicaciones perinatales en pacientes con insuficiencia renal crónica.

BACKGROUND: Pregnant patients with chronic renal insufficiency (CRI) have a high risk of perinatal complications and deterioration of renal filtration (RF). OBJECTIVE: To report perinatal complications and changes of RF according to disease severity. MATERIAL AND METHOD: Cross-sectional study including 28 pregnant patients grouped into three categories of CRI according to initial creatinine (Cr): mild CRI < 1.5, moderate CRI 1.5-2.5 and severe CRI > 2.5 mg/dL. Pre-labor vs initial perinatal complications and changes in endogenous creatinine clearance (CrCI) were reported. Descriptive statistics and Student t-test were used for statistical analyses. RESULTS: Mild CRI was found in 50%, moderate in 35.72% and severe in 14.28% of patients. Maternal complications were as follows. Mild CRI: Cesarean (35.72%), deterioration of RF (21.42%) and worsening of systemic arterial hypertension (SAH) (7.14%); moderate CRI: Cesarean (28.57%), deterioration of RF (28.57%) and worsening of SAH (14.28%); severe CRI: Cesarean (14.28%), deterioration of RF (14.28%) and anemia (14.28%). Fetal complications were as follows. Mild CRI: prematurity (25%), fetal growth restriction (FGR) (7.14%) and fetal death (7.14%), moderate CRI: prematurity (21.42%), FGR (3.57%) and no reassuring fetal status (NRFS) (3.57%), severe CRI: prematurity (14.28%), NRFS (7.14%) and respiratory insufficiency (7.14%). Mild CRI showed a reduction of endogenous CrCI (p = 0.03) not shown in other categories. CONCLUSION: An elevated frequency of complications was found, with the most serious occurring in patients with severe CRI. Deterioration of RF was found in patients with mild CRI.