Relative fat mass as an estimator of body fat percentage in Chilean adults.

BACKGROUND/OBJECTIVE: The Relative Fat Mass (RFM) is an alternative index to body mass index (BMI) for estimating whole body fat percentage (BF%). Our aims were to determine the accuracy of the RFM for 1) identifying individuals with elevated BF% and, 2) estimating the BF% compared to Dual-energy X-ray absorptiometry (DXA) in a Chilean adult population. SUBJECTS/METHODS: Body composition was assessed by DXA in 270 healthy participants (125 women/145 men). Anthropometric measurements were assessed to calculate RFM and BMI. Receiver operating characteristic (ROC) curves were obtained to assess the sensitivity and specificity of both, RFM and BMI. Bland-Altman analysis between BF% measured by DXA vs. predicted BF% derived from RFM was performed to assess validity. Pearson´s correlation coefficients to analyze the association between BMI, RFM and DXA were also calculated. RESULTS: For RFM, the cut-off for elevated BF% was ≥22.7% for men and ≥32.4% for women and for BMI was ≥24.4 kg/m2 for men and ≥24.1 kg/m2 for women. The area under the ROC curve between RFM and BMI was not significantly different in men (0.970 vs. 0.959; p = 0.420) and women (0.946 vs. 0.942, p = 0.750). The Bland-Altman analysis showed that the estimation bias is more pronounced in men than in women. CONCLUSION: RFM is an accurate tool for identifying individuals with elevated BF%, although it was not as accurate as DXA for estimating the BF%. RFM may be an alternative method useful in primary care to select individuals for lifestyle counseling and in research to select patients for epidemiological studies.

Retrospective registry of patients with locally advanced/metastatic HR+/HER2- breast cancer treated in clinical practice in Andalusia.

BACKGROUND: Limited data are available regarding the real-world effectiveness and safety of Cyclin Dependent Kinase 4/6 inhibitor (CDK4/6i) (palbociclib/ribociclib) just as a first-line treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2‒) metastatic breast cancer (MBC). OBJECTIVE: To assess whether clinical or demographic characteristics limit access to first-line CDK4/6i treatment in clinical practice in the Autonomous Community of Andalusia (Spain) between November 2017 and April 2020. In addition, effectiveness will be described in an exploratory analysis. METHODS: Physicians from 12 centers participated in selecting demographic and clinical characteristics, treatment, and outcome data from women with HR + /HER2- MBC treated with or without CDK4/6i in addition to hormonal in the first-line setting, in a 3:1 proportion. Kaplan-Meier analysis estimated progression-free rates (PFRs) and survival rates (SRs). RESULTS: A total of 212 patients were included, of whom 175 (82.5%) were in the CDK4/6i treatment group and 37 (17.5%) were in the non-CDK4/6i treatment group (control group). Patients in the CDK 4/6i treatment group were younger (p = 0.0011), the biopsies of the metastatic site at the moment of the relapse were most commonly performed (p = 0.0454), and had multiple metastatic sites (p = 0.0025). The clinical benefit rate (CBR) was 82.3% in the CDK4/6i group and 67.8% in the control group. Median time to a progression event or death (PFS) was 20.4 months (95%CI 15.6-28) in the CDK4/6i group and 12.1 months (95%CI 7.9-not reached) in the control group. CONCLUSIONS: Younger patients, biopsies of metastatic disease and with multiple metastatic sites were more frequently treated with CDK4/6i in our daily clinical practice.

Real-world experience with pertuzumab and trastuzumab combined with chemotherapy in neoadjuvant treatment for patients with early-stage HER2-positive breast cancer: the NEOPERSUR study.

PURPOSE: HER2-targeted therapies have dramatically improved outcomes of patients with HER2-positive breast cancer (BC), as demonstrated in neoadjuvant trials. This study aims to provide real-world evidence on the use and effectiveness of combined pertuzumab, trastuzumab and chemotherapy (CT) in early-stage HER2-positive BC. METHODS: A retrospective, multicentre study was conducted on patients diagnosed with HER2-positive early BC treated with neoadjuvant pertuzumab and trastuzumab plus CT at 13 Spanish sites. The primary endpoint was pathological complete response (pCR). RESULTS: A total of 310 patients were included. Pertuzumab and trastuzumab were combined with anthracyclines and taxanes, carboplatin and docetaxel, and taxane-based CT in 77.1%, 16.5%, and 6.5% of patients, respectively. Overall, the pCR rate was 62.2%. The pCR was higher amongst patients with hormone receptor-negative tumours and with tumours expressing higher levels of Ki-67 (> 20%). After postoperative adjuvant treatment, 13.9% of patients relapsed. Those patients who did not achieve pCR, with tumours at advanced stages (III), and with node-positive disease were more likely to experience distant relapse. Median overall survival (OS) and distant disease-free survival (D-DFS) were not reached at the study end. The estimated mean OS and D-DFS times were 7.5 (95% CI 7.3-7.7) and 7.3 (95% CI 7.1-7.5) years, respectively (both were significantly longer amongst patients who achieved pCR). Grade 3-4 anti-HER2 related toxicities were reported in six (1.9%) patients. CONCLUSION: Neoadjuvant pertuzumab and trastuzumab plus CT achieve high pCR rates in real-life patients with HER2-positive early BC, showing an acceptable safety profile. Innovative adjuvant strategies are essential in patients at high risk of distant disease recurrence.

Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in gBRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer.

PURPOSE: The OlympiA randomized phase III trial compared 1 year of olaparib (OL) or placebo (PL) as adjuvant therapy in patients with germline BRCA1/2, high-risk human epidermal growth factor receptor 2-negative early breast cancer after completing (neo)adjuvant chemotherapy ([N]ACT), surgery, and radiotherapy. The patient-reported outcome primary hypothesis was that OL-treated patients may experience greater fatigue during treatment. METHODS: Data were collected before random assignment, and at 6, 12, 18, and 24 months. The primary end point was fatigue, measured with the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary end points, assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 item, included nausea and vomiting (NV), diarrhea, and multiple functional domains. Scores were compared between treatment groups using mixed model for repeated measures. Two-sided P values <.05 were statistically significant for the primary end point. All secondary end points were descriptive. RESULTS: One thousand five hundred and thirty-eight patients (NACT: 746, ACT: 792) contributed to the analysis. Fatigue severity was statistically significantly greater for OL versus PL, but not clinically meaningfully different by prespecified criteria (≥3 points) at 6 months (diff OL v PL: NACT: -1.3 [95% CI, -2.4 to -0.2]; P = .022; ACT: -1.3 [95% CI, -2.3 to -0.2]; P = .017) and 12 months (NACT: -1.6 [95% CI, -2.8 to -0.3]; P = .017; ACT: -1.3 [95% CI, -2.4 to -0.2]; P = .025). There were no significant differences in fatigue severity between treatment groups at 18 and 24 months. NV severity was worse in patients treated with OL compared with PL at 6 months (NACT: 6.0 [95% CI, 4.1 to 8.0]; ACT: 5.3 [95% CI, 3.4 to 7.2]) and 12 months (NACT: 6.4 [95% CI, 4.4 to 8.3]; ACT: 4.5 [95% CI, 2.8 to 6.1]). During treatment, there were some clinically meaningful differences between groups for other symptoms but not for function subscales or global health status. CONCLUSION: Treatment-emergent symptoms from OL were limited, generally resolving after treatment ended. OL- and PL-treated patients had similar functional scores, slowly improving during the 24 months after (N)ACT and there was no clinically meaningful persistence of fatigue severity in OL-treated patients.

[Commitment of Asunción. A call to action]. / Compromiso de Asunción. Un llamado a la acción.

Introduction: The Latin American Federation of Nutritional Therapy, Clinical Nutrition, and Metabolism - FELANPE, was founded in 1988. It brings together interdisciplinary societies and associations in Clinical Nutrition and Nutritional Therapy from Latin America and the Caribbean, as well as Spain and Portugal. Currently, it comprises representations from 18 countries. The objectives of the Federation are described, taking into account the assumed commitment. This is an observational cross-sectional, multicenter study that included 132 hospitals with more than 100 beds, of high complexity, both state-owned and private, from 14 countries in Latin America that are members of FELANPE. The study assessed hospital characteristics, implementation of nutritional assessment, nutritional diagnosis of patients, the team responsible for nutritional therapy, nutritional therapy (oral, enteral, and parenteral), monitoring, and nutritional follow-up. For this purpose, a digital questionnaire and an explanatory video were designed and validated to ensure the quality of the collected data. Validation was carried out through a pilot study conducted in Paraguay, approved by the Ethics Committee for Research at the Faculty of Medical Sciences of the National University of Asunción. The current research has the approval of the Research Ethics Committee of the Faculty of Chemical Sciences of the National University of Asunción and the Ethics Committee of FELANPE. The results presented at the XVIII Latin American Congress of FELANPE in Asunción, Paraguay, on October 12, 2023, serve as a basis for characterizing the implementation of Parenteral and Enteral Nutritional Therapy (medical nutritional therapy) in hospitals in Latin America and are used as technical support for the present Asunción Commitment.

Introducción: La Federación Latinoamericana de Terapia Nutricional, Nutrición Clínica y Metabolismo ­ FELANPE, fue fundada en el año 1988. Reúne a Sociedades y Asociaciones Interdisciplinarias de Nutrición Clínica y Terapia Nutricional de América Latina y el Caribe, además de España y Portugal. Actualmente la conforman representaciones de 18 países. Se describen los objetivos de la Federación teniendo en cuenta el compromiso asumido. Se trata de estudio observacional transversal, multicéntrico en que se incluyeron 132 hospitales con más de 100 camas, de alta complejidad, estatales y privados de 14 países de Latinoamérica miembros de FELANPE. Se evaluaron las características del hospital, la implementación de la valoración nutricional, el diagnóstico nutricional de pacientes, el equipo responsable de la terapia nutricional, la terapéutica nutricional (oral, enteral y parenteral), la monitorización y el seguimiento nutricional. Para tal, se diseñó y validó un cuestionario digital y un video explicativo para garantizar la calidad de los datos recolectados. La validación se efectúo mediante un estudio piloto realizado en Paraguay, aprobado por el Comité de Ética en la Investigación de la Facultad de Ciencias Médicas de la Universidad Nacional de Asunción. La investigación actual cuenta con la aprobación del Comité de Ética de Investigación de la Facultad de Ciencias Químicas de la Universidad Nacional de Asunción y del Comité de Ética de FELANPE. Los resultados presentados en el XVIII Congreso Latinoamericano de FELANPE, en Asunción del Paraguay, el 12 de octubre del 2023, sirven como base para caracterizar la implementación de la Terapia Nutricional Parenteral y Enteral (terapia nutricional médica) en Hospitales de Latinoamérica y son utilizados como sustento técnico del presente Compromiso de Asunción.

Determinants of Tricuspid Regurgitation Progression and Its Implications for Adequate Management.

BACKGROUND: Tricuspid regurgitation (TR) is associated with an increased mortality. Previous studies have analyzed predictors of TR progression and the clinical impact of baseline TR. However, there is a lack of evidence regarding the natural history of TR: the pattern of change and clinical impact of progression. OBJECTIVES: The authors sought to evaluate predictors of TR progression and assess the prognostic impact of TR progression. METHODS: A total of 1,843 patients with at least moderate TR were prospectively followed up with consecutive echocardiographic studies and/or clinical evaluation. All patients with less than a 2-year follow-up were excluded. Clinical and echocardiographic features, hospitalizations for heart failure, and cardiovascular death and interventions were recorded to assess their impact in TR progression. RESULTS: At a median 2.3-year follow-up, 19% of patients experienced progression. Patients with baseline moderate TR presented a rate progression of 4.9%, 10.1%, and 24.8% 1 year, 2 years, and 3 years, respectively. Older age (HR: 1.03), lower body mass index (HR: 0.95), chronic kidney disease (HR: 1.55), worse NYHA functional class (HR: 1.52), and right ventricle dilation (HR: 1.33) were independently associated with TR progression. TR progression was associated with an increase in chamber dilation as well as a decrease in ventriculoarterial coupling and in left ventricle ejection fraction (P < 0.001). TR progression was associated with an increased cardiovascular mortality and hospitalizations for heart failure (P < 0.001). CONCLUSIONS: Marked individual variability in TR progression hindered accurate follow-up. In addition, TR progression was a determinant for survival regardless of initial TR severity.

Pocillopora damicornis-associated macroinvertebrate responses to spatial gradients in the southern Mexican Pacific.

We explicitly tested for spatial changes in Pocillopora damicornis-associated invertebrates across several spatial scales in the southern Mexican Pacific. Sorting of invertebrates from 40 coral heads along 882 km of the coast yielded 325 taxa, 283% more than any other Pocillopora spp. coral host study to date, but estimators signals that richness might be 17-39% larger than the current number. Permutation, ordination, and regression analysis indicate that the composition and abundance of invertebrates vary in response to the spatial distance among coral heads: high similarity and variation occur among coral heads within localities (<500 m), probably related to faunal homogenization, but progressively modest reduction in similarity and variation as spatial distance increases suggesting a weak role for environmental sorting across southern Mexican Pacific coral reefs. Future studies should explicitly explore spatial, environmental, and historical biogeography processes that regulate and maintain community structure and biodiversity on eastern Pacific reefs.

[Intermittent fasting and human metabolic health]. / El ayuno intermitente y sus efectos en la salud metabólica en humanos.

Intermittent fasting (IF) has gained increasing scientific and general attention. Most studied forms of IF include alternate-day fasting, modified alternate-day fasting, and time-restricted eating (TRE). Several cardiometabolic effects of IF have been described in animal models and, to a lesser extent, in humans. This review analyzes the impact of IF on weight loss, glucose metabolism, blood pressure, and lipid profile in humans. A literature search was conducted in the Pubmed/Medline, Scopus, and Google Scholar databases. Controlled observational or interventional studies in humans, published between January 2000 and June 2021, were included. Studies comparing IF versus religious fasting were not included. Most studies indicate that the different types of IF have significant benefits on body composition, inducing weight loss and reducing fat mass. Changes in cardiometabolic parameters show more divergent results. In general, a decrease in fasting glucose and insulin levels is observed, together with an improved lipid profile associated with cardiovascular risk. High heterogeneity in study designs was observed, particularly in studies with TRE, small sample sizes, and short-term interventions. Current evidence shows that IF confers a range of cardiometabolic benefits in humans. Weight loss, improvement of glucose homeostasis and lipid profile, are observed in the three types of IF protocols evaluated.

SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer (2022).

Breast cancer is the leading cause of cancer in women in Spain and its annual incidence is rapidly increasing. Thanks to the screening programs in place, nearly 90% of breast cancer cases are detected in early and potentially curable stages, despite the COVID-19 pandemic possibly having impacted these numbers (not yet quantified). In recent years, locoregional and systemic therapies are increasingly being directed by new diagnostic tools that have improved the balance between toxicity and clinical benefit. New therapeutic strategies, such as immunotherapy, targeted drugs, and antibody-drug conjugates have also improved outcomes in some patient subgroups. This clinical practice guideline is based on a systematic review of relevant studies and on the consensus of experts from GEICAM, SOLTI, and SEOM.

El ayuno intermitente y sus efectos en la salud metabólica en humanos / Intermittent fasting and human metabolic health

Intermittent fasting (IF) has gained increasing scientific and general attention. Most studied forms of IF include alternate-day fasting, modified alternate-day fasting, and time-restricted eating (TRE). Several cardiometabolic effects of IF have been described in animal models and, to a lesser extent, in humans. This review analyzes the impact of IF on weight loss, glucose metabolism, blood pressure, and lipid profile in humans. A literature search was conducted in the Pubmed/Medline, Scopus, and Google Scholar databases. Controlled observational or interventional studies in humans, published between January 2000 and June 2021, were included. Studies comparing IF versus religious fasting were not included. Most studies indicate that the different types of IF have significant benefits on body composition, inducing weight loss and reducing fat mass. Changes in cardiometabolic parameters show more divergent results. In general, a decrease in fasting glucose and insulin levels is observed, together with an improved lipid profile associated with cardiovascular risk. High heterogeneity in study designs was observed, particularly in studies with TRE, small sample sizes, and short-term interventions. Current evidence shows that IF confers a range of cardiometabolic benefits in humans. Weight loss, improvement of glucose homeostasis and lipid profile, are observed in the three types of IF protocols evaluated.

Guidance for assessment of the muscle mass phenotypic criterion for the Global Leadership Initiative on Malnutrition (GLIM) diagnosis of malnutrition.

The Global Leadership Initiative on Malnutrition (GLIM) provides consensus criteria for the diagnosis of malnutrition that can be widely applied. The GLIM approach is based on the assessment of three phenotypic (weight loss, low body mass index, and low skeletal muscle mass) and two etiologic (low food intake and presence of disease with systemic inflammation) criteria, with diagnosis confirmed by any combination of one phenotypic and one etiologic criterion fulfilled. Assessment of muscle mass is less commonly performed than other phenotypic malnutrition criteria, and its interpretation may be less straightforward, particularly in settings that lack access to skilled clinical nutrition practitioners and/or to body composition methodologies. In order to promote the widespread assessment of skeletal muscle mass as an integral part of the GLIM diagnosis of malnutrition, the GLIM consortium appointed a working group to provide consensus-based guidance on assessment of skeletal muscle mass. When such methods and skills are available, quantitative assessment of muscle mass should be measured or estimated using dual-energy x-ray absorptiometry, computerized tomography, or bioelectrical impedance analysis. For settings where these resources are not available, then the use of anthropometric measures and physical examination are also endorsed. Validated ethnic- and sex-specific cutoff values for each measurement and tool are recommended when available. Measurement of skeletal muscle function is not advised as surrogate measurement of muscle mass. However, once malnutrition is diagnosed, skeletal muscle function should be investigated as a relevant component of sarcopenia and for complete nutrition assessment of persons with malnutrition.

Guidance for assessment of the muscle mass phenotypic criterion for the Global Leadership Initiative on Malnutrition diagnosis of malnutrition.

The Global Leadership Initiative on Malnutrition (GLIM) provides consensus criteria for the diagnosis of malnutrition that can be widely applied. The GLIM approach is based on the assessment of three phenotypic (weight loss, low body mass index, and low skeletal muscle mass) and two etiologic (low food intake and presence of disease with systemic inflammation) criteria, with diagnosis confirmed by any combination of one phenotypic and one etiologic criterion fulfilled. Assessment of muscle mass is less commonly performed than other phenotypic malnutrition criteria, and its interpretation may be less straightforward, particularly in settings that lack access to skilled clinical nutrition practitioners and/or to body composition methodologies. In order to promote the widespread assessment of skeletal muscle mass as an integral part of the GLIM diagnosis of malnutrition, the GLIM consortium appointed a working group to provide consensus-based guidance on assessment of skeletal muscle mass. When such methods and skills are available, quantitative assessment of muscle mass should be measured or estimated using dual-energy x-ray absorptiometry, computerized tomography, or bioelectrical impedance analysis. For settings where these resources are not available, then the use of anthropometric measures and physical examination are also endorsed. Validated ethnic- and sex-specific cutoff values for each measurement and tool are recommended when available. Measurement of skeletal muscle function is not advised as surrogate measurement of muscle mass. However, once malnutrition is diagnosed, skeletal muscle function should be investigated as a relevant component of sarcopenia and for complete nutrition assessment of persons with malnutrition.

Meal timing across the day modulates daily energy intake in adult patients with type 2 diabetes.

BACKGROUND/OBJECTIVES: We assessed the association between the timing of meals across the day with diet composition and metabolic parameters in patients with type-2 diabetes (T2D). SUBJECTS/METHODS: Eighty adults (55.2 ± 6.8 years, 45% males) patients with T2D (without insulin therapy) were included. Three non-consecutive dietary records assessed food intake. The onset time of each consumed meal/beverage was identified and assigned to one of three periods of the day: Period 1 (P1, 06:00-11:59 h), Period 2 (P2, 12:00-17:59 h), and Period 3 (P3, 18:00-00:30 h). RESULTS: Energy intake in P1 was lower compared to P2 and P3 (22.8 ± 7.9%, 37.5 ± 9.6%, and 39.7 ± 9.9%, respectively, P < 0.001). The same pattern was found for both total protein and fat intake, but carbohydrate intake was similar among periods. Patients with greater daily energy intake (as % of total energy) in P3 showed increased total food consumption, total energy, protein, and fat intake (all P < 0.05). The opposite pattern was observed in patients with greater daily energy intake in P1 (all P < 0.05). Regression analysis showed that daily energy intake was significantly reduced when a higher proportion of carbohydrates was eaten in P1 (vs. P3, P < 0.04). CONCLUSION: Increased energy intake late during the day is related to increased total food and daily energy intake in patients with T2D. A greater proportion of total carbohydrates eaten early during the day relates to lower total energy intake. Our results suggest that earlier food intake may be a nutritional tool for dietary and metabolic control in these patients.

Holothuriophilus trapeziformis Nauck, 1880 (Decapoda: Pinnotheridae) from the Pacific coast of Mexico: taxonomic revision based on integrative taxonomy.

BACKGROUND: Holothuriophilus trapeziformis Nauck, 1880 is a holothurian-dweller pinnotherid crab representing one of the two species of the genus distributed along the Pacific coast of Mexico and Chile, respectively. While the parasitic ecological interaction with its host is well established, the morphology of the male remains unknown, and DNA information for the species is not available. Furthermore, the only morphological trait separating both species of the genus is subjective and corresponds to the presence or absence of a gap between the fingers of the chelae. Our goal is to complete and clarify the taxonomic status of H. trapeziformis and describe the male morphology with the use of the integrative taxonomy, providing additional characters to differentiate this species. METHODS: We collected new biological material in the Pacific coast of Mexico including the topotypes. We also reviewed material from national collections to integrate morphology (based on a complete and detailed description and illustration of the species using light microscopy), ecological data (based on the identification of the host and the place where it was located within the host), and the mtCOI gene information (commonly known as DNA barcode) to differentiate Holothuriophilus trapeziformis from other related crabs. RESULTS: This species presents marked sexual dimorphism only in the primary sexual characters. For the first time we describe morphological variability of traditionally stable characters. In addition to the gap between the fingers of the chelae, Holothuriophilus trapeziformis differs from H. pacificus (Poeppig, 1836) by their ornamentation, the shape of the male abdomen, and the gonopod. Cytocrome Oxidase 1 gene (COI) distance divergence was >3% between both Holothuriophilus species forming a clear clade. DNA barcoding indicates only one taxon, with a maximum divergence of 2.2%. All the specimens have the same Barcode Index Number (BIN; BOLD: ADE9974). All the hosts for H. trapeziformis were identified as Holothuria (Halodeima) inornata Semper, 1868; the presence of the crab in the host's coelomic cavity was confirmed, and for the first time we found it within the intestine. The geographical distribution is the Pacific coast of Mexico. Based on the data presented here, the taxonomic status of Holothuriophilus trapeziformis is now complete.

SEOM clinical guidelines for the prophylaxis of infectious diseases in cancer patients (2021).

Infections are still a major cause of morbi-mortality in patients with cancer. Some of these infections are preventable through specific measures, such as vaccination or prophylaxis. This guideline aims to summarize the evidence and recommendations for the prevention of infections in cancer patients, devoting special attention to the most prevalent preventable infectious disease. All the evidences will be graded according to The Infectious Diseases Society of America grading system.

Genes Involved in Immune Reinduction May Constitute Biomarkers of Response for Metastatic Melanoma Patients Treated with Targeted Therapy.

Targeted therapy in metastatic melanoma often achieves a major tumour regression response and significant long-term survival via the release of antigens that reinduce immunocompetence. The biomarkers thus activated may guide the prediction of response, but this association and its mechanism have yet to be established. Blood samples were collected from nineteen consecutive patients with metastatic melanoma before, during, and after treatment with targeted therapy. Differential gene expression analysis was performed, which identified the genes involved in the treatment, both in the first evaluation of response and during progression. Although clinical characteristics of the patients were poorer than those obtained in pivotal studies, radiological responses were similar to those reported previously (objective response rate: 73.7%). In the first tumour assessment, the expression of some genes increased (CXCL-10, SERPING1, PDL1, and PDL2), while that of others decreased (ARG1, IL18R1, IL18RAP, IL1R1, ILR2, FLT3, SLC11A1, CD163, and S100A12). The analysis of gene expression in blood shows that some are activated and others inhibited by targeted therapy. This response pattern may provide biomarkers of the immune reinduction response, which could be used to study potential combination treatments. Nevertheless, further studies are needed to validate these results.

Nutrition competencies for undergraduate medical education: Results of an international interdisciplinary consensus.

BACKGROUND: The gap between the nutrition education provided to medical students and the nutrition competencies and attitudes needed for physicians to provide adequate nutrition care is a global concern. There is no universally accepted benchmark on nutrition competencies for doctors. The objective of this study was to establish, by expert consensus, the objectives of undergraduate nutrition medial education, the nutrition core competencies, and strategies for curriculum development in medical nutrition education. METHODS: We administered a Delphi survey to systematically gather the opinion of a panel of Latin American experts in nutrition. The survey questionnaire was constructed considering scientific literature by using a 5-point Likert scale. Consensus was defined as >70% agreement on the importance of an item (Likert scale 4 and 5). RESULTS: A four-round Delphi survey was conducted for this research. In the second, third, and fourth rounds, we validated a total of 130 competencies by consensus, which were distributed into four different thematic areas: (1) basic nutrition concepts, (2) public nutrition and nutrition prevention throughout the life cycle, (3) nutrition status and disease, and (4) nutrition care process. CONCLUSION: The curricula for general physician education in medical school must include health promotion, prevention, and treatment of diseases related to nutrition. This goal can be reached by integrating ≤130 competencies into four different fundamental areas.

Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study.

The PANGEA-Breast trial evaluated a new chemo-immunotherapeutic combination that would synergistically induce long-term clinical benefit in HER2-negative advanced breast cancer patients. Treatment consisted of 21-day cycles of 200 mg of pembrolizumab (day 1) plus gemcitabine (days 1 and 8). The primary objective was the objective response rate (ORR). The tumor infiltrating lymphocytes (TILs) density and PD-L1 expression in tumor, and the myeloid-derived suppressor cells (MDSCs) level in peripheral blood, were analyzed to explore associations with treatment efficacy. Considering a two-stage Simon's design, the study recruitment was stopped after its first stage as statistical assumptions were not met. A subset of 21 triple-negative breast cancer (TNBC) patients was enrolled. Their median age was 49 years; 15 patients had visceral involvement, and 16 had ≤3 metastatic locations. Treatment discontinuation due to progressive disease (PD) was reported in 16 patients. ORR was 15% (95% CI 3.2-37.9). Four patients were on treatment >6 months before PD. Grade ≥3 treatment-related adverse events were observed in 8 patients, where neutropenia was the most common. No association was found between TILs density, PD-L1 expression or MDSCs levels and treatment efficacy. ORR in TNBC patients also did not meet the assumptions, but 20% were on treatment >6 months.

Lower Survival and Increased Circulating Suppressor Cells in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma with Deficit of Vitamin D Levels Using R-GDP Plus Lenalidomide (R2-GDP): Results from the R2-GDP-GOTEL Trial.

The search of prognostic factors is a priority in diffuse large B-cell lymphoma (DLBCL) due to its aggressiveness. We have recently found that the level of circulating MDSCs is a good marker of survival in a translational study based on a trial (EudraCT Number: 2014-001620-29), using lenalidomide combined with R-GDP (rituximab plus gemcitabine, cisplatin, and dexamethasone). Since Vitamin D is a known immunomodulator, we have studied blood levels of these cell populations comparing patients with deficit of vitamin D levels (<15 ng/mL with those with normal levels >15 ng/mL. Mann-Whitney U test was used to compare cells distributions between groups, Wilcoxon test to compare cells distribution at different times and Spearman test to measure the association between cell populations. Patients with vitamin D deficit maintained the increased level of immune suppressor cells, whereas we observed a depletion of all immune suppressor cells in patients with normal vitamin D levels. In conclusion, we have confirmed the importance of vitamin D in the response to treatment in R/R DLBCL, suggesting that vitamin D deficit may be involved in the immune deficit of these patients, and thus, vitamin D supplementation in these patients may help to obtain a better response, warranting further investigation.