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Single-agent metronomic versus weekly oral vinorelbine as first-line chemotherapy in patients with HR-positive/HER2-negative advanced breast cancer: The randomized Tempo Breast study.
No full text20.500.12530/87908Single-agent oral vinorelbine is a standard of care for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) that has progressed on endocrine therapy. Metronomic administration may offer a better balance of efficacy and safety than standard regimens, but data from previous trials are scarce. In this open-label, multicenter, phase II trial, patients were randomized to oral vinorelbine administered on a metronomic (50 mg three times weekly) or weekly (60 mg/m2 in cycle 1, increasing to 80 mg/m2 if well tolerated) schedule. Treatment was continued until disease progression or intolerance. The primary endpoint was disease control rate (DCR, the proportion of patients with a best overall confirmed response of CR, PR, or stable disease lasting 6 months or more). One-hundred sixty-three patients were randomized and treated. The DCR was 63.4% (95% confidence interval [CI]: 52.0-73.8) with metronomic vinorelbine and 72.8% (95% CI: 61.8-82.1) with weekly vinorelbine. Weekly vinorelbine was also associated with longer progression-free survival (5.6 vs 4.0 months) and overall survival (26.7 vs 22.3 months) than metronomic vinorelbine, but was associated with more adverse events. In this randomized phase II trial, single-agent metronomic oral vinorelbine was effective and well tolerated as first-line chemotherapy for patients with HR-positive/HER2-negative ABC. Formal comparisons are not done in this phase II study and one can simply observe that confidence intervals of all endpoints overlap. When deciding for a chemotherapy after failure of endocrine therapy and CDK 4/6 inhibitors, oral vinorelbine might be an option to be given with either schedule. EudraCT 2014-003860-19
Linking preterm infant gut microbiota to nasograstric enteral feeding tubes: exploring potential interactions and microbial strain transmission.
No full text20.500.12530/87857Preterm birth is a growing problem worldwide. Staying at a neonatal intensive care unit (NICU) after birth is critical for the survival of preterm infants whose feeding often requires the use of nasogastric enteral feeding tubes (NEFT). These can be colonized by hospital-associated pathobionts that can access the gut of the preterm infants through this route. Since the gut microbiota is the most impactful factor on maturation of the immune system, any disturbance in this may condition their health. Therefore, the aim of this study is to assess the impact of NEFT-associated microbial communities on the establishment of the gut microbiota in preterm infants. A metataxonomic analysis of fecal and NEFT-related samples obtained during the first 2 weeks of life of preterm infants was performed. The potential sharing of strains isolated from the same set of samples of bacterial species involved in NICU's outbreaks, was assessed by Random Amplification of Polymorphic DNA (RAPD) genotyping. In the samples taken 48 h after birth (NEFT-1 and Me/F1), Staphylococcus spp. was the most abundant genera (62% and 14%, respectively) and it was latter displaced to 5.5% and 0.45%, respectively by Enterobacteriaceae. Significant differences in beta diversity were detected in NEFT and fecal samples taken at day 17 after birth (NEFT-3 and F3) (p = 0.003 and p = 0.024, respectively). Significant positive correlations were found between the most relevant genera detected in NEFT-3 and F3. 28% of the patients shared at least one RAPD-PCR profile in fecal and NEFT samples and 11% of the total profiles were found at least once simultaneously in NEFT and fecal samples from the same patient. The results indicate a parallel bacterial colonization of the gut of preterm neonates and the NEFTs used for feeding, potentially involving strain sharing between these niches. Moreover, the same bacterial RAPD profiles were found in neonates hospitalized in different boxes, suggesting a microbial transference within the NICU environment. This study may assist clinical staff in implementing best practices to mitigate the spread of pathogens that could threaten the health of preterm infants
Women in Radiology: A perspective from Spain.
No full textThere are gender inequalities in all fields, including radiology. Although the situation is improving, the presence of radiologists in leadership positions continues to be a minority. The objective of this article is to analyse the situation of women in the spanish radiology, comparing it with Europe and the United States. We selected the years 2000-2022 as reference period to make a comparison with feminization data throughout history. In addition, relevant specific data from the just begun 2023 were also included. The variables in which we investigated feminization were the following: medical students, medical graduates, radiology residents and specialists, section chiefs, department chairs, radiology residency programme directors, radiology university professors, presidents of the main radiological entities and societies in Spain, Europe and the United States, recipients of the main awards given by these radiological societies and chief editors of their journals. In order to perform this analysis we conducted an in-depth bibliographic research, we contacted the radiological societies of Spain, Europe and the USA and we carried out a survey in the main Spanish radiology departments. The female presence in radiology decreases as we rise to leadership positions, a situation that is patent in Spain, Europe and the US, comparison that will be analysed in depth throughout the article. In Spanish hospitals in 2021 there were 58.1% female radiology residents, 55% female radiologists, 42.9% female section chiefs and 24.4% female department chairs. In SERAM's history there have been 10% female presidents, 22% female gold medallists and 5% female editors-in-chief. If we analyse data from 2000 to 2023, female presidents reach 32% and female gold medallists 31%. Although gender inequality is declining, in radiology women continue to be underrepresented in leadership positions. Work must be done in order to build a diverse and inclusive profession that reflects demographic reality
The potential role of fatigue in difficult-to-treat rheumatoid arthritis.
No full text20.500.12530/87907A subset of patients with rheumatoid arthritis (RA) who remains symptomatic after failing to multiple drugs are deemed to have "difficult-to-treat RA" (D2T RA). Fatigue is a burdensome symptom for RA patients, hindering their improvement. Our purpose was to evaluate the role of fatigue in D2T RA. This cross-sectional study included rheumatoid arthritis (RA) patients between 2018 and 2022, treated with biological agents or targeted synthetic disease-modifying antirheumatic drugs. D2T RA was defined attending EULAR criteria. Independent variable was fatigue (dimensions and impact) assessed by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire and Numerical Rating Scales. Covariables: sociodemographic, clinical and treatment. To identify factors independently associated to D2T RA, multivariable logistic regression was run. The study included 145 patients and 38 (26.21%) developed D2T RA. D2T RA group were older, with more comorbidity and disability. D2T RA patients scored higher for global fatigue (p = 0.003), and almost for all their dimensions except for cognitive fatigue (p = 0.06) and fatigue coping (p = 0.07). Females with D2T RA showed more fatigue than those with non-D2T RA. In the adjusted models, all fatigue dimensions were associated with D2T RA: global fatigue RA (OR: 1.03; p = 0.007), physical (OR: 1.09; p = 0.008), living (OR: 1.09; p = 0.016), cognitive (OR: 1.1; p = 0.046) and emotional (OR: 1.18; p = 0.012). Despite the absence of an explicit mention of fatigue in the definition of D2T RA, it appears to be associated to this outcome. Fatigue should be evaluated in a multidimensional perspective, and gender-specific differences should be considered
Family Planning Concerns Among Women With Psoriasis: A Descriptive, Cross-Sectional, Multicenter Study
No full text20.500.12530/87857Background and objective: A significant proportion of women of childbearing age have psoriasis. The aim of this study was to examine family planning concerns in this population. Material and methods: Observational, descriptive, cross-sectional, multicenter study conducted between March 2020 and October 2021. We collected sociodemographic data and analyzed responses to a family planning questionnaire administered to women aged 18 to 45 years with plaque psoriasis who were candidates for systemic treatment. Results: We studied 153 patients (mean [SD] age, 35.4 [8.0] years; mean disease duration, 16.7 years) being treated at 11 Spanish hospitals. Overall, 38.4% of women were considered to have moderate to severe psoriasis by their physicians; perceived severity ratings were significantly higher among women. Psoriasis affected the women's desire to become pregnant or led to their delaying pregnancy in 1 in 3 respondents. They were concerned that their condition might worsen if they had to discontinue or switch treatment or that the treatment might harm the baby. Approximately half of the women had not received family planning counseling from their physicians, and this was more likely to be the case among never-pregnant women. Women on biologic therapy (58.7%) had better psoriasis control and a better quality of life than women on other treatments. Their sexual health was also less affected. Conclusions: Women with psoriasis have numerous family planning concerns, which in some cases can lead them to delay pregnancy or affect their desire to become pregnant. Dermatologists need to receive better training regarding family planning in women with psoriasis so that they can provide their patients with more and better information. (c) 2023 AEDV. Published by Elsevier Espana, S.L.U. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
COVID-19 Outcomes in Patients with Hematologic Malignancies in the Era of COVID-19 Vaccination and the Omicron Variant.
No full text20.500.12530/87862A greater understanding of clinical trends in COVID-19 outcomes among patients with hematologic malignancies (HM) over the course of the pandemic, particularly the Omicron era, is needed. This ongoing, observational, and registry-based study with prospective data collection evaluated COVID-19 clinical severity and mortality in 1818 adult HM patients diagnosed with COVID-19 between 27 February 2020 and 1 October 2022, at 31 centers in the Madrid region of Spain. Of these, 1281 (70.5%) and 537 (29.5%) were reported in the pre-Omicron and Omicron periods, respectively. Overall, patients aged ≥70 years (odds ratio 2.16, 95% CI 1.64-2.87), with >1 comorbidity (2.44, 1.85-3.21), or with an underlying HM of chronic lymphocytic leukemia (1.64, 1.19-2.27), had greater odds of severe/critical COVID-19; odds were lower during the Omicron BA.1/BA.2 (0.28, 0.2-0.37) or BA.4/BA.5 (0.13, 0.08-0.19) periods and among patients vaccinated with one or two (0.51, 0.34-0.75) or three or four (0.22, 0.16-0.29) doses. The hospitalization rate (75.3% [963/1279], 35.7% [191/535]), rate of intensive care admission (30.0% [289/963], 14.7% [28/191]), and mortality rate overall (31.9% [409/1281], 9.9% [53/536]) and in hospitalized patients (41.3% [398/963], 22.0% [42/191]) decreased from the pre-Omicron to Omicron period. Age ≥70 years was the only factor associated with higher mortality risk in both the pre-Omicron (hazard ratio 2.57, 95% CI 2.03-3.25) and Omicron (3.19, 95% CI 1.59-6.42) periods. Receipt of prior stem cell transplantation, COVID-19 vaccination(s), and treatment with nirmatrelvir/ritonavir or remdesivir were associated with greater survival rates. In conclusion, COVID-19 mortality in HM patients has decreased considerably in the Omicron period; however, mortality in hospitalized HM patients remains high. Specific studies should be undertaken to test new treatments and preventive interventions in HM patients
Comparison of the effectiveness of three different skin substitutes for the treatment of pediatric burns.
No full text20.500.12530/87857Early debridement of partial-thickness burns and coverage with skin substitutes is currently the standard of care in children, although there is currently no "gold standard" skin substitute. Our aim is to compare the effectiveness of three different skin substitutes, analyzing the medium- and long-term outcomes. A retrospective study was conducted on burn patients under 18 years admitted to our Burn Unit between 2015 and 2021, who were divided into 3 groups according to the type of skin substitute used (EZ-derm®, Biobrane®, and Suprathel®). Demographic and clinical data and short- and long-term outcomes were analyzed. Effectiveness was analyzed by escharectomy and grafting rate during acute management and long-term follow-up reintervention rate. A total of 378 patients were included (179 EZ-derm® group, 107 Biobrane® group, and 92 Suprathel® group). No differences in demographics or burn characteristics were observed between the groups. Patients treated with Suprathel® had a significantly shorter hospital stay (median 4 days (IQR 2-9)), a lower rate of escharectomy and grafting during acute management (21.1%), and a lower long-term follow-up reintervention rate (18.5%) when compared to the EZ-derm® group (median stay 9 days (IQR 6-13); escharectomy and graft 24.6% and reintervention 26.8%) and to the Biobrane® group (median stay 9 days (IQR 7-14); escharectomy and graft 32.1% and reintervention 26.2%). Treatment of partial-thickness burns with Suprathel® is associated with a shorter hospital stay, lower need for escharectomy and grafting, and lower need for long-term reintervention. Therefore, it should be considered the treatment of choice for pediatric partial-thickness burns. • Different types of skin substitutes are available for the treatment of skin burns in paediatric patients. • Suprathel® is linked to a reduction in hospital stays, a lower need for escharectomy and grafting, and a lower likelihood of requiring long-term re-interventions
Prevalence of Homologous Recombination Deficiency Among Patients With Germline RAD51C/D Breast or Ovarian Cancer.
No full textRAD51C and RAD51D are involved in DNA repair by homologous recombination. Germline pathogenic variants (PVs) in these genes are associated with an increased risk of ovarian and breast cancer. Understanding the homologous recombination deficiency (HRD) status of tumors from patients with germline PVs in RAD51C/D could guide therapeutic decision-making and improve survival. To characterize the clinical and tumor characteristics of germline RAD51C/D PV carriers, including the evaluation of HRD status. This retrospective cohort study included 91 index patients plus 90 relatives carrying germline RAD51C/D PV (n = 181) in Spanish hospitals from January 1, 2014, to December 31, 2021. Genomic and functional HRD biomarkers were assessed in untreated breast and ovarian tumor samples (n = 45) from June 2022 to February 2023. Clinical and pathologic characteristics were assessed using descriptive statistics. Genomic HRD by genomic instability scores, functional HRD by RAD51, and gene-specific loss of heterozygosity were analyzed. Associations between HRD status and tumor subtype, age at diagnosis, and gene-specific loss of heterozygosity in RAD51C/D were investigated using logistic regression or the t test. A total of 9507 index patients were reviewed, and 91 patients (1.0%) were found to carry a PV in RAD51C/D; 90 family members with a germline PV in RAD51C/D were also included. A total of 157 of carriers (86.7%) were women and 181 (55.8%) had received a diagnosis of cancer, mainly breast cancer or ovarian cancer. The most prevalent PVs were c.1026+5_1026+7del (11 of 56 [19.6%]) and c.709C>T (9 of 56 [16.1%]) in RAD51C and c.694C>T (20 of 35 [57.1%]) in RAD51D. In untreated breast cancer and ovarian cancer, the prevalence of functional and genomic HRD was 55.2% (16 of 29) and 61.1% (11 of 18) for RAD51C, respectively, and 66.7% (6 of 9) and 90.0% (9 of 10) for RAD51D. The concordance between HRD biomarkers was 91%. Tumors with the same PV displayed contrasting HRD status, and age at diagnosis did not correlate with the occurrence of HRD. All breast cancers retaining the wild-type allele were estrogen receptor positive and lacked HRD. In this cohort study of germline RAD51C/D breast cancer and ovarian cancer, less than 70% of tumors displayed functional HRD, and half of those that did not display HRD were explained by retention of the wild-type allele, which was more frequent among estrogen receptor-positive breast cancers. Understanding which tumors are associated with RAD51C/D and HRD is key to identify patients who can benefit from targeted therapies, such as PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitors
Surgical treatment of obstructive sleep apnea: adenotonsillectomy in adults
No full text20.500.12530/87896Introduction and objective: Obstructive sleep apnea (OSA) is a multifactorial etiology disease that leads to the collapse of the upper airway. Hypertrophy of lymphoid tissues contributes to airway collapsibility. Conceptual review of adenotonsillectomy in the adult patient with OSA. Synthesis: In the presence of grade >= 3 tonsillar hypertrophy, tonsillectomy is the first-line treatment. The different available adenotonsillectomy techniques are suitable for treating patients with OSA. The integrity of the palatoglossus and palatopharyngeus muscles must be respected. In addition to healing and surgical success, tonsillectomy offers benefits such as reducing necessary pressure applied to CPAP and consequently increasing its tolerance. Conclusions: The removal of hypertrophic lymphoid tissues in adult patients with OSA is essential. This surgery eliminates obstructive elements from the upper airway, favoring its patency and stability
Cardiac amyloidosis worsens prognosis in patients with heart failure: findings from the PREVAMIC study.
No full text20.500.12530/87908Cardiac amyloidosis (CA) is a common pathology in elderly patients that usually presents as heart failure (HF). However, it is not clear whether CA associated with HF has a worse prognosis compared with HF due to other etiologies. Prospective, observational cohort study that recruited patients ≥65 years of age with HF in 30 Spanish centers. The cohort was divided according to whether the patients had AC or not. Patients were followed for 1 year. A total of 484 patients were included in the analysis. The population was elderly (median 86 years) and 49% were women CA was present in 23.8 % of the included patients. In the CA group, there was a lower prevalence of diabetes mellitus and valvular disease. At one year of follow-up, mortality was significantly more frequent in patients with CA compared to those without (33.0 vs.14.9%, p The presence of CA in elderly patients with HF is related to a worse prognosis at one year of follow-up. Early diagnosis of the pathology and multidisciplinary management can help improve patient outcomes