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Fortnightly or fractionated weekly docetaxel-cisplatin-5-FU as first-line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study

Cancer Med. 2021 May 31. doi: 10.1002/cam4.3976. Online ahead of print.

ABSTRACT

BACKGROUND: While docetaxel/cisplatin/5-fluorouracil (DCF) outperforms CF in first-line gastric adenocarcinoma, toxicity remains an issue.

METHODS: This multicenter phase II trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m2 , C 35 mg/m², F 1800 mg/m² over 24 h, on days 1 and 8 every 3 weeks, arm (1) or fortnightly DCF (D 50 mg/m2 , C 50 mg/m², F 2000 mg/m² over 48 h every 2 weeks, arm (2). Prophylactic granulocyte colony-stimulating factor (G-CSF) was not allowed. The primary endpoint was the rate of febrile neutropenia within the first six treatment weeks (early FN).

RESULTS: A total of 106 eligible patients were recruited. The early and overall FN rates were 9.5% and 17% in arm 1, respectively, and 5.9% and 8% in arm 2, respectively. Grade ≥3 toxicities occurred in 81% of patients in arm 1 and 90% of patients in arm 2, the most common being neutropenia (33% vs. 61%), fatigue (27% vs. 25%), vomiting (21% vs. 12%), anorexia (19% vs. 18%), and diarrhea (17% vs. 10%). Median progression-free survival and overall survival were 5.1 (95% CI, 3.2-6.5) and 8.2 months (95% CI, 6.0-14.5), respectively, in arm 1 and 5.2 (95% CI, 3.0-6.9) and 11.9 months (95% CI, 7.4-15.9), respectively, in arm 2.

CONCLUSIONS: Fractionated weekly and fortnightly DCF regimens are associated with a low risk of early FN, and a better hematological toxicity profile as compared to historical DCF without compromising efficacy. Both regimens offer greater convenience removing the need for systematic use of prophylactic G-CSF.

PMID:34057299 | DOI:10.1002/cam4.3976

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Ethnicity and Antiphospholipid Syndrome in Israel

Arthritis Care Res (Hoboken). 2021 May 31. doi: 10.1002/acr.24720. Online ahead of print.

ABSTRACT

BACKGROUND: The Antiphospholipid Syndrome (APS) is an acquired coagulopathy associated with the presence of antiphospholipid antibodies. Whether ethnicity modulates APS clinical course is not known. The aim of our study was to assess the interplay ethnicity and APS in Israel.

METHODS: We retrospectively evaluated the ethnic distribution of APS patients from 3 medical centres in Israel compared to the general population. Ethnic groups were defined according to the Israeli bureau of statistics as Ashkenazi (European), former Union of Soviet Socialist Republics (USSR), North African, Asian (West Asia, Greece and Turkey), Israeli Arabs and others.

RESULTS: Our cohort included 382 patients. With the prevalence of Ashkenazi and Asian ethnicities were more pronounce (33% vs. 12.8% and 15.4% vs. 7.7% respectively; p<0.001), while Israeli Arabs were less represented (5.2% vs. 31.1%; p<0.001) relative to their part in the general population. Arab patients were younger at presentation (28±10y vs. 34±13y; p<0.001), more likely to present with venous thrombosis (50% vs. 35%; p=0.037) and to suffer from venous thrombotic recurrence (45% vs.16%; p<0.001) compared to other ethnicities. Mortality was higher among patients of Asian ethnic origin (8.8% vs. 1.1%; p=0.005), intriguingly this group suffered more often from cardiovascular risk factors (i.e. dyslipidaemia as well hypertension).

CONCLUSION: Ethnicity may affect the prevalence and/or natural course of APS which is less prevalent and differs clinically in Israeli Arabs patients while mortality was linked with Asian ethnicity.

PMID:34057315 | DOI:10.1002/acr.24720

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Cross-sectional study of psychosocial well-being among lesbian, gay, bisexual, and heterosexual gynecologic cancer survivors

Cancer Rep (Hoboken). 2021 May 31:e1461. doi: 10.1002/cnr2.1461. Online ahead of print.

ABSTRACT

BACKGROUND: Delays in care and increased risk for mental health diagnoses put individuals identifying as a sexual minority with cancer at risk for decreased quality of life.

AIM: To assess psychosocial health among sexual minority gynecologic cancer survivors, we compared self-reported quality of life and psychosocial measures between individuals diagnosed with gynecologic cancers identifying as lesbian/gay/bisexual (LGB) and heterosexual.

METHODS AND RESULTS: English-speaking adults with gynecologic cancers were invited to participate in an ongoing cohort survey study. Quality of life and psychosocial measures included the Functional Assessment of Cancer Therapy-General, Distress Thermometer (distress), Patient Health Questionnaire-8 (depression), General Anxiety Disorder-7 (anxiety), and Post-traumatic Stress Disorder Checklist for DSM-5 (post-traumatic stress disorder; PTSD). Measures were compared by self-reported sexual orientation (heterosexual vs. LGB) using descriptive statistics (frequencies and means) and linear and logistic regression models, adjusting for college education. Of 814 patients invited, 457 enrolled (56.1%) and 401 (92.6%) completed the survey and provided information on their sexuality. All but one self-identified as cisgender women and 22 (5.5%) as LGB. LGB participants were more likely to have completed college (68.2% vs. 40.1%, p = .009) but were otherwise similar across demographic and clinical characteristics. Quality of life and distress scores were similar between groups. LGB participants, compared to heterosexual, reported higher rates of depression (31.8% vs. 10.6%, adjusted odds ratio [OR] = 4.1 [95% confidence interval [CI]: 1.6-11.0], p = .004), anxiety (25.0% vs. 7.1%, adjusted OR = 5.4 [95% CI: 1.7-16.7], p= .004), and PTSD (13.6% vs. 3.5%, adjusted OR = 4.2 [95% CI: 1.1-16.3], p = .04).

CONCLUSION: LGB participants reported poorer emotional health following a gynecologic cancer diagnosis than heterosexual participants. Our data suggest this population may need additional resources and support during and after their cancer diagnosis. Future work is needed to identify additional risk factors and the underlying sources of these disparities in order to improve patient care and wellness in this population.

PMID:34057316 | DOI:10.1002/cnr2.1461

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Protein energy wasting and long-term outcomes in nondialysis dependent chronic kidney disease

J Ren Care. 2021 May 30. doi: 10.1111/jorc.12378. Online ahead of print.

ABSTRACT

BACKGROUND: Nutritional status and protein energy wasting (PEW) is prevalent in patients with nondialysis-dependent chronic kidney disease (CKD). The relationship between PEW and long-term development of clinically important outcomes remains to be examined.

OBJECTIVES: To investigate the relationships between PEW, as measured by Subjective Global Assessment (SGA 1-7), and progression to important clinical outcomes: mortality and/or kidney failure.

DESIGN: Prospective cohort design.

PARTICIPANTS: One hundred and thirty-nine participants were well-nourished and 37 moderately malnourished patients with CKD 3-5.

MEASUREMENTS: The outcomes were 2, 5, and 10-year progression to kidney failure (dialysis or transplant) or mortality, kidney failure alone, and mortality alone. SGA was determined by a registered renal dietitian. Food frequency questionnaires were used to assess dietary intake. Clinical and laboratory baseline characteristics were collected. Multivariable regression models and Cox models were created to examine the relationship between SGA and outcomes.

RESULTS: PEW was associated with the combined outcome of kidney failure or mortality at 2 (p = 0.003), 5 (p = 0.004), but not at 10 (p = 0.73) years. This relationship was primarily driven by the relationship between PEW and kidney failure. In Cox models, the relationship between PEW and kidney failure remained after adjusting for Kidney Failure Risk Equation scores. The multivariable modeling revealed that PEW remained a statistically significant predictor of the combined outcome and ESKD after adjustment for age, estimated glomerular filtration rate (eGFR), sex, albumin-to-creatinine ratio, diabetes, albumin, and protein intake.

CONCLUSIONS: PEW, determined by the SGA 1-7, is an important prognostic tool. Further research looking at clinically important outcomes are needed to implement nutritional interventions for nondialysis-dependent CKD patients.

PMID:34053197 | DOI:10.1111/jorc.12378

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Clinicopathological characteristics of patients with esophageal squamous papilloma in Turkey and comparison with the literature data: the largest case series ever reported from Turkey

Int J Clin Pract. 2021 May 30:e14420. doi: 10.1111/ijcp.14420. Online ahead of print.

ABSTRACT

AIM: Esophageal squamous papilloma (ESP) is a rare tumoral lesion of the esophagus considered to have a benign course. Due to the fact that they are rare lesions, there are not many publications with large case series on ESPs in the literature. In this study, we aimed to investigate the clinical, endoscopic and histopathological characteristics of ESPs.

METHODS: Reports of upper gastrointestinal endoscopies performed in the endoscopy unit within the Division of Gastroenterology of a tertiary care hospital in the Southeastern Anatolia Region of Turkey in the last eight-year period were evaluated retrospectively. Patients who were determined to have esophageal polypoid lesions during the endoscopic procedure and were then diagnosed with esophageal squamous cell papilloma in the histopathological examination were included in the study.

RESULTS: Of 11541 patients who underwent upper gastrointestinal endoscopy, 51 were diagnosed with a total number of 55 ESPs (0.44%). In addition, 26 of these patients (51%) were female, and the mean age of the patients at the time of diagnosis was 42.2 years. The average size of the ESPs was 3.47 millimeters, and the most frequent location was the middle esophagus with 51%. No statistically significant relationship was found between the location of ESPs and gender, endoscopy indication, esophagitis, lower esophageal sphincter dysfunction, hiatal hernia, gastroesophageal reflux disease (GERD) and Helicobacter pylori positivity.

CONCLUSION: In this study with the largest case series ever reported from Turkey, it was determined that ESPs were seen in younger ages in Turkey and were also smaller in size, which is not in agreement with the literature data. Besides, this study, in which ESPs were most frequently detected in the middle esophagus, supports the view that GERD may not be the main factor in ESP etiology.

PMID:34053176 | DOI:10.1111/ijcp.14420

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Concentration-Dependent Clinical and Prognostic Importance of High-Sensitivity Cardiac Troponin T in Heart Failure and a Reduced Ejection Fraction and the Influence of Empagliflozin: the EMPEROR-Reduced Trial

Eur J Heart Fail. 2021 May 30. doi: 10.1002/ejhf.2256. Online ahead of print.

ABSTRACT

BACKGROUND: Circulating troponin is an important measure of risk in patients with heart failure, but it has not been used to determine if disease severity influences the responses to drug treatments in randomized controlled trials.

METHODS: In the EMPEROR-Reduced trial, patients with class II-IV heart failure and a reduced ejection fraction were randomly assigned to placebo or empagliflozin 10 mg daily and followed for the occurrence of serious heart failure and renal events. High-sensitivity cardiac troponin T (hs-cTnT) was measured in 3636 patients (> 97%) at baseline, and patients were divided into four groups based on the degree of troponin elevation.

RESULTS: With increasing concentrations of hs-cTnT, patients were progressively more likely to have diabetes and atrial fibrillation, to have New York Heart Association class III-IV symptoms and been hospitalized for heart failure within the prior year, and to have elevated levels of natriuretic peptides and worse renal function (P-trend <0.0001 for all comparisons), but importantly, the troponin groups did not differ with respect to ejection fraction. A linear relationship was observed between the logarithm of hs-cTnT and the combined risk of cardiovascular death or hospitalization for heart failure (P = 0.0015). When treated with placebo, patients with the highest levels of hs-cTnT had risks of cardiovascular death and hospitalization for heart failure that were 3-5 fold greater than those with values in the normal range. Patients with higher levels of hs-cTnT were also more likely to experience worsening of renal function and serious adverse renal events and show the least improvement in health status (as measured by the Kansas City Cardiomyopathy questionnaire). When compared with placebo, empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure, regardless of the baseline level of hs-cTnT, whether the effects of treatment were analyzed as hazard ratios or absolute risk reductions (Graphical Abstract)..

CONCLUSIONS: Elevations in hs-cTnT reflect the clinical severity, stability and prognosis of patients with heart failure and a reduced ejection fraction, with biomarkers, comorbidities, clinical course and risks that are proportional to the magnitude of hs-cTnT elevation. Empagliflozin exerted favorable effects on heart failure and renal outcomes, regardless of the baseline concentration of hs-cTnT.

PMID:34053177 | DOI:10.1002/ejhf.2256

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Impact of technological and departmental changes on incident rates in radiation oncology over a seventeen-year period

J Med Radiat Sci. 2021 May 29. doi: 10.1002/jmrs.517. Online ahead of print.

ABSTRACT

INTRODUCTION: Advancements in technology and processes are designed to bring improvement. However, this is often achieved in parallel with increases in complexity, simultaneously presenting opportunities for new types of errors. This study aims to contextualise the impact of internal departmental changes upon radiation incidents and near misses recorded.

METHODS: A timeline of events and a comprehensive incident categorisation system were applied to all radiation incidents and near misses recorded at the Princess Alexandra Hospital Radiation Oncology department from 2003 to 2019, inclusive. Descriptive statistics were performed to identify the type and number of incidents reported during the time period in relation to potential changes within the department, with a focus on the implementation of an electronic environment.

RESULTS: Over the seventeen-year period, 157 incidents and 76 near misses were reported. The majority of incidents were classified as ‘procedural’ (78%), with ‘treatment’ being both the highest point of error and point of detection (49% and 85%, respectively). The largest number of incidents and near misses were reported in 2018 (n = 39) which was also a year that experienced the largest number of departmental changes (n = 16), including the move to a completely electronic planning process.

CONCLUSIONS: Changes within the department were followed by an increasing number of reported incidents. Proactive measures should be undertaken prior to the implementation of major changes within the department to aid in the minimisation of incident occurrence.

PMID:34053193 | DOI:10.1002/jmrs.517

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The vaginal microbiota composition of women undergoing assisted reproduction: a prospective cohort study

BJOG. 2021 May 30. doi: 10.1111/1471-0528.16782. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the impact of vaginal microbiota on pregnancy outcomes in women undergoing assisted reproduction.

DESIGN: A prospective cohort study.

SETTING: A university-based assisted reproductive technology (ART) centre.

POPULATION: 223 women undergoing ART treatment.

METHODS: Prior to embryo transfer, vaginal samples were collected from the posterior fornix. Vaginal microbiota identification was carried out using next-generation sequencing and categorised according to the V3-V4 hypervariable region in the 16S rRNA gene region.

MAIN OUTCOME MEASURES: ART clinical outcomes (implantation, clinical pregnancy rates, and live birth rates) RESULT(S): The live birth rate in women with community state type (CST)-I (39%) was higher than that in women with CST-III (21.5%), but the difference was not statistically significant (p = 0.052). The relative abundance of Lactobacillus was lower in women who failed to become pregnant (NP group) (67.71%) than in women who became pregnant (PR group) (79.72%). However, this difference was not statistically significant (p = 0.06). In the NP group, the relative abundance of Streptococcus (7.81%) and Gardnerella (9.40%) was higher than that in the PR group (relative abundance of Streptococcus and Gardnerella was 2.28% and 5.56%, respectively). The abundance of Streptococcus was found to be statistically significantly different between the two study groups (p = 0.014). Linear discriminant analysis (LDA) further validated that Streptococcus had the highest contribution (LDA score >4.0) to the difference between these two groups.

CONCLUSION(S): Streptococcus has the highest contribution to the distinction between the PR and NP groups.

FUNDING: This study was supported by the Scientific and Technological Research Council of Turkey (TÜBİTAK), project number 215S738.

PMID:34053157 | DOI:10.1111/1471-0528.16782

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Use of Radiological Tests in COVID-19 Positive Child Cases: Is Chest Computed Tomography Necessary?

Int J Clin Pract. 2021 May 30:e14259. doi: 10.1111/ijcp.14259. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to correlate the radiographic findings of the coronavirus disease 2019 (COVID-19) positive children with their clinical and laboratory findings, discuss the frequency and necessity of chest computed tomography (CT) used for the radiological imaging in pediatric patients with COVID-19 infection.

MATERIALS AND METHODS: Sixty-nine pediatric inpatient cases were retrospectively analyzed using their clinical, laboratory, and imaging features. The National Public Health Guide was used in the diagnosis and treatment of pediatric patients. COVID-19 infections for all patients were confirmed by the COVID-19 nucleic acid test using a pharyngeal swab.

RESULTS: The median age of the patients was 11 [3-15] years. The most common clinical symptoms were fever (40,6%) and cough (33,3%). When the laboratory findings of patients were examined, the median WBC count was 5.8/mm3 [4.8-8.05/mm3 ], median lymphocyte count was 2.3/mm3 [1.7-3.55/mm3 ], and median C-reactive protein (CRP) level was 2.3/mm3 [1-2.1/mm3 ]. All patients had chest radiographs (CRXs), while only 44.9% of the patients underwent a chest CT. The 8.7% of CXRs and 12.8% of chest CT findings were found as pathological. Ground-glass opacity was the most frequent finding. In the tomography group, the count of lymphocytes was lower, and creatine kinase (CK) and lactate dehydrogenase (LDH) levels were significantly higher. The patients with pathological tomography findings demonstrated no statistically significant difference in lymphocyte count, and CK and LDH levels; however, their CRP value was significantly higher.

CONCLUSION: In this study, it is emphasized that chest CT should be requested by considering the underlying diseases and severity of clinical findings in pediatric patients. In this way, unnecessary chest CT could be prevented in the pediatric population.

PMID:34053160 | DOI:10.1111/ijcp.14259

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Effect of Workplace Fun on Chinese Nurse Innovative Behavior: The Intermediary Function of Affective Commitment

J Nurs Manag. 2021 May 30. doi: 10.1111/jonm.13387. Online ahead of print.

ABSTRACT

AIM: To assess the effects of workplace fun on nurse innovative behavior and to confirm the intermediary function of affective commitment.

BACKGROUND: Employee innovative behavior has a crucial function in survival and development of an organization. On the basis of the theory of social exchange, there has been inadequate study of the influence of workplace fun on nurse innovative behavior mediated by affective commitment.

METHODS: A cross-sectional, descriptive correlational research design was conducted for 331 Chinese nurses from five public hospitals. The measurements were obtained from a questionnaire on workplace fun, affective commitment, nurse innovative behavior, and a sociodemographic datasheet. Descriptive statistics were used to analyze the personal profile, and inferential statistics were used to test hypotheses.

RESULTS: We identified a positive correlation between workplace fun and nurse innovative behavior. Affective commitment had a mediating effect.

CONCLUSIONS: Workplace fun and affective commitment can promote nurse innovative behavior.

IMPLICATIONS FOR PRACTICE: Managers need to provide measures that promote workplace fun and affective commitment to enhance nurse innovative behavior.

PMID:34053146 | DOI:10.1111/jonm.13387