Anti-PD-1, trastuzumab, and chemotherapy are used in the treatment of patients with advanced HER2-positive esophagogastric adenocarcinoma (EGA), but long-term survival remains limited. Herein, we report extended follow-up data from the INTEGA trial (NCT03409848), which investigated the efficacy of the anti-PD-1 nivolumab, trastuzumab, and FOLFOX chemotherapy (FOLFOX arm) in comparison to a chemotherapy-free regimen involving nivolumab, trastuzumab, and the anti-CTLA-4 ipilimumab (Ipi arm) in the first-line setting for advanced disease. The 12-month overall survival (OS) showed no statistical difference between the arms, with 57% OS (95% CI: 41%-71%) in the Ipi arm and 70% OS (95% CI: 54%-82%) in the FOLFOX arm.
View Article and Find Full Text PDFObjective: To investigate the costs and profile of patients who have filed a lawsuit against the Ministry of Health for the treatment of spinal muscular atrophy (SMA) with the onasemnogene abeparvovec (Zolgensma®).
Methods: This is a cross-sectional, descriptive study with a census design, based on records of lawsuits filed against the Ministry of Health between January 2019 and September 2022. Data was requested from the Ministry of Health via the Access to Information Act.
Background: In the pivotal phase III RECOURSE trial, trifluridine/tipiracil (FTD/TPI) improved progression-free and overall survival (PFS, OS) of patients with pre-treated metastatic colorectal cancer (mCRC). Subsequently, the TALLISUR trial provided post-authorisation efficacy and safety data and patient-reported outcomes on quality of life (QoL) in a German patient cohort. The present analysis reports the final data on efficacy, safety and QoL and investigates the impact of baseline characteristics and associated prognostic subgroups on outcome.
View Article and Find Full Text PDFLancet Gastroenterol Hepatol
August 2024
Background: There is an unmet need for effective therapies in pretreated advanced biliary tract cancer. We aimed to evaluate the efficacy of nanoliposomal irinotecan and fluorouracil plus leucovorin compared with fluorouracil plus leucovorin as second-line treatment for biliary tract cancer.
Methods: NALIRICC was a multicentre, open-label, randomised, phase 2 trial done in 17 German centres for patients aged 18 years or older, with an Eastern Cooperative Oncology Group performance status of 0-1, metastatic biliary tract cancer, and progression on gemcitabine-based therapy.
Varying the electrode potential rearranges the charges in the double layer (DL) of an electrochemical interface by a resistive-capacitive current response. The capacitances of such charge relocations are frequently used in the research community to estimate electrochemical active surface areas (ECSAs), yet the reliability of this methodology is insufficiently examined. Here, the relation of capacitances and ECSAs is critically assessed with electrochemical impedance spectroscopy (EIS) and cyclic voltammetry (CV) data on polished (Au, Ti, Ru, Pt, Ni, glassy carbon, graphite plate) and porous (carbon fleeces) electrodes.
View Article and Find Full Text PDFHabits pose a fundamental puzzle for those aiming to understand human behavior. They pervade our everyday lives and dominate some forms of psychopathology but are extremely hard to elicit in the lab. In this Registered Report, we developed novel experimental paradigms grounded in computational models, which suggest that habit strength should be proportional to the frequency of behavior and, in contrast to previous research, independent of value.
View Article and Find Full Text PDFThe effect of two atmospheric post-treatment conditions directly after the KOH activation of polyacrylonitrile-based nanofibres is studied in this work. As post-treatment different N : O flow conditions, namely high O-flow and low O-flow, are applied and their impact on occurring reactions and carbon nanofibres' properties is studied by thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), scanning electron microscopy (SEM), Raman spectroscopy, elemental analysis and CO and Ar gas adsorption. At high O-flow conditions a pyrophoric effect was observed on the KOH-activated carbon nanofibers.
View Article and Find Full Text PDFImportance: Adding immune checkpoint inhibitors to chemotherapy has been associated with improved outcomes in metastatic esophagogastric adenocarcinoma, but treatment combinations and optimal patient selection need to be established.
Objective: To investigate the efficacy and tolerability of the programmed cell death ligand 1 (PDL-1) inhibitor avelumab with paclitaxel plus ramucirumab.
Design, Setting, And Participants: This multicenter, single-group, phase 2 nonrandomized controlled trial was conducted among patients with second-line metastatic esophagogastric adenocarcinoma.
Objective: Which traits best describe individuals who are recognized as exemplary in different domains? And can self-rated positively valued personality traits distinguish such individuals from the general population?
Background: The study of exemplary individuals' personality traits traditionally focused on general and broad traits. Using character strengths, which are narrower and designed to describe desirable behavior, could provide new insights.
Method: In this study, we examined 204 outstanding individuals-exemplars who received or were nominated for a public award recognizing their exemplary behavior (e.
Purpose: This trial evaluates the addition of the PD-L1 antibody atezolizumab (ATZ) to standard-of-care fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) as a perioperative treatment for patients with resectable esophagogastric adenocarcinoma (EGA).
Methods: DANTE started as multicenter, randomized phase II trial, which was subsequently converted to a phase III trial. Here, we present the results of the phase II proportion, focusing on surgical pathology and safety outcomes on an exploratory basis.
Background: Clinical trials in metastatic colorectal cancer (mCRC) are usually conducted irrespective of sex. Sex-associated differences relating to safety and efficacy in the treatment of mCRC, however, are gaining interest.
Methods: PanaMa investigated the efficacy of panitumumab (Pmab) plus fluorouracil and folinic acid (FU/FA) versus FU/FA alone after induction therapy with six cycles of FU/FA and oxaliplatin plus Pmab in patients with RAS wild-type mCRC.
An exact understanding of the conductivity of individual fibers and their networks is crucial to tailor the overall macroscopic properties of polyacrylonitrile (PAN)-based carbon nanofibers (CNFs). Therefore, microelectrical properties of CNF networks and nanoelectrical properties of individual CNFs, carbonized at temperatures from 600 to 1000 °C, are studied by means of conductive atomic force microscopy (C-AFM). At the microscale, the CNF networks show good electrical interconnections enabling a homogeneously distributed current flow.
View Article and Find Full Text PDFAmphidiniopsis is a benthic, heterotrophic and thecate dinoflagellate genus that has a smaller epitheca and larger hypotheca. The genus contains 24 described species, but is considered to be polyphyletic based on morphological characters and molecular phylogenetics. In this study, two new species were discovered from two distant sampling localities, Amphidiniopsis crumena sp.
View Article and Find Full Text PDFIn this cross-sectional study, we hypothesized that a high dietary ratio of omega-6 (n-6) to omega-3 (n-3) fatty acids could be associated with an altered gut bacterial composition and with the disease severity in patients with nonalcoholic fatty liver disease (NAFLD). A total of 101 NAFLD patients were included in the study, of which 63 underwent a liver biopsy. All 101 patients completed a 14-day food and activity record.
View Article and Find Full Text PDFObjective: Real-world evidence on the application of the granulocyte colony-stimulating factor lipegfilgrastim for the reduction of chemotherapy-induced neutropenia and febrile neutropenia (FN) is limited. The NADIR study aimed to evaluate effectiveness and safety of lipegfilgrastim as primary or secondary prophylaxis in patients with lung cancer undergoing chemotherapy in routine clinical practice.
Methods: The non-interventional study NADIR (German Clinical Trials Register (DRKS) Number DRKS00005711) enrolled 156 patients with small-cell lung cancer (SCLC) and 145 patients with non-small-cell lung cancer (NSCLC), who received lipegfilgrastim during chemotherapy.
Purpose: High pathologic complete response (pCR) rates and comparably good survival data were seen in a phase II trial combining perioperative fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy with trastuzumab for resectable, esophagogastric adenocarcinoma (EGA). The current trial evaluates the addition of trastuzumab and pertuzumab to FLOT as perioperative treatment for human epidermal growth factor receptor 2-positive resectable EGA.
Methods: In this multicenter, randomized phase II/III trial, patients with human epidermal growth factor receptor 2-positive, resectable EGA (≥ clinical tumor 2 or clinical nodal-positive) were assigned to four pre- and postoperative cycles of either FLOT alone (arm A) or combined with trastuzumab and pertuzumab, followed by nine cycles of trastuzumab/pertuzumab (arm B).
In response to the concerns of beekeepers on the decline of honey bee populations on lavender honey flow in the lavender fields of southeast France and the consequent decrease of honey production, our long-term survey (2009-2021) monitored the total weight gain collected by these colonies. This study shows the variations in the total weight gain according to regions, years, populations structure (bee number and quantity of capped brood) and Varroa load. Among these factors, years and regions support one third of the variations over this 13-year survey.
View Article and Find Full Text PDFThe development of highly selective adsorbents for CO is a key part to advance separation by adsorption as a viable technique for CO capture. In this work, polyacrylonitrile (PAN) based carbon nanofibers (CNFs) were investigated for their CO separation capabilities using dynamic gas adsorption. The CNFs were prepared by electrospinning and subsequent carbonization at various temperatures ranging from 600 to 1000 °C.
View Article and Find Full Text PDFObjective: Research on the associations between cognitive and noncognitive personality traits has widely neglected character strengths, that means positively and morally valued personality traits that constitute good character.
Method: The present study aimed to bridge this gap by studying the associations between character strengths and fluid intelligence using different operationalizations of character strengths (including self- and informant-reports) and fluid intelligence in children, adolescents, and adults.
Results: The results, based on four samples (N = 193/290/330/324), suggested that morally valued personality traits are independent of fluid intelligence, with the exception of love of learning, which showed small but robust positive relationships with fluid intelligence across all samples.
Character strengths are assessed in adults and adolescents using different measurements. However, a comparison of character strengths across age groups requires the equivalence of these measurements. The present study examined the comparability of the two questionnaires most frequently used in research: The VIA Inventory of Strengths (VIA-IS) for adults and the VIA Inventory of Strengths for Youth (VIA-Youth).
View Article and Find Full Text PDFIntroduction: Trifluridine/tipiracil (FTD/TPI) improved both overall and progression-free survival (OS, PFS) of patients with pre-treated metastatic colorectal cancer (mCRC) in the pivotal phase III RECOURSE trial. However, health-related quality of life (HRQoL) was not assessed directly. To this end and to generate post-authorisation data, the TALLISUR trial was conducted.
View Article and Find Full Text PDFBackground: The understanding of longitudinal changes in the urinary microbiota of healthy women and its relation to intestinal microbiota is limited.
Methods: From a cohort of 15 premenopausal women without known urogenital disease or current symptoms, we collected catheter urine (CU), vaginal and periurethral swabs, and fecal samples on four visits over six months. Additionally, ten participants provided CU and midstream urine (MU) to assess comparability.
Objective: This article aims to investigate the reality of anticoagulation treatment for cancer patients with thrombosis in the outpatient sector of Germany.
Methods: For the analysis period 2012 to 2015, anonymized data from 4.1 million statutory insured patients were analyzed.