title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Abstract | Current address for D.C. Cho: New York Medical College, Westchester Medical Center, Valhalla, New York; and current address for S. O'Day: Agenus, Lexington, Massachusetts. | PMC10729644 | ||
Purpose: | This phase Ib open-label, multicenter, platform study (NCT02646748) explored safety, tolerability, and preliminary activity of itacitinib (Janus kinase 1 inhibitor) or parsaclisib (phosphatidylinositol 3-kinase δ inhibitor) in combination with pembrolizumab [programmed death-1 (PD-1) inhibitor]. | PMC10729644 | ||
Experimental Design: | DISEASE PROGRESSION, SOLID TUMORS | Patients with advanced or metastatic solid tumors with disease progression following all available therapies were enrolled and received itacitinib (Part 1 initially 300 mg once daily) or parsaclisib (Part 1 initially 10 mg once daily; Part 2 all patients 0.3 mg once daily) plus pembrolizumab (200 mg every 3 weeks). | PMC10729644 | |
Results: | A total of 159 patients were enrolled in the study and treated with itacitinib (Part 1, | PMC10729644 | ||
Conclusions: | SOLID TUMORS | Although combination of itacitinib or parsaclisib with pembrolizumab showed modest clinical activity in this study, the overall response rates observed did not support continued development in patients with solid tumors. | PMC10729644 | |
Significance: | T-cell infiltration, tumor | TUMOR, SOLID TUMORS | PD-1 blockade combined with targeted therapies have demonstrated encouraging preclinical activity. In this phase I study, patients with advanced solid tumors treated with pembrolizumab (PD-1 inhibitor) and either itacitinib (JAK1 inhibitor) or parsaclisib (PI3Kδ inhibitor) experienced limited clinical activity beyond t... | PMC10729644 |
Introduction | Janus kinase-signal transducer, tumor | TUMOR, SOLID TUMORS | Immune checkpoint receptors are expressed on tumor, stromal, and immune cells, and negatively regulate the immune response in the tumor microenvironment (TME; ref. Excessive Janus kinase-signal transducer and activator of transcription (JAK/STAT) signaling within the TME may reduce antitumor responses, suggesting JAK e... | PMC10729644 |
Materials and Methods | PMC10729644 | |||
Study Design | NSCLC, SCLC, pembrolizumab, PAD, toxicity, UC | SCLC, SOLID TUMORS, SMALL CELL LUNG CANCER, PAD, NSCLC | This phase Ib, multicenter, open-label, platform study (ClinicalTrials.gov identifier: NCT02646748) was conducted in the United States. The study evaluated combination of itacitinib or parsaclisib plus pembrolizumab in two parts: Part 1 consisted of Part 1a dose-escalation (enrolling all solid tumors) and Part 1b safet... | PMC10729644 |
Patient Inclusion and Exclusion Criteria | NSCLC, SCLC, tumor, colorectal cancer, pneumonitis, melanoma, hepatitis B, toxicities, HNSCC, renal cell carcinoma, UC, infection, tumors | CARCINOMATOUS MENINGITIS, TUMOR, MELANOMA, TRIPLE-NEGATIVE BREAST CANCER, CENTRAL NERVOUS SYSTEM METASTASES, SURGICAL COMPLICATIONS, JC VIRUS INFECTION, ONCOLOGY, AUTOIMMUNE DISEASE, PANCREATIC DUCTAL ADENOCARCINOMA, COLORECTAL CANCER, SCLC, INTERSTITIAL LUNG DISEASE, GASTRIC CANCER, HEPATITIS B, ADVERSE EVENTS, METAST... | The study enrolled men and women ≥18 years of age with an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1, who were willing to provide a baseline and on-treatment tumor biopsy specimen, and had measurable disease based on RECIST v1.1. In Part 1a, enrolled patients had histologically or cytologically ... | PMC10729644 |
Study Endpoints and Assessments | tumor | ADVERSE EVENT, TUMOR, DISEASE, EVENT, ADVERSE EVENT | The primary study endpoint was safety and tolerability in Part 1, assessed by monitoring the frequency, duration, and severity of AEs. A treatment-emergent adverse event (TEAE) was defined as an AE either reported for the first time or worsening of a preexisting event after first dose of study drug. AEs were classified... | PMC10729644 |
Translational Biomarker Analyses | nontumor, tumor | TUMOR | Changes in TILs and the ratio of Teff to Tregs (CD8In Part 1, a single-color, Singleplex chromogenic assay (Indivumed) was used to quantify cells in the combined tumor plus stromal (nontumor) regions in baseline and on-treatment biopsy samples. In Part 2, a five-color, Multiplex IHC assay (Indivumed) was used to quanti... | PMC10729644 |
Plasma Protein Analysis | To further evaluate the pharmacodynamic effects and potential association with clinical response to study treatment, the presence of immune and nonimmune plasma proteins was determined using a Multiplex Proximity Extension Assay by Olink Proteomics. In this assay, each biomarker is identified by a matched pair of antib... | PMC10729644 | ||
Statistical Analysis | NSCLC, SCLC, tumor, DLTs, toxicity, UC | NSCLC, TUMOR, SCLC, EVENT | All patients enrolled in the study who received ≥1 dose of study drug (pembrolizumab, itacitinib, or parsaclisib) comprised the safety analysis population and the full analysis set (FAS) for baseline demographic and efficacy analyses. Descriptive statistics were used to summarize continuous and categorical variables. T... | PMC10729644 |
Data Availability Statement | Access to individual patient-level data is not available for this study. | PMC10729644 | ||
Ethics Statement | The study was performed in accordance with the International Council for Harmonisation Guideline for Good Clinical Practice, the principles of the Declaration of Helsinki, and other applicable local ethical and legal requirements. The study protocol and its amendments were reviewed and approved by institutional review ... | PMC10729644 | ||
Results | PMC10729644 | |||
Patient Characteristics and Disposition | head and neck squamous cell carcinoma, SCLC, NSCLC, PD | COLORECTAL CANCER, SCLC, PROGRESSIVE DISEASE, UROTHELIAL CARCINOMA, SMALL CELL LUNG CANCER, NSCLC, ONCOLOGY, RENAL CELL CARCINOMA, RCC | At the data cut-off date (March 10, 2020), a total of 159 patients had been enrolled at 11 study sites and were included in both the safety population and FAS. Forty-nine patients were included in all of Part 1/Group A [itacitinib plus pembrolizumab; Patient demographics and baseline characteristics are summarized in S... | PMC10729644 |
Safety | Itacitinib 300 mg once daily was selected as the MTD in dose-escalation Part 1a/Group A and used in safety-expansion Part 1b/Group A-1 [PD-(L)1 treatment-experienced] and A-2 [PD-(L)1 treatment-naïve]. Parsaclisib 30 mg once daily was selected as the MTD/PAD in dose-escalation Part 1a/Group B, and parsaclisib 20 mg onc... | PMC10729644 | ||
Part 1: Itacitinib plus Pembrolizumab | NSCLC, SCLC, primary pancreatic carcinoma, TEAEs, pain, pyrexia, chills | NON-SMALL CELL LUNG CANCER, SCLC, UROTHELIAL CARCINOMA, MALIGNANT NEOPLASM PROGRESSION, SMALL CELL LUNG CANCER, DRUG-INDUCED LIVER INJURY, ADVERSE EVENT, NSCLC | No patient in Part 1a/Group A, or Part 1b/Group A-1 [PD-(L)1 treatment-experienced] or A-2 [PD-(L)1 treatment-naïve] experienced a DLT. All patients in Part 1 treated with itacitinib experienced ≥1 TEAE (Summary of itacitinib and parsaclisib treatment-related TEAEs by MedDRA preferred term (≥5% of patients in the safet... | PMC10729644 |
Part 1: Parsaclisib plus Pembrolizumab | NSCLC, pneumonitis, DLTs, TEAEs, depressed, oliguria | PNEUMONITIS, NSCLC, OLIGURIA | One 72-year-old patient with NSCLC in Part 1a/Group B (receiving parsaclisib 2.5 mg once daily plus pembrolizumab) experienced two grade 4 DLTs of pneumonitis (day 12, considered related to pembrolizumab and parsaclisib; not resolved) and oliguria (day 14, considered related to parsaclisib; fatal). No patient in Part 1... | PMC10729644 |
Part 2: Parsaclisib plus Pembrolizumab | DLTs, TEAEs | No DLTs were reported in patients enrolled in Part 2. All patients experienced ≥1 TEAE (Nine patients (33.3%) in Part 2 experienced TEAEs leading to discontinuation of parsaclisib, and 8 patients (29.6%) had TEAEs leading to discontinuation of pembrolizumab. | PMC10729644 | |
Efficacy | NSCLC, SCLC, SD, Tumor | SCLC, TUMOR, DISEASE, UROTHELIAL CARCINOMA, SMALL CELL LUNG CANCER, NSCLC | Of patients receiving itacitinib plus pembrolizumab in Part 1, 4 (8.2%) had partial response (PR) and 19 (38.8%) had stable disease (SD; Tumor response by RECIST (full analysis set)Abbreviations: CI, confidence interval; NSCLC, non–small cell lung cancer; ORR, objective response rate; Q3W, every 3 weeks; QD, once daily... | PMC10729644 |
Pharmacokinetics | Itacitinib exposures were higher in patients receiving 300 mg compared with 400 mg once daily (Parsaclisib exposures increased with higher doses ( | PMC10729644 | ||
Tumor Lymphocyte IHC | NSCLC, SCLC, tumor, UC | TUMOR, EVALUABLE, SCLC, NSCLC | Representative Singleplex and Multiplex IHC images are shown in IHC analysis of paired screening and on-treatment (week 5–6) tumor biopsies, from patients receiving itacitinib or parsaclisib in combination with pembrolizumab. Because doses of parsaclisib examined in Part 1/Group B-1/B-2 (20–30 mg once daily) may also i... | PMC10729644 |
Plasma Proteomics | HEAT | Plasma proteomic heat map analyses (Heat map of plasma proteins significantly changed (logNine unique proteins were significantly changed between cycle 1 and 2 in the itacitinib plus pembrolizumab combination groups (A-1/A-2; Twenty-seven unique proteins were differentially expressed between cycle 1 and 2 across the pa... | PMC10729644 | |
Discussion | NSCLC, tumor, T-cell, pembrolizumab | TUMOR, INFILTRATION, GROUP B, ENDOMETRIAL ADENOCARCINOMA, MINOR, SOLID TUMORS, OF LUNG ADENOCARCINOMA, SECONDARY, ADENOCARCINOMA, NSCLC, CHOLANGIOCARCINOMA | This phase Ib platform study evaluated the safety, efficacy, and pharmacodynamics of itacitinib (JAK1 inhibitor) or parsaclisib (PI3Kδ inhibitor) in combination with pembrolizumab (anti-PD-1) in patients with advanced or metastatic solid tumors. The study primary objective was to define a preliminary safety profile of ... | PMC10729644 |
Supplementary Material | GROUP B | Supplementary Figure 1. Singleplex and Multiplex immunohistochemistry examples.Supplementary Table 1. Summary of patient disposition (Part 1a Group A) (Full Analysis Set)Supplementary Table 2. Summary of patient disposition (Part 1a Group B) (Full Analysis Set)Supplementary Table 3. Summary of patient disposition (Part... | PMC10729644 | |
Acknowledgments | Funding for this study was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., and Incyte Corporation. The authors wish to thank the patients, investigators, and site personnel who participated in this study. Pharmacokinetic analysis was performed by April M. Barbour of Incyte Corporation. Medical w... | PMC10729644 | ||
Authors’ Disclosures | Melanoma, cancers, Tumor, P., Lyell | MELANOMA, DISORDERS, CANCERS, TUMOR, LYELL | P. Munster reports grants from Amgen, Pfizer, AstraZeneca, GSK, Novartis, Oric, Revolution Medicine, Aevinas, Cyteir, Tempest, Arch, and H3Bio during the conduct of the study; personal fees and other from Alessa and Janssen, Atlas, RasCal; non-financial support from Hap10; personal fees from Parthenon outside the submi... | PMC10729644 |
Authors’ Contributions | PMC10729644 | |||
References | PMC10729644 | |||
2. Materials and Methods | PMC10146641 | |||
2.1. Compliance with Ethical Standards | After receiving permission from Zonguldak Bülent Ecevit University Clinical Research Ethics Committee (protocol No: 2019-96-12/06, ClinicalTrials.gov Identifier: NCT05499754), this prospective randomized study was conducted in Zonguldak Bülent Ecevit University Hospital, Turkey, between July 2019 and 2020. Informed wri... | PMC10146641 | ||
2.2. Patient Population | cerebral edema, glaucoma, SAD | CEREBRAL EDEMA, UNCONTROLLED HYPERTENSION, DIABETIC NEUROPATHY, GLAUCOMA | Ninety patients (aged 18–65 years) in the American Society of Anesthesiologists (ASA) class I–II who were scheduled for elective non-ophthalmic procedures that would last 1–2 h under general anesthesia in the supine position were included in this study. The sample of the study excluded patients with Mallampati and thos... | PMC10146641 |
2.3. Application of General Anesthesia and Monitoring | All patients were instructed to fast for at least 8 h before surgery. No premedication was given. When the patient was in the anesthesia room, their head was placed on a soft, 7 cm high pillow before the induction of anesthesia, with their neck flexed and head extended. The patients were connected to electrocardiograph... | PMC10146641 | ||
2.4. Data Management | The ONSD values were measured by an experienced anesthesiologist who was not informed about the study using an Esaote MyLab 30 GOLDThe mean arterial pressure (MAP), HR, and ONSD values of the patients were recorded before induction (T0), 1 min after SAD placement (T1), 5 min after SAD placement (T5), and 10 min after S... | PMC10146641 | ||
2.5. Statistical Analysis | The planned sample size required to detect 95.9% test power (1 − β), 95% confidence (1 − α) and effect size d = 1.16 was 10 people per group. We included 30 patients in each group to compensate for patient dropouts [ | PMC10146641 | ||
3. Results | Clinical and Demographic CharacteristicsNinety patients were included in the study, and ninety completed the study (Whereas there was no significant difference among the HR values of the groups (Likewise, whereas there was no significant difference among the MAP values of the groups (An increase in ONSD was seen in all... | PMC10146641 | ||
4. Discussion | neurological deficits, ONSD, SAD | COMPLICATION, COMPLICATIONS | In our study, when they were inserted into adult patients with normal airways, the effects of the pLMA, sLMA, and I-gel on hemodynamic responses and ONSD values were similar. In all three groups, the HR and MAP values measured 1 min after SAD insertion were similar to each other, and in the intragroup comparisons, thes... | PMC10146641 |
5. Limitations | intracranial pathologies, SAD | CEREBRAL ISCHEMIA, CARDIOVASCULAR DISEASES | There were some limitations to this study. One of the most important was that it was not technically possible for the person who recorded the data to be unaware of the airway device being used. Furthermore, as patients with normal airways were included in this study, the results may not be applicable to patients with d... | PMC10146641 |
Author Contributions | Conceptualization, R.D.O. and G.K.; Data curation, G.K., B.G.K., and Ö.P.; Formal analysis, R.D.O. and H.A.; Investigation, R.D.O., G.K., and B.G.K.; Methodology, R.D.O., G.K., and B.G.K.; Resources, R.D.O. and G.K.; Visualization, H.A. and Ö.P.; Writing—original draft, R.D.O., G.K., and B.G.K.; Writing—review & editin... | PMC10146641 | ||
Institutional Review Board Statement | The study was approved by the institute ethics committee (protocol No: 2019-96-12/06, ClinicalTrials.gov identifier: NCT05499754). | PMC10146641 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10146641 | ||
Data Availability Statement | The data used and/or analyzed during the current study are available from the corresponding author. | PMC10146641 | ||
Conflicts of Interest | The authors declare no competing interests and no conflict of interest. | PMC10146641 | ||
Objective | obesity, cardiometabolic diseases | OBESITY | Human brown adipose tissue (BAT) has gained considerable attention as a potential therapeutic target for obesity and its related cardiometabolic diseases; however, whether the gut microbiota might be an efficient stimulus to activate BAT metabolism remains to be ascertained. We aimed to investigate the association of f... | PMC9938059 |
Methods | 82 young adults (58 women, 21.8 ± 2.2 years old) participated in this cross-sectional study. DNA was extracted from fecal samples and 16S rRNA sequencing was performed to analyse the fecal microbiota composition. BAT was determined via a static | PMC9938059 | ||
Results | The relative abundance of | PMC9938059 | ||
Conclusion | Our results suggest that fecal microbiota composition is involved in the regulation of BAT and glucose uptake by other tissues in young adults. Further studies are needed to confirm these findings. | PMC9938059 | ||
Clinical trial information | ClinicalTrials.gov no. NCT02365129 (registered 18 February 2015). | PMC9938059 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s40618-022-01936-x. | PMC9938059 | ||
Keywords | / CBUA | Funding for open access charge: Universidad de Granada / CBUA | PMC9938059 | |
Introduction | obesity, cardiometabolic diseases, Eukarya | OBESITY, BROWN | Brown adipose tissue (BAT) is a tissue that dissipates energy through the action of the uncoupling protein-1 (UCP1) in rodents and in humans [The human gut harbours a vast array of microorganisms such as Eukarya, Archaea, fungi, and mainly bacteria [We hypothesized that the relative abundance of gut bacteria previously... | PMC9938059 |
Material and methods | PMC9938059 | |||
Design study and participants | This cross-sectional study was carried out within the framework of the ACTIBATE study [ | PMC9938059 | ||
Body composition assessment | We measured the participants’ weight and height while being barefoot and wearing light clothing, using a SECA scale and stadiometer (model 799, Electronic Column Scale, Hamburg, Germany). Lean body mass and body fat mass were determined by Dual Energy X-ray Absorptiometry (Hologic Discovery Wi, Marlborough, MA, USA). B... | PMC9938059 | ||
Fecal microbiota composition analyses | PMC9938059 | |||
Stool collection and DNA extraction | STERILE, LYSIS | The participants collected a fecal sample (50–60 g) 3 ± 7 days [mean ± standard deviation] prior to the positron emission tomography/computed tomography (PET/CT). They transported the fecal sample in plastic sterile containers inside a portable cooler until arrival at the research centre. Fecal samples were stored at −... | PMC9938059 | |
Sequencing analysis | We amplified DNA extracted by polymerase chain reaction (PCR) with primer pairs, 16S Amplicon PCR Forward Primer: 5’CCTACGGGNGGCWGCAG, and 16S Amplicon PCR Reverse Primer: 5’GACTACHVGGGTATCTAATCC targeting the V3 and V4 hypervariable regions of the bacterial 16S rRNA gene [ | PMC9938059 | ||
Bioinformatics analyses | “Dada2” [Taxonomic affiliation of phylotypes was assigned using the “classifier” function from Ribosomal Database Project (RDP), based on the naive Bayesian classification [ | PMC9938059 | ||
Brown adipose tissue measurements | PMC9938059 | |||
Shivering threshold test | To personalize the cooling protocol used to activate human BAT, subjects underwent a cooling test 48–72 h before the | PMC9938059 | ||
Personalized cooling protocol prior to positron emission tomography/computed tomography scan | shivering | After 48–72 h of the shivering threshold test, the participants went to the | PMC9938059 | |
Brown adipose tissue quantification | All PET/CT images were examined using the Beth Israel plug-in for FIJI software ( | PMC9938059 | ||
Statistical analysis | Data are presented as means ± standard deviations unless otherwise stated. All variables were tested for normality using D’Agostino and Pearson omnibus. Most of the variables displayed a non-normal distribution and, thus, non-parametric tests were used for all analyses. We did not detect any sex interaction across the ... | PMC9938059 | ||
Results | PMC9938059 | |||
Relationship between fecal microbiota composition and cold-induced BAT variables | We observed that the relative abundance of the Partial Spearman correlation of fecal microbiota composition with BAT volume, SUVmean, SUVpeak, and mean radiodensity adjusted for the PET/CT scan date. Boxes represent the statistically significant (Next, we investigated whether the relative abundance of specific genera w... | PMC9938059 | ||
Relationship of fecal microbiota composition with cold-induced uptake of | The relative abundance of Partial Spearman correlation of fecal microbiota composition with tissues related to | PMC9938059 | ||
Discussion | This study shows, for the first time, that the relative abundance of The role of gut microbiota composition in BAT activation and metabolism has been investigated in mouse models [We also observed a positive correlation of the relative abundance of | PMC9938059 | ||
Limitations and strengths | comorbidity | DISEASE | The cross-sectional design of this study precluded us from establishing cause-effect relationships. Our study population includes young adults without relevant disease or comorbidity; thus, our results cannot be extrapolated to older or unhealthier populations. Importantly, SCFAs were not measured and could be of inter... | PMC9938059 |
Conclusions | This is the first study showing a negative correlation of the relative abundance of | PMC9938059 | ||
Acknowledgements | This study is part of a PhD thesis conducted within the Biomedicine Doctoral Studies Program of the University of Granada, Spain. | PMC9938059 | ||
Author contributions | L.O-A, F.M.A and B.M-T and J.R.R: designed the research. L.O-A, F.M.A, and B.M-T: conducted the research. G.S-D., R.V-V, A.L, J.P-D, J.M.L, A.G, I.L, and P.C.N.R: provided essential reagents or materials. L.O-A, H.X, F.M.A, and B.M-T: analysed data or performed the statistical analysis. L.O-A, F.M.A, and B.M-T: wrote t... | PMC9938059 | ||
Funding | RVV, AiA | DEL | Funding for open access charge: Universidad de Granada / CBUA. The study was supported by the Spanish Ministry of Economy and Competitiveness via Fondo de Investigación Sanitaria del Instituto de Salud Carlos III (PI13/01393) and PTA 12264-I, Retos de la Sociedad (DEP2016- 79512-R), and European Regional Development Fu... | PMC9938059 |
Data availability | The datasets generated during the current study are available from the corresponding author upon reasonable request. | PMC9938059 | ||
Declarations | PMC9938059 | |||
Conflict of interest | The authors have no conflicts of interest. | PMC9938059 | ||
Research involving human participants and/or animals | The study protocol and the written informed consent were performed in accordance with the Declaration of Helsinki, as revised in 2013, and were approved by the Human Research Ethics Committee of the University of Granada (n°924) and the “Servicio Andaluz de Salud” (Centro de Granada, CEI-Granada). | PMC9938059 | ||
Informed consent | Informed consent was obtained from all individual participants included in the study. | PMC9938059 | ||
References | PMC9938059 | |||
Background | Lung cancer | DISEASE, ADVERSE EFFECTS, LUNG CANCER | Lung cancer (LC) is associated with high mortality and poor quality of life (QoL). The disease as well as oncological treatments such as radiation and chemotherapy with adverse effects can impair the QoL of patients. Add-on treatment with extracts of | PMC9990362 |
Methods | REGRESSION | A real-world data study was conducted using registry data. Self-reported QoL was assessed by the evaluation of the European Organization of Research and Treatment Health-Related Quality of Life Core Questionnaire scale (EORTC QLQ-C30). Adjusted multivariate linear regression analyses were performed to analyze factors a... | PMC9990362 | |
Results | pain, non-small-cell lung cancer | A total of 112 primary LC patients (all stages, 92% non-small-cell lung cancer, median age 70 (ICR: 63–75)), answered the questionnaires at first diagnosis and 12 months later. Assessment of 12 months changes in QoL revealed significant improvement of 27 points for pain (p = 0.006) and 17 points for nausea/vomiting (p ... | PMC9990362 | |
Keywords | PMC9990362 | |||
Introduction | cancer deaths, Lung cancer | LUNG CANCER | Lung cancer (LC) remains the leading cause of cancer deaths worldwide [ | PMC9990362 |
Methods | PMC9990362 | |||
Study design and patients | ONCOLOGY | We conducted a longitudinal monocentric RWD study by extracting and analyzing demographic data, information on diagnosis, histology, integrative oncological treatment data as well as QoL data from the oncological registry Network Oncology (NO) [ | PMC9990362 | |
Objective | The objective of this study was to analyze the self-reported QoL in guideline-treated LC patients in a LC center and the association with additional VA therapy applied alone or in combination with radiation. | PMC9990362 | ||
Data collection | As described in detail previously [ | PMC9990362 | ||
Analyses of self-reported QoL | For the explorative evaluation of self-reported QoL the EORTC QLQ-C30 questionnaire was utilized and analyzed which includes evaluations of global health, functioning and symptom scales [ | PMC9990362 | ||
Statistical analysis | REGRESSION | Demographic and diagnostic variables were collected at T0. Continuous variables were described as median with interquartile range (IQR); categorical variables were summarized as frequencies and percentages. Student´s t-tests were applied, to detect differences; p-values < 0.05 were considered to be significant. Multiva... | PMC9990362 | |
Results | PMC9990362 | |||
Discussion | breast cancer, cancer, Cancer-related pain, pain, lung cancer | BREAST CANCER, CANCER, ADVANCED CANCER, LUNG CANCER, REGRESSION | The findings of the present RWD study reveal significant improvements of self-reported QoL in LC patients receiving VA therapy alone or in addition to radiotherapy.Regarding QoL, it has been shown in clinical trials that VA treatment reduces chemotherapy-related side effects and improve tolerability, which then in turn... | PMC9990362 |
Conclusions | lung cancer, nausea, vomiting, pain | LUNG CANCER | Our results suggest that self-reported QoL has been improved 12 months after diagnosis in lung cancer patients receiving VA therapy. A remarkable benefit on self-reported pain, nausea and vomiting appears to be associated with combined radiation and VA treatment in this cohort. This stresses the importance of consideri... | PMC9990362 |
Acknowledgements | We would like to thank all medical documentation officers of the NO consortium involved in the present work. | PMC9990362 | ||
Author contributions | Study conception and design: FS, DS, SLO, AT, CG; Project administration and resources: FS; Methodology: FS, DS, SLO, AT, CG; Provision of patients FS, CG; Supervision: FS, DS; Data curation and formal analysis: SLO, AT. Writing-original draft preparation: SLO. Writing—review and editing: FS, DS, AT, CG; All authors ha... | PMC9990362 | ||
Funding | The NO was partially funded by Iscador AG Arlesheim, Switzerland, Abnoba GmbH Pforzheim, Germany, and Helixor Heilmittel GmbH Rosenfels, Germany. By contract, researchers were independent from the funder. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the m... | PMC9990362 | ||
Availability of data and materials | The anonymized data that support the findings of this study are openly available in the repository figshare.com ( | PMC9990362 | ||
Declarations | PMC9990362 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.