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result(s) for
"Pinnavaia, L."
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Validation of the European Oncology toolkit for the self-assessment of Quality of Life (EUonQoL-Kit) in cancer patients and survivors: study protocol of a pan European survey
2024
Background
European cancer programmes and policies lack a unified health-related quality of life (HRQoL) assessment tool. The European oncology quality of life toolkit (EUonQoL-Kit) is a novel set of HRQoL questionnaires, co-designed with cancer patients and survivors, translated and culturally adapted into 31 European languages, and with both static and dynamic electronic administration modes. The main aim of this study is the psychometric assessment of the static version. Secondary aims include evaluating the EUonQoL-Kit acceptability, cross-validating the administration modes, exploring individual factors potentially affecting HRQoL and HRQoL inequalities between countries.
Methods
A sample of 4,500 participants, including three groups (active treatment, survivors, and palliative care) from 45 centres in 25 EU Member States and 7 associated countries, will be enrolled in a multicentre observational cross-sectional study. All participants will complete the static EUonQoL-Kit; three subsamples (each 10% of the total sample) will also respectively complete the following: a) dynamic EUonQoL-Kit, based on Item Response Theory (IRT)/Computer Adaptive Testing (CAT), b) FACT-G and EQ-5L-5D, and c) static EUonQoL-Kit (re-test). Psychometric analyses will encompass exploratory and confirmatory factor analyses (measurement model and structural validity), Cronbach's alpha (internal consistency), intraclass correlation coefficient (test–retest reliability), Pearson/Spearman correlation (concurrent validity), comparison of group scores (construct validity), and Differential Item Functioning (cross-country item equivalence). Secondary analyses will evaluate participant response time and rate, and static/dynamic score differences. Regression models will estimate associations between individual factors and HRQoL.
Discussion
The EUonQoL-Kit will serve to systematically incorporate patient perspectives into European cancer policies and to address HRQoL inequalities across Europe.
Trial registration
ClinicalTrials.gov Identifier: NCT05947903, 2023–06-28.
Journal Article
Urea Kinetics with Dialyzer Reuse – A Prospective Study
by
Ferrand, Kathleen
,
Reger, Deborah
,
Pinnavaia, Leah
in
Aged
,
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
,
Biological and medical sciences
1999
We performed a prospective study to examine the impact of dialyzer reuse on KT/V under rigidly standardized conditions on 3 membrane types. Heparin dosage was standardized with ACT during an eight week run-in period and remained unchanged through the study. Post dialysis BUN and weight were obtained at five minutes after exactly 80 ± 0.5 l of blood were processed through the dialyzer. Dialyzers were reused after automated glutaraldehyde processing and after ensuring >80% open fiber bundles. Each membrane type was utilized 3 times on a set of 3 patients; each individual dialyzer was reused 8 times. KT/V was done on the 1st, 2nd, 4th and 8th uses of each dialyzer (36 measurements) starting mid week; BUN measurements were grouped. The KT/V (mean ± SD) for the 1st, 2nd, 4th, and 8th uses of the cellulose acetate dialyzer were 1.3 ± 0.2, 1.3 ± 0.3, 1.3 ± 0.2, 1.3 ± 0.2 respectively; the corresponding values of the cuprophane dialyzer were 1.4 ± 0.3, 1.4 ± 0.3, 1.3 ± 0.4, 1.3 ± 0.3 respectively; and those of the polysulfone dialyzer 1.7 ± 0.3, 1.6 ± 0.2, 1.6 ± 0.2 respectively. By a 3 way ANOVA there were no significant differences between the 1st and subsequent uses of any of the dialyzers tested. Conclusions: Reuse of dialyzers up to 8 times does not result in a loss of urea clearance. We believe this model is useful for further studies on reuse and quality assurance.
Journal Article
5PSQ-154 Co-administration of ribociclib/palbociclib and proton pump inhibitors (PPI): a real-world analysis in an Italian oncology centre
2025
Background and ImportanceRibociclib and palbociclib, CDK4/6 inhibitors, are often prescribed with aromatase inhibitors or fulvestrant to treat advanced/metastatic ER+ and HER2- breast cancer. Many patients concurrently take proton pump inhibitors (PPIs, ATC=A02BC) and/or antacids (ATC=A02A). PPIs can impact the absorption of drugs affected by pH, including ribociclib and palbociclib, both weak bases. Ribociclib, a CYP3A4 inhibitor and substrate, shares a metabolic pathway with omeprazole, also metabolised by CYP3A4. Ribociclib can prolong the QT interval, a risk potentially exacerbated by PPI use, especially in women.Aim and ObjectivesThis study aims to analyse prescription patterns of ribociclib/palbociclib and PPIs/antacids among patients treated at an Italian oncology centre, focusing on potential drug interactions.Material and MethodsPrescription data for ribociclib, palbociclib, PPIs, and antacids were collected from the prescription software, patient medical records, and interviews with patients at the hospital pharmacy from January to July 2024. Drug interactions were assessed using Terap, Micromedex, and drug leaflets.ResultsData were analysed from 88 ribociclib patients (all female) and 12 palbociclib patients (two male), with median ages of 66 and 63, respectively. Among ribociclib patients, 26 (39%) used PPIs concurrently, and eight (9%) also took antacids. In the palbociclib cohort, nine (67%) were on PPIs, with one also using an antacid. Regarding specific PPI use, 44% (11/26) of ribociclib patients used omeprazole and 35% (9/26) pantoprazole. In the palbociclib group, 42% (5/12) used pantoprazole and 17% (2/12) omeprazole. Among ribociclib patients not using PPIs/antacids, 43% received a standard dose, compared to 38% of those on PPIs/antacids. One patient stopped ribociclib and omeprazole due to QT prolongation.Conclusion and RelevanceThis analysis highlights the need for clinician awareness of drug interactions in polytherapy, especially for patients on CDK4/6 inhibitors and PPIs. Competition for CYP enzymes can impact drug efficacy or toxicity risk. The intervention of hospital pharmacists was twofold: providing physician education on possible interactions and interviewing patients starting CDK4/6 therapy to identify potential interactions with chronic therapy, including medications not disclosed to their physician, which could interfere with efficacy and cause toxicity of the anti-tumour treatment. Real-world data stress the importance of medication reconciliation by hospital pharmacists to optimise patient care.References and/or AcknowledgementsConflict of InterestNo conflict of interest
Journal Article
5PSQ-039 Raf-kinasi pathway inhibitors in treatment of metastatic melanoma: when compliance does not match with tolerance
2023
Background and ImportanceBackground and importance: Melanoma is a malignant tumour that originates from melanocytes of the skin and mucous membranes or rarely from melanocytes located in extracutaneous sites. In 2020 in Europe, approximately 50.972 females and 55.397 males are diagnosed with melanoma, and 9.457 males and 7.031 females died because of it. 45–50% of melanomas have a mutation in the BRAF gene and the most frequent is V600E.Oncogenic mutations of BRAF lead to constitutive activation of the RAS/RAF/MEK/ERK pathway. Target therapies are the most appropriate to obtain an effective therapeutic action.Aim and ObjectivesWe analysed the 2 most prescribed oral associated therapies in our centre for the treatment of mutated BRAF metastatic melanoma with the aim of identifying which is the most tolerated and highlighting the types of toxicity that emerged from real life data bases.Material and MethodsThe data were extrapolated from our prescription software and from the electronic medical records of the investigated patients.ResultsIn the period 2019–2022 we considered 36 patients treated with Dabrafenib 75 mg + Trametinib 2 mg or Encorafenib 75 mg + Binimetinib 15 mg, 50% treated with both therapies. 33 patients started the combination therapy of Dabrafenib + Trametinib and of these only 7 (20%) did not show any severe toxicity leading to discontinuation of treatment. The most frequent toxicity was pyrexia (40%), followed by skin toxicity (25%), gastrointestinal toxicity (12.5%), asthenia (8%). Patients who discontinued treatment for progression disease were 9 (28%). Owing to unacceptable toxicity, 14 patients (43%) switched to Encorafenib + Binimetinib: only 2 of these patients showed toxicity (G1-G3 asthenia, G2 nausea) upon discontinuing treatment. 3 patients of analysed population started therapy with Encorafenib + Binimetinib as first-line treatment, without toxicity to discontinue therapy.Conclusion and RelevanceThese data point out that the first choice is a combination therapy Dabrafenib + Trametinib associated with better patient compliance, thanks to more easily manageable number of tablets to take daily. However, the toxicity appears to be higher. For this reason, the therapy with a lower compliance is actually the best tolerated and prolonged therapy with fewer suspensions, ensuring better continuity of care and therapeutic efficacy.References and/or Acknowledgements1. (https://ecis.jrc.ec.europa.eu/pdf/factsheets/Melanoma_cancer_en.pdf)2. https://www.aiom.it/linee-guida-aiom/Conflict of InterestNo conflict of interest.
Journal Article