Publications by authors named "Francesca Martinelli"

Introduction: Immune-checkpoint inhibitors (IO) have significantly improved outcomes of patients with non-oncogene-addicted non-small cell lung cancer (NSCLC), becoming the first-line agents for advanced disease. However, resistance remains a significant clinical challenge, limiting their effectiveness.

Areas Covered: Hereby, we addressed standard and innovative therapeutic approaches for NSCLC patients experiencing progression after IO treatment, discussing the emerging resistance mechanisms and the ongoing efforts to overcome them.

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Introduction: The European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) measures 15 health-related quality of life (HRQoL) scales relevant to the disease and treatment of patients with cancer. A study by Martinelli (2011) demonstrated that these scales could be grouped into three main clusters: physical, psychological and gastrointestinal. This study aims to validate Martinelli's findings in an independent dataset and evaluate whether these clusters are consistent across cancer types and patient characteristics.

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  • The study focuses on maintaining health-related quality of life (HRQoL) for glioma patients during their progression-free survival (PFS) period.
  • Analysis of HRQoL data from past trials shows that 47% of patients experienced deterioration in HRQoL despite not progressing in the disease, with only poor performance status being a significant factor linked to this decline.
  • The findings highlight the need for regular monitoring of patients' well-being throughout their treatment to identify and address HRQoL issues early on.
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  • The study explores how the position of button solid oxide fuel cells affects their electrochemical performance when using Gadolinium doped Ceria barrier layers deposited via sputtering.
  • Analysis techniques such as Atomic Force Microscopy reveal that roughness decreases from the edges to the center of the sputtering target, and variations in layer coverage impact performance.
  • Results indicate that button cells with uniformly thin buffer layers perform significantly better in terms of current density compared to those with standard screen-printed layers, highlighting the importance of layer thickness and coverage on electrochemical outcomes.
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Objectives: To provide reference values for the European Organisation for Treatment and Research of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) in advanced-stage Hodgkin lymphoma (HL) patients and 5-year HL survivors. The QLQ-C30 is the most widely used cancer-specific questionnaire to assess Health-Related Quality of Life (HRQoL).

Methods: The EORTC database was searched to identify HL RCTs in which patients' and survivors' HRQoL was assessed by the QLQ-C30.

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  • Two methods for combining survival and health-related quality of life (HRQoL) data in glioma trials—Quality-adjusted effect sizes (QASES) and joint modeling (JM)—were evaluated for calculating "net clinical benefit."
  • In the EORTC 26951 trial, additional treatments improved overall survival but negatively impacted HRQoL, leading to a notable decrease in perceived survival benefit when adjusting for symptoms like appetite loss and nausea.
  • The findings indicate that while both methods provided different outcomes, accounting for HRQoL diminished the apparent benefits of survival from treatments in glioma trials.
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Background: Different analytical methods may lead to different conclusions about the impact of treatment on health-related quality of life (HRQoL). This study aimed to examine 3 different methods to evaluate change in HRQoL and to study whether these methods result in different conclusions.

Methods: HRQoL data from 15 randomized clinical trials were combined (CODAGLIO project).

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This report summarizes the presentations and discussion in the first Japan Clinical Oncology Group-European Organisation for Research and Treatment of Cancer Quality of Life/Patient-Reported Outcome workshop funded by the National Cancer Center Hospital that was held on Saturday, 1 September 2018 in Tokyo, Japan. The infrastructure and understanding regarding the Quality of Life/Patient-Reported Outcome assessment of cancer patients in Japan is still immature, in spite of the increased demand for oncological Patient-Reported Outcome research felt not only by researchers but also by patients or other stakeholders of cancer drug development. The workshop aimed to share each perspective, common issues to be considered and future perspectives regarding the strong alliance between the European Organisation for Research and Treatment of Cancer Quality of Life Group and the Japan Clinical Oncology Group for Quality of Life/Patient-Reported Outcome research as well as explore the possibility of conducting collaborative research.

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  • Patient-reported outcomes (PROs) in cancer trials are important for understanding treatment effects on symptoms and quality of life, but there is no agreed-upon method for analyzing them, which complicates result interpretation.
  • A consortium was created to establish recommendations for PRO analysis, focusing on research objectives, appropriate statistical methods, and how to handle missing data.
  • This Policy Review outlines these recommendations based on comprehensive literature reviews and collaboration among international experts, and it also discusses future developments in this area.
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  • The study aimed to provide reference values (RVs) for health-related quality of life (HRQoL) in breast cancer patients, comparing early breast cancer (EBC) and metastatic breast cancer (MBC) using two different datasets.
  • Analysis included data from both the European Organization for Research and Treatment of Cancer (EORTC) and Project Data Sphere (PDS), revealing that EBC patients generally reported better HRQoL compared to MBC patients, who faced more severe symptoms and lower functioning scores.
  • The findings highlight that baseline HRQoL varies significantly with disease stage, performance status, and comorbidities, and the provided RVs will enhance clinical assessments and comparisons in future breast cancer research.
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  • A review from 2008 emphasized the importance of baseline patient-reported outcomes (PROs) as significant independent predictors of cancer patients' overall survival in clinical studies.
  • In response to earlier studies' limitations, new recommendations were made to improve methodological rigor in prognostic factor research.
  • Our updated systematic review of 44 studies from 2006 to 2018 showed enhanced standardization and rigor in methods, with 93% reporting at least one PRO domain as prognostic, particularly highlighting physical functioning and quality of life as key factors.
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  • Symptom management in glioma patients is complex, with many experiencing multiple symptoms simultaneously; the study aimed to identify symptom clusters and their impact on functioning.
  • Data from the CODAGLIO project, involving 4,307 glioma patients, revealed four major symptom clusters: motor, fatigue, pain, and gastrointestinal/seizures/bladder control.
  • The motor and fatigue symptom clusters were significantly linked to reduced physical and role functioning in patients, underscoring the need for targeted symptom management strategies.
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Objective: Prognostic value of health-related quality of life (HRQoL) data may be important to inform patients in clinical practice and to guide clinical decision-making. Our study investigated the added prognostic value of HRQoL for overall survival (OS) and progression-free survival (PFS) in a large heterogeneous sample of glioma patients, besides known prognostic factors.

Methods: We included individual baseline data from previously published randomised controlled trials (RCTs) in glioma patients in which HRQoL was assessed through the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BN20 questionnaires.

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Although patient-reported outcomes (PROs), such as health-related quality of life, are important endpoints in randomised controlled trials (RCTs), there is little consensus about the analysis, interpretation, and reporting of these data. We did a systematic review to assess the variability, quality, and standards of PRO data analyses in advanced breast cancer RCTs. We searched PubMed for English language articles published in peer-reviewed journals between Jan 1, 2001, and Oct 30, 2017.

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  • There is currently a lack of agreement on how to analyze and interpret health-related quality of life and patient-reported outcomes in cancer clinical trials, complicating comparisons and the application of findings in healthcare settings.
  • The SISAQOL Consortium was formed to create standardized guidelines for analyzing these outcomes in cancer randomized controlled trials, focusing on key priorities identified through member discussions.
  • Their efforts aim to develop clear research objectives, select appropriate statistical methods, and establish best practices for dealing with missing data, with input from a diverse membership that includes patients, regulators, and researchers.
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  • Olive pomace, a byproduct of olive oil production, is rich in beneficial compounds and was tested in a study involving 62 participants with high cholesterol, who consumed olive pomace-enriched biscuits for 8 weeks.
  • The study found no significant changes in the overall diversity of gut microbiota or cardiovascular disease markers, but a tendency towards reduced oxidized LDL cholesterol and increased bifidobacteria was observed in those consuming the biscuits.
  • Ingestion of these biscuits increased certain phenolic acid levels in urine and blood, indicating a metabolic change in gut bacteria, with noticeable differences between male and female participants.
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Eighty percent of melanomas are diagnosed at a localised stage, when they are highly curable. Their survival rate induces long follow-up periods, transforming melanoma into a chronic disease and patients' health-related quality of life (HRQoL). Understanding which patient characteristics are associated with poor HRQoL should allow a more personalised management of their HRQoL.

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  • Health-related quality of life (HRQOL) measures in cancer trials are crucial for evaluating treatments but face challenges in analysis and comparison across studies.
  • The SISAQOL initiative aims to standardize the analysis of HRQOL and patient-reported outcomes to improve clarity and applicability of research findings.
  • This project hopes to enhance cancer research, assist in decision-making for patients and providers, improve care delivery, and inform health policy.
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  • The EORTC PROBE initiative aims to improve the understanding of health-related quality of life (HRQOL) for cancer patients and educate various stakeholders in healthcare.
  • A pooled analysis of HRQOL data from multiple randomized controlled trials revealed that HRQOL can provide valuable prognostic information that enhances accuracy beyond traditional clinical measures.
  • Findings underscore the importance of considering both patient and clinician-reported outcomes, while also highlighting variations in HRQOL interpretation across different patient demographics and the influence of timing on questionnaire responses.
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Background: Cancer incidence increases exponentially with advancing age, cancer patients live longer than in the past, and many new treatments focus on stabilizing disease and HRQOL. The objective of this study is to examine how cancer affects patients' HRQOL and whether their HRQOL is age-dependent.

Methods: Data from 25 EORTC randomized controlled trials was pooled.

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  • * Researchers analyzed data from 7417 patients across 11 cancer types, employing statistical models to determine the relationship between HRQOL parameters and survival, while accounting for factors like age and sex.
  • * Findings showed that specific HRQOL domains, such as physical and emotional functioning, were linked to survival outcomes for various cancers, highlighting the importance of patient quality of life in prognosis.
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  • The study evaluates how well patient and clinician symptom scores align and their impact on predicting overall survival in cancer patients using established reporting systems.
  • Data was analyzed from 2279 cancer patients across 14 clinical trials, focusing on symptoms like pain and fatigue to gauge the accuracy of survival predictions.
  • Results indicated that patient-reported scores, especially for fatigue, often differed from clinician evaluations, and combining both types of scores improved predictive accuracy for patient survival compared to using clinician scores alone.
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Aims: Cancer patients experience multiple and concurrent health-related problems and symptoms due to their illness and therapies. The first objective of this analysis was to identify how health-related quality-of-life (HRQoL) indicators cluster among cancer patients and how possible clusters change across patients with different sociodemographic and clinical characteristics. The second objective of this study was to identify which HRQoL indicators are linked to patients' perception of overall quality of life.

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  • The study aimed to identify the smallest clinically meaningful changes in health-related quality of life (HRQOL) scores for patients with non-small-cell lung cancer (NSCLC) using the EORTC QLQ-C30 questionnaire.
  • Researchers used WHO performance status (PS) and weight change as anchors to determine minimal important differences (MIDs) in HRQOL score changes.
  • Findings showed that MID estimates varied depending on whether patients were improving or deteriorating, offering valuable insights for clinicians and researchers assessing treatment impacts and designing future trials.
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  • This paper discusses using Bayesian blind source separation (BSS) techniques to separate and restore images that have been degraded by unknown blur and noise, focusing on applications in document analysis.
  • It examines two models for document representation: one for multispectral views of a single-sided document and another for two-sided documents, aiming to recover the main text and enhance underlying features.
  • The authors utilize Bayesian estimation and Gibbs priors to address the complexity of these images and validate their approach through numerical and real-world experiments.
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