Cancer Awareness Among People Living with HIV (PLWH): Insights from an Italian Survey of Oncologists and Infectious Disease Specialists.

Introduction: Since the mid-1990s, the adoption of combined antiretroviral therapy (cART) has significantly reduced HIV-related mortality and morbidity. Nevertheless, cancer continues to be the leading cause of death in people living with HIV (PLWH). We conducted a survey to assess the knowledge and inter-disciplinarity among the Italian oncologists and infectious disease specialists in the cancer prevention and treatment of PLWH.

The BioSUD Biobank as a genomic resource for substance use disorders in Italy.

Substance Use Disorders (SUDs) are a significant public health concern with complex etiologies involving genetic, environmental, and psychological factors. Here, we present BioSUD, a biobank that, by integrating genomic data with comprehensive phenotypic assessments, including sociodemographic, psychosocial, and addiction-related variables, was designed to investigate the etiology of SUDs within the Southern Italian population. We assessed a cohort of 1,806 participants (1,508 controls and 298 individuals with SUD diagnosis).

Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM).

Objective: Patient-reported outcomes (PROs) are considered the gold standard for the assessment of subjective symptoms, quality of life (QoL) and patient well-being in both clinical trials and clinical practice. Here, we report key discussions and findings from the 21st National Conference of the Italian Association of Medical Oncology, held in Bologna on 21-22 June 2024, with a focus on the integration and impact of PROs in oncology research and clinical practice.

Methods And Analysis: Leading national and international experts presented and analysed data regarding the use of PROs in clinical trials and routine oncology care.

Comparison of baseline patient characteristics in phase 1 and phase 2/3 clinical trials for anticancer treatments.

Background: Characteristics of patients significantly differ between registrational clinical trials (CTs) and Italian real-world practice, with older median age, higher elderly (≥ 65) rate and worse performance status (PS) in the latter, without imbalance in female rate. We compared the same characteristics between registrational phase 2/3 and phase 1 CTs.

Methods: Data on age, sex and PS were extracted from European Public Assessment Reports of European Medicines Agency.

Effect of immuno-oncology on clinical and economic outcomes for a selection of cancers in Italy.

Objectives: This study assesses the impact of immune-oncology (IO) drugs' availability on cancer incidence-adjusted mortality rates from melanoma, lung, and renal cancers at population level in Italy between 2008 and 2019.

Methods: We conducted a retrospective study on cross-sectional time-series aggregated data collected from publicly available sources and IQVIA proprietary databases. Three fixed-effects regression models were used to estimate how IO availability affects incidence-adjusted mortality for each cancer type.

Press releases of industry-sponsored clinical trials in oncology: Characteristics, timing and financial impact.

Background: Press releases (PRs) anticipate the results of a clinical trial, possibly without providing detailed data. The purpose of this analysis was to describe the characteristics of PRs in oncology, delays in the availability of results and the impact on the financial market.

Materials And Methods: PRs published between 2018 and 2022 about solid tumors, archived on the websites of the top 20 oncology pharmaceutical companies, were screened.

Vaccination of people with solid tumors and diabetes: existing evidence and recommendations. A position statement from a multidisciplinary panel of scientific societies.

Diabetes and cancer are two of the most common public health concerns worldwide. The complex interplay of these two conditions is a growing area of research, as patients with diabetes are at increased risk for developing cancer, and vice versa. Furthermore, both patient populations show increased risk of many communicable infectious diseases and their adverse consequences, while vaccination can play a crucial role in their prevention, improving patient outcomes.

How Should We Manage the Impact of Antimicrobial Resistance in Patients With Cancer? An Oncological and Infectious Disease Specialist Point of View.

Patients with solid tumors present a higher risk of infectious diseases with worse outcomes compared with immunocompetent patients. Prolonged treatment of prophylactic and empirically chosen antibiotics and health care-acquired infections can predispose patients with cancer to infections with antimicrobial-resistant (AMR) organisms. AMR is a global health priority and can affect patients with cancer.

Implications of hormonal carcinogenesis for transgender and gender-diverse people undergoing gender-affirming hormone therapy: an up-to-date review.

Transgender and gender-diverse (TGD) individuals face an elevated risk of cancer in comparison with the general population. This increased risk is primarily attributed to an imbalanced exposure to modifiable risk factors and a limited adherence to cancer screening programmes, stemming from historical social and economic marginalisation. Consequently, these factors contribute to poorer clinical outcomes in terms of cancer diagnosis and mortality.

Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE®) in breast cancer patients: The prospective observational multicenter VIP study.

Patients' self-reporting is increasingly considered essential to measure quality-of-life and treatment-related side-effects. However, if multiple patient-reported instruments are used, redundancy may represent an overload for patients. Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) are a tool allowing direct patients' reporting of side-effects.

Corrigendum to "Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study" [The Lancet Regional Health - Europe 41 (2024) 100912].

[This corrects the article DOI: 10.1016/j.lanepe.

Corrigendum to "Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study" [The Lancet Regional Health - Europe 41 (2024) 100912].

[This corrects the article DOI: 10.1016/j.lanepe.

Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study.

Background: Generalizability of registrative clinical trials to real-world clinical practice is influenced by comparability of patients in the two settings. We compared characteristics of cancer patients in registrative trials with real-world clinical practice in Italy.

Methods: Data on age, sex and performance status (PS) were derived from web-based monitoring registries developed by Italian Medicines Agency (AIFA) and corresponding registrative trials reported in the European Public Assessment Reports (EPAR) of European Medicines Agency (EMA).

Systematic review of adoption, reporting and impact of health-related quality of life in phase III non-inferiority trials of systemic oncology treatments.

Background: Quality of life (QoL) assessment and patient-reported outcomes appear to be crucial in the rationale and interpretation of non-inferiority (NI) trials. The aim of this study was to assess the inclusion of QoL among endpoints in phase III NI oncology trials and the relevance of QoL results in the reporting and interpretation of these studies.

Materials And Methods: By PubMed search and hand-search of 11 selected journals, we identified phase III NI trials in adult patients affected by solid tumours, published between 2012 and 2021.

Financial Toxicity and Health-Related Quality of Life Profile of Patients With Hematologic Malignancies Treated in a Universal Health Care System.

Purpose: We investigated the association of financial toxicity (FT) with the health-related quality of life (HRQoL) profile of patients with hematologic malignancies treated in a universal health care system.

Methods: We did a secondary analysis of six multicenter studies enrolling patients with hematologic malignancies. FT was evaluated using the financial difficulties item of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

Pembrolizumab plus chemotherapy versus chemotherapy in untreated advanced pleural mesothelioma in Canada, Italy, and France: a phase 3, open-label, randomised controlled trial.

Background: Pleural mesothelioma usually presents at an advanced, incurable stage. Chemotherapy with platinum-pemetrexed is a standard treatment. We hypothesised that the addition of pembrolizumab to platinum-pemetrexed would improve overall survival in patients with pleural mesothelioma.

Position paper of the Italian association of medical oncology on health disparities among transgender and gender-diverse people: the Assisi recommendations.

Transgender and gender-diverse individuals experience substantial health disparities across the cancer care continuum. Despite well recognized unique healthcare needs, there are barriers in accessing cancer prevention and treatment services, influenced by disadvantages in key social-economic determinants of health which result in worse clinical outcomes, as compared to the general population. The Italian Association of Medical Oncology (AIOM) acknowledges the critical relevance of this issue.