Off-label use of thalidomide for the treatment of a bleeding cutaneous metastasis

We herein describe the case of a 65-year-old man with frequent hospitalizations for severe anemia due to several recurrent bleedings of a cutaneous metastasis of hepatocellular carcinoma, and its successful off label treatment with thalidomide therapy for controlling bleeding and reducing transfusion requirements

Fundamentals of care: revisione narrativa della letteratura

ABSTRACT Introduction Over the last decades, several research lines have been carried out to investigate factors hindering or promoting patient\u2019s safety and quality of care. Among them, the Fundamentals of Care (FOC) framework has reached an increased relevance worldwide. The aim of this narrative review is to summarize the debate on FOC\u2019s concept, as well as its commonalities and differences with other relevant theoretical frameworks, and to underline some practical implications. Methods A narrative literature review has been performed in 2020. Studies have been identified in Medline (via PubMed) and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases, and the International Learning Collaborative website by using the following keywords: \u2018Fundamentals of Care\u2019, \u2018Fundamental of Care\u2019, \u2018Nursing\u2019; publications performed by the eminent authors in the field (prof. Kitson A. & Feo R) have also been retrieved. Results The nurse-patient relationship is a crucial component to meet the fundamental care needs, articulated in physical, relational, and socio-psychological dimensions. Commonalities with the patient-centred care movement and with that of compassionate and unfinished nursing care have been summarized. Moreover, models of care delivery, studies highlighting the perspective of patients with regards to the FOC and the relevance of nursing minimum data set have been highlighted. Conclusions It is important to continue to build a professional and scientific dialogue on fundamentals of care by including them in the professional and scientific agenda of prioritie

Missed nursing education: Findings from a qualitative study

To understand what nursing education activities are missed in the daily life of nursing programmes, by also identifying antecedents and consequences of missed educational activities

Episodes of psychomotor agitation among medical patients: findings from a longitudinal multicentre study

The management of delirium among older in-hospital patients is a challenge, leading to worse outcomes, including death. Specifically, psychomotor agitation, one of the main characteristics of hyperactive delirium, requires a significant amount of medical and nursing surveillance. However, despite its relevance, to date incidence and/or prevalence of psychomotor agitation, its predictors and outcomes have not been studied among Italian older patients admitted in medical units

Prognostic and clinical impact of the endocrine resistance/sensitivity classification according to international consensus guidelines for advanced breast cancer: an individual patient-level analysis from the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) studies

Background: Prior exposure to adjuvant endocrine therapy (ET) and timing to recurrence are crucial factors for first-line treatment choices in patients with hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancer (BC) and in clinical trial eligibility, classifying metastatic HR+/HER2- BC as endocrine sensitive (ES) or primary (1ER)/secondary (2ER) resistant. However, this classification is largely based on expert opinion and no proper evidence exists to date to support its possible prognostic and clinical impact. Methods: This analysis included individual patient-level data from 4 adjuvant phase III randomized trials by the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) study groups. The impact of endocrine resistance/sensitivity classification on overall survival (mOS, defined as time between date of distant relapse and death) was assessed in both univariate and multivariate Cox proportional hazards models. Findings: Between November 1992 and July 2012, 9058 patients were randomized in 4 trials, of whom 6612 had HR+/HER2- BC. Median follow-up was 9.1 years (interquartile range [IQR] 5.6-15.0). In the whole cohort, disease-free survival and OS were 90.4% and 96.6% at 5 years, and 79.1% and 89.4% at 10 years, respectively. The estimated hazard of recurrence raised constantly during the first 15 years from diagnosis, being more pronounced during the first 2 years and less pronounced after year 7. Among the 493 patients with a distant relapse as first disease-free survival event and available date on ET completion, 72 (14.6%), 207 (42.0%) and 214 (43.4%) were classified as having 1ER, 2ER and ES, respectively. Median follow-up from diagnosis of a distant relapse was 3.8 years (IQR 1.6-7.5). Patients with 1ER were significantly more likely to be younger, to have N2/N3 nodal status, grade 3 tumours and to develop visceral metastases. Site of first distant relapse was significantly different between the 3 groups (p = 0.005). In patients with 1ER, 2ER and ES breast cancer, median mOS was 27.2, 38.4 and 43.2 months, respectively (p = 0.03). As compared to patients with ES disease, a higher risk of death was observed in those with 1 ER (adjusted Hazard Ratio [aHR] 1.54; 95% CI 1.03-2.30) and 2ER (aHR 1.17; 95% CI 0.87-1.56) (p = 0.11). Interpretation: This large analysis with long-term follow-up provides evidence on the prognostic and clinical impact of the currently adopted endocrine resistance/sensitivity classification in patients with HR+/HER2- advanced BC. This classification may be considered a valid tool to guide clinical decision-making and to design future ET trials in the metastatic setting. Funding: AIRC

Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry

To evaluate the efficacy and safety of rituximab (RTX) in patients with systemic lupus erythematosus (SLE) refractory to standard therapy in the clinical practice setting

Intermediate clinical endpoints in early-stage breast cancer: an analysis of individual patient data from the Gruppo Italiano Mammella and Mammella Intergruppo trials

Background: Intermediate clinical endpoints (ICEs) are frequently used as primary endpoint in randomised trials (RCTs). We aim to assess whether changes in different ICEs can be used to predict changes in overall survival (OS) in adjuvant breast cancer trials. Methods: Individual patient level data from adjuvant phase III RCTs conducted by the Gruppo Italiano Mammella (GIM) and Mammella Intergruppo (MIG) study groups were used. ICEs were computed according to STEEP criteria. Using a two-stage meta-analytic model, we assessed the surrogacy of each ICE at both the outcome (i.e., OS and ICE are correlated irrespective of treatment) and trial (i.e., treatment effects on ICE and treatment effect on OS are correlated) levels. The following ICEs were considered as potential surrogate endpoints of OS: disease-free survival (DFS), distant disease-free survival (DDFS), distant relapse-free survival (DRFS), recurrence-free survival (RFS), recurrence-free interval (RFI), distant recurrence-free interval (DRFI), breast cancer-free interval (BCFI), and invasive breast cancer-free survival (IBCFS). The estimates of the degree of correlation were obtained by copula models and weighted linear regression. Kendall's τ and R2 ≥ 0.70 were considered as indicators of a clinically relevant surrogacy. Findings: Among the 12,397 patients enrolled from November 1992 to July 2012 in six RCTs, median age at enrolment was 57 years (interquartile range (IQR) 49-65). After a median follow-up of 10.3 years (IQR 6.4-14.5), 2131 (17.2%) OS events were observed, with 1390 (65.2%) attributed to breast cancer. At the outcome-level, Kendall's τ ranged from 0.69 for BCFI to 0.84 for DRFS. For DFS, DDFS, DRFS, RFS, RFI, DRFI, BCFI, and IBCFS endpoints, over 95% of the 8-year OS variability was attributable to the variation of the 5-year ICE. At the trial-level, treatment effects for the different ICEs and OS were strongly correlated, with the highest correlation for RFS and DRFS and the lowest for BCFI. Interpretation: Our results provide evidence supporting the use of DFS, DDFS, DRFS, RFS, RFI, DRFI, and IBCFS as primary endpoint in breast cancer adjuvant trials. Funding: This analysis was supported by the Italian Association for Cancer Research ("Associazione Italiana per la Ricerca sul Cancro", AIRC; IG 2017/20760) and by Italian Ministry of Health-5 × 1000 funds (years 2021-2022)

Factors and comorbidities associated with first neuropsychiatric event in systemic lupus erythematosus: does a risk profile exist? A large multicentre retrospective cross-sectional study on 959 Italian patients

To analyse risk factors and comorbidities potentially associated with CNS involvement in a large cohort of Italian patients affected by SLE