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Introduction: Single-agent oral vinorelbine is a standard of care for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) that has progressed on endocrine therapy. Metronomic administration may offer a better balance of efficacy and safety than standard regimens, but data from previous trials are scarce., Methods: In this open-label, multicenter, phase II trial, patients were randomized to oral vinorelbine administered on a metronomic (50 mg three times weekly) or weekly (60 mg/m 2 in cycle 1, increasing to 80 mg/m 2 if well tolerated) schedule. Treatment was continued until disease progression or intolerance. The primary endpoint was disease control rate (DCR, the proportion of patients with a best overall confirmed response of CR, PR, or stable disease lasting 6 months or more)., Results: One-hundred sixty-three patients were randomized and treated. The DCR was 63.4% (95% confidence interval [CI]: 52.0-73.8) with metronomic vinorelbine and 72.8% (95% CI: 61.8-82.1) with weekly vinorelbine. Weekly vinorelbine was also associated with longer progression-free survival (5.6 vs 4.0 months) and overall survival (26.7 vs 22.3 months) than metronomic vinorelbine, but was associated with more adverse events., Conclusions: In this randomized phase II trial, single-agent metronomic oral vinorelbine was effective and well tolerated as first-line chemotherapy for patients with HR-positive/HER2-negative ABC. Formal comparisons are not done in this phase II study and one can simply observe that confidence intervals of all endpoints overlap. When deciding for a chemotherapy after failure of endocrine therapy and CDK 4/6 inhibitors, oral vinorelbine might be an option to be given with either schedule., Clinical Trial Registration Number: EudraCT 2014-003860-19., Competing Interests: Declarations of competing interest GF: scientific coordinator and principal investigator of the study; participated in advisory boards, acted as a speaker, and conducted training sessions on behalf of Pierre Fabre. NM-J: received consultancy fees from AstraZeneca, Daiichi Sankyo, Pfizer, Novartis, Lilly, Pierre Fabre, Roche, and GSK; and travel support from Roche, AstraZeneca, Pfizer, and Novartis. MM: received personal fees from Roche, Novartis, and Eisai; and other financial support from Roche and Lilly. LC: received honoraria from AstraZeneca, MSD, and Pfizer; Novartis, and Gilead. MP: received consultancy fees from AstraZeneca, Novartis, Pfizer, Eli Lilly, and Amgen. EP: received consultancy fees from AstraZeneca, Daiichi Sankyo, Pfizer, Novartis, Lilly, Pierre Fabre, Roche, and GSK; research funding from Daiichi Sankyo, Pfizer, Lilly, Novartis, Seattle Genetics, AstraZeneca, and Roche; and travel support from AstraZeneca, GSK, Pfizer, Lilly, and GSK. JE: received consultancy fees from AstraZeneca, Daiichi Sankyo, Pfizer, Novartis, Lilly, Pierre Fabre, Roche, and Tesaro; research funding from Daiichi Sankyo, Pfizer, Lilly, Novartis, Seattle Genetics, AstraZeneca, Roche, and Odonate; and travel support from AstraZeneca, Daiichi Sankyo, Celgene, Pfizer, Novartis, Lilly, and Tesaro. AR: received honoraria for participating in advisory boards for Boehringer Ingelheim, Bristol Myers Squibb, and MSD; and in internal training events at Pfizer and AstraZeneca. MEC: participated in an advisory board for Eli Lilly and Pierre Fabre. CdA, GV, RR and CTTM: employees of Pierre Fabre. BK-B, MU, HB, SM, JBC, TP, and NC: no conflicts to declare., (Copyright © 2024. Published by Elsevier Ltd.)

This article's main contributions are twofold: 1) to demonstrate how to apply the general European Union's High-Level Expert Group's (EU HLEG) guidelines for trustworthy AI in practice for the domain of healthcare and 2) to investigate the research question of what does "trustworthy AI" mean at the time of the COVID-19 pandemic. To this end, we present the results of a post-hoc self-assessment to evaluate the trustworthiness of an AI system for predicting a multiregional score conveying the degree of lung compromise in COVID-19 patients, developed and verified by an interdisciplinary team with members from academia, public hospitals, and industry in time of pandemic. The AI system aims to help radiologists to estimate and communicate the severity of damage in a patient's lung from Chest X-rays. It has been experimentally deployed in the radiology department of the ASST Spedali Civili clinic in Brescia, Italy, since December 2020 during pandemic time. The methodology we have applied for our post-hoc assessment, called Z-Inspection®, uses sociotechnical scenarios to identify ethical, technical, and domain-specific issues in the use of the AI system in the context of the pandemic.

Namodenoson, an A3 adenosine-receptor agonist, showed promising results in advanced hepatocellular carcinoma (HCC) and moderate hepatic dysfunction (Child-Pugh B; CPB) in a phase I/II clinical study. This phase II study investigated namodenoson as second-line therapy in such patients. Patients were randomized 2:1 to twice a day (BID) namodenoson (25 mg; n = 50) or placebo ( n = 28). The primary endpoint (overall survival [OS]) was not met. Median OS was 4.1/4.3 months for namodenoson/placebo (hazard ratio [HR], 0.82; 95% confidence interval [CI] 0.49-1.38; p = 0.46). Pre-planned subgroup analysis of CPB7 patients (34 namodenoson-treated, 22 placebo-treated) showed a nonsignificant improvement in OS/progression-free survival (PFS). OS: 6.9 versus 4.3 months; HR, 0.81; 95% CI: 0.45-1.43, p = 0.46. PFS: 3.5 versus 1.9 months; HR, 0.89; 95% CI: 0.51-1.55, p = 0.67 (log-rank test). The difference in 12-month OS was significant (44% versus 18%, p = 0.028). Response rates were determined in patients for whom ≥ 1 assessment post-baseline was available (34 namodenoson-treated, 21 placebo-treated). Partial response was achieved by 3/34 (8.8%) and 0/21 (0%) patients, respectively. Namodenoson was well-tolerated, with a safety profile comparable to that of the placebo group. No treatment-related deaths were reported; no patients withdrew due to toxicity. In conclusion, namodenoson demonstrated a favorable safety profile and a preliminary efficacy signal in HCC CPB.

This study represents a descriptive epidemiologic analysis of the morbidity and mortality incidence by lung cancer in Dolj. The usual processing of the registered values in primary evidences (report of the new cases to 100,000 residents) is in accordance with the literature about the variation of the incidence depending on residential environment and sex greater values in urban environment and at man, beginning from the fifth decade of life. The epidemiologic analysis by indirect standardisation of the mortality and the morbidity emphasizes in Dolj higher incidence up to the media of the Dolj, specially in the rural environment, aspects that suggest the intervention of the environmental factors and behaviour factors in the etiology of the lung cancer.

The study carried out during 1991-1995 concerns 50 subjects with lung cancer confirmed by microscopy registered in the Oncology Department of Craiova University Hospital. The patients were studied on terms of clinical stage which indicated the regime of treatment associations: surgery + chemotherapy + radiotherapy, chemo-radiotherapy, chemo-immunotherapy, in order to improve surviving. The treatment results were assayed for each group of patients according to the international criteria of treatment response evaluation. The efficiency of various cytostatics associations according to histopathologic form was finally evaluated on terms of asymptomatic period and survival duration.