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An open-label, randomized phase III study of early switch maintenance vs delayed second-line nivolumab in advanced stage squamous non-small cell lung cancer (NSCLC) patients after standard first-line platinum-based chemotherapy-EDEN trial GOIRC 04-2016.
Lung Cancer
December 2024
Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Background: As for squamous (Sq)-NSCLC, Checkmate-017 trial showed a significant overall survival (OS) improvement in favor of Nivolumab (Nivo) over Docetaxel in 2nd-line. We hypothesized that anticipating Nivo use, as early switch maintenance after 1st-line chemotherapy (CHT), might have improved survival as compared to delayed 2nd-line treatment.
Methods: EDEN was an open-label, 2-arm, phase III study which randomized (1:1) stage IIIB/IV Sq-NSCLC pts non-progressive after 1st-line platinum-based CHT, to receive early Nivo as switch maintenance (Arm A) or standard best supportive care followed by 2nd-line Nivo at disease progression (Arm B).
Importance: Most patients with locally advanced hepatocellular carcinoma (HCC) recur within the liver following systemic therapy.
Objective: To determine whether stereotactic body radiation therapy (SBRT) improves outcomes in patients with locally advanced HCC compared with sorafenib alone.
Design, Setting, And Participants: This multicenter phase 3 randomized clinical trial randomized patients with HCC 1:1 to sorafenib or SBRT followed by sorafenib, stratified by performance status, liver function, degree of metastases, and macrovascular invasion.
A Randomized Study of Consolidation Chemoradiation (CTRT) versus Observation after first line chemotherapy (CT) in Advanced Gall bladder Cancers (GBC):RACE-GB study.
Int J Radiat Oncol Biol Phys
December 2024
Departments of Surgical Gastroenterology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow.
Purpose: CT is the standard of care for patients presenting with unresectable advanced GBC but their prognosis remains poor. The value of consolidation CTRT after initial CT is uncertain. We therefore conducted a single centre open label randomised trial evaluating consolidation CTRT versus Observation after four cycles of CT in patients whose disease did not progress during CT (partial responders/stable disease).
View Article and Find Full Text PDFAssociation of Lupus Low Disease Activity State And Remission With Reduced Organ Damage And Flare in Systemic lupus erythematosus Patients With High Disease Activity.
Rheumatology (Oxford)
December 2024
Department of Medicine, Sub-faculty of Clinical and Molecular Medicine, Monash University, Clayton, Victoria, Australia.
Objective: High disease activity status (HDAS) in patients with systemic lupus erythematosus (SLE) is associated with adverse long-term outcomes. We examined the frequency of lupus low disease activity state (LLDAS) and remission (REM) attainment in HDAS patients and whether their attainment was associated with improved patient outcomes.
Methods: Demographic, clinical and outcomes data, collected prospectively from a multinational cohort between 2013 and 2020, were analysed.
Accrual of organ damage and one-year mortality in systemic sclerosis: A prospective observational study.
Semin Arthritis Rheum
December 2024
Instituto de Investigación Biomédica de Málaga (IBIMA)-Plataforma Bionand, Málaga 29010, Spain; UGC de Reumatología, Hospital Regional Universitario de Málaga, Málaga 29009, Spain; Departamento de Medicina, Universidad de Málaga, Málaga 29010, Spain.
Objective: To determine cumulative organ damage in patients with systemic sclerosis (SSc) according to the Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI), assess 1-year mortality risk, and identify associated factors.
Methods: A prospective, single-center study was conducted in a cohort of patients with SSc. A cross-sectional study and a 12-month longitudinal follow-up were carried out.
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