Purpose: The phase III PACIFIC trial compared durvalumab with placebo in patients with unresectable, stage III non-small-cell lung cancer and no disease progression after concurrent chemoradiotherapy. Consolidation durvalumab was associated with significant improvements in the primary end points of overall survival (OS; stratified hazard ratio [HR], 0.68; 95% CI, 0.53 to 0.87; = .00251) and progression-free survival (PFS [blinded independent central review; RECIST v1.1]; stratified HR, 0.52; 95% CI, 0.42 to 0.65; < .0001), with manageable safety. We report updated, exploratory analyses of survival, approximately 5 years after the last patient was randomly assigned.
Methods: Patients with WHO performance status 0 or 1 (any tumor programmed cell death-ligand 1 status) were randomly assigned (2:1) to durvalumab (10 mg/kg intravenously; administered once every 2 weeks for 12 months) or placebo, stratified by age, sex, and smoking history. Time-to-event end point analyses were performed using stratified log-rank tests. Medians and landmark survival rates were estimated using the Kaplan-Meier method.
Results: Seven hundred and nine of 713 randomly assigned patients received durvalumab (473 of 476) or placebo (236 of 237). As of January 11, 2021 (median follow-up, 34.2 months [all patients]; 61.6 months [censored patients]), updated OS (stratified HR, 0.72; 95% CI, 0.59 to 0.89; median, 47.5 29.1 months) and PFS (stratified HR, 0.55; 95% CI, 0.45 to 0.68; median, 16.9 5.6 months) remained consistent with the primary analyses. Estimated 5-year rates (95% CI) for durvalumab and placebo were 42.9% (38.2 to 47.4) versus 33.4% (27.3 to 39.6) for OS and 33.1% (28.0 to 38.2) versus 19.0% (13.6 to 25.2) for PFS.
Conclusion: These updated analyses demonstrate robust and sustained OS and durable PFS benefit with durvalumab after chemoradiotherapy. An estimated 42.9% of patients randomly assigned to durvalumab remain alive at 5 years and 33.1% of patients randomly assigned to durvalumab remain alive and free of disease progression, establishing a new benchmark for standard of care in this setting.
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http://dx.doi.org/10.1200/JCO.21.01308 | DOI Listing |
BMC Med Ethics
January 2025
Department of Midwifery, Nursing and Midwifery Faculty, Bushehr University of Medical Sciences, Bushehr, Iran.
Introduction: Despite the existing reports on mistreatment and disrespectful maternal care, few studies have investigated interventions to mitigate this issue. The present study aims to assess the impact of consulting midwives on maternal rights charter on perception of respectful maternity care and postpartum blues among postpartum women in two hospitals in southern Iran.
Methodology: This quasi-experimental study was conducted on 437 postpartum women (217 mothers before the intervention and 220 mothers after the intervention) and 44 midwives working in the maternity ward of two hospitals affiliated to Bushehr University of Medical Sciences in 2023-2024.
BMC Med
January 2025
Department of Cardiology, The Third Xiangya Hospital of Central South University, Yuelu District, 138 Tongzipo Road, Changsha, 410013, Hunan, China.
Background: Guidelines recognized dual combination in initial antihypertensive therapy. Studies found that low-dose quadruple combination were superior to monotherapy. However, whether low-dose quadruple therapy is better than dual combination is unknown.
View Article and Find Full Text PDFArab J Gastroenterol
January 2025
PG Dept. of Moalajat, (Medicine) RRIUM, Srinagar, India.
Background And Study Aims: Non-alcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver disorder, affecting 23% to 32% of the global population. This clinical study aimed to assess the efficacy of Curcuma zedoaria Rosc. compared to vitamin E in managing NAFLD.
View Article and Find Full Text PDFBMJ Open
January 2025
China Center for Health Development Studies, Peking University, Beijing, China
Introduction: Lung cancer is the leading cause of cancer-related mortality globally, with non-small cell lung cancer (NSCLC) comprising the majority of cases. For advanced NSCLC, immunotherapy offers substantial survival benefits but is often accompanied by severe immune-related adverse events symptoms, significantly affecting health-related quality of life (HRQoL). Routinely collection of patient-reported outcomes (PROs) followed by automated alerts has been shown to improve overall survival and HRQoL for cancers.
View Article and Find Full Text PDFBMJ Open
January 2025
Southern Medical University Institute for Global Health, Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China
Introduction: Traditional Chinese medicine (TCM) is commonly used alongside Western medicine for stroke management in China. However, there is significant variation in TCM practice, and the utilisation of evidence-based clinical practice guidelines is inadequate. This study aims to evaluate the effectiveness of three popular frameworks-Consolidated Framework for Implementation Research (CFIR), Theoretical Domains Framework (TDF) and Normalization Process Theory (NPT)-in improving implementation outcomes for the integrated TCM and Western medicine clinical practice guideline for stroke management.
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