Eur J Cancer
Department of Medical Oncology, West German Cancer Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Published: January 2015
Background: Pancreatic ductal adenocarcinoma (PDAC) is one of the most common malignant tumours and is still associated with a poor prognosis in advanced disease. To improve the standard therapy with gemcitabine, we initiated a prospective randomised phase-II trial with gemcitabine (GEM) versus gemcitabine plus sunitinib (SUNGEM) based on data of in vitro trials and phase-I data for the combination treatment. The rational of adding sunitinib was its putative antiangiogenic mechanism of action.
Methods: A total of 106 eligible patients with locally advanced, unresectable or metastatic PDAC without previous system therapy were randomised to receive GEM at a dosage of 1.000mg/m(2) d1, 8, 15 q28 versus a combination of SUNGEM at a dosage of GEM 1.000mg/m(2) d1+8 and sunitinib 50mg p.o. d1-14, q21d. The primary end-point was progression free survival (PFS), secondary end-points were overall survival (OS), toxicity and overall response rate (ORR).
Results: The confirmatory analysis of PFS was based on the intend-to-treat (ITT) population (N=106). The median PFS was 13.3 weeks (95% confidence interval (95%-CI): 10.4-18.1 weeks) for GEM and 11.6 weeks for SUNGEM (95%-CI: 7.0-18.0 weeks; p=0.78 one-sided log-rank). The ORR was 6.1% (95%-CI: 0.7-20.2%) for GEM and for 7.1% (95%-CI: 0.9-23.5%) for SUNGEM (p=0.87). The median time to progression (TTP) was 14.0 weeks (95%-CI: 12.4-22.3 weeks) for GEM and 18.0 weeks (95%-CI: 11.3-19.3 weeks) for SUNGEM (p=0.60; two-sided log-rank). The median OS was 36.7 weeks (95%-CI: 20.6-49.0 weeks) for the GEM arm and 30.4 weeks (95%-CI: 18.1-37.6 weeks) for the SUNGEM (p=0.78, one-sided log-rank). In regard to toxicities, suspected SAEs were reported in 53.7% in the GEM arm and 71.2% in the SUNGEM arm. Grade 3 and 4 neutropenia was statistically significantly higher in the SUNGEM arm with 48.1% versus 27.8% in the GEM arm (p=0.045, two sided log-rank).
Conclusions: The combination SUNGEM was not sufficient superior in locally advanced or metastatic PDAC compared to GEM alone in regard to efficacy but was associated with more toxicity.
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http://dx.doi.org/10.1016/j.ejca.2014.10.010 | DOI Listing |
Front Immunol
January 2025
Department of Gastroenterology and Hepatology, Tianjin Third Central Hospital, Tianjin Key Laboratory of Extracorporeal Life Support for Critical Diseases, Institute of Hepatobiliary Disease, Tianjin, China.
Objective: Although pegylated interferon α-2b (PEG-IFN α-2b) therapy for chronic hepatitis B has received increasing attention, determining the optimal treatment course remains challenging. This research aimed to develop an efficient model for predicting interferon (IFN) treatment course.
Methods: Patients with chronic hepatitis B, undergoing PEG-IFN α-2b monotherapy or combined with NAs (Nucleoside Analogs), were recruited from January 2018 to December 2023 at Tianjin Third Central Hospital.
Pak J Med Sci
January 2025
Sadia Nazir, FCPS Assistant Professor, Obstetrics and Gynaecology Department, DG Khan Medical College, DG Khan, Pakistan.
Objective: To determine the risk factors and outcomes of maternal sepsis.
Methods: This case-control study was performed at the departments of Obstetrics & Gynecology, Nishtar Hospital, Multan, and Ghazi Khan Hospital, Dera Ghazi Khan, Pakistan, from June 2023 to May 2024. Cases were comprised of females aged 18-45 years diagnosed with maternal sepsis, and admitted during the study period.
Rev Cardiovasc Med
January 2025
Department of Cardiology, Hospital Clinico Universitario de Valencia, 46010 Valencia, Spain.
Background: Exercise-based cardiac rehabilitation programs (CRP) are recommended for patients following acute coronary syndrome to potentially improve high-density lipoprotein cholesterol (HDL-C) levels and prognosis. However, not all patients reach target HDL-C levels. Here we analyze the dynamics and predictors of HDL-C increase during CRP in patients following ST-segment elevation myocardial infarction or occlusion myocardial infarction.
View Article and Find Full Text PDFInt J Nurs Stud Adv
June 2025
Centre of Excellence in Early Intervention and Family Studies, Department of Psychology, University of Copenhagen, Denmark.
Background: Screening for perinatal depression using the Edinburgh Postnatal Depression Scale (EPDS) improves detection and increases health service utilization. However, previous studies with antenatal samples indicate that positive screenings might reflect transient distress that resolves without intervention, raising concerns about over-pathologizing typical postnatal responses and inefficiencies in referral practices. Therefore, distinguishing between transient and enduring depressive symptoms for appropriate referrals to secondary services is crucial, highlighting the need for a refined screening practice.
View Article and Find Full Text PDFUrinary Tract Infections (UTIs) in pregnant women can lead to pyelonephritis and preterm birth. We assessed UTI prevalence, etiology, antimicrobial resistance, and associated risk factors among pregnant women receiving antenatal care in rural Amhara, Ethiopia. 604 pregnant women were screened for UTI at ≤ 24 weeks gestational age from August 2020 to June 2022.
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