کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
6102818 1211120 2015 9 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Research ArticleSafety and efficacy of tigatuzumab plus sorafenib as first-line therapy in subjects with advanced hepatocellular carcinoma: A phase 2 randomized study
ترجمه فارسی عنوان
مقاله پژوهشی مقاله ایمنی و کارآیی تیگاتوزومب و سارافنیب به عنوان درمان اولیه در افراد مبتلا به سرطان کولون کارسینوم پیشرفته: یک مطالعه کارآزمایی فاز 2
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی بیماری‌های گوارشی
چکیده انگلیسی

Background & AimsTigatuzumab is a humanized monoclonal antibody that acts as a death receptor-5 agonist and exerts tumour necrosis factor-related apoptosis-inducing ligand-like activity. In this phase II study, safety and tolerability of the combination of tigatuzumab and sorafenib was evaluated in patients with advanced hepatocellular carcinoma.MethodsAdults with advanced hepatocellular carcinoma, measurable disease, and an Eastern Cooperative Oncology Group performance score ⩽ 1 were enrolled. Eligible subjects were randomly assigned 1:1:1 to tigatuzumab (6 mg/kg loading, 2 mg/kg/week maintenance) plus sorafenib 400 mg twice daily; tigatuzumab (6 mg/kg loading, 6 mg/kg/week maintenance) plus sorafenib 400 mg twice daily; or sorafenib 400 mg twice daily. The primary end point was time to progression. Secondary end points included overall survival and safety.Results163 subjects were randomized to treatment. Median time to progression was 3.0 months in the tigatuzumab 6/2 mg/kg combination group (p = 0.988 vs. sorafenib), 3.9 months in the tigatuzumab 6/6 mg/kg combination group (p = 0.586 vs. sorafenib), and 2.8 months in the sorafenib alone group. Median overall survival was 12.2 months in the tigatuzumab 6/6 mg/kg combination group (p = 0.659 vs. sorafenib), vs. 8.2 months in both other treatment groups (p = 0.303, tigatuzumab 6/2 mg/kg combination vs. sorafenib). The most common treatment-emergent adverse events were palmar-plantar erythrodysesthesia syndrome, diarrhea, and decreased appetite.ConclusionsTigatuzumab combined with sorafenib vs. sorafenib alone in adults with advanced hepatocellular carcinoma did not meet its primary efficacy end point, although tigatuzumab plus sorafenib is well tolerated in hepatocellular carcinoma.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Hepatology - Volume 63, Issue 4, October 2015, Pages 896-904
نویسندگان
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