医学
中期分析
危险系数
安慰剂
临床终点
内科学
不利影响
化疗
临时的
癌症
外科
临床试验
胃肠病学
置信区间
替代医学
考古
病理
历史
出处
期刊:Lancet Oncology
[Elsevier BV]
日期:2022-07-07
卷期号:23 (8): 988-988
被引量:4
标识
DOI:10.1016/s1470-2045(22)00443-0
摘要
The anti-PD-1 antibody tislelizumab is an effective first-line treatment for advanced oesophageal squamous cell carcinoma, according to data from a randomised, controlled, phase 3 trial. Harry Yoon (Mayo Clinic, Rochester, MN, USA) presented interim results from the RATIONALE-306 trial, in which 649 patients were randomly assigned (1:1) to receive tislelizumab 200 mg intravenously every 3 weeks plus investigator's choice of chemotherapy (n=326) or placebo plus chemotherapy (n=323). At the interim analysis (median follow-up 16·3 months in the tislelizumab group and 9·8 months in the placebo group), overall survival (primary endpoint) was significantly longer with tislelizumab than with placebo (median 17·3 months vs 10·6 months; hazard ratio [HR] 0·66 [95% CI 0·54–0·80]; p<0·0001). Rates of treatment-emergent adverse events were similar between the groups, and no new safety signals were observed.
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