帕唑帕尼
医学
耐受性
不利影响
肾细胞癌
内科学
性能状态
肿瘤科
肾癌
临床试验
进行性疾病
实体瘤疗效评价标准
肾透明细胞癌
临床研究阶段
癌症
外科
化疗
舒尼替尼
作者
Anjali Zarkar,Sarah Pirrie,Clive Stubbs,Anne-Marie Hodgkins,David Farrugia,Kathryn H Fife,Carey MacDonald-Smith,Naveen S. Vasudev,Emilio Porfiri
标识
DOI:10.1016/j.clgc.2022.06.012
摘要
Patients with advanced renal cell carcinoma and poor performance status (PS≥2) are often deemed unsuitable for treatment. The Pazo2 trial aimed to assess tolerability and efficacy of pazopanib as first-line treatment in renal cancer patients with ECOG PS2.Pazo2 was a prospective, single arm, open label, multicentre, phase II trial, conducted in 26 UK centres. Eligible patients were aged ≥18 years, with advanced or metastatic renal cancer and a clear cell component (aRCC), measurable disease as per RECIST Criteria 1.1, and ECOG PS2. Co-primary outcomes, assessed at 6-months after patients entered the trial, were tolerability, defined as the proportion of patients who did not develop "intolerable" adverse events, and efficacy, defined as the proportion of all patients who were progression-free and alive.Between February 21, 2013 and August 12, 2016, 75 patients were registered. Median age was 68.6 years (IQR 64.6-76.0), 100% ECOG PS2, 62.7% 'poor risk' (International Metastatic Renal-Cell Carcinoma Database Consortium). Of the 65 evaluable patients, 70.8% (95% CI: 58.8, 80.4) did not develop "intolerable" adverse events and 56.9% (95% CI: 44.8, 68.2) were still alive and progression-free 6 months after starting pazopanib. Twenty-seven patients developed serious adverse events deemed to be related to pazopanib.These data suggests that pazopanib is tolerated and effective in aRCC patients with PS2 and represents a treatment option for patients who cannot receive or tolerate immune checkpoint inhibitors.
科研通智能强力驱动
Strongly Powered by AbleSci AI