PIK3CA 突变的 III 期或高危 II 期结肠癌中阿司匹林与安慰剂的对比:一项法国随机双盲 III 期试验(PRODIGE 50-ASPIK)。

Aspirin versus placebo in stage III or high-risk stage II colon cancer with PIK3CA mutation: A French randomised double-blind phase III trial (PRODIGE 50-ASPIK).

机构信息

Normandie Univ, UNIROUEN, Inserm 1245, IRON Group, Department of Hepato-Gastroenterology, Rouen University Hospital, Rouen, France.

Department of Oncologic Medicine, Gustave Roussy, Villejuif, France.

出版信息

Dig Liver Dis. 2018 Mar;50(3):305-307. doi: 10.1016/j.dld.2017.12.023. Epub 2017 Dec 30.

Abstract

Oxaliplatin-based adjuvant chemotherapy is standard of care for radically resected stage III colon cancer and an accepted option for high-risk stage II. Two recent retrospective studies strongly suggested that low-dose aspirin used (100 mg/d) after surgical resection of colorectal cancer with a PIK3CA mutation could act as a targeted therapy with a major protective effect on the risk of recurrence. We propose a double-blind randomized phase III study to evaluate aspirin (100 mg/d during 3 years or until recurrence) versus placebo. Main inclusion criteria are patients aged 18 or 20, stage III or high risk stage II. The primary endpoint of the study is 3-year disease-free survival (DFS). Hypotheses are to improve 3-years DFS from placebo: 72% to aspirin: 83% (HR = 0.56). 94 events and 264 patients with PIK3CA mutation are required. The secondary endpoints are DFS at 5 years, the overall survival rate at 5 years, grade 3-4 severe bleeding.

摘要

奥沙利铂为基础的辅助化疗是根治性切除 III 期结肠癌的标准治疗方法,也是高危 II 期结肠癌的可接受选择。最近两项回顾性研究强烈表明,结直肠癌手术后使用低剂量阿司匹林(每天 100mg),如果存在 PIK3CA 突变,可能作为一种靶向治疗,对复发风险有显著的保护作用。我们建议进行一项双盲随机 III 期研究,评估阿司匹林(每天 100mg,持续 3 年或直至复发)与安慰剂的疗效。主要纳入标准为年龄在 18 或 20 岁、III 期或高危 II 期的患者。研究的主要终点是 3 年无病生存率(DFS)。假设阿司匹林组 3 年 DFS 较安慰剂组改善:72%至 83%(HR=0.56)。需要 94 例事件和 264 例 PIK3CA 突变患者。次要终点是 5 年 DFS、5 年总生存率、3-4 级严重出血。

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