一项针对既往接受过治疗的晚期胃癌患者，比较每周或每3周剂量的纳米白蛋白结合型紫杉醇与每周剂量的聚氧乙烯蓖麻油基紫杉醇的随机III期试验（ABSOLUTE试验）。
A randomized Phase III trial of weekly or 3-weekly doses of nab-paclitaxel versus weekly doses of Cremophor-based paclitaxel in patients with previously treated advanced gastric cancer (ABSOLUTE Trial).
作者信息
Koizumi Wasaburo, Morita Satoshi, Sakata Yuh
机构信息
Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara-shi, Kanagawa
Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto-shi, Kyoto.
出版信息
Jpn J Clin Oncol. 2015 Mar;45(3):303-6. doi: 10.1093/jjco/hyu205. Epub 2014 Dec 16.
Abstract
Paclitaxel is an agent widely used in second-line chemotherapy for advanced gastric cancer. The aim of this trial is to evaluate the efficacy and safety of 3-weekly or weekly doses of nanoparticle albumin-bound-paclitaxel compared with weekly doses of Cremophor-based paclitaxel in patients with unresectable or recurrent gastric cancer refractory to first-line chemotherapy comprising fluoropyrimidines. A total of 730 patients will be enrolled from 72 institutions. The primary endpoint is the overall survival, and the secondary endpoints are progression-free survival, time to treatment failure, overall response rate, disease control rate, quality of life (by using the EQ-5D system) and safety.
摘要
紫杉醇是一种广泛用于晚期胃癌二线化疗的药物。本试验的目的是评估每3周或每周一次剂量的纳米白蛋白结合型紫杉醇与每周一次剂量的聚氧乙烯蓖麻油基紫杉醇相比，在一线含氟嘧啶化疗难治的不可切除或复发性胃癌患者中的疗效和安全性。将从72个机构招募总共730名患者。主要终点是总生存期，次要终点是无进展生存期、治疗失败时间、总缓解率、疾病控制率、生活质量（使用EQ-5D系统）和安全性。
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