Shimoyama Ryo, Omori Shota, Nomura Shogo, Kenmotsu Hirotsugu, Takahashi Toshiaki, Harada Hideyuki, Ishikura Satoshi, Mizutani Tomonori, Ando Masahiko, Kataoka Tomoko, Fukuda Haruhiko, Ohe Yuichiro
JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Jpn J Clin Oncol. 2021 Apr 30;51(5):836-841. doi: 10.1093/jjco/hyab025.
Daily low-dose carboplatin plus concurrent thoracic radiotherapy is the standard treatment for elderly patients with unresectable clinical stage (c-Stage) III non-small cell lung cancer (NSCLC) in Japan. However, a phase I study by Omori et al. suggests that weekly carboplatin and nab-paclitaxel plus concurrent thoracic radiotherapy have comparable efficacy outcomes with more manageable adverse events. In December 2020, we initiated a randomized controlled trial in Japan to confirm whether the weekly carboplatin plus nab-paclitaxel regimen is noninferior to the daily low-dose carboplatin regimen for concurrent chemoradiotherapy in elderly patients with unresectable c-Stage III NSCLC. We plan to enroll 166 patients from 50 institutions in 3.5 years. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, response rate, proportion of patients starting maintenance durvalumab therapy, adverse events, site of progression, Functional Assessment of Cancer Therapy-Trial Outcome Index deterioration and Instrumental Activities of Daily Living deterioration.
在日本，每日低剂量卡铂联合同期胸部放疗是不可切除的临床Ⅲ期非小细胞肺癌（NSCLC）老年患者的标准治疗方法。然而，大森等人进行的一项Ⅰ期研究表明，每周卡铂和纳米白蛋白结合型紫杉醇联合同期胸部放疗具有相当的疗效，且不良事件更易于管理。2020年12月，我们在日本启动了一项随机对照试验，以确认对于不可切除的c-Ⅲ期NSCLC老年患者，每周卡铂联合纳米白蛋白结合型紫杉醇方案在同期放化疗中是否不劣于每日低剂量卡铂方案。我们计划在3.5年内从50家机构招募166名患者。主要终点是总生存期。次要终点是无进展生存期、缓解率、开始维持度伐利尤单抗治疗的患者比例、不良事件、进展部位、癌症治疗功能评估-试验结果指数恶化情况和日常生活工具性活动恶化情况。
