Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center, Tokyo.
Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai.
Jpn J Clin Oncol. 2018 Aug 1;48(8):777-780. doi: 10.1093/jjco/hyy085.
A randomized phase III trial comparing watchful waiting with first-line rituximab for advanced stage follicular lymphoma commenced in Japan in December 2016. Watchful waiting is the current standard treatment for stages III and IV (Ann Arbor classification) follicular lymphoma with low tumour burden. This study aimed to confirm the superiority of early administration of first-line rituximab in terms of event-free survival to watchful waiting for stages III and IV follicular lymphoma with low tumour burden. A total of 290 patients will be accrued from 50 Japanese institutions within 5 years. The primary endpoint is event-free survival defined as the period from registration to diagnosis of high tumour burden, therapy using cytotoxic chemotherapy and/or radiotherapy, or death. The secondary endpoints are overall survival, progression-free survival, cytotoxic chemotherapy/radiotherapy-free survival, histological transformation-free survival, response rate, adverse events and serious adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000025187 (http://www.umin.ac.jp/ctr/index.htm).
一项在日本于 2016 年 12 月开始进行的比较观察等待与一线利妥昔单抗治疗晚期滤泡淋巴瘤的随机 III 期试验。观察等待是目前低肿瘤负荷 III 期和 IV 期（安阿伯分类）滤泡淋巴瘤的标准治疗方法。本研究旨在确认对于低肿瘤负荷的 III 期和 IV 期滤泡淋巴瘤，早期给予一线利妥昔单抗在无事件生存方面优于观察等待。将在 5 年内从 50 家日本机构中招募 290 名患者。主要终点是无事件生存，定义为从登记到高肿瘤负荷诊断、使用细胞毒性化疗和/或放疗治疗或死亡的时间段。次要终点是总生存、无进展生存、无细胞毒性化疗/放疗生存、组织学转化无生存、缓解率、不良事件和严重不良事件。该试验已在 UMIN 临床试验注册中心注册，编号为 UMIN000025187（http://www.umin.ac.jp/ctr/index.htm）。
