JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan.
Jpn J Clin Oncol. 2020 Sep 28;50(10):1209-1213. doi: 10.1093/jjco/hyaa107.
Anatomical segmentectomy or wedge resection is recommended for high-risk operable patients with clinical stage IA non-small cell lung cancer in guidelines of the National Comprehensive Cancer Network and the Japanese Lung Cancer Society. However, there is no clear evidence comparing the sublobar resections. The less invasive and more generally performed is wedge resection but anatomical segmentectomy may have better survival benefits than wedge resection owing to its superiority in locoregional control. In April 2020, we have initiated a randomized phase III trial in Japan to confirm the superiority of anatomical segmentectomy over wedge resection in high-risk operable patients with clinical stage IA non-small cell lung cancer. We plan to enroll a total of 370 patients from 47 institutions over a period of 5 years. The primary endpoint is overall survival; the secondary endpoints are adverse events, postoperative respiratory function, relapse-free survival, proportion of local recurrence, operative time and blood loss.
解剖性肺段切除术或楔形切除术推荐用于美国国家综合癌症网络和日本肺癌学会指南中具有临床ⅠA 期非小细胞肺癌高危因素的可手术患者。然而，目前并没有明确的证据比较亚肺叶切除术。侵袭性较小、更为常用的术式是楔形切除术，但由于解剖性肺段切除术在局部区域控制方面的优势，可能比楔形切除术具有更好的生存获益。2020 年 4 月，我们在日本启动了一项随机 III 期临床试验，以确认解剖性肺段切除术在临床ⅠA 期非小细胞肺癌高危可手术患者中优于楔形切除术。我们计划在 5 年内从 47 家机构共招募 370 名患者。主要终点是总生存期；次要终点是不良事件、术后呼吸功能、无复发生存期、局部复发比例、手术时间和出血量。
