Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan.
BJS Open. 2024 Oct 29;8(6). doi: 10.1093/bjsopen/zrae133.
The Japan Clinical Oncology Group (JCOG) 1006 was a phase III trial of patients with clinical T3/T4 colon cancer comparing the no-touch isolation technique ('No Touch') with the conventional technique ('Conventional'). The planned primary analysis at 3 years failed to confirm the superiority of the No Touch over the 'Conventional'. The present study aimed to compare the 'No Touch' and 'Conventional' using long-term (6-year) follow-up data.
Patients aged 20-80 years who had a clinical classification of T3-4, N0-2, and M0 with histologically proven colon cancer were randomly assigned (1 : 1) to undergo open surgery using 'Conventional' or 'No Touch' techniques. The primary endpoint was disease-free survival.
In total, 853 patients from 30 institutions were assigned to the 'Conventional' (427) or 'No Touch' (426) groups between June 2011 and November 2015. The 6-year disease-free survival was 70.3% and 69.4% for 'Conventional' and 'No Touch' arms respectively (HR 1.030; 95% c.i. 0.813 to 1.304; one-sided P = 0.60). The 6-year overall survival was 89.4% and 86.6% respectively (HR 1.276; 95% c.i. 0.902 to 1.807). The 6-year relapse-free survival was 78.9% and 75.0% respectively (HR 1.209; 95% c.i. 0.920 to 1.589). The 6-year liver relapse-free survival was 85.1% and 80.2% respectively (HR 1.311; 95% c.i. 0.961 to 1.787).
Long-term follow-up data did not support the superiority of 'No Touch' over 'Conventional' technique in patients with stages II and III colon cancer. These study findings indicate that the conventional technique is still standard surgery for managing colon cancers.
UMIN000004957.
日本临床肿瘤学组（JCOG）1006 是一项 III 期临床试验，纳入了临床 T3/T4 结肠癌患者，比较了无接触隔离技术（“无接触”）与传统技术（“常规”）。3 年的计划主要分析未能证实无接触优于常规。本研究旨在使用 6 年随访数据比较“无接触”和“常规”。
纳入年龄 20-80 岁、临床分类 T3-4、N0-2、M0 且组织学证实为结肠癌的患者，按 1:1 随机分配至接受开放手术的常规或无接触技术组。主要终点为无病生存。
2011 年 6 月至 2015 年 11 月，来自 30 个机构的 853 例患者被分配至常规（427 例）或无接触（426 例）组。常规组和无接触组的 6 年无病生存率分别为 70.3%和 69.4%（HR 1.030；95%CI 0.813 至 1.304；单侧 P=0.60）。6 年总生存率分别为 89.4%和 86.6%（HR 1.276；95%CI 0.902 至 1.807）。6 年无复发生存率分别为 78.9%和 75.0%（HR 1.209；95%CI 0.920 至 1.589）。6 年肝无复发生存率分别为 85.1%和 80.2%（HR 1.311；95%CI 0.961 至 1.787）。
长期随访数据不支持无接触优于常规技术在 II 期和 III 期结肠癌患者中的应用。这些研究结果表明，常规技术仍然是治疗结肠癌的标准手术。
UMIN000004957。
