Lymphovascular invasion (LVI), which includes vascular or lymphatic invasions, is a representative prognostic factor even in patients with resected stage IA non-small cell lung cancer (NSCLC). Because tegafur-uracil is effective on cancers with LVI, we conducted a multi-center single-arm phase II study to estimate the efficacy of adjuvant tegafur-uracil in patients with LVI-positive stage IA NSCLC. Patients with completely resected LVI-positive stage IA NSCLC were registered. LVI was diagnosed by consensus of two of three pathologists. Adjuvant chemotherapy consisted of 2 years of oral tegafur-uracil at 250 mg/m2/day. Fifty-five patients from 7 institutions were enrolled from June 2007 to September 2012. Among the 52 eligible patients, 36 (69.2%) completed the treatment course. There were 39 male and 13 female patients. The observation period was calculated as 562 to 3107 days using the reverse Kaplan-Meier method. The 5-year overall and relapse free survival rates were 94.2 and 88.5% respectively, which were significantly better than that of any other studies conducted on patients with LVI-positive stage IA NSCLC. Notably, the overall survival rate was 15% better than that of our prior retrospective study. The retrospective analysis of stage IA NSCLC patients who had received an operation in the same period revealed that the 5-year overall survival rate of the LVI positive group was 73.6% when adjuvant chemotherapy was not applied. Among 55 safety analysis sets, 4 cases of grade 3 hepatic function disorder (9.1%) and 5 cases of grade 2 anorexia (10.9%) were most frequently observed. No grade 4 adverse effects were encountered. A 2-year course of oral tegafur-uracil administration is feasible and might have a significant benefit in the adjuvant treatment of LVI-positive stage IA NSCLC. UMIN identifier: UMIN000005921 ; Date of enrolment of the first participant to the trial: 19 June 2007; Date of registration: 5 July 2011 (retrospectively registered).

中文翻译：

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口服替加氟尿嘧啶辅助化疗用于病理性淋巴管浸润阳性IA期非小细胞肺癌的单臂2期研究：LOGIK0602研究

淋巴血管浸润（LVI）包括血管或淋巴管浸润，即使在IA期非小细胞肺癌（NSCLC）切除的患者中，也是代表性的预后因素。由于替加氟尿嘧啶对LVI癌症有效，因此我们进行了多中心单臂II期研究，以评估替加氟尿嘧啶对LVI阳性IA NSCLC患者的疗效。登记了LVI阳性IA NSCLC完全切除的患者。LVI由三位病理学家中的两位病理学家共同诊断。辅助化疗包括2年口服替加氟尿嘧啶250 mg / m2 /天。从2007年6月至2012年9月，共有7家机构的55名患者入选。在52名合格患者中，有36名（69.2％）完成了治疗过程。男39例，女13例。使用反向Kaplan-Meier方法计算的观察期为562至3107天。5年总生存率和无复发生存率分别为94.2和88.5％，明显优于对LVI阳性IA NSCLC患者进行的任何其他研究。值得注意的是，总生存率比我们以前的回顾性研究高15％。对同期接受手术的IA期NSCLC患者的回顾性分析显示，不使用辅助化疗时，LVI阳性组的5年总生存率为73.6％。在55个安全性分析集中，最常观察到4例3级肝功能障碍（9.1％）和5例2级厌食症（10.9％）。没有遇到4级不良反应。口服替加氟尿嘧啶为期2年的疗程是可行的，并且可能在LVI阳性IA NSCLC的辅助治疗中具有显着的益处。UMIN标识符：UMIN000005921; 首次参加试验的参与者的日期：2007年6月19日；注册日期：2011年7月5日（追溯注册）。