Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, 852-8501, Japan.
Department of Thoracic Surgery, Oita Prefectural Hospital, Oita, Japan.
BMC Cancer. 2020 Dec 4;20(1):1192. doi: 10.1186/s12885-020-07691-7.
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/m/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).
脉管侵犯（LVI）包括血管或淋巴管侵犯，即使在接受完全切除的ⅠA 期非小细胞肺癌（NSCLC）患者中，也是一个重要的预后因素。由于替加氟尿嘧啶对有 LVI 的癌症有效，我们进行了一项多中心单臂Ⅱ期研究，以评估 LVI 阳性ⅠA 期 NSCLC 患者辅助替加氟尿嘧啶的疗效。
入组完全切除的 LVI 阳性ⅠA 期 NSCLC 患者。LVI 由 3 位病理学家中的 2 位共同诊断。辅助化疗包括口服替加氟尿嘧啶 2 年，剂量为 250mg/m/天。2007 年 6 月至 2012 年 9 月，来自 7 家机构的 55 名患者入组。
52 名合格患者中，36 名（69.2%）完成了治疗疗程。其中 39 名男性和 13 名女性患者。采用反向 Kaplan-Meier 法计算观察期为 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%，明显优于任何其他 LVI 阳性ⅠA 期 NSCLC 患者的研究。值得注意的是，总生存率比我们之前的回顾性研究提高了 15%。同期接受手术的ⅠA 期 NSCLC 患者的回顾性分析显示，未行辅助化疗时，LVI 阳性组的 5 年总生存率为 73.6%。在 55 例安全性分析集中，最常见的是 4 例 3 级肝功能障碍（9.1%）和 5 例 2 级食欲不振（10.9%）。未发生 4 级不良事件。
口服替加氟尿嘧啶 2 年疗程是可行的，可能对 LVI 阳性ⅠA 期 NSCLC 的辅助治疗有显著益处。
UMIN 标识符：UMIN000005921；首例患者入组日期：2007 年 6 月 19 日；注册日期：2011 年 7 月 5 日（回顾性注册）。
