Abstract
BackgroundLymphovascular 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.MethodsPatients 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.ResultsAmong 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.ConclusionA 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.Trial registrationUMIN identifier: UMIN000005921; Date of enrolment of the first participant to the trial: 19 June 2007; Date of registration: 5 July 2011 (retrospectively registered).
Highlights
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)
Safety analysis set (SAS) was 55 because all patients were treated by tegafur-uracil postoperatively
The present study identified significant benefits of tegafur-uracil for the LVI-positive stage IA NSCLC
Summary
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). A recent public health study indicates an increase in stage IA non-small cell lung cancer (NSCLC) and an improved prognosis for the disease [2]. Stage IA NSCLCs have been sub-divided according to poor prognostic factors such as smoking history, serum level of carcinoembryonic antigen (CEA), resection area, tumor size, lymphatic vessel invasion and vessel invasion [3,4,5,6,7,8,9,10,11,12]. Poor prognostic group of stage IA NSCLC might obtain benefit form adjuvant chemotherapy. Detailed analysis of 221 stage IA NSCLC patients showed that both lymphatic vessel invasion and blood vessel invasion were significant poor prognostic factors [14]. The targeted adjuvant therapy for LVI-positive stage IA NSCL C has not been conducted so far
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