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Meta-Analysis of Postoperative Adjuvant Chemotherapy With Tegafur-Uracil in Non–Small-Cell Lung Cancer

From Faculty of Engineering, Tokyo University of Science, Tokyo; The West Japan Study Group for Lung Cancer Surgery, Kyoto; The Japan Lung Cancer Research Group, Fukuoka; Northeast Japan Study Group for Lung Cancer Surgery, Sendai; Osaka Lung Cancer Study Group, Osaka; Adjuvant Chemotherapy for Lung Cancer Research Group, Nagoya

Address reprint requests to Chikuma Hamada, Faculty of Engineering, Tokyo University of Science, 1-3, Kagurazaka, Shinjuku-ku, Tokyo 162-8601, Japan; e-mail: hamada{at}ms.kagu.tus.ac.jp

PURPOSE: Recent clinical trials have shown the efficacy of platinum-based adjuvant chemotherapy for completely resected non–small-cell lung cancer (NSCLC). In Japan, many clinical trials of adjuvant chemotherapy with tegafur-uracil (UFT) have been conducted, and some trials showed positive results while others showed negative results. Thus, we performed a meta-analysis to assess the efficacy of postoperative adjuvant chemotherapy with UFT in NSCLC.

METHODS: Among nine trials of postoperative adjuvant UFT-containing chemotherapy, six trials comparing surgery alone with surgery plus UFT were identified. Of six trials, two were three-arm trials including cisplatin-based chemotherapy followed by UFT, and data from that arm were not included in the meta-analysis.

RESULTS: Of 2,003 eligible patients, most (98.8%) had squamous cell carcinoma or adenocarcinoma, and most had stage I disease; the tumor classification was T1 in 1,308 (65.3%), T2 in 674 (33.6%), and the nodal status was N0 in 1,923 (96.0%). The two treatment groups did not differ significantly in major prognostic factors. The median duration of follow-up was 6.44 years. The survival rates at 5 and 7 years were significantly higher in the surgery plus UFT group (81.5% and 76.5%, respectively) than in the surgery alone group (77.2% and 69.5%, respectively; P = .011 and .001, respectively). The overall pooled hazard ratio was 0.74, and its 95% CI was 0.61 to 0.88 (P = .001).

CONCLUSION: This meta-analysis showed that postoperative adjuvant chemotherapy with UFT was associated with improved 5- and 7-year survival in a Japanese patient population composed primarily of stage I adenocarcinoma patients.

Supported by Taiho Pharmaceutical Co, Tokyo, Japan (the six trials, including the meta-analysis). This company had no role in the meta-analysis study design, data collection, data analysis, data interpretation, or in writing the report.

Presented at the 12th European Cancer Conference meeting, Copenhagen, Denmark, 2003 and the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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