A randomized trial of adjuvant chemotherapy with uracil-tegafur for adenocarcinoma of the lung

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N Engl J Med. 2004 Apr 22;350(17):1713-21.

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Comment in:
Cancer Treat Rev. 2004 Nov;30(7):661-4.
N Engl J Med. 2004 Apr 22;350(17):1777-9.
N Engl J Med. 2004 Aug 12;351(7):713-4; author reply 713-4.
N Engl J Med. 2004 Aug 12;351(7):713-4; author reply 713-4.

A randomized trial of adjuvant chemotherapy with uracil-tegafur for adenocarcinoma of the lung.

Kato H, Ichinose Y, Ohta M, Hata E, Tsubota N, Tada H, Watanabe Y, Wada H, Tsuboi M, Hamajima N, Ohta M; Japan Lung Cancer Research Group on Postsurgical Adjuvant Chemotherapy.
Department of Surgery, Tokyo Medical University, Tokyo, Japan.
BACKGROUND:
In a previous phase 3 trial of adjuvant chemotherapy after resection of
non-small-cell lung cancer, a combination of uracil and tegafur (often
referred to as UFT) taken orally was shown to prolong survival. A
subgroup analysis disclosed that most patients who benefited had
pathological stage I adenocarcinoma.
METHODS: We randomly assigned
patients with completely resected pathological stage I adenocarcinoma
of the lung to receive either oral uracil-tegafur (250 mg of tegafur
per square meter of body-surface area per day) for two years or no
treatment. Randomization was performed with stratification according to
the pathological tumor category (T1 vs. T2), sex, and age. The primary
end point was overall survival.
RESULTS: From January 1994 through
March 1997, 999 patients were enrolled. Twenty patients were found to
be ineligible and were excluded from the analysis after randomization;
491 patients were assigned to receive uracil-tegafur and 488 were
assigned to observation. The median duration of follow-up for surviving
patients was 73 months. The difference in overall survival between the
two groups was statistically significant in favor of the uracil-tegafur
group (P=0.04 by a stratified log-rank test). Grade 3 toxic effects
occurred in 10 of the 482 patients (2 percent) who actually received
uracil-tegafur.
CONCLUSIONS: Adjuvant chemotherapy with uracil-tegafur
improves survival among patients with completely resected pathological
stage I adenocarcinoma of the lung. Copyright 2004 Massachusetts
Medical Society