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Tegafur is a pro-drug that is converted to fluorouracil, and the serum concentration of fluorouracil is enhanced by uracil. While fluorouracil itself has no apparent effect on survival in non-small cell lung cancer, Japanese studies of uracil-tegafur have reported a mortality benefit when used as an adjuvant therapy. In subgroup analysis this benefit was confined to adenocarcinoma.
The present study randomised patients to receive oral uracil-tegafur (250 mg/m2/day, n = 491) or no treatment (n = 488) for 2 years following resection of stage 1 (T1M0N0 or T2M0N0) adenocarcinoma of the lung. Despite being an open label study, it was well planned and adequately powered. Median follow up was 73 months. Overall there was a statistically significant survival advantage favouring treatment (p = 0.04) with a 5 year survival of 88% (CI 85 to 91) compared with 85% (CI 82 to 89). On subgroup analysis this difference was only apparent in those patients with T2 disease: 5 year survival with treatment was 85% (CI 79 to 91) compared with 74% without (CI 66 to 81). There were few serious drug related adverse events but only 61% of patients completed the 2 year treatment period.
This study shows a survival advantage for postoperative adjuvant oral uracil-tegafur in stage 1 (T2) adenocarcinoma of the lung.
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