A Randomized Trial of Adjuvant Chemotherapy with Uracil-Tegafur for Adenocarcinoma of the Lung

doi:10.1056/NEJMoa032792

Volume 350:1713-1721		April 22, 2004		Number 17

A Randomized Trial of Adjuvant Chemotherapy with Uracil–Tegafur for Adenocarcinoma of the Lung

Harubumi Kato, M.D., Yukito Ichinose, M.D., Morio Ohta, M.D., Enjo Hata, M.D., Noriaki Tsubota, M.D., Hirohito Tada, M.D., Yoh Watanabe, M.D., Hiromi Wada, M.D., Masahiro Tsuboi, M.D., Nobuyuki Hamajima, M.D., Mitsuo Ohta, M.D., for the Japan Lung Cancer Research Group on Postsurgical Adjuvant Chemotherapy

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ABSTRACT

Background In a previous phase 3 trial of adjuvant chemotherapyafter resection of non–small-cell lung cancer, a combinationof uracil and tegafur (often referred to as UFT) taken orallywas shown to prolong survival. A subgroup analysis disclosedthat most patients who benefited had pathological stage I adenocarcinoma.

Methods We randomly assigned patients with completely resectedpathological stage I adenocarcinoma of the lung to receive eitheroral uracil–tegafur (250 mg of tegafur per square meterof body-surface area per day) for two years or no treatment.Randomization was performed with stratification according tothe pathological tumor category (T1 vs. T2), sex, and age. Theprimary end point was overall survival.

Results From January 1994 through March 1997, 999 patients wereenrolled. Twenty patients were found to be ineligible and wereexcluded from the analysis after randomization; 491 patientswere assigned to receive uracil–tegafur and 488 were assignedto observation. The median duration of follow-up for survivingpatients was 73 months. The difference in overall survival betweenthe two groups was statistically significant in favor of theuracil–tegafur group (P=0.04 by a stratified log-ranktest). Grade 3 toxic effects occurred in 10 of the 482 patients(2 percent) who actually received uracil–tegafur.

Conclusions Adjuvant chemotherapy with uracil–tegafurimproves survival among patients with completely resected pathologicalstage I adenocarcinoma of the lung.

Source Information

From the Department of Surgery, Tokyo Medical University, Tokyo (H.K., M.T.); the Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka (Y.I., Mitsuo Ohta); the Department of Surgery, National Okinawa Hospital, Okinawa (Morio Ohta); the Department of Surgery, Respiratory Disease Center, Mitsui Memorial Hospital, Tokyo (E.H.); the Department of Thoracic Surgery, Hyogo Medical Center for Adults, Akashi (N.T.); the Department of Pulmonary Surgery, Osaka City General Hospital, Osaka (H.T.); the First Department of Surgery, Kanazawa University, Kanazawa (Y.W.); the Department of Thoracic Surgery, Kyoto University, Kyoto (H.W.); and the Department of Preventive Medicine/Biostatistics and Medical Decision Making, Nagoya University, Nagoya (N.H.) — all in Japan.

Address reprint requests to Dr. Ichinose at the National Kyushu Cancer Center, Department of Thoracic Oncology, 3-1-1, Notame, Minami-ku, Fukuoka 811-1395, Japan, or at yichinos{at}nk-cc.go.jp.

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Related Letters:

Uracil–Tegafur in Early-Stage Lung Cancer
Altundag O., Altundag K., Gunduz M., Graziano F., Ichinose Y., Hamajima N.
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N Engl J Med 2004; 351:713-714, Aug 12, 2004. Correspondence

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