Masafumi Yamaguchi1, Hirohito Tada2, Tetsuya Mitsudomi3, Takashi Seto1, Kohei Yokoi4, Nobuyuki Katakami5, Kazuhiko Nakagawa6, Makoto Oda7, Mitsunori Ohta8, Toshiyuki Sawa9, Motohiro Yamashita10, Norihiko Iked11, Hideo Saka12, Masahiko Higashiyama13, Hiroaki Nomori14, Hiroshi Semba15, Shunichi Negoro16, Yasutaka Chiba17, Mototsugu Shimokawa18, Masahiro Fukuoka6, Yoichi Nakanishi19. 1. Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka City, Fukuoka, Japan. 2. Department of Thoracic Surgery, Osaka City General Hospital, Osaka City, Osaka, Japan. htada@asahi.email.ne.jp. 3. Department of Thoracic Surgery, Aichi Cancer Center, Nagoya City, Aichi, Japan. 4. Department of Thoracic Surgery, Nagoya University School of Medicine, Nagoya City, Aichi, Japan. 5. Division of Pulmonary Medicine, Kobe City Medical Center General Hospital, Kobe City, Hyogo, Japan. 6. Department of Medical Oncology, Kinki University School of Medicine, Osakasayama City, Osaka, Japan. 7. Department of Thoracic Surgery, Kanazawa University School of Medicine, Kanazawa City, Ishikawa, Japan. 8. Department of Thoracic Surgery, Osaka Habikino Medical Center, Habikino City, Osaka, Japan. 9. Department of Pulmonary Medicine, Gifu Municipal Hospital, Gifu City, Gifu, Japan. 10. Department of Thoracic Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama City, Ehime, Japan. 11. Department of Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan. 12. Department of Pulmonary Medicine, National Hospital Organization Nagoya Hospital, Nagoya City, Aichi, Japan. 13. Department of General Thoracic Surgery, Osaka International Cancer Institute, Osaka City, Osaka, Japan. 14. Department of Thoracic Surgery, School of Medicine, Kumamoto University, Kumamoto City, Kumamoto, Japan. 15. Division of Respiratory Disease, Kumamoto Regional Medical Center, Kumamoto City, Kumamoto, Japan. 16. Department of Medical Oncology, Hyogo Cancer Center, Akashi City, Hyogo, Japan. 17. Division of Biostatistics, Clinical Research Center, Kinki University School of Medicine, Osakasayama CIty, Osaka, Japan. 18. Department of Biostatistics, Yamaguchi University School of Medicine, Yamaguchi City, Yamaguchi, Japan. 19. Research Institute for Diseases of the Chest, Kyushu University, Fukuoka City, Fukuoka, Japan.
Abstract
BACKGROUND: Adjuvant oral uracil-tegafur (UFT) has led to significantly longer postoperative survival among patients with non-small-cell lung cancer (NSCLC). Gemcitabine (GEM) monotherapy is also reportedly effective for NSCLC and has minor adverse events (AEs). This study compared the efficacy of GEM- versus UFT-based adjuvant regimens in patients with completely resected pathological stage (p-stage) IB-IIIA NSCLC. PATIENTS AND METHODS: Patients with completely resected p-stage IB-IIIA NSCLC were randomly assigned to GEM or UFT. The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS), and AEs. RESULTS: We assigned 305 patients to the GEM group and 303 to the UFT group. Baseline factors were balanced between the arms. Of the 608 patients, 293 (48.1%) had p-stage IB disease, 195 (32.0%) had p-stage II disease and 121 (19.9%) had p-stage IIIA disease. AEs were generally mild in both groups, and only one death occurred, in the GEM group. After a median follow-up of 6.8 years, the two groups did not significantly differ in survival: 5 year OS rates were GEM: 70.0%, UFT: 68.8% (hazard ratio 0.948; 95% confidence interval 0.73-1.23; P = 0.69). CONCLUSION: Although GEM-based adjuvant therapy for patients with completely resected stage IB-IIIA NSCLC was associated with acceptable toxicity, it did not provide longer OS than did UFT.
BACKGROUND: Adjuvant oral uracil-tegafur (UFT) has led to significantly longer postoperative survival among patients with non-small-cell lung cancer (NSCLC). Gemcitabine (GEM) monotherapy is also reportedly effective for NSCLC and has minor adverse events (AEs). This study compared the efficacy of GEM- versus UFT-based adjuvant regimens in patients with completely resected pathological stage (p-stage) IB-IIIA NSCLC. PATIENTS AND METHODS: Patients with completely resected p-stage IB-IIIA NSCLC were randomly assigned to GEM or UFT. The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS), and AEs. RESULTS: We assigned 305 patients to the GEM group and 303 to the UFT group. Baseline factors were balanced between the arms. Of the 608 patients, 293 (48.1%) had p-stage IB disease, 195 (32.0%) had p-stage II disease and 121 (19.9%) had p-stage IIIA disease. AEs were generally mild in both groups, and only one death occurred, in the GEM group. After a median follow-up of 6.8 years, the two groups did not significantly differ in survival: 5 year OS rates were GEM: 70.0%, UFT: 68.8% (hazard ratio 0.948; 95% confidence interval 0.73-1.23; P = 0.69). CONCLUSION: Although GEM-based adjuvant therapy for patients with completely resected stage IB-IIIA NSCLC was associated with acceptable toxicity, it did not provide longer OS than did UFT.
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