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Phase III study of adjuvant gemcitabine compared with adjuvant uracil-tegafur in patients with completely resected pathological stage IB–IIIA non-small cell lung cancer (WJTOG0101)

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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.

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Acknowledgements

We express our sincere gratitude and respect to the late Dr. Yukito Ichinose (1953-2018), National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan who continuously supported this clinical trial and the West Japan Thoracic Oncology Group (WJTOG).

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Authors and Affiliations

  1. Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka City, Fukuoka, Japan

    Masafumi Yamaguchi & Takashi Seto

  2. Department of Thoracic Surgery, Osaka City General Hospital, Osaka City, Osaka, Japan

    Hirohito Tada

  3. Department of Thoracic Surgery, Aichi Cancer Center, Nagoya City, Aichi, Japan

    Tetsuya Mitsudomi

  4. Department of Thoracic Surgery, Nagoya University School of Medicine, Nagoya City, Aichi, Japan

    Kohei Yokoi

  5. Division of Pulmonary Medicine, Kobe City Medical Center General Hospital, Kobe City, Hyogo, Japan

    Nobuyuki Katakami

  6. Department of Medical Oncology, Kinki University School of Medicine, Osakasayama City, Osaka, Japan

    Kazuhiko Nakagawa & Masahiro Fukuoka

  7. Department of Thoracic Surgery, Kanazawa University School of Medicine, Kanazawa City, Ishikawa, Japan

    Makoto Oda

  8. Department of Thoracic Surgery, Osaka Habikino Medical Center, Habikino City, Osaka, Japan

    Mitsunori Ohta

  9. Department of Pulmonary Medicine, Gifu Municipal Hospital, Gifu City, Gifu, Japan

    Toshiyuki Sawa

  10. Department of Thoracic Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama City, Ehime, Japan

    Motohiro Yamashita

  11. Department of Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan

    Norihiko Iked

  12. Department of Pulmonary Medicine, National Hospital Organization Nagoya Hospital, Nagoya City, Aichi, Japan

    Hideo Saka

  13. Department of General Thoracic Surgery, Osaka International Cancer Institute, Osaka City, Osaka, Japan

    Masahiko Higashiyama

  14. Department of Thoracic Surgery, School of Medicine, Kumamoto University, Kumamoto City, Kumamoto, Japan

    Hiroaki Nomori

  15. Division of Respiratory Disease, Kumamoto Regional Medical Center, Kumamoto City, Kumamoto, Japan

    Hiroshi Semba

  16. Department of Medical Oncology, Hyogo Cancer Center, Akashi City, Hyogo, Japan

    Shunichi Negoro

  17. Division of Biostatistics, Clinical Research Center, Kinki University School of Medicine, Osakasayama CIty, Osaka, Japan

    Yasutaka Chiba

  18. Department of Biostatistics, Yamaguchi University School of Medicine, Yamaguchi City, Yamaguchi, Japan

    Mototsugu Shimokawa

  19. Research Institute for Diseases of the Chest, Kyushu University, Fukuoka City, Fukuoka, Japan

    Yoichi Nakanishi

Authors
  1. Masafumi Yamaguchi
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  2. Hirohito Tada
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  3. Tetsuya Mitsudomi
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  4. Takashi Seto
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  6. Nobuyuki Katakami
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  8. Makoto Oda
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  9. Mitsunori Ohta
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  10. Toshiyuki Sawa
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  11. Motohiro Yamashita
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  12. Norihiko Iked
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  13. Hideo Saka
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  14. Masahiko Higashiyama
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  15. Hiroaki Nomori
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  16. Hiroshi Semba
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  17. Shunichi Negoro
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  18. Yasutaka Chiba
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  19. Mototsugu Shimokawa
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  20. Masahiro Fukuoka
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  21. Yoichi Nakanishi
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West Japan Thoracic Oncology Group (WJTOG)

Corresponding author

Correspondence to Hirohito Tada.

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Yamaguchi, M., Tada, H., Mitsudomi, T. et al. Phase III study of adjuvant gemcitabine compared with adjuvant uracil-tegafur in patients with completely resected pathological stage IB–IIIA non-small cell lung cancer (WJTOG0101). Int J Clin Oncol 26, 2216–2223 (2021). https://doi.org/10.1007/s10147-021-02012-9

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  • DOI: https://doi.org/10.1007/s10147-021-02012-9

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