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Phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer: a West Japan Thoracic Oncology Group (WJTOG) study

  • PHASE II STUDIES
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Summary

Purpose: We conducted a multicenter phase II study of amrubicin, a novel 9-aminoanthracycline, to evaluate its efficacy and safety in patients with non-small-cell lung cancer (NSCLC). Patients and methods: Entry requirements included cytologically or histologically proven measurable NSCLC, stage III or IV, no prior therapy, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, and adequate organ function. Amrubicin was given by daily intravenous injection at 45 mg/m2/day for three consecutive days, repeated at 3 week intervals. Each patient received at least three treatment cycles. Results: Sixty-two patients were enrolled in this study. Of the 62 registered patients, 60 were eligible and assessable for efficacy, and 59 for toxicity. Overall response rate was 18.3% (95% confidence interval [CI], 9.5 to 30.4%) and median survival time was 8.2 months (95% CI, 6.7 to 10.4 months). Major toxicity was myelosuppression, with incidences of grade 3 or 4 toxicity of 78.0% for neutropenia, 54.2% for leukopenia, 30.5% for anemia, and 28.8% for thrombocytopenia. Non-hematological toxicities with a greater than 50% incidence were anorexia (69.5%), nausea/vomiting (55.9%), and alopecia (75.9%), but were relatively mild, with grade 3 toxicities observed in only one patient each (1.7%). Conclusion: Amrubicin was an active, well-tolerated agent in the treatment of NSCLC.

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Authors and Affiliations

  1. Department of Clinical Oncology, Osaka City General Hospital, 2-13-22, Miyakojimahondohri, Miyakojima-ku, Osaka, 5340021, Japan

    Koji Takeda & Nobuhide Takifuji

  2. Department of Thoracic Oncology, Hyogo Medical Center for Adults, Akashi, Japan

    Shunichi Negoro

  3. Department of Internal Medicine, National Kinki Central Hospital for Chest Diseases, Sakai, Japan

    Kiyoyuki Furuse

  4. Department of Pulmonary Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    Shinichiro Nakamura & Harumichi Ikegami

  5. Department of Radiolgy, Hyogo Medical Center for Adults, Akashi, Japan

    Yoshiki Takada

  6. Department of Respiratory Medicine, Wakayama Rosai Hospital, Wakayama, Japan

    Takanobu Hoso

  7. Department of Respiratory Medicine, Kumamoto-Chuo Hospital, Kumamoto, Japan

    Shinichi Hayasaka

  8. Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan

    Takashi Nakano

  9. Department of Internal Medicine, Sasebo City General Hospital, Sasebo, Japan

    Jun Araki

  10. Division of Respiratory Diseases, Kumamoto Regional Medical Center, Kumamoto, Japan

    Hiroshi Senba

  11. Division of Respiratory Medicine, National Minamikyushu Hospital, Kajiki, Japan

    Fumiyuki Iwami

  12. Department of Respiratory Medicine, Mitoyo General Hospital, Toyohama, Japan

    Yasufumi Yamaji

  13. Department of Medical Oncology, Kinki University School of Medicine, Osakasayama, Japan

    Masahiro Fukuoka

Authors
  1. Koji Takeda
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  2. Nobuhide Takifuji
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  3. Shunichi Negoro
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  4. Kiyoyuki Furuse
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  5. Shinichiro Nakamura
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  6. Yoshiki Takada
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  7. Takanobu Hoso
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  8. Shinichi Hayasaka
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  9. Takashi Nakano
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  10. Jun Araki
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  11. Hiroshi Senba
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  12. Fumiyuki Iwami
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  13. Yasufumi Yamaji
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  14. Masahiro Fukuoka
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  15. Harumichi Ikegami
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Correspondence to Koji Takeda.

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Takeda, K., Takifuji, N., Negoro, S. et al. Phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer: a West Japan Thoracic Oncology Group (WJTOG) study. Invest New Drugs 25, 377–383 (2007). https://doi.org/10.1007/s10637-007-9039-6

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  • DOI: https://doi.org/10.1007/s10637-007-9039-6

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