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Phase I study of amrubicin and vinorelbine in non-small cell lung cancer previously treated with platinum-based chemotherapy

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Abstract

Background

Combination chemotherapy comprising amrubicin and vinorelbine as a second-line therapy for advanced non-small cell lung cancer (NSCLC) has not been fully evaluated. To determine the maximum tolerated dose (MTD) and recommended dose (RD), the present phase I study examined patients with advanced NSCLC.

Methods

The subjects were nine patients with histologically confirmed advanced NSCLC, Eastern Cooperative Oncology Group performance status 0–1, prior platinum-based first-line chemotherapy, and measurable or evaluable lesions. Treatment consisted of five dose levels, with amrubicin 35–45 mg/m2 administered as a 5-min intravenous infusion on days 1–3 and vinorelbine 15–25 mg/m2 given as a 1-h intravenous infusion on days 1 and 8, every 3 weeks.

Results

All patients had received carboplatin and paclitaxel as first-line therapy. Dose-limiting toxicity (DLT) was seen in two of six patients (febrile neutropenia and deep vein thrombosis ) at level 1, allowing us to conduct level 2. At level 2, all three patients experienced DLT (leucopenia ≥4 days in one patient; febrile neutropenia in three patients; and infection in two patients), and this level was determined as the MTD. Subsequently, level 1 (amrubicin 35 mg/m2 and vinorelbine 15 mg/m2) was defined as the RD. Responses in the nine patients included a partial response in one patient and stable disease in four patients.

Conclusion

As second-line therapy, the RD of the combination of amrubicin and vinorelbine is 35 mg/m2 and 15 mg/m2, respectively. Further study should proceed to clarify the efficacy of this regimen.

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Authors and Affiliations

  1. First Department of Medicine, Hokkaido University School of Medicine, North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan

    Satoshi Oizumi, Koichi Yamazaki, Hiroshi Yokouchi, Jun Konishi, Fumihiro Hommura & Masaharu Nishimura

  2. Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo, Japan

    Tetsuya Kojima & Hiroshi Isobe

Authors
  1. Satoshi Oizumi
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  2. Koichi Yamazaki
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  3. Hiroshi Yokouchi
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  4. Jun Konishi
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  5. Fumihiro Hommura
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  6. Tetsuya Kojima
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  7. Hiroshi Isobe
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  8. Masaharu Nishimura
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Hokkaido Lung Cancer Clinical Study Group

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Correspondence to Satoshi Oizumi.

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Oizumi, S., Yamazaki, K., Yokouchi, H. et al. Phase I study of amrubicin and vinorelbine in non-small cell lung cancer previously treated with platinum-based chemotherapy. Int J Clin Oncol 14, 125–129 (2009). https://doi.org/10.1007/s10147-008-0808-9

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  • DOI: https://doi.org/10.1007/s10147-008-0808-9

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