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Phase I study of Nedaplatin, a platinum based antineoplastic drug, combined with nab-paclitaxel in patients with advanced squamous non–small cell lung cancer

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Summary

Background This study was designed to determine the recommended dose of a combination of nedaplatin (NED) and nab-paclitaxel (nab-PTX) in chemotherapy-naive patients with advanced squamous non-small-cell lung cancer (NSCLC). Methods Patients received escalating doses of NED on day 1 and nab-PTX on days 1, 8, and 15 every 4 weeks by an intravenous infusion for up to six cycles. Results A dose of 100 mg/m2 NED and 100 mg/m2 nab-PTX was determined to be the recommended dose for patients with advanced squamous NSCLC. The study had an overall response rate of 66.7% (95% confidence interval [CI]: 38.4–88.2) and disease control rate of 93.3% (95% CI: 68.1–99.8). The median progression-free survival time and survival time was 7.0 months (95% CI: 5.9–8.1) and 13.1 months (95% CI: 6.2–20.1), respectively. The most common adverse events were neutropenia (grade 3/4, 33%) and leukopenia (grade 3/4, 27%). Although peripheral neuropathy was observed in 5 patients (grade 1/2), non-hematological toxic effects were relatively mild. Febrile neutropenia, pneumonitis, and treatment-related death were not observed. Conclusions The combination of NED and nab-PTX was a tolerable and effective regimen and its recommended dose was 100 mg/m2 and 100 mg/m2, respectively, in chemotherapy-naive patients with advanced squamous NSCLC (UMIN000010963).

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Acknowledgements

The authors thank all participants of this study. The authors would like to thank Dr. Akihiro Tamiya (Department of Internal Medicine, Kinki-Chuo Chest Medical Center, Osaka) for evaluating the eligibility, evaluability, and responses in this study. The authors also thank Dr. Seiichiro Kusuhara (Department of Respiratory Medicine, Kitasato University School of Medicine) for collecting the clinical data of this study.

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Authors and Affiliations

  1. Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan

    Satoshi Igawa, Sakiko Otani, Yoshiro Nakahara, Shinichiro Ryuge, Yasuhiro Hiyoshi, Tomoya Fukui, Masaru Kubota & Noriyuki Masuda

  2. Kitasato University School of Nursing, 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0329, Japan

    Hisashi Mitsufuji

  3. School of Allied Health Sciences, Kitasato University, 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0373, Japan

    Masato Katagiri & Yuichi Sato

  4. Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan

    Jiichiro Sasaki

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  1. Satoshi Igawa
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  2. Sakiko Otani
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Correspondence to Satoshi Igawa.

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Informed consent was obtained from all individual participants included in the study.

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Igawa, S., Otani, S., Nakahara, Y. et al. Phase I study of Nedaplatin, a platinum based antineoplastic drug, combined with nab-paclitaxel in patients with advanced squamous non–small cell lung cancer. Invest New Drugs 36, 45–52 (2018). https://doi.org/10.1007/s10637-017-0472-x

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