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Phase II study of nedaplatin and irinotecan as adjuvant chemotherapy for completely resected non-small cell lung cancer

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Abstract

Introduction

Cisplatin-based chemotherapy is the standard adjuvant therapy for patients with completely resected stage II or III non-small cell lung cancer (NSCLC). However, the completion rate of four cycles of cisplatin-based chemotherapy is about 50%. This phase II study was conducted to evaluate the tolerability and efficacy of nedaplatin and irinotecan as adjuvant chemotherapy.

Methods

Patients with pathological stage II or III NSCLC who underwent complete resection were enrolled. Treatment consisted of four cycles of nedaplatin (50 mg/m2) and irinotecan (50 mg/m2) on days 1 and 8 every 4 weeks. The primary end-point was the completion rate of four cycles of nedaplatin and irinotecan.

Results

Between January 2009 and March 2012, 39 patients (23 males and 16 females; median age 68 years) were registered. Overall, 36/39 (92.3%) patients completed four cycles. The median clinical follow-up time was 56 months (range 11–88 months). There were no differences in adverse events between patients with UGT1A1 polymorphisms and patients with wild-type UGT1A1. The median disease-free survival (DFS) was 49.4 months (95% confidence interval 14.2–84.5 months). Median overall survival (OS) was not reached. There were no treatment-related deaths, and adverse events were acceptable. The 5-year DFS and OS rates were 43.1 and 69.8%, respectively.

Conclusion

Nedaplatin and irinotecan is a tolerable regimen for adjuvant chemotherapy, and was associated with adequate 5-year DFS and OS rates.

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Authors and Affiliations

  1. Department of Thoracic Oncology, Kanagawa Cancer Center, Nakao 2-3-2, Asahi-ku, Yokohama, 241-8515, Japan

    Shuji Murakami, Haruhiro Saito, Tetsuro Kondo & Kouzo Yamada

  2. Department of Thoracic Surgery, Kanagawa Cancer Center, Yokohama, Japan

    Hiroyuki Ito

  3. Department of Internal Medicine, Kanagawa Prefectural Ashigarakami Hospital, Ashigarakami-gun, Japan

    Fumihiro Oshita

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  1. Shuji Murakami
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  2. Haruhiro Saito
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  3. Tetsuro Kondo
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  4. Hiroyuki Ito
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  5. Fumihiro Oshita
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  6. Kouzo Yamada
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Correspondence to Haruhiro Saito.

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The authors received no funding specifically for this study.

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None of the authors have any financial or personal relationships with people or organizations that could inappropriately influence this work.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

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

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Murakami, S., Saito, H., Kondo, T. et al. Phase II study of nedaplatin and irinotecan as adjuvant chemotherapy for completely resected non-small cell lung cancer. Cancer Chemother Pharmacol 81, 81–87 (2018). https://doi.org/10.1007/s00280-017-3460-0

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  • DOI: https://doi.org/10.1007/s00280-017-3460-0

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