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A phase II study of pemetrexed monotherapy in chemo-naïve Eastern Cooperative Oncology Group performance status 2 patients with EGFR wild-type or unknown advanced non-squamous non-small cell lung cancer (HANSHIN Oncology Group 002)

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Abstract

Purpose

The aim of our study was to investigate the efficacy and safety of pemetrexed monotherapy in chemo-naïve Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients with epidermal growth factor receptor (EGFR) wild-type or unknown advanced non-squamous non-small cell lung cancer (NSCLC).

Methods

Pemetrexed was administered at 500 mg/m2 triweekly until progression with supplementations in chemo-naïve ECOG PS 2 patients with EGFR wild-type or unknown advanced non-squamous NSCLC.

Results

Between September 2009 and April 2013, twenty-eight patients were enrolled. Median age was 75 (range 59–89). Nineteen (68 %) of 28 were ever smoker, and 18 (64 %) had pulmonary emphysema. Sixteen (57 %) had comorbidities such as hypertension, heart disease, and/or diabetes. In 26 eligible patients, the overall response rate, disease control rate, median PFS, and median overall survival were 11.5, 53.8 %, 3.0 [95 % confidence interval (CI) 1.9–5.7] months and 9.5 (95 % CI 3.3–12.5) months, respectively. Median administered course number was 3 (range 1–14). Median duration of PS maintenance ≤2 was 4.9 (95 % CI 1.3–9.7) months. Common (≥10 %) grade 3/4 toxicities included 7 (27 %) neutropenia, 7 (27 %) leukopenia, 4 (15 %) fatigue, and 3 (12 %) thrombocytopenia. Febrile neutropenia and interstitial lung disease were not observed. There were no treatment-related deaths.

Conclusion

Pemetrexed monotherapy demonstrated moderate efficacy and good safety in chemo-naïve PS 2 patients with EGFR wild-type or unknown non-squamous NSCLC. It can be a therapeutic option in “frail” PS 2 non-squamous NSCLC patients without the indication of combination regimens, if the patient is EGFR wild-type.

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Acknowledgments

This study was supported by Foundation for Biomedical Research and Innovation.

Conflict of interest

Akito Hata, Nobuyuki Katakami, and Satoshi Morita received a lecture fee from Eli Lilly. The other authors have declared no conflicts of interest.

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Authors and Affiliations

  1. Division of Integrated Oncology, Institute of Biomedical Research and Innovation, 2-2, Minatojima-minamimachi, Chuo-ku, Kobe, 650-0047, Japan

    Akito Hata, Nobuyuki Katakami, Shiro Fujita, Shigeki Nanjo, Jumpei Takeshita & Kosuke Tanaka

  2. Department of Respiratory Medicine, Kobe City Medical Center, West Hospital, Kobe, Japan

    Toshihiko Kaneda

  3. Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan

    Akihiro Nishiyama

  4. Department of Respiratory Medicine, Kyoto Katsura Hospital, Kyoto, Japan

    Takashi Nishimura

  5. Department of Respiratory Medicine, Kobe City Medical Center, General Hospital, Kobe, Japan

    Atsushi Nakagawa & Kojiro Otsuka

  6. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan

    Satoshi Morita

  7. Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan

    Yoshiko Urata & Shunichi Negoro

Authors
  1. Akito Hata
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  2. Nobuyuki Katakami
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  3. Shiro Fujita
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  4. Shigeki Nanjo
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  8. Akihiro Nishiyama
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  9. Takashi Nishimura
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  10. Atsushi Nakagawa
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  11. Kojiro Otsuka
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  12. Satoshi Morita
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  13. Yoshiko Urata
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  14. Shunichi Negoro
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Corresponding author

Correspondence to Akito Hata.

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Hata, A., Katakami, N., Fujita, S. et al. A phase II study of pemetrexed monotherapy in chemo-naïve Eastern Cooperative Oncology Group performance status 2 patients with EGFR wild-type or unknown advanced non-squamous non-small cell lung cancer (HANSHIN Oncology Group 002). Cancer Chemother Pharmacol 75, 1267–1272 (2015). https://doi.org/10.1007/s00280-015-2755-2

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  • DOI: https://doi.org/10.1007/s00280-015-2755-2

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