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Pemetrexed monotherapy for chemo-naïve elderly (aged ≥80) patients with non-squamous non-small cell lung cancer: results from combined analysis of two single arm phase II studies (HANSHIN002 and 003)

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Abstract

Purpose

The aim of this retrospective study was to evaluate via combined analysis the efficacy and safety of pemetrexed monotherapy for chemo-naïve elderly patients aged ≥80 with non-squamous non-small cell lung cancer (NSCLC).

Methods

We conducted a combined analysis from two phase II studies of pemetrexed for chemo-naïve elderly (aged ≥75) (n = 47) and performance status 2 (n = 28) patients with advanced non-squamous NSCLC. Population aged ≥80 (80+ Group) was compared to those aged 70–79 (70’s Group).

Results

We analyzed a total of 66 patients (37 70s and 29 80+ Groups) after exclusion of 4 ineligible and 5 aged ≤69 patients. Overall response rate, disease control rate, median progression-free survival, and median overall survival of 70s vs. 80+ Groups were 13.5 vs. 13.8% [p = not significant (NS)], 67.6 vs. 58.6% (p = 0.608), 3.7 months vs. 4.2 months (p = 0.5588) and 18.5 vs. 13.5 months (p = 0.2621), respectively. Non-hematological and hematological toxicities ≥grade 3 of 70s vs. 80+ Groups were 24 vs. 35% (p = 0.4192) and 49 vs. 52% (p = NS), respectively. Dose reduction and/or delay due to toxicities of 70s vs. 80+ Groups was 19 vs. 28% (p = 0.7784). Febrile neutropenia and interstitial lung disease were not observed. Treatment-related death (bacterial pneumonia) was confirmed in one (3%) of 29 80+ Group patients.

Conclusions

Pemetrexed monotherapy demonstrated similar efficacy and safety between aged ≥80 and aged 70–79 populations. It could be a therapeutic option in clinical practice for elderly non-squamous NSCLC patients aged ≥80 without indications of carboplatin-based combination regimens or docetaxel monotherapy.

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Acknowledgements

We thank Mr. David Martin for his writing support and Ms. Mizuho Edagawa and Ms. Konomi Mizushima for data collection and management.

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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, Kosuke Tanaka & Shiro Fujita

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

    Yoshihiro Hattori, Miyako Satouchi & Shunichi Negoro

  3. Department of Respiratory Medicine, Kobe University Hospital, Kobe, Japan

    Yoshikazu Kotani

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

    Takashi Nishimura

  5. Department of Respiratory Medicine, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    Fumio Imamura

  6. Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, Toyonaka, Japan

    Soichiro Yokota

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

    Kazuya Monden & Kojiro Otsuka

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

    Akihiro Nishiyama, Kazuya Tsubouchi, Toshihiko Kaneda & Hiroshige Yoshioka

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

    Satoshi Morita

Authors
  1. Akito Hata
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  2. Nobuyuki Katakami
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  17. Satoshi Morita
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  18. Shunichi Negoro
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Corresponding author

Correspondence to Akito Hata.

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Funding

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

Conflict of interest

Akito Hata, Nobuyuki Katakami, Miyako Satouchi, and Satoshi Morita have received a speaker honorarium from Eli Lilly. The other authors have declared no conflicts of interest.

Ethical approval

This study was approved by the independent Institute Research Ethics Committee at Institute of Biomedical Research and Innovation Hospital and conducted in accordance with the Declaration of Helsinki. All patients in original studies signed informed consent before participation.

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Hata, A., Katakami, N., Hattori, Y. et al. Pemetrexed monotherapy for chemo-naïve elderly (aged ≥80) patients with non-squamous non-small cell lung cancer: results from combined analysis of two single arm phase II studies (HANSHIN002 and 003). Cancer Chemother Pharmacol 79, 689–695 (2017). https://doi.org/10.1007/s00280-017-3259-z

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  • DOI: https://doi.org/10.1007/s00280-017-3259-z

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