Abstract
Purpose
Immune checkpoint inhibitors (ICIs) are an effective subsequent-line treatment for patients with advanced non-small cell lung cancer (NSCLC). However, it remains unclear whether the efficacy and safety of subsequent-line ICI monotherapy in elderly patients (aged ≥ 75 years) are similar to that in non-elderly patients. Therefore, we aimed to investigate the efficacy and safety of ICI monotherapy in pretreated elderly patients with NSCLC.
Methods
Between January 2016 and February 2018, 131 elderly patients with advanced NSCLC who received subsequent-line ICI monotherapy at 13 Japanese institutions were enrolled in this study. Baseline characteristics, the efficacy of ICI treatment, and adverse events were evaluated.
Results
Ninety-eight men and 33 women (median age 77 [range 75–87] years) were enrolled. Among those who received subsequent-line ICI monotherapy, the overall response, disease control rates, median progression-free survival (PFS), and overall survival (OS) were 27.4%, 61.8%, 4.5 months, and 16.0 months, respectively. Adverse events such as anorexia, fatigue, pneumonitis, and hypothyroidism were observed. There were two treatment-related deaths due to pneumonitis and thrombocytopenia. Subsequent-line ICI monotherapy in patients with good performance status (PS), receiving steroids for immune-related adverse events (irAEs), and exhibiting partial response (PR) was associated with improved PFS, as well as OS in patients with good PS and PR.
Conclusions
Subsequent-line ICI monotherapy in elderly patients, with previously treated NSCLC, was effective, safe and showed outcomes equivalent to those in non-elderly patients. Immunotherapy provides a survival benefit for elderly patients, who exhibit its efficacy and a favorable general condition.
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Acknowledgements
We thank Mr. Masato Ohtsuka and Drs. Takako Mouri, Yoichiro Hamamoto, and Tamotsu Ishizuka for their assistance in preparing this manuscript. We would also like to thank Editage (www.editage.jp) for English language editing.
Funding
This work was supported by Grant-in-Aid for general research from Gunma Prefectural Hospitals.
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None of the authors has any financial or personal relationships with people or organizations that could inappropriately influence this work.
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This study has been approved by The Gunma Prefectural Cancer Center Ethics Committee on 27 September 2018 (ethic code: 405-30051). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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The need for informed consent was waived by the institutional review boards of the participating institutions because of the retrospective nature of the study.
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Yamaguchi, O., Imai, H., Minemura, H. et al. Efficacy and safety of immune checkpoint inhibitor monotherapy in pretreated elderly patients with non-small cell lung cancer. Cancer Chemother Pharmacol 85, 761–771 (2020). https://doi.org/10.1007/s00280-020-04055-7
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DOI: https://doi.org/10.1007/s00280-020-04055-7