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Clinical outcomes and predictive value of programmed cell death-ligand 1 expression in response to anti-programmed cell death 1/ligand 1 antibodies in non-small cell lung cancer patients with performance status 2 or greater

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Abstract

Background

Anti-programmed cell death protein-1/ligand-1 (anti-PD-1/PD-L1) therapy is promising for patients with non-small-cell lung cancer (NSCLC); however, clinical trials have focused on patients with a performance status (PS) 0 or 1. This study aimed to evaluate the clinical outcomes and correlation between PD-L1 expression status and tumor response to anti-PD-1/PD-L1 therapy among NSCLC patients with poor PS (i.e., PS ≥ 2).

Methods

In total, 130 patients with NSCLC and PS ≥ 2 treated with anti-PD-1/PD-L1 monotherapy at 12 institutions between January 2016 and August 2019 were retrospectively reviewed. PD-L1 expression status was divided into four groups: < 1%, 1–49%, ≥ 50%, and unknown.

Results

The objective response rate and PS improvement rate were 23 and 21% and were higher in the PD-L1 ≥ 50% group than in other groups (P < 0.01). Median progression-free survival (PFS) was 62 days and was longer in the PD-L1 ≥ 50% group than in other groups (P = 0.03). Multivariate analyses revealed that PD-L1 expression is significantly associated with prolonged PFS (PD-L1 < 1%; reference; 1–49%, hazard ratio [HR] 0.19, 95% confidence interval [CI] 0.04–0.99, P = 0.05; ≥ 50%, HR 0.12, 95% CI 0.02–0.71, P = 0.02; unknown, HR 0.30, 95% CI 0.08–1.22, P = 0.09).

Conclusions

NSCLC patients with poor PS and PD-L1 ≥ 50% are expected to benefit from anti-PD-1/PD-L1 therapy, despite a modest overall response among NSCLC patients with poor PS. Accordingly, PD-L1 expression provides useful information regarding decision-making for anti-PD-1/PD-L1 therapy even in these populations.

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Authors and Affiliations

  1. Department of Respiratory Medicine, Kumamoto University Hospital, 1-1-1, Honjo, Chuo-ku, Kumamoto, 860-8556, Japan

    Takayuki Jodai, Koichi Saruwatari, Yusuke Tomita, Sho Saeki, Hidenori Ichiyasu & Takuro Sakagami

  2. Department of Clinical Investigation, Kumamoto University Hospital, Kumamoto, Japan

    Tokunori Ikeda

  3. Department of Medical Oncology, Miyazaki Higashi Hospital, Miyazaki, Japan

    Eiji Moriyama

  4. Department of Respiratory Medicine, Kumamoto Regional Medical Center, Kumamoto, Japan

    Kosuke Kashiwabara

  5. Department of Respiratory Medicine, Saiseikai Kumamoto Hospital, Kumamoto, Japan

    Naoki Shingu

  6. Department of Respiratory Medicine, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan

    Kazuhiro Iyonaga

  7. Department of Respiratory Medicine, Kumamoto Chuo Hospital, Kumamoto, Japan

    Megumi Inaba

  8. Department of Respiratory Medicine, Miyazaki Prefectural Nobeoka Hospital, Nobeoka, Japan

    Yusuke Ajishi

  9. Department of Respiratory Medicine, Tamana Central Hospital, Tamana, Japan

    Chiharu Honda

  10. Department of Respiratory Medicine, Omuta Tenryo Hospital, Omuta, Japan

    Susumu Hirosako

  11. Department of Respiratory Medicine, Japan Organization of Occupational Health and Safety, Kumamoto Rosai Hospital, Yatushiro, Japan

    Hirotaka Maruyama

  12. Department of Respiratory Medicine, National Hospital Organization Kumamoto Saishun Medical Center, Koshi, Japan

    Yosuke Kakiuchi

  13. Department of Respiratory Medicine, Minamata City General Hospital and Medical Center, Minamata, Japan

    Hirofumi Eida

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  1. Takayuki Jodai
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Correspondence to Koichi Saruwatari.

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Jodai, T., Saruwatari, K., Ikeda, T. et al. Clinical outcomes and predictive value of programmed cell death-ligand 1 expression in response to anti-programmed cell death 1/ligand 1 antibodies in non-small cell lung cancer patients with performance status 2 or greater. Int J Clin Oncol 26, 78–86 (2021). https://doi.org/10.1007/s10147-020-01789-5

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