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PILE: a candidate prognostic score in cancer patients treated with immunotherapy

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Abstract

Background

Although the immune checkpoint inhibitors (ICIs) became a vital part of cancer care, many patients do not respond to treatment, indicating need for biomarkers. The Pan-Immune-Inflammation Value (PIV) is a recently developed peripheral blood count-based biomarker. Herein, we evaluated a PIV-based candidate scoring system as a prognostic biomarker in ICI-treated patients.

Methods

A total of 120 advanced cancer patients treated with anti-PD-1 or anti-PD-L1 inhibitors for any cancer type were included in this study. The PILE scoring system incorporating the PIV (< median vs. ≥ median), lactate dehydrogenase levels (normal vs. > normal) and Eastern Cooperative Oncology Group performance status (0 vs. ≥ 1) was constructed from the multivariate analyses and used for stratification. The association between overall survival (OS), progression-free survival and PILE risk category was evaluated with multivariate analysis.

Results

The median follow-up was 9.62 months and the median OS of all cohort were 12.42 ± 2.75 months. Patients with higher PIV had significantly decreased OS (7.75 ± 1.64 vs. 18.63 ± 4.26 months, p = 0.037). The patients in the PILE high-risk group (PILE score 2–3) had decreased OS (18.63 ± 4.02 vs. 5.09 ± 1.23 months, HR: 2.317, 95% CI: 1.450–3.700, p < 0.001) and PFS (7.69 ± 1.30 vs. 2.69 ± 0.65 months, HR: 1.931, 95% CI: 1.263–2.954, p = 0.002) compared to PILE low-risk group (PILE score 0–1). The Harrell C-Index values were 0.65 and 0.61 for OS and PFS prediction, respectively.

Conclusion

In this study, we demonstrated a decreased overall survival in ICI-treated patients with a higher PILE score. If prospective studies validate our results, PILE score could be a biomarker for immunotherapy.

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Funding

The authors received no financial support for this article.

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 Helsinki declaration and its later amendments or comparable ethical standards. The study was approved by the ethics committee of Hacettepe University.

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Authors and Affiliations

  1. Hacettepe University Cancer Institute, Ankara, Turkey

    D. C. Guven, H. C. Yildirim, O. H. Aktepe, H. Taban, S. Akin, O. Dizdar, S. Aksoy, S. Yalcin, M. Erman & S. Kilickap

  2. Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey

    E. Bilgin, T. K. Sahin & I. Y. Cakir

  3. Department of Medical Oncology, Hacettepe University Cancer Institute, 06100, Sihhiye, Ankara, Turkey

    D. C. Guven

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  1. D. C. Guven
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Correspondence to D. C. Guven.

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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 Helsinki declaration and its later amendments or comparable ethical standards.

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Due to the retrospective nature of the study, informed consent is not required for the study.

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Guven, D.C., Yildirim, H.C., Bilgin, E. et al. PILE: a candidate prognostic score in cancer patients treated with immunotherapy. Clin Transl Oncol 23, 1630–1636 (2021). https://doi.org/10.1007/s12094-021-02560-6

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