期刊
CLINICA CHIMICA ACTA
卷 519, 期 -, 页码 51-59出版社
ELSEVIER
DOI: 10.1016/j.cca.2021.04.008
关键词
Cancer-testis antigen; Autoantibody; Automated immunoassay; Immune-checkpoint therapy; Biomarker; Lung cancer
资金
- JSPS KAKENHI [18K09235]
- Sysmex Corporation
- Grants-in-Aid for Scientific Research [18K09235] Funding Source: KAKEN
The study developed a fully automated immunoassay system to measure NY-ESO-1/XAGE1 antibody levels in NSCLC patients. Results showed that levels of NY-ESO-1/XAGE1 antibodies were significantly higher in NSCLC patients who responded to anti-PD-1 monotherapy compared to non-responders and healthy donors. The combination prediction with NY-ESO-1/XAGE1 antibodies achieved the highest AUROC value.
Background: Anti-programmed cell death-1 (PD-1) antibodies (Abs) are key drugs in non-small-cell lung cancer (NSCLC) treatment; however, clinical benefits with anti-PD-1 monotherapy are limited. We reported that serum Abs against cancer-testis antigens NY-ESO-1 and XAGE1 predicted clinical benefits. We aimed to develop a fully automated immunoassay system measuring NY-ESO-1/XAGE1 Abs. Methods: Sera from 30 NSCLC patients before anti-PD-1 monotherapy were reacted with recombinant NY-ESO-1 protein- or synthetic XAGE1 peptide-coated magnetic beads. ALP-conjugated Ab and chemiluminescent substrate were added and luminescence measured. These procedures were automated using high sensitivity chemiluminescent enzyme immunoassay (HISCLTM). NY-ESO-1/XAGE1 Ab stability was tested under various conditions. Response prediction accuracy was evaluated using area under receiver operating curve (AUROC). Results: HISCL detected specific serum NY-ESO-1/XAGE1 Abs, which levels in ELISA and HISCL were highly correlated. The Ab levels in HISCL were stable at four temperatures, five freeze/thaw cycles, and long-term storage; the levels were not interfered by common blood components. The Ab levels in 15 NSCLC responders to anti-PD-1 monotherapy were significantly higher than those in non-responders and healthy donors. The AUROC was the highest (0.91; 95% CI, 0.78-1.0) in combinatory prediction with NY-ESO-1/XAGE1 Abs. Conclusion: Our immunoassay system is useful to predict clinical benefits with NSCLC immune-checkpoint therapy.
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