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Background <p>Programmed cell death protein-1 (PD-1) blockade improves survival in esophageal squamous cell carcinoma (ESCC), although only a subset of patients respond. We aimed to identify tumor-related biomarkers associated with response and outcome in patients with unresectable or recurrent ESCC.</p> Methods <p>This multicenter retrospective study included 250 patients with unresectable or recurrent ESCC who received nivolumab as second- or later-line therapy. Pretreatment tumor specimens were evaluated by immunohistochemistry for p53, NY-ESO-1, MLH1, and programmed death-ligand 1 (PD-L1). PD-L1 expression was assessed using both tumor proportion score (TPS) and combined positive score (CPS) by using automated digital image analysis. Associations with objective response, progression-free survival (PFS), and overall survival (OS) were analyzed.</p> Results <p>NY-ESO-1 expression was significantly associated with response to nivolumab (28.6% vs. 11.1%, <i>P</i> = 0.005) and remained independently associated with response in multivariate analysis (OR 3.32, 95% CI 1.49–7.28, <i>P</i> = 0.0027). PD-L1 expression was also associated with response according to both CPS and TPS. Patients with CPS ≥ 10% showed higher response rates than those with CPS &lt; 10% (24.1% vs. 10.2%, <i>P</i> = 0.003), as well as longer median PFS (2.6 vs. 2.0&#xa0;months, <i>P</i> = 0.0173) and OS (12.3 vs. 10.4&#xa0;months, <i>P</i> = 0.0479). In contrast, p53 expression showed no significant association with response or survival, and MLH1 loss was rare.</p> Conclusions <p>NY-ESO-1 expression was associated with response to nivolumab, while PD-L1 expression, particularly CPS, may provide clinically relevant prognostic information. Integrated assessment of tumor-related biomarkers and the host immune microenvironment may further improve patient stratification in ESCC.</p>

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NY-ESO-1 and PD-L1 as biomarkers associated with nivolumab response and outcome in unresectable or recurrent esophageal squamous cell carcinoma: a multicenter biomarker study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月12日

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  • Shigeto Nakai,
  • Tomoki Makino,
  • Kota Momose,
  • Kotaro Yamashita,
  • Koji Tanaka,
  • Hiroshi Miyata,
  • Sachiko Yamamoto,
  • Masaaki Motoori,
  • Yutaka Kimura,
  • Tomohira Takeoka,
  • Motohiro Hirao,
  • Jin Matsuyama,
  • Yusuke Akamaru,
  • Yukinori Kurokawa,
  • Eiichi Morii,
  • Hidetoshi Eguchi,
  • Yuichiro Doki

摘要

Background

Programmed cell death protein-1 (PD-1) blockade improves survival in esophageal squamous cell carcinoma (ESCC), although only a subset of patients respond. We aimed to identify tumor-related biomarkers associated with response and outcome in patients with unresectable or recurrent ESCC.

Methods

This multicenter retrospective study included 250 patients with unresectable or recurrent ESCC who received nivolumab as second- or later-line therapy. Pretreatment tumor specimens were evaluated by immunohistochemistry for p53, NY-ESO-1, MLH1, and programmed death-ligand 1 (PD-L1). PD-L1 expression was assessed using both tumor proportion score (TPS) and combined positive score (CPS) by using automated digital image analysis. Associations with objective response, progression-free survival (PFS), and overall survival (OS) were analyzed.

Results

NY-ESO-1 expression was significantly associated with response to nivolumab (28.6% vs. 11.1%, P = 0.005) and remained independently associated with response in multivariate analysis (OR 3.32, 95% CI 1.49–7.28, P = 0.0027). PD-L1 expression was also associated with response according to both CPS and TPS. Patients with CPS ≥ 10% showed higher response rates than those with CPS < 10% (24.1% vs. 10.2%, P = 0.003), as well as longer median PFS (2.6 vs. 2.0 months, P = 0.0173) and OS (12.3 vs. 10.4 months, P = 0.0479). In contrast, p53 expression showed no significant association with response or survival, and MLH1 loss was rare.

Conclusions

NY-ESO-1 expression was associated with response to nivolumab, while PD-L1 expression, particularly CPS, may provide clinically relevant prognostic information. Integrated assessment of tumor-related biomarkers and the host immune microenvironment may further improve patient stratification in ESCC.