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Purpose <p>Near-infrared photoimmunotherapy (NIR-PIT) is a new cancer treatment that selectively kills cancer cells and triggers a therapeutic immune response. This exploratory retrospective study aimed to investigate potential predictive biomarkers of sequential NIR-PIT and immune checkpoint inhibitors (ICI) in non-surgical candidates with recurrent head and neck squamous cell carcinoma (HNSCC).</p> Methods <p>Between January 2022 and May 2025, 11 non-surgical candidates with recurrent HNSCC received NIR-PIT, including 9 sequential treatments with ICI. Association between peripheral blood biomarkers and oncological outcomes were assessed. Tumor response was evaluated according to RECIST v1.1, and statistical analyses included Fisher’s exact test and Mann–Whitney U test.</p> Results <p>Target tumor lesions in distinct regions of the head and neck, totaling 13, were treated; one patient was treated for three separate lesions. The best overall response rate was 84.6%, with five complete and six partial responses. Elevated relative eosinophil increase (REI) was more frequently observed in better response group (<i>p</i> = 0.08, <i>r</i> = 0.47) whereas higher absolute monocyte counts (AMC) were observed in worse disease progression group (<i>p</i> = 0.003, <i>r</i> = 0.81). Grade 1–2 local pain was the most frequent adverse event, reported in eight patients, while grade 3 events were observed in three patients. No immune-related adverse events were observed during ICI therapy.</p> Conclusion <p>Sequential NIR-PIT and ICI therapy may enhance the antitumor efficacy and demonstrate a favorable safety profile in non-surgical candidates with recurrent HNSCC. REI may serve as a potential predictor of NIR-PIT response, while higher AMC levels were observed in patients who experienced tumor progression.</p>

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Preliminary observations on peripheral inflammatory markers in NIR-PIT and ICI-treated recurrent head and neck squamous cell carcinoma

  • 期刊论文

  • 发表日期：

    2026年2月1日

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  • Hitoshi Hirakawa,
  • Taro Ikegami,
  • Hidetoshi Kinjyo,
  • Shinya Agena,
  • Shunsuke Kondo,
  • Norimoto Kise,
  • Yuki Kayo,
  • Hironori Nakayoshi,
  • Takahiro Miyahira,
  • Hiroyuki Maeda,
  • Mikio Suzuki

摘要

Purpose

Near-infrared photoimmunotherapy (NIR-PIT) is a new cancer treatment that selectively kills cancer cells and triggers a therapeutic immune response. This exploratory retrospective study aimed to investigate potential predictive biomarkers of sequential NIR-PIT and immune checkpoint inhibitors (ICI) in non-surgical candidates with recurrent head and neck squamous cell carcinoma (HNSCC).

Methods

Between January 2022 and May 2025, 11 non-surgical candidates with recurrent HNSCC received NIR-PIT, including 9 sequential treatments with ICI. Association between peripheral blood biomarkers and oncological outcomes were assessed. Tumor response was evaluated according to RECIST v1.1, and statistical analyses included Fisher’s exact test and Mann–Whitney U test.

Results

Target tumor lesions in distinct regions of the head and neck, totaling 13, were treated; one patient was treated for three separate lesions. The best overall response rate was 84.6%, with five complete and six partial responses. Elevated relative eosinophil increase (REI) was more frequently observed in better response group (p = 0.08, r = 0.47) whereas higher absolute monocyte counts (AMC) were observed in worse disease progression group (p = 0.003, r = 0.81). Grade 1–2 local pain was the most frequent adverse event, reported in eight patients, while grade 3 events were observed in three patients. No immune-related adverse events were observed during ICI therapy.

Conclusion

Sequential NIR-PIT and ICI therapy may enhance the antitumor efficacy and demonstrate a favorable safety profile in non-surgical candidates with recurrent HNSCC. REI may serve as a potential predictor of NIR-PIT response, while higher AMC levels were observed in patients who experienced tumor progression.