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Purpose <p>Proton pump inhibitors (PPIs) are associated with reduced effectiveness of immune checkpoint inhibitors in patients with cancer. This study clarifies whether probiotics could restore the reduced effectiveness of nivolumab or pembrolizumab in Japanese patients with advanced esophageal cancer (EC) receiving PPIs.</p> Methods <p>This multicenter retrospective observational study was conducted in five hospitals in Japan. The medical records of consecutive patients with advanced EC treated with nivolumab or pembrolizumab monotherapy between September 2017 and March 2024 were reviewed. Treatment efficacy and safety were compared for cases with and without concomitant probiotic use. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by Cox regression analysis.</p> Results <p>Of 106 patients included in this study, 14 were treated with probiotics. The median PFS was 2.3 months (95% CI, 1.3–9.8) in the probiotic group and 4.0 months (95% CI, 2.7–5.9) in the non-probiotic group (crude HR, 1.16; 95% CI, 0.61–2.02). Similarly, the median OS was 4.9 months (95% CI, 1.6–17.7) and 8.1 months (95% CI, 6.3–13.9) in the probiotic and non-probiotic groups, respectively (crude HR, 1.50; 95% CI, 0.75–2.75). Similar trends were obtained from multivariable analyses of PFS (adjusted HR, 1.35; 95% CI, 0.64–2.86) and OS (adjusted HR, 3.01; 95% CI, 1.37–6.08). Adverse events were similar in both groups.</p> Conclusion <p>Concomitant probiotic use was not associated with improved survival outcomes; however, further large-scale studies are required to confirm these findings.</p>

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Association of Probiotics with Effectiveness of Nivolumab or Pembrolizumab in Patients with Esophageal Cancer Taking Proton Pump Inhibitors: A Multicenter Retrospective Study

  • 期刊论文

  • 发表日期：

    2026年5月25日

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  • Ayumi Fujimoto,
  • Ryuji Uozumi,
  • Hironori Fujii,
  • Shinya Tamaki,
  • Tomoaki Eto,
  • Mikumi Yamaguchi,
  • Yu Maehara,
  • Hirotoshi Iihara,
  • Tomoaki Hatakeyama,
  • Ayako Higuchi,
  • Hitoshi Kawazoe,
  • Hisakazu Ohtani

摘要

Purpose

Proton pump inhibitors (PPIs) are associated with reduced effectiveness of immune checkpoint inhibitors in patients with cancer. This study clarifies whether probiotics could restore the reduced effectiveness of nivolumab or pembrolizumab in Japanese patients with advanced esophageal cancer (EC) receiving PPIs.

Methods

This multicenter retrospective observational study was conducted in five hospitals in Japan. The medical records of consecutive patients with advanced EC treated with nivolumab or pembrolizumab monotherapy between September 2017 and March 2024 were reviewed. Treatment efficacy and safety were compared for cases with and without concomitant probiotic use. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by Cox regression analysis.

Results

Of 106 patients included in this study, 14 were treated with probiotics. The median PFS was 2.3 months (95% CI, 1.3–9.8) in the probiotic group and 4.0 months (95% CI, 2.7–5.9) in the non-probiotic group (crude HR, 1.16; 95% CI, 0.61–2.02). Similarly, the median OS was 4.9 months (95% CI, 1.6–17.7) and 8.1 months (95% CI, 6.3–13.9) in the probiotic and non-probiotic groups, respectively (crude HR, 1.50; 95% CI, 0.75–2.75). Similar trends were obtained from multivariable analyses of PFS (adjusted HR, 1.35; 95% CI, 0.64–2.86) and OS (adjusted HR, 3.01; 95% CI, 1.37–6.08). Adverse events were similar in both groups.

Conclusion

Concomitant probiotic use was not associated with improved survival outcomes; however, further large-scale studies are required to confirm these findings.