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Abstract
We elucidated the efficacy of gut microbiome–altering drugs on pembrolizumab efficacy in patients with metastatic urothelial carcinoma (mUC). Clinical data were analyzed retrospectively from 133 patients with mUC who received second-line pembrolizumab therapy between January 2018 and January 2021, following failed platinum-based chemotherapy. We evaluated the effects of gut microbiome–altering drugs (proton pump inhibitors [PPI]/potassium-competitive acid blockers [P-CAB], H2 blockers, antibiotics, non-steroidal anti-inflammatory drugs [NSAIDs], metformin, antipsychotics, steroids, and opioids), taken by patients within 30 days before/after pembrolizumab treatment, on progression-free survival (PFS) and overall survival (OS). Fifty-one patients received PPI/P-CAB (37/14, respectively); H2 blockers, 7; antibiotics, 35; NSAIDs, 22; antipsychotics, 8; metformin, 3; steroids, 11; and opioids, 29. Kaplan–Meier curves revealed PPI or P-CAB users showed shorter PFS than non-PPI-P-CAB users (p = 0.001, p = 0.005, respectively). Multivariate analysis highlighted PPI/P-CAB use as the only independent prognostic factor for disease progression (hazards ratio: 1.71, 95% confidence interval: 1.14–2.07, p = 0.010) but not death (p = 0.177). Proton pump inhibitors/potassium-competitive acid blockers may decrease the efficacy of pembrolizumab therapy for mUC, possibly via gut microbiome modulation.
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1 Nagoya City University, Department of Nephro-urology, Graduate School of Medical Sciences, Nagoya, Japan (GRID:grid.260433.0) (ISNI:0000 0001 0728 1069); Gamagori City Hospital, Department of Urology, Gamagori City, Japan (GRID:grid.260433.0)
2 Nagoya City University, Department of Nephro-urology, Graduate School of Medical Sciences, Nagoya, Japan (GRID:grid.260433.0) (ISNI:0000 0001 0728 1069)
3 Nagoya City University Hospital, Department of Pharmacy, Nagoya, Japan (GRID:grid.411885.1) (ISNI:0000 0004 0469 6607)
4 Anjo Kosei Hospital, Department of Urology, Anjo City, Japan (GRID:grid.413779.f) (ISNI:0000 0004 0377 5215)
5 Nagoya City University, Department of Nephro-urology, Graduate School of Medical Sciences, Nagoya, Japan (GRID:grid.260433.0) (ISNI:0000 0001 0728 1069); Toyota Kosei Hospital, Department of Urology, Toyota City, Japan (GRID:grid.452852.c) (ISNI:0000 0004 0568 8449)
6 Daido Hospital, Department of Urology, Nagoya City, Japan (GRID:grid.260433.0)
7 Kainan Hospital, Department of Urology, Yatomi City, Japan (GRID:grid.260433.0)
8 Gamagori City Hospital, Department of Urology, Gamagori City, Japan (GRID:grid.260433.0); Nagoya City University Graduate School of Medical Sciences, Department of Education and Research Center for Community Medicine, Nagoya, Japan (GRID:grid.260433.0) (ISNI:0000 0001 0728 1069)