Adverse events of hepatic function disorder in Japanese patients with radically unresectable or metastatic renal cell carcinoma treated with pembrolizumab plus axitinib: a post-marketing surveillance study
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Summary
This summary is machine-generated.This study found that hepatic function disorder adverse events (AEs) in Japanese patients with advanced renal cell carcinoma (RCC) treated with pembrolizumab and axitinib were consistent with prior findings. No new safety signals were identified.
Area Of Science
- Oncology
- Pharmacovigilance
- Nephrology
Background
- Post-marketing surveillance for hepatic function disorder was initiated due to higher incidence with pembrolizumab plus axitinib versus sunitinib in KEYNOTE-426.
- Focus on real-world Japanese clinical practice for unresectable/metastatic renal cell carcinoma (RCC).
Purpose Of The Study
- Evaluate the prevalence and risk factors of hepatic function disorder adverse events (AEs).
- Assess safety of pembrolizumab plus axitinib in Japanese patients with advanced RCC.
Main Methods
- Retrospective analysis of 193 patients with unresectable/metastatic RCC treated with pembrolizumab plus axitinib.
- Observation period of 9 months post-treatment initiation.
- Analysis of adverse events, focusing on hepatic function disorder.
Main Results
- The incidence of any-grade hepatic function disorder AEs was 30.1% (58/193), with 15.0% (29/193) being grade ≥3.
- Most hepatic function disorder AEs occurred within 3 months of treatment initiation.
- No background factors were associated with the occurrence of hepatic function disorder AEs.
Conclusions
- No new safety signals for hepatic function disorder AEs were identified.
- The incidence of hepatic function disorder AEs was consistent with KEYNOTE-426 trial findings.
- Pembrolizumab plus axitinib demonstrated a safety profile for hepatic function disorder in Japanese RCC patients consistent with prior studies.
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