Renal cell carcinoma is the most common type of kidney cancer, accounting for approximately 90% of all cases. Pazopanib, a tyrosine kinase inhibitor, has emerged as an effective treatment option for advanced and metastatic renal cell carcinoma, demonstrating progression‐free survival benefits compared to placebo or interferon in previous Phase 3 clinical trials. However, real‐world data on its safety profile remain limited, underscoring the need for observational studies to assess the efficacy and safety of approved treatments in clinical practice. This retrospective observational study aims to evaluate the real‐world safety of pazopanib in patients with advanced renal cell carcinoma, providing clinical safety data from a hospital unit in the Alentejo region, Portugal, between 2015 and 2024. A total of 22 patients were included in the study, with a median age of 69 years (range: 45–86); the majority were male. The results revealed a higher incidence of adverse drug reactions compared to clinical trials, with hematological and hepatic toxicities being the most common. Thrombocytopenia was observed in 81.8% of patients, while hepatic impairment was reported in 68.2%. Dose adjustments due to analytical intolerance were required in 54.5% of cases. The study also assessed drug interactions in eligible participants within a real‐world clinical setting, revealing a high prevalence of potential drug interactions. On average, 1.36 interactions per patient were identified, with 73.3% classified as high‐risk (Category X). These findings highlight the importance of active pharmacovigilance in optimizing drug safety and treatment outcomes. Strategies such as personalized dosing, medication reconciliation, and close monitoring by clinical pharmacists are essential to mitigate risks and improve patient care. The safety profile and tolerability were found to be consistent with that reported in previous pivotal and real‐world evidence studies, underscoring the need for further research to refine treatment protocols and enhance patient outcomes.
Fonseca et al. (Thu,) studied this question.