Abstract
Angiogenesis inhibitors have become standard of care for advanced and/or metastatic renal cell carcinoma (RCC), but data on the impact of adverse events (AEs) and treatment modifications associated with these agents are limited. Medical records were abstracted at 10 tertiary oncology centers in Europe for 291 patients ≥18 years old treated with sunitinib as first-line treatment for advanced RCC (no prior systemic treatment for advanced disease). Logistic regression models were estimated to compare dose intensity among patients who did and did not experience AEs during the landmark periods (18, 24, and 30 weeks). Cox proportional hazard models were used to explore the possible relationship of low-dose intensity (defined using thresholds of 0.7, 0.8, and 0.9) and treatment modifications during the landmark periods to survival. 64.4% to 67.9% of patients treated with sunitinib reported at least one AE of any grade, and approximately 10% of patients experienced at least one severe (grade 3 or 4) AE. Patients reporting severe AEs were statistically significantly more likely to have dose intensities below either 0.8 or 0.9. Dose intensity below 0.7 and dose discontinuation during all landmark periods were statistically significantly associated with shorter survival time. This study of advanced RCC patients treated with sunitinib in Europe found a significant relationship between AEs and dose intensity. It also found correlations between dose intensity and shorter survival, and between dose discontinuation and shorter survival. These results confirm the importance of tolerable treatment and maintaining dose intensity.
Highlights
Renal cell carcinoma (RCC) is the most common cancer of the kidney, with 30% of patients presenting with metastatic disease
Sutentâ, received accelerated approval from the Food and Drug Administration (FDA) for treatment of advanced RCC in January 2006 [2]. Safety data from both clinical trials and the expanded access program (EAP) for sunitinib demonstrated that adverse events (AEs) are common among patients undergoing this treatment [3,4,5]
This study, which relied on data from medical charts from 291 treatment-na€ıve patients across five countries in Europe, contributes to the growing body of knowledge regarding the tolerability and management of side effects for patients receiving first-line anti-angiogenic agents for the treatment of advanced RCC [4, 5, 7,8,9,10,11,12,13,14,15]
Summary
Renal cell carcinoma (RCC) is the most common cancer of the kidney, with 30% of patients presenting with metastatic disease. Cytokines (e.g., interleukin-2 or interferon alpha) have been widely used as first-line treatment for advanced or metastatic RCC, but have low-response rate, coupled with relevant toxicity; they do not have a survival benefit for patients with disease of intermediate prognosis [1]. Antiangiogenesis agents have been used as alternative treatment. One such agent, Sutentâ (sunitinib malate), received accelerated approval from the Food and Drug Administration (FDA) for treatment of advanced RCC in January 2006 [2]. Safety data from both clinical trials and the expanded access program (EAP) for sunitinib demonstrated that adverse events (AEs) are common among patients undergoing this treatment [3,4,5]. More recent data suggest an emerging role for immunotherapy using the new approach targeting the immune check point in RCC [6]
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