Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first-line sunitinib: a medical chart review across ten centers in five european countries
Porta, Camillo Levy, Antonin Hawkins, Robert Castellano, Daniel Bellmunt, Joaquim Nathan, Paul McDermott, Ray Wagstaff, John Donnellan, Paul McCaffrey, John
Porta, Camillo
Levy, Antonin
Hawkins, Robert
Castellano, Daniel
Bellmunt, Joaquim
Nathan, Paul
McDermott, Ray
Wagstaff, John
Donnellan, Paul
McCaffrey, John
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Publication Date
2014-07-18
Type
Article
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Citation
Porta, Camillo; Levy, Antonin; Hawkins, Robert; Castellano, Daniel; Bellmunt, Joaquim; Nathan, Paul; McDermott, Ray; Wagstaff, John; Donnellan, Paul; McCaffrey, John; Vekeman, Francis; Neary, Maureen P. Diaz, Jose; Mehmud, Faisal; Duh, Mei Sheng (2014). Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first-line sunitinib: a medical chart review across ten centers in five european countries. Cancer Medicine 3 (6), 1517-1526
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.
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Publisher
Wiley-Blackwell
Publisher DOI
10.1002/cam4.302
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Attribution-NonCommercial-NoDerivs 3.0 Ireland