Open AccessImpact 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
Author(s) -
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
Publication year - 2014
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.302
Subject(s) - sunitinib , medicine , renal cell carcinoma , discontinuation , adverse effect , proportional hazards model , common terminology criteria for adverse events , hazard ratio , oncology , confidence interval
Angiogenesis inhibitors have become standard of care for advanced and/or metastatic renal cell carcinoma ( RCC ), but data on the impact of adverse events ( AE s) 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 AE s 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 AE s 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 AE s 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.