van der Veldt AAM et al. - In a study to determine the efficacy and safety of sunitinib in pts with advanced renal cell cancer (RCC), it was concluded that on the basis of age and gender, a model was developed that could predict the probability of severe toxicity Methods
Efficacy and safety of sunitinib was determined in pts with advanced RCC included in an expanded access program
ECOG performance status >1, histology other than clear cell and presence of brain metastases were no exclusion criteria
Results
82 pts were treated: 23% reached a partial response, 50% had stable disease, 20% progressed, and 6 pts were not evaluable
Median progression-free survival (PFS) was 9 months and median overall survival (OS) was 15 months
47 pts needed a dose reduction, 35 because of treatment-related adverse events, 10 because of continuous dosing, and 2 because of both
Stomatitis, fatigue, hand–foot syndrome, and a combination of grade 1–2 adverse events were the most frequent reasons for dose reduction
In 40 pts, there was severe toxicity, defined as dose reduction or permanent discontinuation, which was correlated with low body surface area, high age, and female gender
