* Not included in multivariable analysis (not evaluable for some histological subtypes).
Dose-limiting toxicity- exposure relationship.
Both STS and BS patients (n=118) were included in the DLT analysis. Overall, 51 DLT events was observed in xx (%) patients during the first 3 months of treatment, including hypertension in 14% of patients (n=17), asthenia 12% (n=14), anorexia 10% (n=12), hepatic cytolysis 6.5% (n=8). Grade 3-4 toxicities led to dose decrease, treatment interruption and discontinuation in 25 patients (21%) (including 19 patients with 800 mg initial dose), 42 patients (35.5%) and 29 patients (24.5%) respectively. Eighteen patients (15%) were able to have a dose increase within the first three months and a further eleven patients (9%) after three months.
Baseline characteristics associated with occurrence of DLT are shown in table 4.