* 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.