Purpose. The prognosis of advanced soft tissue sarcoma is poor, only
a few drugs showing some activity with response rates around 15– 25%. Consequently drug
development seems mandatory to improve treatment outcome. Following previous
favourable EORTC experience, the Italian Group on Rare Tumors started a phase II study
with docetaxel to confirm the activity of this drug in soft tissue sarcoma.Patients and methods. Thirty-seven patients with soft tissue sarcoma
resistant to at least one anthracyclinecontaining regimen were enrolled in a phase II multicenter
study evaluating docetaxel 100 mg/m2
in a 1-h i.v. infusion q3
weeks.Results.Thirty-seven patients were enrolled onto this phase II study and
36 were evaluable for response. Only one partial remission was observed [2.8% with 95%
confidence interval (CI) 0.1– 16.2%]. Median progression-free and overall survival
were 42 and 350 days, respectively. Neutropenia and leukopenia as well as cutaneous
manifestations were the most common toxicities.Discussion. The results of this phase II study do not confirm a previous
EORTC repor t on the activity of docetaxel in soft tissue sarcoma, but are consistent with
other more recent phase II studies. The accumulated evidence does not justify the use of this
drug in the management of patients suffering from this disease, resistant to
anthracyclinecontaining regimens.