Docetaxel as rescue medication in anthracycline- and ifosfamide-resistant locally advanced or metastatic soft tissue sarcoma: results of a phase II trial.

BACKGROUND: Metastatic soft tissue sarcoma not amenable to curative surgery has a dismal prognosis. Aggressive treatment with anthracyclines and ifosfamide represents the current therapeutic mainstay in these patients, most of whom succumb to relapses. Thus, the efficacy of subsequent therapeutic approaches has to be weighed against toxicity caused by palliative treatment. PATIENTS AND METHODS: Patients with locally advanced or metastatic soft tissue sarcoma refractory to treatment with anthracyclines and ifosfamide were enrolled into the present phase II study. Patients were assigned to receive docetaxel at 100 mg/m2 every three weeks. In case of severe toxicity, patients were switched to a weekly schedule of docetaxel (40 mg/m2).
RESULTS: A total of 106 cycles (80% at the scheduled 100 mg/m2 dose level) were administered in 27 patients. Partial response was observed in 4 (15%) patients and 4 (15%) patients experienced disease stabilization. Median progression free survival and overall survival were 2.4 (range: 0.9-23.9) and 7.7 (range: 1.0-44.3) months, respectively. Upon renewed progression, three patients initially responsive to treatment with docetaxel were successfully reinduced by treatment with docetaxel. The safety profile of docetaxel was tolerable and the administration mostly manageable on an outpatient basis.
CONCLUSIONS: Our results suggest that docetaxel represents an efficacious and tolerable treatment in a minority of patients refractory to standard treatment. There is a need for better identification of patients most likely to benefit from salvage treatment with docetaxel.

RCT Entities:   Population Interventions Outcomes