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 ifosf amide represents the current therapeutic mainstay in these patients, most o f whom succumb to relapses. Thus, the efficacy of subsequent therapeutic ap proaches has to be weighed against toxicity caused by palliative treatment. Patients and methods: Patients with locally advanced or metastatic soft tis sue sarcoma refractory to treatment with anthracyclines and ifosfamide were enrolled into the present phase II study. Patients were assigned to receiv e docetaxel at 100 mg/m(2) every three weeks. In case of severe toxicity, p atients were switched to a weekly schedule of docetaxel (40 mg/m(2)). Results: A total of 106 cycles (80% at the scheduled 100 mg/m(2) dose level ) were administered in 27 patients. Partial response was observed in 4 (15% ) patients and 4 (15%) patients experienced disease stabilization. Median p rogression free survival and overall survival were 2.4 (range: 0.9-23.9) an d 7.7 (range: 1.0-44.3) months, respectively. Upon renewed progression, thr ee patients initially responsive to treatment with docetaxel were successfu lly reinduced by treatment with docetaxel. The safety profile of docetaxel was tolerable and the administration mostly manageable on an outpatient bas is. Conclusions: Our results suggest that docetaxel represents an efficacious a nd tolerable treatment in a minority of patients refractory to standard tre atment. There is a need for better identification of patients most likely t o benefit from salvage treatment with docetaxel.