PHASE-II TRIAL OF PACLITAXEL IN PATIENTS WITH SOFT-TISSUE SARCOMA

The response rate (RR) to single-agent chemotherapy with doxorubicin o r ifosfamide in patients with advanced soft-tissue sarcoma (STS) is in the range of 20%. Paclitaxel is clinically useful in treating several solid tumors and has demonstrated activity in a series of human sarco ma cell lines. Twenty-Fight patients with measurable advanced STS part icipated in this phase II trial of paclitaxel at 250 mg/m(2) administe red as a 3-hr i.v. infusion once every 3 weeks. All patients received granulocyte colony-stimulating factor JC-CSF) beginning on the day aft er paclitaxel and lasting until recovery from neutropenia. No prior ch emotherapy had been used in 17 patients; 10 patients had had prior dox orubicin-based therapy; and I patient had had intraperitoneal therapy with edatrexate. Two partial responses (PRs) (7%; 95% confidence inter val [CI] = 1-23%) were observed. The responding patients included a pa tient with angiosarcoma of the scalp who had complete regression of cu taneous lesions and improvement of nonmeasurable pulmonary disease las ting 6 months. The other PR occurred in a woman with metastatic uterin e leiomyosarcoma and lasted 9 months. Seven patients had stable diseas e for 3-4 months. Median time to progression for all patients was 3.5 months (range: 2.5-9 months). The mean nadir in the white-blood-cell ( (WBC) count was 3.8 X 10(3)/mu l (range: [0.2-16.2] X 10(3)/mu l), wit h a mean nadir in the absolute neutrophil count (ANC) of 2.4 X 10(3)/m u l (range: [0.0-7.1] X 10(3)/mu l). Three patients died while in the study. Two patients with angiosarcoma of the scalp who did not qualify for this study were treated with paclitaxel off protocol, and experie nced dramatic tumor regression. The overall response to paclitaxel obs erved in this heterogeneous group of patients was disappointing. Howev er; rite activity seen in angiosarcoma of the scalp suggests that furt her evaluation is warranted in patients with STS.