A phase II trial of paclitaxel in patients with advanced soft tissue sarcomas. A southwest oncology group study

BACKGROUND: The objectives of this Phase II trial of paclitaxel were to estimate the response rate and to define the toxicities of paclitaxel administered with recombinant granulocyte-colony stimulating factor in patients with advanced soft tissue sarcomas. METHODS: Patients were eligible if they had a histologic diagnosis of unresectable, recurrent or metastatic soft tissue sarcoma and had had no prior chemotherapy or radiotherapy. Paclitaxel at 250 mg/m2 was given by continuous intravenous infusion over 24 hours every 21 days. Doses were modified in subsequent courses based on nadir counts. Granulocyte-colony stimulating factor was given at 5 micrograms/kg subcutaneously days 3-18. RESULTS: Forty-eight patients were treated; 1 patient had a complete response and 5 had partial responses for an overall response rate of 12.5% (95% confidence interval, 4.7%-25.3%). Thirty-eight of the 48 patients experienced grade 4 toxicities, with most of these life-threatening toxicities being hematologic. No deaths were attributed to therapy. CONCLUSIONS: At the tested dose and schedule paclitaxel has antitumor activity approximating that of decarbazine in soft tissue sarcomas. Whether paclitaxel would be more effective administered in a longer infusion or with a chemosensitizer remains to be tested in this group of heterogeneous neoplasms.