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 t o estimate the response rate and to define the toxicities of paclitaxe l 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, recurren t or metastatic soft tissue sarcoma and had had no prior chemotherapy or radiotherapy. Paclitaxel at 250 mg/m(2) was given by continuous int ravenous infusion over 24 hours every 21 days. Doses were modified in subsequent courses based on nadir counts. Granulocyte-colony stimulati ng factor was given at 5 mu g/kg subcutaneously days 3-18. Results. Fo rty-eight patients were treated; 1 patient had a complete response and 5 had partial responses for an overall response rate of 12.5% (95% co nfidence interval, 4.7%-25.3%). Thirty-eight of the 48 patients experi enced grade 4 toxicities, with most of these life-threatening toxiciti es being hematologic. No deaths were attributed to therapy. Conclusion s. At the tested dose and schedule paclitaxel has antitumor activity a pproximating that of dacarbazine in soft tissue sarcomas. Whether pacl itaxel would be more effective administered in a longer infusion or wi th a chemosensitizer remains to be tested in this group of heterogeneo us neoplasms.