PACLITAXEL (TAXOL) PLUS DOXORUBICIN PLUS FILGRASTIM IN ADVANCED SARCOMA - A PHASE-II STUDY

The authors evaluated the novel chemotherapeutic regimen of paclitaxel (Taxol, Bristol-Myers Squibb, Princeton, NJ, U.S.A.) plus doxorubicin plus filgrastim-a granulocyte colony-stimulating factor (G-CSF)-in ad vanced or metastatic sarcoma. Eligible patients must have had histolog ically confirmed advanced previously untreated soft-tissue sarcoma. Al l patients must have had bidimensionally measurable metastases. Treatm ent consisted of doxorubicin, 50 mg/m(2) by intravenous push, followed 4 hours later by paclitaxel, 150 mg/m(2) by continuous infusion over 24 hours every 3 weeks, plus G-CSF, 5 mu g/kg, on days 3 through 12 of each cycle. Cycles were repeated every 21 days. A one-time dose escal ation for doxorubicin only (60 mg/m(2)) was allowed in all patients wh o experienced no significant toxicity after their first cycle of pacli taxel plus doxorubicin. From November 1993 through May 1996, 29 patien ts were entered in this study. Grade 3 anemia occurred in three patien ts. Grade 3-4 neutropenia occurred in 20 patients. Seven patients expe rienced at least one episode of neutropenic fever, including one death . Grade 3 thrombocytopenia occurred in four patients. There were six p artial responses in 27 eligible patients, for a response rate of 22.2% (95% confidence interval, 7%-38%). Median time to progression was 4.5 months, and median overall survival was 10.2 months. The regimen of p aclitaxel plus doxorubicin plus filgrastim as used in this study appea rs to have no more activity than single-agent doxorubicin.