• La Clinica terapeutica · Mar 1998

    Clinical Trial

    [Phase II study of docetaxel in patients with advanced stage soft tissue sarcoma].

    • A Amodio, S Carpano, G Paoletti, T Gionfra, M Rinaldi, C Manfredi, P Foggi, and M Lopez.
    • Istituto Regina Elena per lo Studio e la Cura dei Tumori, Roma, Italia.
    • Clin Ter. 1998 Mar 1; 149 (2): 121-5.

    PurposeTo evaluate the activity and toxicity of docetaxel (TXT) as second line therapy in advanced soft-tissue sarcoma.Patients And MethodsAdult patients (pts) with histologically proven locally advanced or metastatic soft tissue sarcoma, were treated with TXT at a dose of 100 mg/m2 in a 1-hour i.v. infusion every 21 days and steroid premedication with oral prednisone 50 mg twice a day for five days starting 24 hours prior to TXT.ResultsFrom November 1995 to May 1997, 19 pretreated pts entered the trial. Characteristics of the pts: males/females 11/8, median age 58 years (30-74), median WHO performance status 1 (0-2); histotypes: leiomyosarcoma 6 pts, malignant fibrous histiocytoma 6 pts, fibrosarcoma 2 pts, others 5 pts. No objective responses were seen. The disease remained stable in 8 pts (42%). Median time to progression was 3.5 months (range, 2-8), median survival 6 months (range, 2-20). The treatment was well-tolerated: the main side effect was hematological toxicity with G3/4 leukopenia and neutropenia in 58% of the pts; G3 anemia and thrombocytopenia occurred only in 1 case. Other toxicities were alopecia that was universal, G3 emesis in 1 pt, G3 diarrhea in 2 pts, G3 stomatitis in 1 pt. Mild fluid retention was recorded only in 2 pts.ConclusionsThe results of this study do not suggest the use of TXT at this dosage and schedule in advanced soft tissue sarcoma.

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