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Phase II Trial of Paclitaxel–Epirubicin in Patients With Recurrent Soft-Tissue Sarcoma

Pivot, Xavier; Chevreau, Christine; Cupissol, Didier; Lortholary, Alain; Bui, Nguyen-Binh; Eymard, Jean-Christophe; Bay, Jacques-Olivier; Baranzelli, Marie-Christine; Mita, Monica; Barnouin, Laurence; Savary, Jacqueline; Thyss, Antoine

American Journal of Clinical Oncology: December 2002 - Volume 25 - Issue 6 - p 561-564

Twenty-seven patients with recurrent soft-tissue sarcoma (STS) entered a multicenter study to determine the efficacy of the combination paclitaxel 200 mg/m2 and epirubicin 75 mg/m2 administered every 21 days. Patient characteristics included the following: 14 women and 13 men, median age of 52 years, 12 patients had local recurrence and 20 had metastasis. Eighteen patients had previously received chemotherapy for recurrent disease. The main grade III to IV hematologic toxicities were neutropenia (70%), anemia (3.7%), and thrombocytopenia (7.4%). Febrile neutropenia occurred in 5 patients (18.5%). Severe nonhematologic toxicities were rare. Two patients had a partial response (7.4%; 95% CI: 2.6–12.2%), with a median response duration of 3 and 5 months. Six patients had stable disease (22.2%), and 19 had progressive disease (70.5%). The median overall survival from study inclusion was 8 months. This study suggests the association paclitaxel–epirubicin does not increase the known activity of anthracycline in recurrent STS.

From CHU J. Minjoz (X.P.), Besancon; Centre Claudius Regaud (C.C., M.M.), Toulouse; Centre Val d’Aurel (D.C.), Montpellier; Centre Paul Papin (A.L.), Angers; Institut Bergonie (N.-B.B.), Bordeaux; Institut Jean Godinot (J.-C.E.), Reims; Centre Jean Perrin (J.-O.B.), Clermont-Ferrand; Centre Oscar Lambret (M.-C.B.), Lille; Bristol Myers Squibb (L.B., J.S.), Paris, and Centre Antoine Lacassagne (A.T.), Nice, France.

Address correspondence to Xavier Pivot, Centre Antoine Lacassagne, 33 Av de Valombrose, 06189 Nice Cedex 2, France.

© 2002 Lippincott Williams & Wilkins, Inc.