Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: A study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group

Purpose: To assess antitumor response and time to progression (TTP) with do cetaxel compared with doxorubicin in first-line treatment of advanced and/o r metastatic soft tissue sarcoma. Patients and Methods: patients with measurable soft tissue sarcoma lesions and adequate bone marrow, liver, and renal function were entered onto the s tudy. They were randomized to either docetaxel 100 mg/m(2) given as a 1-hou r intravenous infusion every 3 weeks or doxorubicin 75 mg/m(2) given as a b olus injection every 3 weeks. A maximum of seven cycles of treatment were s cheduled. The study was designed as a randomized phase III study evaluating TTP by log-rank model. There was a clause for premature closure of the tri al if fewer than five responses were observed among the first 25 assessable patients in the docetaxel treatment arm. Results: Eighty-six patients were entered onto the study; 85 were assessabl e for toxicity and 83 for response. The rate of severe granulocytopenia was not significantly different between the two arms. Nausea (P =.001), vomiti ng (P <.001), and stomatitis (P =.005) were more common with doxorubicin th erapy, whereas neurotoxicity was more frequent with docetaxel treatment. Th e response rate to doxorubicin therapy was 30% (95% confidence interval, 17 % to 46%), whereas no responses to docetaxel therapy were seen (P <.001). I n view of this, the trial was closed prematurely and the phase III study pa rt was not conducted. Conclusion: Docetaxel is inactive in soft tissue sarcomas and cannot be rec ommended for further use in treatment of this disease. J Clin Oncol 18:2081 -2086. (C) 2000 by American Society of Clinical Oncology.