• J Verweij, S M Lee, W Ruka, J Buesa, R Coleman, R van Hoessel, C Seynaeve, E D di Paola, M van Glabbeke, D Tonelli, and I R Judson.
• Department of Medical Oncology, Rotterdam Cancer Institute, and University Hospital Rotterdam, Nijmegen, the Netherlands.
• J. Clin. Oncol. 2000 May 1; 18 (10): 2081-6.

PurposeTo assess antitumor response and time to progression (TTP) with docetaxel compared with doxorubicin in first-line treatment of advanced and/or metastatic soft tissue sarcoma.Patients And MethodsPatients with measurable soft tissue sarcoma lesions and adequate bone marrow, liver, and renal function were entered onto the study. They were randomized to either docetaxel 100 mg/m(2) given as a 1-hour intravenous infusion every 3 weeks or doxorubicin 75 mg/m(2) given as a bolus injection every 3 weeks. A maximum of seven cycles of treatment were scheduled. 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 trial if fewer than five responses were observed among the first 25 assessable patients in the docetaxel treatment arm.ResultsEighty-six patients were entered onto the study; 85 were assessable for toxicity and 83 for response. The rate of severe granulocytopenia was not significantly different between the two arms. Nausea (P =.001), vomiting (P <.001), and stomatitis (P =.005) were more common with doxorubicin therapy, whereas neurotoxicity was more frequent with docetaxel treatment. The response rate to doxorubicin therapy was 30% (95% confidence interval, 17% to 46%), whereas no responses to docetaxel therapy were seen (P <.001). In view of this, the trial was closed prematurely and the phase III study part was not conducted.ConclusionDocetaxel is inactive in soft tissue sarcomas and cannot be recommended for further use in treatment of this disease.

31 keywords...

hide…