BACKGROUND: Metastatic soft tissue sarcoma (STS) prognosis remains poor and few 
cytotoxic agents offer proven efficacy. This randomized open phase III study 
examines whether high-dose (HD) chemotherapy with peripheral blood stem cells 
(PBSCs) could improve overall survival (OS) of chemosensitive patients.
PATIENTS AND METHODS: Advanced STS patients aged 18-65 years received four 
courses of standard mesna, adryamycin, ifosfamide and dacarbazine (MAID) 
treatment. Chemotherapy-responding patients and patients with at least stable 
disease amenable to complete surgical resection were randomized to receive 
standard dose (SD) with two successive MAID cycles or HD treatments of one MAID 
then MICE intensification: mesna (3.6 g/m(2), day 1-5), ifosfamide (2.5 g/m(2), 
day 1-4), carboplatin [area under the curve (AUC) 5/day 2-4] and etoposide (300 
mg/m(2), day 1-4) with PBSC reinjection at day 7.
RESULTS: From 2000 to 2008, 207 patients received four cycles of MAID and 87 
assessable patients were randomly assigned to receive the following: 46 SD, 41 
HD, with 45 and 38 maintained for analyses after secondary centralized 
histological review. Futility analyses led to study closure in November 2008. 
Three-year OS was 49.4% for the SD group versus 32.7% for HD arm, hazard ratio= 
1.26, 95% confidence interval 0.70-2.29; progression-free survival was 32.4% and 
14.0%, respectively. HD treatment led to higher grades 3-4 toxicity.
CONCLUSION: This study failed to show an OS advantage for advanced STS patients 
treated with dose-intensified chemotherapy with PBSC.