Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas

摘要: We have estimated progression-free rates (PFR) for various groups of soft-tissue sarcoma patients from our clinical trials database, to provide reference values conducting phase II studies with PFR as the principal end-point. In 146 pretreated receiving an active agent, estimates were 39 and 14% at 3 6 months, inactive regimens (234 patients), those 21 8% respectively. 1154-non-pretreated patients, varied 77% (synovial sarcoma) 57% (malignant fibrous histiocytoma (MFH)) 56% 38% (MFH ) months. 61 leiomyosarcomas gastrointestinal origin, corresponding figures 44 30%, Consequently, first-line therapy, a 6-month greater than or equal 30-56% (depending on histology) can be considered value suggest drug activity; second-line 3-month 40% would activity, less 20% inactivity. (C) 2002 Elsevier Science Ltd. All rights reserved.