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