Document Detail

Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas.
MedLine Citation:
PMID:  11872347     Owner:  NLM     Status:  MEDLINE    
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.
M Van Glabbeke; J Verweij; I Judson; O S Nielsen;
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Publication Detail:
Type:  Journal Article; Meta-Analysis; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  European journal of cancer (Oxford, England : 1990)     Volume:  38     ISSN:  0959-8049     ISO Abbreviation:  Eur. J. Cancer     Publication Date:  2002 Mar 
Date Detail:
Created Date:  2002-03-01     Completed Date:  2002-05-30     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9005373     Medline TA:  Eur J Cancer     Country:  England    
Other Details:
Languages:  eng     Pagination:  543-9     Citation Subset:  IM    
EORTC Data Center, Av Mounier 83/11, B1200, Brussels, Belgium.
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MeSH Terms
Antineoplastic Agents / therapeutic use*
Clinical Trials, Phase II as Topic / statistics & numerical data*
Disease-Free Survival
Middle Aged
Reference Values
Sarcoma / drug therapy*
Grant Support
Reg. No./Substance:
0/Antineoplastic Agents

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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