| Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. | |
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MedLine Citation:
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PMID: 11872347 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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M Van Glabbeke; J Verweij; I Judson; O S Nielsen; |
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Publication Detail:
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Type: Journal Article; Meta-Analysis; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: European journal of cancer (Oxford, England : 1990) Volume: 38 ISSN: 0959-8049 ISO Abbreviation: Eur. J. Cancer Publication Date: 2002 Mar |
Date Detail:
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Created Date: 2002-03-01 Completed Date: 2002-05-30 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9005373 Medline TA: Eur J Cancer Country: England |
Other Details:
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Languages: eng Pagination: 543-9 Citation Subset: IM |
Affiliation:
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EORTC Data Center, Av Mounier 83/11, B1200, Brussels, Belgium. mvg@eortc.be |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Antineoplastic Agents / therapeutic use* Clinical Trials, Phase II as Topic / statistics & numerical data* Disease-Free Survival Female Humans Male Middle Aged Reference Values Sarcoma / drug therapy* |
| Grant Support | |
ID/Acronym/Agency:
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2U10 CA11488/CA/NCI NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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