Absence of progression as assessed by response evaluation criteria in solid tumors predicts survival in advanced GI stromal tumors treated with imatinib mesylate: the intergroup EORTC-ISG-AGITG phase III trial.

Details

Serval ID
serval:BIB_681BF8D23E08
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Absence of progression as assessed by response evaluation criteria in solid tumors predicts survival in advanced GI stromal tumors treated with imatinib mesylate: the intergroup EORTC-ISG-AGITG phase III trial.
Journal
Journal of Clinical Oncology
Author(s)
Le Cesne A., Van Glabbeke M., Verweij J., Casali P.G., Findlay M., Reichardt P., Issels R., Judson I., Schoffski P., Leyvraz S., Bui B., Hogendoorn P.C., Sciot R., Blay J.Y.
ISSN
1527-7755[electronic]
Publication state
Published
Issued date
2009
Volume
27
Number
24
Pages
3969-3974
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't Publication Status: ppublish
Abstract
PURPOSE: From February 2001 to February 2002, 946 patients with advanced GI stromal tumors (GISTs) treated with imatinib were included in a controlled EORTC/ISG/AGITG (European Organisation for Research and Treatment of Cancer/Italian Sarcoma Group/Australasian Gastro-Intestinal Trials Group) trial. This analysis investigates whether the response classification assessed by RECIST (Response Evaluation Criteria in Solid Tumors), predicts for time to progression (TTP) and overall survival (OS). PATIENTS AND METHODS: Per protocol, the first three disease assessments were done at 2, 4, and 6 months. For the purpose of the analysis (landmark method), disease response was subclassified in six categories: partial response (PR; > 30% size reduction), minor response (MR; 10% to 30% reduction), no change (NC) as either NC- (0% to 10% reduction) or NC+ (0% to 20% size increase), progressive disease (PD; > 20% increase/new lesions), and subjective PD (clinical progression). RESULTS: A total of 906 patients had measurable disease at entry. At all measurement time points, complete response (CR), PR, and MR resulted in similar TTP and OS; this was also true for NC- and NC+, and for PD and subjective PD. Patients were subsequently classified as responders (CR/PR/MR), NC (NC+/NC-), or PD. This three-class response categorization was found to be highly predictive of further progression or survival for the first two measurement points. After 6 months of imatinib, responders (CR/PR/MR) had the same survival prognosis as patients classified as NC. CONCLUSION: RECIST perfectly enables early discrimination between patients who benefited long term from imatinib and those who did not. After 6 months of imatinib, if the patient is not experiencing PD, the pattern of radiologic response by tumor size criteria has no prognostic value for further outcome. Imatinib needs to be continued as long as there is no progression according to RECIST.
Keywords
Antineoplastic Agents/therapeutic use, Disease Progression, Gastrointestinal Stromal Tumors/drug therapy, Gastrointestinal Stromal Tumors/mortality, Humans, Piperazines/therapeutic use, Pyrimidines/therapeutic use
Pubmed
Web of science
Create date
08/01/2010 14:25
Last modification date
20/08/2019 14:23
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