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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 of Clinical Oncology, 08/24/09
Cesne AL et al. - Study reports that RECIST (Response Evaluation Criteria in Solid Tumors), 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 progressive disease (PD), the pattern of radiologic response by tumor size criteria has no prognostic value for further outcome.
Methods- An investigation of whether the response classification assessed by RECIST predicts for time to progression (TTP) and overall survival (OS)
- Per protocol, the first 3 disease assessments were done at 2, 4, and 6 mo
- For the purpose of the analysis, disease response was subclassified in 6 categories:
- Partial response (PR; > 30% size reduction)
- Minor response (MR; 10% to 30% reduction)
- No change 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)
- 906 pts had measurable disease at entry
- At all measurement time points, CR, PR, and MR resulted in similar TTP and OS
- This was also true for NC– and NC+, and for PD and subjective PD
- Pts were subsequently classified as responders (CR/PR/MR), NC (NC+/NC–), or PD
- This 3-class response categorization was found to be highly predictive of further progression or survival for the first 2 measurement points
- After 6 mo of imatinib, responders (CR/PR/MR) had the same survival prognosis as pts classified as NC
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