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Observer variability in a phase II trial - assessing consistency in RECIST application.
Kristin Skougaard1, Mark James Dusgaard McCullagh, Dorte Nielsen
1Department of Oncology, Copenhagen University Hospital Herlev, Denmark. kristinskougaard@dadlnet.dk
Acta Oncologica (Stockholm, Sweden)
|March 22, 2012
Summary
Response Evaluation Criteria in Solid Tumours (RECIST) application lacked consistency in a phase II trial. A peer-review process with dedicated radiologists is recommended to improve accuracy in cancer trials.
Area of Science:
- Oncology
- Radiology
- Clinical Trials
Background:
- Assessing treatment response in metastatic colorectal cancer relies on standardized criteria.
- The Response Evaluation Criteria in Solid Tumours (RECIST) is widely used for evaluating tumor burden changes in clinical trials.
- Variability in RECIST application can impact trial outcomes and patient management.
Purpose of the Study:
- To evaluate the consistency of RECIST application in a phase II clinical trial for metastatic colorectal cancer.
- To identify factors contributing to discrepancies in RECIST assessments.
- To determine the impact of RECIST discrepancies on best overall response (BOR) determination.
Main Methods:
- Retrospective review of computed tomography (CT) scans from 100 patients with metastatic colorectal cancer.
- Initial assessment by a heterogeneous group of radiologists, followed by a review by an experienced radiologist.
- Quantification of inter-reader agreement using kappa (κ) coefficients and discrepancy rates.
- Correlation of discrepancies with the number of readers per patient using chi-squared (χ²) test.
Main Results:
- Discrepancies in RECIST application were observed in 47 out of 100 patients.
- Best overall response (BOR) changed in 17 patients post-review, with six changes being potentially treatment-altering.
- Inter-reader agreement was good overall (κ=0.71) but fair in responding patients (κ=0.21).
- A significant increase in discrepancies was noted when three or more radiologists read scans (p=0.0003).
Conclusions:
- RECIST was not consistently applied in this phase II trial, with most discrepancies related to its application.
- A peer-review system involving dedicated radiologists for double-blinded readings is recommended for cancer trials.
- Implementing a standardized review process can enhance the reliability of treatment response assessments and potentially alter clinical decisions.
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