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Selection of large and objectively measurable target lesions in EORTC phase II trials: impact on recruitment and
M Van Glabbeke1, A T van Oosterom, W Steward
1EORTC Data Center, Brussels, Belgium.
Abstract:
The EORTC has recently issued minimum requirements for target lesions in phase II trials, aiming at a decrease in measurement errors [minimum size, computer tomography (CT) scan or ultrasound for deep lesions]. Their impact on recruitment and response has been retrospectively studied in a trial of the EORTC Soft Tissue and Bone Sarcoma Group (STBSG), investigating high-dose chemotherapy in patients with advanced soft tissue sarcoma, where 46/103 objective responses were seen, including 10 complete responses. For the 20 patients who did not satisfy the criteria, a similar objective response rate and a significantly higher complete response rate were reported. Among 265 target lesions, the same trends were observed when comparing small to large lesions, for different tumour sites. For deep lesions clinically assessed, significantly higher response rates were reported than for those measured by CT scans or ultrasound. The new stricter EORTC criteria improve the reliability of measurements and have been adopted for future phase II trials of the STBSG. This will not result in the selection of potentially poor responders. Less than 20% of the present recruitment will be lost.
Insights
New European Organisation for Research and Treatment of Cancer (EORTC) criteria for phase II trials enhance measurement reliability in soft tissue sarcoma. These stricter guidelines do not exclude potential responders and minimally impact recruitment.
Area of Science:
- Oncology
- Clinical Trials
- Radiology
Background:
- The European Organisation for Research and Treatment of Cancer (EORTC) introduced minimum requirements for target lesions in phase II trials to reduce measurement errors.
- These criteria include specifications for minimum size and imaging modalities (CT scan or ultrasound) for deep lesions.
Purpose of the Study:
- To retrospectively evaluate the impact of new EORTC criteria on patient recruitment and response assessment in a phase II trial for advanced soft tissue sarcoma.
- To determine if the stricter criteria affect the identification of potential responders and overall trial recruitment.
Main Methods:
- Retrospective analysis of a phase II trial conducted by the EORTC Soft Tissue and Bone Sarcoma Group (STBSG) investigating high-dose chemotherapy for advanced soft tissue sarcoma.
- Comparison of objective response rates and complete response rates between patients who met the new EORTC criteria and those who did not.
- Analysis of response trends based on lesion size (small vs. large) and measurement method (clinical assessment vs. CT/ultrasound for deep lesions).
Main Results:
- Patients not meeting the new criteria showed similar objective response rates but a significantly higher complete response rate.
- Analysis of 265 target lesions indicated trends where smaller lesions and clinically assessed deep lesions had higher reported response rates compared to larger or CT/ultrasound-measured lesions.
- The study suggests that the new criteria improve measurement reliability without excluding potentially good responders, with an anticipated recruitment loss of less than 20%.
Conclusions:
- The new, stricter EORTC criteria enhance the reliability of target lesion measurements in phase II trials for soft tissue sarcoma.
- Adoption of these criteria by the STBSG for future trials is recommended as they improve data quality without compromising the identification of responders or significantly impacting recruitment.
- The findings support the use of standardized criteria for more consistent and reliable outcomes in clinical trials.