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Response rate or time to progression as predictors of survival in trials of metastatic colorectal cancer or
Kent R Johnson1, Clare Ringland, Barrie J Stokes
1Faculty of Health, University of Newcastle, Callaghan, Australia.
The Lancet. Oncology
|September 2, 2006
Summary
Using surrogate endpoints like tumor response or time to progression in cancer trials can reduce duration and cost. However, large changes in tumor response are needed to predict survival benefits, making time to progression a more reliable surrogate.
Area of Science:
- Oncology
- Clinical Trial Design
- Biostatistics
Background:
- Cancer clinical trials are lengthy and expensive.
- Surrogate endpoints could potentially shorten trial duration and reduce costs.
- Tumor response and time to progression are potential surrogate endpoints for survival.
Purpose of the Study:
- To assess the predictive value of tumor response and time to progression as surrogate endpoints for mortality.
- To evaluate these surrogates in metastatic colorectal cancer and non-small-cell lung cancer.
Main Methods:
- Meta-analysis of summary data from randomized trials of first-line treatments.
- Included 146 colorectal cancer trials and 191 lung cancer trials.
- Linear regression and prediction bands were used to analyze data and determine surrogate threshold effects.
Main Results:
- Both tumor response and time to progression correlated significantly with survival improvement in both cancer types (p<0.0001).
- Large differences in tumor response rates were required to predict significant survival gains, varying by trial size.
- Modest differences in time to progression were sufficient to predict survival benefits across different trial sizes.
Conclusions:
- Tumor response rate is a less reliable surrogate endpoint due to the large effect sizes needed to predict survival benefits.
- Time to progression is a preferred surrogate endpoint as it requires more modest and achievable differences to predict survival.
- Clinical trials in metastatic lung and colorectal cancer should prioritize overall survival as the primary outcome unless a substantial surrogate difference is expected.
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