期刊
CANCER JOURNAL
卷 15, 期 5, 页码 421-425出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/PPO.0b013e3181b9c602
关键词
meta-analysis; surrogate endpoint; biomarker; colorectal cancer; breast cancer; ovarian cancer; prostate cancer
类别
This article discusses statistical approaches to the validation of surrogate biomarkers and endpoints. One approach that has been successfully used in oncology consists of estimating associations at two levels: the association between the surrogate and the clinical endpoint, called the individual-level association, and the association between the effects of treatment on the surrogate and the clinical endpoint, called the trial-level association. This approach requires data to be available from multiple randomized trials, such as in a meta-analysis of trials based on individual patient data. The approach is illustrated using randomized trials of first-line treatments for advanced tumors of the colon, breast, ovary, and prostate. Data from several meta-analyses suggest that progression-free survival is an acceptable surrogate in advanced colorectal and ovarian cancer, but not in breast and prostate cancer.
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