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JNCI Journal of the National Cancer Institute 2005 97(12):866-867; doi:10.1093/jnci/dji168
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© 2005 Oxford University Press

EDITORIAL

Development and Validation of Therapeutically Relevant Multi-Gene Biomarker Classifiers

Richard Simon

Affiliation of author: Biometric Research Branch, National Cancer Institute, Bethesda, MD

Correspondence to: Richard Simon, DSc, National Cancer Institute, 9000 Rockville Pike, MSC 7434, Bethesda, MD 20892 (e-mail: rsimon@nih.gov).

The first 150 words of the full text of this article appear below.

In June 2004 Ma et al. (1) described a two-gene expression ratio that they claimed accurately predicted clinical outcome of early-stage breast cancer patients treated with adjuvant tamoxifen monotherapy. In the current issue of this journal, Reid et al. (2) reported their failure to confirm the usefulness of the two-gene expression ratio on independent data. I will attempt to try to provide possible explanations for the inconsistency of results of the two studies and to draw some general conclusions.

Oncologists need improved tools for selecting treatments for individual patients. Most cancer treatments benefit only a minority of the patients to whom they are administered. Being able to predict which patients are most likely to benefit not only would save patients from unnecessary toxicity and inconvenience but also might facilitate their receiving drugs that are more likely to help them. In addition, the current overtreatment of patients . . . [Full Text of this Article]


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