National Cancer Institute Stops Gene-based Clinical Trials – Part 1
August 26, 2010 1 Comment
In prior posts we have discussed the clinical potential of genomic profiling for the selection of chemotherapeutics. Although, genomic analyses offer many insights, we described the limitations of these platforms. A recent report in the national media gives further credence to our position.
On July 22 and 23, 2010, the National Cancer Institute suspended two lung cancer and one breast cancer clinical trial that used genomic profiling to select active treatments for patients. The technique applied was developed at Duke University and reported, to much fanfare, in Lancet Oncology in 2007. The rather stunning success reported in this and related articles by the investigators from Duke, lead to a widespread belief that gene profiles would select active therapies for patients.
The first chink in the armor of this argument came when scientific reviewers issued an “expression of concern” regarding the validity of the method. Further analyses revealed evidence that the technologies for the prediction of response in individual patients could not be reproduced. As the reviewers stated, “The scientific community should be able to replicate the results with the reported data available.” They continued, “Having tried, we can confidently state that this is not yet true.” The NCI convened a group of 31 scientists, who concluded, “It is absolutely premature to use these prediction models to influence the therapeutic options open to cancer patients.”
Next week we’ll explore what went wrong with these seemingly promising trials.