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Circulating Tumor Cells and the CellSearch Assay


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CellSearch Use in MCRC Clinical Trial8

Slide 17

April 2011

A multicenter, prospective clinical trial was conducted between 2004 and 2006 to determine whether circulating tumor cell enumeration could predict colorectal cancer disease progression and survival. Prior to initiation of a new line of therapy, 430 patients with measurable metastatic colorectal cancer were enrolled. Measurable disease was defined as a minimum of one 2-cm lesion to a maximum of 10 lesions. Imaging methods were determined for each patient as per the current standard of care defined by the patient's physician. All lesions seen at baseline were followed using the same method for all successive studies, either CT or MRI of the chest, abdomen, and pelvis.

A baseline circulating tumor cell count was established prior to the start of therapy and follow-up counts were determined every 3 to 4 weeks. Progression-free survival was measured from the time of baseline draws until the time of detectable disease progression based on CT or MRI scans and clinical findings. Overall survival was determined from the time of baseline blood draws to the time of death. Finally, unlike the metastatic breast cancer trial, which used a cutoff of greater than or equal to 5 circulating tumor cells, the metastatic colorectal trial used a cutoff of greater than or equal to 3 circulating tumor cells.

CellSearch Use in MCRC Clinical Trial8


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