Abstract
7205 Background: There is a need to improve our ability to monitor the status of NSCLC during therapy as well as to determine relapse. In addition, there is a need to more rationally select therapeutics based upon the molecular characteristics of the tumor. Repetitive biopsy of NSCLC is not feasible. CCC are present in a range of malignancies and have been documented to correlate with disease activity. In addition, cells can be stained for markers of chemotherapeutic sensitivity including ERCC1, beta tubulin III and RRM1. Methods: Patients with Stage III or IV NSCLC undergoing therapy were evaluated utilizing the BloodBiopsy system. 20 cc. of blood was drawn and are isolated utilizing a negative selection technique which involves density gradient centrifugation and immunomagnetic cell sorting to to remove RBC and WBC. Cells are then stained with a pan anti-cytokeratin fluorescently labeled antibody cocktail and counted utilizing atutomated immunofluorescence microscopy. Three fluorescent labeled monoclonal antibody markers can be assessed. Digital images can be quantitatively analyzed. Preliminary evaluations with blood spiked with NSCLC cell lines were performed. Results: 24 patients were evaluated with at least one determination, 14 had two or more determinations. Stage III A or B (without effusion) = 8, Stage IIIB (effusion) or IV = 16. 16M, 9F. Median age = 61 years. 19 79%(95% CI = 58%–93%) demonstrated CCC at some point in their disease, 12 50% (95%CI = 29%–71%) at baseline. When present, the number of cells detected varied from 1–11 (mean=4, median =2). There was no clear correlation between presence/absence and number of CCC and outcome, but the numbers are small. In vitro marker studies utilizing the system have been successfully performed and pt samples are now being analyzed. Conclusions: 1. Circulating cancer cells are present in the majority of patients with locally advanced (Stage III a and nodal IIIb) and advanced (IIIb (effusion) and IV) NSCLC. 2. It is unclear whether CCC correlate with disease activity. 3. It is feasible to analyze these cells for putative markers of drug sensitivity. Supported in part by NCI SBIR Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration CCC Diagnostics CCC Diagnostics
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