9625 Background: Determining the anatomical site of origin is fundamental for the optimal treatment of patients with cancer. Currently there are no definitive, cost-effective analytical methods to identify the site of origin in carcinoma when the primary is unknown or uncertain. This study was undertaken to demonstrate that when applied to microarray gene expression data, PathWork Informatics' analytical models convert gene expression profiles into actionable reports that identify the site of origin for tumors of unknown or uncertain origin. Methods: Published data from a variety of sources was used. The data comprised output files from microarray (Affymetrix U95a or U133) processing of 499 frozen tumor tissue samples. Each specimen was from a primary or metastatic lesion from one of ten known sites (prostate, breast, colorectum, lung, liver, gastroesophagus, pancreas, ovary, kidney, and bladder/ureter). All data was analyzed by the PathWork Informatics software system. Results: Results show that the analytical system is highly sensitive and specific. Of the 10 tests that comprise the system (1 per site of origin), 9 demonstrated 100% specificity; and 5 demonstrated greater than 80% sensitivity, while all demonstrated greater than 65% sensitivity. Conclusions: This novel analytic system can identify the site of origin in a high percentage of tumors, allowing for highly predictive, laboratory-independent classification of microarray data, with high potential clinical utility. No significant financial relationships to disclose.
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Moraleda et al. (2004) studied this question.