American Surgical Association

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A Prospective Clinical Trial of Personalized Medicine for Operable Pancreatic Cancer
Susan Tsai*, Kathleen K. Christians*, Ben George*, Paul S. Ritch*, Kulwinder Dua*, Abdul H. Khan*, A. Craig Mackinnon*, Parag Tolat*, William A. Hall*, Beth A. Erickson*, Douglas B. Evans
Medical College of Wisconsin, Milwaukee, WI

OBJECTIVE(S): One facet of precision medicine is the use of tumor molecular profiling to guide chemotherapeutic selection and maximize treatment response. We conducted the first prospective clinical trial utilizing molecular profiling to guide neoadjuvant therapy in patients with operable pancreatic cancer (PC).
METHODS: In patients with resectable and borderline resectable(BLR) PC, molecular profiling consisted of immunocytochemical staining of pretreatment EUS-FNA tumor biopsies using 6 biomarkers. Neoadjuvant systemic therapy was selected based on the molecular profiling. We hypothesized that more effective systemic therapy would prevent disease progression during neoadjuvant therapy therefore allowing more patients to undergo surgery. The primary endpoint was the completion of all intended neoadjuvant therapy and surgery.
RESULTS: The trial enrolled 130 patients; 60 (47%) resectable and 69 (53%) BLR patients. Molecular profiling was reported within a median of 5 business days (IQR:3). Of the 130 patient samples, 94 (72%) had adequate cellularity for molecular profiling. Of the 94 patients who had molecular profiling performed, 74 (79%) received fluoropyrimidine-based therapy and 20 (21%) received gemcitabine-based therapies. Of the 130 patients, 107 (82%) completed all intended neoadjuvant therapy and surgery; 55 (92%) of the 60 with resectable PC and 52 (74%) of 70 with BLR PC.
CONCLUSIONS: This is the first prospective neoadjuvant clinical trial to utilize molecular profiling to select neoadjuvant therapy in patients with operable PC. Such high resectability rates have not been observed in prior clinical trials of neoadjuvant therapy, suggesting that molecular profiling may improve the efficacy of chemotherapy in patients with localized operable PC..

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