Empiric versus Site-Directed Chemotherapy in Cancer of Unknown Primary

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Empiric versus Site-Directed Chemotherapy in Cancer of Unknown Primary Alwin Krämer Clinical Cooperation Unit Molecular Hematology/Oncology German Cancer Research Center and Dept. of Internal Medicine V, University of Heidelberg

Tissue of Origin Testing Similarity Scores Colorectal 88.2 Pancreas 4.4 NSCLCC 2.3 Breast 2.1 Gastric 1.2 Kidney 0.6 Hepatocellular 0.3 Ovarian Soft Tissue Sarcoma 0.1 NHL Thyroid Prostate Melanoma Bladder GCT 0.0 Core premise: Different tissue types have distinct mRNA profiles Uncertain specimen RNA profile generated >1,500 genes RNA profile compared with known tissue profiles

Gene Expression Profiling in CUP Accuracy of Tissue of Origin Testing

Gene Expression Profiling to Predict the Tissue of Origin and Direct Site-specific Therapy in CUP Patients Hainsworth et al., J Clin Oncol 31: 217-223, 2013

Gene Expression Profiling to Predict the Tissue of Origin and Direct Site-specific Therapy in CUP Patients Overall Survival Hainsworth et al., J Clin Oncol 31: 217-223, 2013

CUP R GEFCAPI 04 Control arm: Empiric chemotherapy (Cisplatin-Gemcitabine) CUP R Personalized treatment Tissue Of Origin® Test Phase III n= 202 pts (HR=0,62 for PFS) Pathwork to provide the TOO test BioTheranostics (Biomerieux): Cancer Type ID® (= CUP-Print) Standardized 92 gene RT-PCR assay Requires 300-500 non-necrotic cancer cells Sensitivity: 85%, Specificity: >99% Courtesy of Karim Fizazi

Hayashi et al., J Clin Oncol 2019 Japanese Trial Hayashi et al., J Clin Oncol 2019

Hayashi et al., J Clin Oncol 2019 CONSORT Diagram Site-specific treatment Hayashi et al., J Clin Oncol 2019

Patient Characteristics Hayashi et al., J Clin Oncol 2019

Results for Site Prediction Hayashi et al., J Clin Oncol 2019