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Title Feasibility and clinical impact of next generation genomic sequencing in selected solid tumor patients

IRB CASE1Y13

CC 13-545

Hospital Main Campus

Disease Adrenal, Biliary, Bladder, Brain, Breast, Colorectal, Glioblastoma, Head and Neck, High Grade Glioma, Lung, Lung - Mesothelioma, Melanoma, Pancreas, Prostate, Renal

Description

1. To evaluate the feasibility of conducting genomic analyses on tumor tissues collected from solid tumor patients seen at the Cleveland Clinic. Feasibility will be defined as the proportion of patients signing consent who are able to have tumor tissue shipped to Foundation Medicine within 14 days of patient consent.

1. To evaluate the time it takes for Foundation Medicine to provide results. We will evaluate what proportion of patients have a result delivered from Foundation Medicine within 21 days of shipment of sample to them.
2. To analyze what proportion of genomic analyses yield actionable genetic aberrations, and what proportion lead to change in patient management plan. Actionable will be defined as a mutation linked to an approved therapy in the solid tumor under study or another solid tumor, a known or suspected contraindication to a given therapy, or a clinical trial linked to the alteration.
3. To evaluate clinical outcomes of specific therapies chosen to target these aberrations. Standard clinical outcome measures (objective response rate, progression-free survival) will be captured.
4. To evaluate the cost implications associated with this testing and subsequent treatment selection, compared with non-genomic-directed standard of care therapy.

Inclusion Criteria

1. Solid tumor with a confirmed histopathologic diagnosis falling into one of the following categories and without a known curative therapeutic option:
   • Metastatic/locally-advanced carcinoma of unknown primary - this includes tumors in which the pathology reads poorly differentiated (adeno)carcinoma in which the primary organ site cannot be discerned with certainty despite adequate clinical, laboratory and radiologic investigations
   • Metastatic/locally-advanced non-small cell lung cancer in a non/light/distant smoker (less than 10 pack-years smoking history, or quit smoking more than 15 years prior) without known EGFR or EML4-ALK mutation in the tumor
   • Unresectable pancreatobiliary cancer
   • Head and neck squamous cell carcinoma, after failure of primary therapy
   • Metastatic/unresectable pleural mesothelioma
   • Metastatic breast cancer: either triple-negative-defined as ER-negative (<1%), PR-negative (<1%), HER2 non-amplified (IHC 0/1 or FISH ratio <2.0) at any line of therapy; or hormone receptor positive/HER2 negative that are endocrine therapy and/or chemotherapy resistant (progressed on more than 2 lines of endocrine therapy and/or more than 2 chemotherapy regimens in the metastatic setting)
   • Metastatic colorectal cancer
2. Age ≥ 18 years
3. ECOG performance status 0, 1 or 2
4. Measurable and/or evaluable disease per RECIST version 1.1
5. Prior therapies (e.g. chemotherapy, targeted therapy, surgery, radiation) are permitted but not required

Exclusion Criteria