Technology assessment of molecular pathology testing for the estimation of prognosis for common cancers

Meleth S, Reeder-Hayes K, Ashok M, Clark R, Funkhouser W, Wines R, Hill C, Shanahan E, McClure E, Burson K, Coker-Schwimmer M, Garge N, Jonas DE
Record ID 32014001088
Authors' objectives: To conduct a systematic review and meta-analysis assessing the prognostic value and test performance (analytic validity, clinical validity, clinical utility, and harms) associated with 11 prognostic molecular pathology tests. Many of these tests are indicated for prediction of therapeutic responses, but this review focuses on their potential use as prognostic factors. Our overarching question was whether there is direct evidence that the addition of these molecular pathology tests changed physician decisionmaking and improved outcomes for adult patients. We evaluated the following tests: microsatellite instability assessment by polymerase chain reaction (PCR) for colorectal cancer (CRC), MLH1 promoter methylation for CRC, KRAS mutation testing for CRC, BRAF mutation testing for CRC, Oncotype DX Colon mRNA expression for CRC, Oncotype DX Breast mRNA expression for breast cancer, MammaPrint mRNA expression for breast cancer, ALK cytogenetics for lung cancer, EGFR mutation testing for lung cancer, KRAS mutation testing for lung cancer, and UroVysion cytogenetics for urinary bladder cancer.
Authors' recomendations: Modest evidence supports added prognostic value (i.e., clinical validity) for over half of the tests evaluated, and that Oncotype DX Breast leads to changes in treatment decisions, but we found no evidence to determine whether using the tests to estimate prognosis leads to improved outcomes for patients.
Project Status: Completed
Year Published: 2014
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: United States
MeSH Terms
  • Humans
  • Molecular Diagnostic Techniques
  • Neoplasms
Organisation Name: Agency for Healthcare Research and Quality
Contact Address: Center for Outcomes and Evidence Technology Assessment Program, 540 Gaither Road, Rockville, MD 20850, USA. Tel: +1 301 427 1610; Fax: +1 301 427 1639;
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Copyright: Agency for Healthcare Research and Quality (AHRQ)
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