Utility of a molecular prescreening program in advanced colorectal cancer for enrollment on biomarker-selected clinical trials

摘要: BACKGROUND: Incorporation of multiple enrichment biomarkers into prospective clinical trials is an active area investigation, but the factors that determine trial enrollment following a molecular prescreening program have not been assessed. PATIENTS AND METHODS: Patients with 5-fluorouracil-refractory metastatic colorectal cancer at MD Anderson Cancer Center were offered screening in Assessment Targeted Therapies Against Colorectal (ATTACC) to identify eligibility for companion phase I or II therapy targeted aberration detected patient, based on testing by immunohistochemistry, gene sequencing panels, and CpG island methylation phenotype assays. RESULTS: Between August 2010 December 2013, 484 patients enrolled, 458 (95%) had biomarker result, 157 (32%) enrolled (92 biomarker-selected 65 nonbiomarker selected). Of was ninefold higher predefined ATTACC-companion as opposed nonpredefined trials, 17.9% versus 2%, P < 0.001. Factors correlated positively multivariate analysis performance status, older age, lack standard care therapy, established patient Anderson, presence eligible study. Early did result rate remaining enrolling 45.1%, contrast 22.7%; odds ratio 3.1, = 0.002. CONCLUSIONS: Though early resulted increase nonrefractory patients, majority refractory therapy. Within programs, tailoring preidentified open temporally linking treatment optimizing both physician engagement are efforts likely improve trials. CLINICAL TRIALS NUMBER: The study NCT number NCT01196130.