Precision medicine: Preliminary results from the initiative for molecular profiling and advanced cancer therapy 2 (IMPACT 2) study

Abstract

Background: Precision medicine is associated with favorable outcomes in selected patients. We initiated IMPACT 2, a randomized study to compare PFS in patients with metastatic cancer treated on the basis of tumor genomic profiling results vs. those whose treatment was not selected based on genomic analysis. Herein, we assessed the association between patient characteristics and overall survival (OS). Methods: Patients with advanced, metastatic cancer underwent tumor biopsy and genomic profiling (Foundation One). Variants were filtered to eliminate germline mutations (annotation, ANNOVAR) and artifacts. Patients were presented at tumor board and were randomized if they met criteria for clinical trials. OS was measured from enrollment on study until last follow-up or death from any cause. Results: From 5/2014 to 4/2017, 320 of 391 enrolled patients completed tumor profiling. Baseline characteristics (n=320) were as follows: men, 47%; median age, 63 yrs (range, 25-83); performance status 1, 88%; median no. of prior therapies, 3 (range, 0- 14); liver metastases, 40%; albumin <3.5 g/L, 12%; LDH> 618 IU/L, 29%; platelet count > or