Table 3.

Concordance assessment of KRASG12/G13 mutations in FFPE tumor tissue and urine cfDNA from patients with advanced cancers

Concordance for urine samples collected before systemic therapy tested for KRASG12/G13 mutations versus FFPE tumor samples tested in the clinical laboratory
Number of patients, N = 71KRASG12/G13 mutation in tumorKRASG12/G13 wild-type in tumor
KRASG12/G13 mutation in cfDNA, number of patients301
KRASG12/G13 wild-type in cfDNA, number of patients1822
Observed concordance52 (73%); kappa, 0.49; SE, 0.09; 95% CI, 0.31–0.66
Sensitivity63% (95% CI, 0.47–0.76)
Specificity96% (95% CI, 0.78–1.00)
PPV97% (95% CI, 0.83–1.00)
Concordance for urine samples (>50 mL of urine) collected before systemic therapy tested for KRASG12/G13 mutations versus FFPE tumor samples tested in the clinical laboratory
Number of patients, N = 43KRASG12/G13 mutation in tumorKRASG12/G13 wild-type in tumor
KRASG12/G13 mutation in cfDNA, number of patients190
KRASG12/G13 wild-type in cfDNA, number of patients1014
Observed concordance33 (77%); kappa, 0.55; SE, 0.11; 95% CI, 0.34–0.77
Sensitivity66% (95% CI, 0.46–0.82)
Specificity100% (95% CI, 0.77–1.00)
PPV100% (95% CI, 0.82–1.00)
Concordance for urine samples (90–110 mL of urine) collected before systemic therapy tested for KRASG12/G13 mutations versus FFPE tumor samples tested in the clinical laboratory
Number of patients, N = 19KRASG12/G13 mutation in tumorKRASG12/G13 wild-type in tumor
KRASG12/G13 mutation in cfDNA, number of patients80
KRASG12/G13 wild-type in cfDNA, number of patients29
Observed concordance17 (89%); kappa, 0.79; SE, 0.14; 95% CI, 0.52–1.00
Sensitivity80% (95% CI, 0.44–0.97)
Specificity100% (95% CI, 0.66–1.00)
PPV100% (95% CI, 0.63–1.00)