Table 4.
Performance of biomarker elevations during months 37 to 48 in predicting HCC during months 37-60 in the entire cohort (table 4a) and in those with cirrhosis (table 4b).
| Table 4a All Patients |
No HCC | HCC | Total | Sens* | Spec* | PPV | NPV | % Elev | AUC | p |
|---|---|---|---|---|---|---|---|---|---|---|
| Number | 718 | 25 | 743 | |||||||
| Maximum M37-M48 | ||||||||||
| AFP >=20, % | 138 | 15 | 153 | 60% | 81% | 10% | 98% | 21% | 0.70 | <0.0001 |
| AFP >=50, % | 57 | 10 | 67 | 40% | 92% | 15% | 98% | 9% | 0.66 | <0.0001 |
| AFP >=200, % | 11 | 5 | 16 | 20% | 98% | 31% | 97% | 2% | 0.59 | <0.0001 |
| AFP >=20 & 2× mean prev yr, % | 31 | 8 | 39 | 32% | 96% | 21% | 98% | 5% | 0.64 | <0.0001 |
| AFP L3% >=10%, % | 31 | 6 | 37 | 24% | 96% | 16% | 97% | 5% | 0.60 | <0.0001 |
| AFP >=20 & AFP L3% >10%, % | 13 | 6 | 19 | 24% | 98% | 32% | 97% | 3% | 0.61 | <0.0001 |
| DCP >=40, % | 358 | 16 | 374 | 64% | 50% | 4% | 98% | 50% | 0.57 | 0.17 |
| DCP >=90, % | 100 | 12 | 112 | 48% | 86% | 11% | 98% | 15% | 0.67 | <0.0001 |
| DCP >=150, % | 58 | 11 | 69 | 44% | 92% | 16% | 98% | 9% | 0.68 | <0.0001 |
| DCP >=90 & 2× mean prev yr, % | 71 | 10 | 81 | 40% | 90% | 12% | 98% | 11% | 0.65 | <0.0001 |
| AFP >=20 & DCP >=90, % | 22 | 7 | 29 | 28% | 97% | 24% | 97% | 4% | 0.63 | <0.0001 |
| AFP >=20 & DCP >=90 & AFP L3% > 10%, % | 3 | 5 | 8 | 20% | 100% | 63% | 97% | 1% | 0.60 | <0.0001 |
| Table 4b Patients with cirrhosis at S00 or M24 | No HCC | HCC | Total | Sens* | Spec* | PPV | NPV | % Elev | AUC | p |
|---|---|---|---|---|---|---|---|---|---|---|
| Number | 358 | 20 | 378 | |||||||
| Maximum M37-M48 | ||||||||||
| AFP >=20, % | 93 | 11 | 104 | 55% | 74% | 11% | 97% | 28% | 0.65 | 0.007 |
| AFP >=50, % | 43 | 8 | 51 | 40% | 88% | 16% | 96% | 13% | 0.64 | 0.001 |
| AFP >=200, % | 9 | 4 | 13 | 20% | 97% | 31% | 96% | 3% | 0.59 | 0.0005 |
| AFP >=20 & 2× mean prev yr, % | 21 | 5 | 26 | 25% | 94% | 19% | 96% | 7% | 0.60 | 0.003 |
| AFP L3% >=10%, % | 18 | 5 | 23 | 25% | 95% | 22% | 96% | 6% | 0.60 | 0.001 |
| AFP >=20 & AFP L3% >10%, % | 9 | 5 | 14 | 25% | 97% | 36% | 96% | 4% | 0.61 | <0.0001 |
| DCP >=40, % | 205 | 13 | 218 | 65% | 43% | 6% | 96% | 58% | 0.54 | 0.50 |
| DCP >=90, % | 65 | 11 | 76 | 55% | 82% | 14% | 97% | 20% | 0.68 | 0.0003 |
| DCP >=150, % | 40 | 10 | 50 | 50% | 89% | 20% | 97% | 13% | 0.69 | <0.0001 |
| DCP >=90 & 2× mean prev yr, % | 47 | 9 | 56 | 45% | 87% | 16% | 97% | 15% | 0.66 | 0.0004 |
| AFP >=20 & DCP >=90, % | 20 | 6 | 26 | 30% | 94% | 23% | 96% | 7% | 0.62 | 0.0002 |
| AFP >=20 & DCP >=90 & AFP L3% > 10%, % | 3 | 4 | 7 | 20% | 99% | 57% | 96% | 2% | 0.60 | <0.0001 |
*
This table includes 743 patients who had at least one biomarker measurement between months 37 and 48 and did not develop HCC before month 37. Twenty-five of these developed HCC between months 37 and 60. Patients are classified according to the maximum biomarker measurement during months 37-48. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), were calculated comparing patients with and without HCC. Area under the receiver operating characteristic curve (AUC) and P values are based on logistic regression analyses.