Table 2.

Sensitivity and specificity of AFP cutoffs in differentiating patients by response status per IRF-assessed RECIST 1.1 and HCC mRECIST.

	RECIST 1.1		HCC mRECIST
	(n = 144)		(n = 144)
Point estimate (95% CI)	≥75% AFP decrease (responders vs. nonresponders)	≤10% AFP increase (disease control vs. primary progressors)	≥75% AFP decrease (responders vs. nonresponders)	≤10% AFP increase (disease control vs. primary progressors)
Sensitivity	0.59 (0.42–0.74)	0.77 (0.68–0.85)	0.56 (0.41–0.70)	0.77 (0.68–0.85)
Specificity	0.86 (0.78–0.92)	0.44 (0.27–0.62)	0.89 (0.81–0.95)	0.43 (0.26–0.61)
Positive predictive value	0.61 (0.43–0.76)	0.82 (0.73–0.89)	0.74 (0.57–0.87)	0.81 (0.72–0.88)
Negative predictive value	0.85 (0.77–0.91)	0.38 (0.23–0.54)	0.79 (0.70–0.87)	0.38 (0.23–0.54)
Area under the curve	0.78	0.66	0.75	0.67

Abbreviations: AFP, alpha-fetoprotein; HCC mRECIST, HCC-modified RECIST; IRF, independent review facility; RECIST 1.1, Response Evaluation Criteria in Solid Tumors version 1.1.