Tumor response evaluation criteria for HCC (hepatocellular carcinoma) treated using TACE (transcatheter arterial chemoembolization): RECIST (response evaluation criteria in solid tumors) version 1.1 and mRECIST (modified RECIST): JIVROSG-0602

Figures & data

Figure 1. A: RECIST ver. 1.1: Response was defined according to a unidimensional measurement of the entire lesion, including the necrotic part. B: mRECIST: Response was defined according to a unidimensional measurement of the viable part, excluding the necrotic part.

Table I. Patients and characteristics.

No. of patients	21
Age, median (range)	68 (27–74)
Sex (male/female)	19/2
HCV/HBV/others	12/3/6
Child–Pugh A/B	20/1
No. of nodules, all (range)	65 (1–5)
Mean tumor size (range), mm	20 (10–132)

HCV = hepatitis C virus; HBV = hepatitis B virus.

Table II. Inter-criteria reproducibility between RECIST version 1.1 and mRECIST criteria. Number of lesions (%).

Response category	Complete response	Partial response	Stable disease	Progressive disease	Overall response^a
Response criteria
RECIST	30 (9.2)	110 (33.8)	180 (55.4)	5 (1.5)	140 (43.1)
	P < 0.001				P < 0.001
mRECIST	185 (56.9)	74 (22.8)	65 (20)	1 (3)	259 (79.7)

^aComplete response + partial response.

RECIST = Response Evaluation Criteria in Solid Tumors; mRECIST = modified RECIST.

Table III. Inter-criteria reproducibility between RECIST version 1.1 and mRECIST criteria: distribution chart.

		RECIST
		Complete response	Partial response	Stable disease	Progressive disease	Total
mRECIST	Complete response	30	89	64	2	185
	Partial response	0	21	53	0	74
	Stable disease	0	0	63	2	65
	Progressive disease	0	0	0	1	1
Total		30	110	180	5	325

Proportion of agreement = 35.5%. Kappa = 0.149.

Table IV. Inter-observer reproducibility.

	Kappa	Proportion of agreement (%)
Inter-observer reproducibility
RECIST	0.628 (95% CI 0.571–0.684)	78.8
mRECIST	0.829 (95% CI 0.792–0.866)	90.0

Table V. Intra-observer reproducibility.

	Kappa	Proportion of agreement (%)
Intra-observer reproducibility
RECIST	0.643 (95% CI 0.565–0.722)	79.4
mRECIST	0.900 (95% CI 0.858–0.942)	94.2

Figure 2. A: CT before TACE: Both criteria (RECIST version 1.1 and mRECIST) measured the longest diameter of the tumor. B: CT after TACE: The tumor had become entirely necrotic. The tumor response was evaluated as CR using mRECIST criteria (i.e. no measurement) and as non-CR using RECIST version 1.1 criteria (i.e. the measurement of the longest diameter of the entire tumor).