p53 gene therapy in combination with transcatheter arterial chemoembolization for HCC: One-year follow-up

Table 1 Characteristics of enrolled patients with hepatocellular carcinoma

Characteristics	Gene group(n = 68)	Control group(n = 82)	Statistic analysis
Age	43.5 (20 - 72)	45.7 (18 - 75)	NS
Sex (M/F)	43/25	40/42	NS
Child class A	41	43	NS
Child class B	27	39	NS
UICC TNM classification
Stage I and II	0	0	NS
Stage III	31 (46.5%)	60 (73.2%)	NS
Stage IV	37 (54.4%)	22 (26.8%)	NS
Size of main tumors
≥ 5 cm	53 (77.9%)	61 (74.3%)	NS
< 5 cm	15 (22.1%)	21 (25.7%)	NS

NS: No statistical difference.

Table 2 Clinical synptoms after treatments

Group	Fever	Gastrointestinal symptoms	Palliation of mass-associated pain	Pain of muscles or joint
Gene group	35 (51.5)a	20 (29.4)b	30 (44.1)c	9 (13.2)d
Control group	24 (29.3)	28 (34.1)	21 (25.6)	1 (1.2)

χ² = 7.679,

^aP = 0.006; χ² = 4.001,

^bP = 0.062; χ² = 5.674,

^cP = 0.017; χ² = 8.626,

^dP = 0.003.

Table 3 Changes in leukocytes before and after treatment

Group	Change degree (×109/L)			n (%)
	< 4.0	< 3.0	< 2.0
Gene group	12 (25.0)	4 (8.3)	2 (4.2)	18 (37.5)
Control group	8 (13.3)	20 (33.3)	11 (18.3)	39 (65.0)

Rank sum tests (Wilcoxon text), T = -3.018, P = 0.003 < 0.05.

Table 4 Changes in Karnofsky index before and after treatment

Group	Upgrade > 20 points	Upgrade > 10 points	No changes	Downgrade > 10 points	Total upgrade[n (%)]
Gene group	14	28	18	8	42 (61.8)
Control group	12	24	18	28	36 (43.9)

χ² = 4.752, P = 0.029.

Table 5 Therapeutic effect evaluated following response evaluation criteria for solid tumors 2 mo after treatment

Group	n	CR	PR	NC	PD	Effective rate (CR + PR)
Gene group	68	0	46	15	7	67.60%
Control group	82	0	42	27	13	51.20%

χ² = 4.137, P = 0.042 < 0.05. CR: Complete response; PR: Partial response; NC: No change; PD: Progressed disease.