Long-term results of a phase II clinical trial of superantigen therapy with staphylococcal enterotoxin C after microwave ablation in hepatocellular carcinoma.
OBJECTIVE
To prospectively evaluate safety and effectiveness of intratumoural injection of superantigen staphylococcal enterotoxin C (SEC) for hepatocellular carcinoma (HCC) after percutaneous microwave ablation (PMWA).


METHODS
HCC patients (260) with tumours of 60 mm or less (average 29.2 ± 11.1 mm) that achieved technique effectiveness evidenced on imagings within one week of PMWA were enrolled. The SEC group consisted of 45 patients with 2000 U SEC injected into the marginal area of ablated tumour under ultrasound guidance on day 24, 28 and month 2, 5, and 7 after PMWA. The control group consisted of 215 patients receiving PMWA alone.


RESULTS
The overall survival rates for 1, 3, and 5 years were 93.3%, 72.9%, 60.8% in the SEC group and 94%, 66%, 44.4% in the control group. The overall survival time had significant difference (p = 0.032). Treatment method was prognostic significance for overall survival on univariate (p = 0.045) and multivariate (p = 0.049) analyses. The disease-free survival time of the SEC group was longer than the control group (p = 0.195). The disease free survival rates at 1 and 3 years were 62% versus 56.6%, 37% versus 9.4% in the SEC and control subgroup of larger (D > 30 mm) tumours, and disease free survival time had significant difference (p = 0.032). Treatment method was a prognostic significance factor for disease free survival of larger tumours on univariate (p = 0.03) and multivariate (p = 0.023) analyses but was not for small tumours. No serious adverse event related to SEC injection happened.


CONCLUSIONS
Local superantigen injection at ablated HCC early after PMWA is safe, and achieves longer overall survival as well as disease free survival of larger tumours.
Department of Interventional Ultrasound, Chinese PLA General Hospital, Beijing, China.
Pei
P
Zhou
Ping
P
Liang
Baowei
B
Dong
Xiaoling
X
Yu
Xiujie
X
Han
Yang
Y
Wang
Zhiyu
Z
Han
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000601:surgery / Q000628:therapy*; D017115:Catheter Ablation / Q000379:methods; D018572:Disease-Free Survival; D004768:Enterotoxins / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000601:surgery / Q000628:therapy*; D008297:Male; D008872:Microwaves / Q000627:therapeutic use*; D008875:Middle Aged; D011379:Prognosis; D018089:Superantigens / Q000627:therapeutic use*; D015996:Survival Rate
D004768:Enterotoxins; D018089:Superantigens; C034959:enterotoxin C, staphylococcal