Clinical study of recombinant adenovirus-p53 combined with fractionated stereotactic radiotherapy for hepatocellular carcinoma.
OBJECTIVE
The purpose of our study was to evaluate the feasibility and treatment outcomes of recombinant adenovirus-p53 (rAd-p53, trademarked as Gendicine) combined with fractionated stereotactic radiotherapy (fSRT) in treatment of primary hepatocellular carcinoma (HCC).


METHODS
We randomly enrolled 40 patients with HCC treated by fSRT alone (fSRT group) or rAd-p53 combined with fSRT (combined group). Tumor size was 2-5.2 cm (average 3.2 cm). We prescribed 50 Gy in 10 fractions at the 50%-80% isodose line of the planning target volume for 2 weeks in two groups. The combined group was treated with two intratumoral injections of rAd-p53 on day 1 and 8 while fSRT started on day 3. Tumor response was assessed after treatment using modified WHO criteria. The follow-up period was 11-44 months (median 35 months).


RESULTS
The overall response rate of fSRT group was 70%, with 4 patients showing complete response (20%), 10 partial response (50%) and 6 stable disease (30%). Correspondingly the overall response rate of combined group was 85%, with 7 patients showing complete response (35%), 10 partial response (50%) and 3 stable disease (15%). The 1-year survival rates of fSRT group and combined group were 70.0% and 90.0%, respectively. The 1-year disease-free survival rates of fSRT group and combined group were 65% and 85%, respectively. These treatments were well tolerated, because grade 3 or 4 toxicity was not observed.


CONCLUSIONS
These results suggest that rAd-p53 combined with fSRT is a relatively safe and effective method for treating primary hepatocellular carcinoma compared with only fSRT. Thus, rAd-p53 combined with fractionated SRT may be preferred as a choice of local treatment for primary HCC when the patients are inoperable or when the patients refuse operation.
Yang
Zhi-xiang
ZX
Cancer Center, Daping Hospital and Institute of Surgery Research, Third Military Medical University, 400042, Chongqing, China. yzhixiang122@tom.com
Wang
Dong
D
Wang
Ge
G
Zhang
Qin-hong
QH
Liu
Jing-mao
JM
Peng
Po
P
Liu
Xiao-hui
XH
D000256:Adenoviridae / Q000235:genetics*; D000328:Adult; D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D016158:Genes, p53; D015316:Genetic Therapy; D006801:Humans; D008113:Liver Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016634:Radiosurgery; D011879:Radiotherapy Dosage; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome