title: Clinical study of recombinant adenovirus-p53 combined with fractionated stereotactic radiotherapy for hepatocellular carcinoma.
abstract: 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.
authors.affiliation: Cancer Center, Daping Hospital and Institute of Surgery Research, Third Military Medical University, 400042, Chongqing, China. yzhixiang122@tom.com
authors.forename: Zhi-xiang
authors.initials: ZX
authors.lastname: Yang
authors.forename: Dong
authors.initials: D
authors.lastname: Wang
authors.forename: Ge
authors.initials: G
authors.lastname: Wang
authors.forename: Qin-hong
authors.initials: QH
authors.lastname: Zhang
authors.forename: Jing-mao
authors.initials: JM
authors.lastname: Liu
authors.forename: Po
authors.initials: P
authors.lastname: Peng
authors.forename: Xiao-hui
authors.initials: XH
authors.lastname: Liu
mesh_terms: 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