[Phase III randomized clinical trial of intratumoral injection of E1B gene-deleted adenovirus (H101) combined with cisplatin-based chemotherapy in treating squamous cell cancer of head and neck or esophagus]

Ai Zheng. 2004 Dec;23(12):1666-70.
[Article in Chinese]


Background & objective: H101 is an E1B-55 kDa gene-deleted replication-selective adenovirus, which showed a significant antitumor activity. This study was to compare effects and toxicities of intratumoral H101 injection combined with cisplatin plus 5-fluorouracil (PF) regimen or adriamycin plus 5-fluorouracil (AF) regimen versus PF or AF regimen alone in treating patients with head and neck or esophagus squamous cell cancer.

Methods: A total of 160 patients were recruited. PF regimen (cisplatin 20 mg/m(2) ivgtt, qd x 5d; 5-fluorouracil 500 mg/m(2) ivgtt, qd x 5d) was administered to patients have no history of PF chemotherapy,or sensitive to PF chemotherapy,while AF regimen (adriamycin 50 mg/m(2) iv,d1; 5-fluorouracil 500 mg/m(2) ivgtt, qd x 5d) was administered to patients didn't response to PF regimen. All patients were randomized to either receive intratumoral H101 injection (5.0 x 10(11)-1.5 x 10(12) VP/day for 5 consecutive days every 3 weeks) or not. Treatment repeated every 3 weeks,all patients have to receive at least 2 cycles of chemotherapy.

Results: Among 123 accordant patients,overall response rate of PF plus H101 group (group A1) was 78.8% (41/52),of PF alone group (group B1) was 39.6% (21/53),of AF plus H101 group (group A2) was 50.0% (7/14),of AF alone group (group B2) was 50.0% (2/4). Differences of response rates between group A1 and group B1,between group A1+A2 and group B1+B2 were significant (P=0.000). Main side effects were fever (45.7%), injection site reaction (28.3%),and influenza-like symptoms (9.8%).

Conclusion: Intratumoral H101 injection showed a distinct efficacy in patients with squamous cell cancer of head and neck or esophagus,and was relatively safe.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • English Abstract
  • Randomized Controlled Trial

MeSH terms

  • Adenoviridae / genetics
  • Adenoviridae / physiology*
  • Adenovirus E1B Proteins / deficiency*
  • Adenovirus E1B Proteins / genetics
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Biological Therapy* / adverse effects
  • Carcinoma, Squamous Cell / therapy
  • Cisplatin / administration & dosage
  • Combined Modality Therapy / adverse effects
  • Doxorubicin / administration & dosage
  • Esophageal Neoplasms / therapy*
  • Female
  • Fever / etiology
  • Fluorouracil / administration & dosage
  • Humans
  • Injections, Intralesional
  • Male
  • Middle Aged
  • Nasopharyngeal Neoplasms / therapy*


  • Adenovirus E1B Proteins
  • Doxorubicin
  • Cisplatin
  • Fluorouracil