A controlled trial of intratumoral ONYX-015, a selectively-replicating adenovirus, in combination with cisplatin and 5-fluorouracil in patients with recurrent head and neck cancer Academic Article uri icon


MeSH Major

  • Adenoviruses, Human
  • Cisplatin
  • Fluorouracil
  • Genetic Therapy
  • Head and Neck Neoplasms
  • Neoplasm Recurrence, Local


  • ONYX-015 is an adenovirus with the E1B 55-kDa gene deleted, engineered to selectively replicate in and lyse p53-deficient cancer cells while sparing normal cells. Although ONYX-015 and chemotherapy have demonstrated anti-tumoral activity in patients with recurrent head and neck cancer, disease recurs rapidly with either therapy alone. We undertook a phase II trial of a combination of intratumoral ONYX-015 injection with cisplatin and 5-fluorouracil in patients with recurrent squamous cell cancer of the head and neck. There were substantial objective responses, including a high proportion of complete responses. By 6 months, none of the responding tumors had progressed, whereas all non-injected tumors treated with chemotherapy alone had progressed. The toxic effects that occurred were acceptable. Tumor biopsies obtained after treatment showed tumor-selective viral replication and necrosis induction.

publication date

  • August 2000



  • Academic Article



  • eng

Digital Object Identifier (DOI)

  • 10.1038/78638

PubMed ID

  • 10932224

Additional Document Info

start page

  • 879

end page

  • 85


  • 6


  • 8