Author: ["Fadlo R. Khuri","John Nemunaitis","Ian Ganly","James Arseneau","Ian F. Tannock","Larry Romel","Martin Gore","Janet Ironside","R.H. MacDougall","Carla Heise","Britta Randlev","Ann M. Gillenwater","Patricia Bruso","Stanley B. Kaye","Waun Ki Hong","David H. Kirn"]
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Abstract
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.
Cite this article
Khuri, F., Nemunaitis, J., Ganly, I. et al. 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. Nat Med 6, 879–885 (2000). https://doi.org/10.1038/78638