| Literature DB >> 10932224 |
F R Khuri1, J Nemunaitis, I Ganly, J Arseneau, I F Tannock, L Romel, M Gore, J Ironside, R H MacDougall, C Heise, B Randlev, A M Gillenwater, P Bruso, S B Kaye, W K Hong, D H Kirn.
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.Entities:
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Year: 2000 PMID: 10932224 DOI: 10.1038/78638
Source DB: PubMed Journal: Nat Med ISSN: 1078-8956 Impact factor: 53.440