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.
Original language | English |
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Pages (from-to) | 879-885 |
Number of pages | 7 |
Journal | Nature Medicine |
Volume | 6 |
Issue number | 8 |
DOIs | |
Publication status | Published - Aug 2000 |
Keywords
- TUMOR-NECROSIS-FACTOR
- SQUAMOUS-CELL CARCINOMA
- HIGH-DOSE CISPLATIN
- 5-FU INFUSION
- PHASE-III
- CHEMOTHERAPEUTIC-AGENTS
- MONOCLONAL-ANTIBODIES
- PHARMACOKINETIC MODEL
- ONCOLOGY-GROUP
- P53