An overview of the initial experience with AK-2123 as a hypoxic cell sensitizer with radiation in the treatment of advanced head and neck cancers.

PURPOSE: AK-2123 (Senazole) is a nitrotriazole with a reported potential for hypoxic cell sensitization. The present study was conducted to evaluate hypoxic cell potentiation in patients with advanced head and neck cancer treated with discontinuous accelerated hyperfractionated radiation. METHODS AND MATERIALS: Histologically proven unresectable oro-pharyngeal cancers Stage T3-4, NO-3 and M0 were randomly allocated to receive discontinuous accelerated hyperfractionated radiation alone or with AK-2123. AK-2123 (880 and 990 mg) was administered as an i.v. infusion between the first and second fraction of radiation for 10 days in two groups of patients. Initial response as a surrogate end point has been analyzed for comparison and documented for follow-up status.
RESULTS: A 100% complete response was observed in both the AK-2123-treated groups (880 mg and 990 mg), while a 44.4% complete response was observed in the control group. There were no treatment-related deaths. Neurotoxicity was not reported.
CONCLUSION: AK-2123 (Senazole) when administered with discontinuous accelerated hyperfractionated radiation showed a significant potentiation that, therefore, requires further evaluation.

RCT Entities:   Population Interventions Outcomes