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 potenti al 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 r adiation. Methods and Materials: Histologically proven unresectable or e-pharyngeal cancers Stage T3-4, N0-3, 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 the second fraction of radiation for 1 0 days in two groups of patients. Initial response as a surrogate end point has been analyzed for comparison and documented for follow-up st atus. Results: A 100% complete response was observed in both the AK-21 23-treated groups (880 mg and 990 mg), chile, a 44.4% complete respons e was observed in the control group. There were no treatment-related d eaths. Neurotoxicity was not reported. Conclusion: Ak-2123 (Senazole) when administered with discontinuous accelerated hyperfractionated rad iation showed significant potentiation that, therefore, requires furth er evaluation.