Phase I study of cetuximab, intensity-modulated radiotherapy (C-IMRT), and intratumoral EGFR antisense (AS) DNA in patients with locally advanced head and neck cancer (HNC)

Autor: Jennifer R. Grandis, Dwight E. Heron, Seungwon Kim, D.A. Clump, Athanassios Argiris, Jonas T. Johnson, Frank R. Miller, Robert L. Ferris, Ahmad Mouhamad Wehbe, Umamaheswar Duvvuri, Julie E. Bauman, William E. Gooding, James Ohr, Brian J Karlovits
Rok vydání: 2015
Předmět:
Zdroj: Journal of Clinical Oncology. 33:6074-6074
ISSN: 1527-7755
0732-183X
Popis: 6074 Background: Epidermal growth factor receptor (EGFR) is a validated therapeutic target in HNC. The combination of C-IMRT is a standard for locally advanced HNC; however, failure of locoregional control (LRC) remains the primary cause of cancer-related death. Intratumoral injection of EGFR-AS DNA oligonucleotide was safe and associated with promising lesional response in a phase I study. We conducted a phase I trial to evaluate the safety of C-IMRT and EGFR-AS DNA injections in patients with locally advanced HNC. Methods: Eligible patients had Stage IVa-IVc HNC, ECOG 0-2, no prior RT, and a measurable lesion accessible for repeated injection. Treatment course was 9 wks. C was loaded wk 1 then administered 250 mg/m2/wk for 8 wks. EGFR-AS DNA (11.92mg/1.78mL; no dose modifications) was injected weekly into the selected lesion starting wk 1 until complete response (CR) or a maximum of 7 injections. IMRT (70 Gy; 2 Gy/fraction) was delivered wks 3-9. Biopsies of injected lesions were obtained at baseline an...
Databáze: OpenAIRE