Therapeutic response to a new enzyme-targeting radiosensitization treatment (KORTUC-SC) for patients with chemotherapy-resistant supraclavicular lymph node metastasis

Abstract

We have developed a new radiosensitizer containing hydrogen peroxide and sodium hyaluronate, part of a method we call “KORTUC II”. This study aimed to evaluate the safety and effectiveness of KORTUC II specifically for patients with chemotherapy-resistant supraclavicular lymph node metastasis (KORTUC-SC). Twelve patients were enrolled after providing fully informed written consent. Most of the patients underwent PET-CT examinations prior to and 3-8 months after KORTUC-SC, and every 6 months thereafter if possible. The patients’ age ranged from 58 to 77. The radiotherapy regimen was 4 Gy/ fraction, 3 fractions/ week, for 4 weeks, and the total dose was 48 Gy. The injection of 3 to 6 mL of the agent was started from the fifth radiotherapy fraction, and it was performed twice a week under ultrasonographic guidance. Therapeutic effects were evaluated by PET-CT examinations performed before and after KORTUC-SC treatment. The patients were well tolerated with minimal adverse effects. Of the 12 patients, 4, 5, 2 and 1 patient showed complete response, partial response, stable disease and progressive disease, respectively. The overall survival rate was 83% at 1 year and 75% at 2 years. The mean duration of follow-up at the end of February 2011 was 35.1 months. Based on the PET-CT studies, remarkable therapeutic effects of the KORTUC II treatment were clearly identified. The treatment outcomes were satisfactory. Welldesigned, prospective, randomized, clinical trials are needed to confirm the therapeutic efficacy of KORTUC-SC.