British Journal of Cancer (2011) 105, 640–648. doi:10.1038/bjc.2011.292www.bjcancer.com
Published online 9 August 2011
Treatment of advanced hepatocellular carcinoma with very low levels of amplitude-modulated electromagnetic fields
F P Costa1, A C de Oliveira1, R Meirelles1, M C C Machado1, T Zanesco1, R Surjan1, M C Chammas2, M de Souza Rocha2, D Morgan3, A Cantor4, J Zimmerman5, I Brezovich6, N Kuster7, A Barbault8 and B Pasche5
- 1Department of Transplantation and Liver Surgery, Hospital das Clínicas da Faculdade de Medicina, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo 05403-000, Brazil
- 2Department of Radiology, Hospital das Clínicas, University of São Paulo, São Paulo 05403-000, Brazil
- 3Department of Radiology, University of Alabama at Birmingham and UAB Comprehensive Cancer Center, Birmingham, AL 35294, USA
- 4Biostatistics and Bioinformatics Shared Facility, University of Alabama at Birmingham and UAB Comprehensive Cancer Center, Birmingham, AL 35294, USA
- 5Division of Hematology/Oncology, Department of Medicine, University of Alabama at Birmingham and UAB Comprehensive Cancer Center, 1802 6th Ave South, NP 2566, Birmingham, AL 35294-3300, USA
- 6Department of Radiation Oncology, The University of Alabama at Birmingham and UAB Comprehensive Cancer Center, Birmingham, AL 35294, USA
- 7IT'IS Foundation, Swiss Federal Institute of Technology, Zurich, Switzerland
- 8Rue de Verdun 20, Colmar 68000, France
Revised 4 July 2011; Accepted 6 July 2011; Published online 9 August 2011.
Therapeutic options for patients with advanced hepatocellular carcinoma (HCC) are limited. There is emerging evidence that the growth of cancer cells may be altered by very low levels of electromagnetic fields modulated at specific frequencies.
A single-group, open-label, phase I/II study was performed to assess the safety and effectiveness of the intrabuccal administration of very low levels of electromagnetic fields amplitude modulated at HCC-specific frequencies in 41 patients with advanced HCC and limited therapeutic options. Three-daily 60-min outpatient treatments were administered until disease progression or death. Imaging studies were performed every 8 weeks. The primary efficacy end point was progression-free survival 6 months. Secondary efficacy end points were progression-free survival and overall survival.
Treatment was well tolerated and there were no NCI grade 2, 3 or 4 toxicities. In all, 14 patients (34.1%) had stable disease for more than 6 months. Median progression-free survival was 4.4 months (95% CI 2.1–5.3) and median overall survival was 6.7 months (95% CI 3.0–10.2). There were three partial and one near complete responses.
Treatment with intrabuccally administered amplitude-modulated electromagnetic fields is safe, well tolerated, and shows evidence of antitumour effects in patients with advanced HCC.
hepatocellular carcinoma; phase II study; radiofrequency electromagnetic fields; tumour-specific modulation frequencies; 27.12 MHz
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