title: Treatment of advanced hepatocellular carcinoma with very low levels of amplitude-modulated electromagnetic fields.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Treatment with intrabuccally administered amplitude-modulated electromagnetic fields is safe, well tolerated, and shows evidence of antitumour effects in patients with advanced HCC.
authors.affiliation: Department 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. fredericoperegocosta@gmail.com
authors.forename: F P
authors.initials: FP
authors.lastname: Costa
authors.forename: A C
authors.initials: AC
authors.lastname: de Oliveira
authors.forename: R
authors.initials: R
authors.lastname: Meirelles
authors.forename: M C C
authors.initials: MC
authors.lastname: Machado
authors.forename: T
authors.initials: T
authors.lastname: Zanesco
authors.forename: R
authors.initials: R
authors.lastname: Surjan
authors.forename: M C
authors.initials: MC
authors.lastname: Chammas
authors.forename: M
authors.initials: M
authors.lastname: de Souza Rocha
authors.forename: D
authors.initials: D
authors.lastname: Morgan
authors.forename: A
authors.initials: A
authors.lastname: Cantor
authors.forename: J
authors.initials: J
authors.lastname: Zimmerman
authors.forename: I
authors.initials: I
authors.lastname: Brezovich
authors.forename: N
authors.initials: N
authors.lastname: Kuster
authors.forename: A
authors.initials: A
authors.lastname: Barbault
authors.forename: B
authors.initials: B
authors.lastname: Pasche
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D006528:Carcinoma, Hepatocellular / Q000473:pathology / Q000628:therapy*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000473:pathology / Q000628:therapy*; D055909:Magnetic Field Therapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D009061:Mouth Mucosa; D011829:Radiation Dosage; D016896:Treatment Outcome; D055815:Young Adult