title: Randomized trial of hyperthermia and radiation for superficial tumors.
abstract: OBJECTIVE
  Randomized clinical trials have demonstrated hyperthermia (HT) enhances radiation response. These trials, however, generally lacked rigorous thermal dose prescription and administration. We report the final results of a prospective randomized trial of superficial tumors (</= 3 cm depth) comparing radiotherapy versus HT combined with radiotherapy, using the parameter describing the number of cumulative equivalent minutes at 43 degrees C exceeded by 90% of monitored points within the tumor (CEM 43 degrees C T(90)) as a measure of thermal dose.
  
  
  METHODS
  This trial was designed to test whether a thermal dose of more than 10 CEM 43 degrees C T(90) results in improved complete response and duration of local control compared with a thermal dose of </= 1 CEM 43 degrees C T(90). Patients received a test dose of HT </= 1 CEM 43 degrees C T(90) and tumors deemed heatable were randomly assigned to additional HT versus no additional HT. HT was given using microwave spiral strip applicators operating at 433 MHz.
  
  
  RESULTS
  One hundred twenty-two patients were enrolled; 109 (89%) were deemed heatable and were randomly assigned. The complete response rate was 66.1% in the HT arm and 42.3% in the no-HT arm. The odds ratio for complete response was 2.7 (95% CI, 1.2 to 5.8; P = .02). Previously irradiated patients had the greatest incremental gain in complete response: 23.5% in the no-HT arm versus 68.2% in the HT arm. No overall survival benefit was seen.
  
  
  CONCLUSIONS
  Adjuvant hyperthermia with a thermal dose more than 10 CEM 43 degrees C T(90) confers a significant local control benefit in patients with superficial tumors receiving radiation therapy.
authors.affiliation: Radiation Oncology, Duke University Medical Center, DUMC Box 3085, Durham, NC 27710, USA. Jones@radonc.duke.edu
authors.forename: Ellen L
authors.initials: EL
authors.lastname: Jones
authors.forename: James R
authors.initials: JR
authors.lastname: Oleson
authors.forename: Leonard R
authors.initials: LR
authors.lastname: Prosnitz
authors.forename: Thaddeus V
authors.initials: TV
authors.lastname: Samulski
authors.forename: Zeljko
authors.initials: Z
authors.lastname: Vujaskovic
authors.forename: Daohai
authors.initials: D
authors.lastname: Yu
authors.forename: Linda L
authors.initials: LL
authors.lastname: Sanders
authors.forename: Mark W
authors.initials: MW
authors.lastname: Dewhirst
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000532:radiotherapy* / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy* / Q000628:therapy*; D006801:Humans; D006979:Hyperthermia, Induced; D008297:Male; D008545:Melanoma / Q000532:radiotherapy* / Q000628:therapy*; D008875:Middle Aged; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000532:radiotherapy* / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome