Randomized trial of hyperthermia and radiation for superficial tumors

J Clin Oncol. 2005 May 1;23(13):3079-85. doi: 10.1200/JCO.2005.05.520.


Purpose: 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.

Conclusion: 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Breast Neoplasms / radiotherapy*
  • Breast Neoplasms / therapy*
  • Combined Modality Therapy
  • Female
  • Head and Neck Neoplasms / radiotherapy*
  • Head and Neck Neoplasms / therapy*
  • Humans
  • Hyperthermia, Induced*
  • Male
  • Melanoma / radiotherapy*
  • Melanoma / therapy*
  • Middle Aged
  • Prospective Studies
  • Skin Neoplasms / radiotherapy*
  • Skin Neoplasms / therapy*
  • Survival Analysis
  • Treatment Outcome