Randomized Trial of Hyperthermia and Radiation for Superficial Tumors

• Published in: Journal of clinical oncology Vol. 23; no. 13; pp. 3079 - 3085
• Main Authors: JONES, Ellen L, OLESON, James R, PROSNITZ, Leonard R, SAMULSKI, Thaddeus V, VUJASKOVIC, Zeijko, DAOHAI YU, SANDERS, Linda L, DEWHIRST, Mark W
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 01.05.2005; Lippincott Williams & Wilkins
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Biological and medical sciences; Breast Neoplasms - radiotherapy; Breast Neoplasms - therapy; Combined Modality Therapy; Female; Head and Neck Neoplasms - radiotherapy; Head and Neck Neoplasms - therapy; Humans; Hyperthermia, Induced; Male; Medical sciences; Melanoma - radiotherapy; Melanoma - therapy; Middle Aged; Prospective Studies; Skin Neoplasms - radiotherapy; Skin Neoplasms - therapy; Survival Analysis; Treatment Outcome; Tumors; Clinical trial; Tumor; Cancerology; Treatment; Induced hyperthermia
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2005.05.520

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. 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. 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. 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.