Radiation Oncology/Hyperthermia/Randomized

Hyperthermia Randomized Evidence

RT +/- Hyperthermia

• Duke (1994-2001)
  • Randomized. 109 patients with superficial tumors (<= 3cm depth); breast 65%, H&N 13%, melanoma 10%. Tumors had to be "heatable" on initial HT. Arm 1) RT alone vs. Arm 2) RT + HT. Hyperthermia to >43C x1 hour, 2x/week. RT dose 30-60 Gy if previous RT, otherwise 60-70 Gy in 1.8-2.0 Gy/fx
  • 2005 PMID 15860867 -- "Randomized trial of hyperthermia and radiation for superficial tumors." (Jones EL, J Clin Oncol. 2005 May 1;23(13):3079-85.)
    • Outcome: CR RT 42% vs. RT+HT 66% (SS). Patients with prior RT had most benefit (68% vs. 23%, SS)
    • Toxicity: Well tolerated, 1 Grade III thermal burn
    • Conclusion: Significant local control benefit for HT

• International Collaborative Hyperthermia Group (1988-1991) -- combined results from five Phase III trials
  • Randomized. 5 trials merged due to slow accrual, closed early after benefit. 306 patients. Advanced primary or recurrent BCA; 50% active disease outside treatment area. Could have had prior RT. Trials: Dutch Hyperthermia Group (DHG), Medical Research Council (MRC BrI and BrR), European Society of Hyperthermic Oncology (ESHO), and Princes Margaret (PMH). Target hyperthermia 43C. RT given in various fractions.
  • 1996 PMID 8690639 -- "Radiotherapy with or without hyperthermia in the treatment of superficial localized breast cancer: results from five randomized controlled trials. International Collaborative Hyperthermia Group." (Vernon CC, Int J Radiat Oncol Biol Phys. 1996 Jul 1;35(4):731-44.)
    • Outcome: CR RT 41% vs. RT+HT 59% (SS); greatest effect in recurrent lesions in previous RT, where re-irradiation dose was low. 2-year OS ~40% (NS), 74% patients progressed outside HT area during follow-up
    • Conclusion: Combined result demonstrated efficacy of hyperthermia as adjunct to RT for treatment of recurrence