Past clinical studies and future directions.

The biological rationale for hyperthermia and radiation is strong, initial results in superficial tumor sites have established efficacy in human cancer, and deep tumor sites are beginning to yield to our efforts at deep regional heating. Major thrusts of new clinical research should go toward improved equipment and defining techniques with existing devices, which can lead us into definitive Phase III trials to assess the role of regional hyperthermia in primary multimodality management of cancer. Detailed thermometry is an absolute requirement for all future clinical studies. Invasive techniques to achieve deep hyperthermia are under investigation and may prove to be useful. Whole-body hyperthermia with radiation and/or chemotherapy has been less well studied in the laboratory than has local hyperthermia, and studies to show clinical efficacy in humans are lacking.