The use of hyperthermia as an adjunct to radiation or chemotherapy treatment of superficial tumors has been an area of active research for the past 20 years, in part due to improvements in instrumentation and temperature monitoring techniques, as well as an increasing understanding of the biology of hyperthermia. One of the first randomized trials of hyperthermia was reported by Overgaard, who randomized 71 patients with superficial melanoma to receive either radiation therapy or combined radiation and hyperthermia. The combined treatment group reported a 46% complete response rate compared to 28% in the radiation only group. (1)
In 1991, Perez and colleagues reported on the results of a study that randomized 236 patients with superficial tumors measuring less than 5 cm in thickness to receive either radiation alone, or radiation in conjunction with hyperthermia. (2) The major endpoints for the study were the initial tumor response, its continuous control, and treatment delivery. The overall complete response rate was not different between the 2 groups (30%–32%). However, when the treatment comparisons were made by the size of the lesion in the patients with lesions <3 cm in diameter, the difference in local control was significantly better for patients assigned to the combined treatment group (50% vs. 39%).
In 1996, the International Collaborative Hyperthermia Group reported on the outcomes of a trial that focused on hyperthermia treatment of superficial breast cancer. (3) A total of 306 patients with advanced primary or recurrent breast cancer were randomized to receive either radiation therapy alone or combined radiation and hyperthermia therapy. The primary endpoint of the trial was complete local control. For those in the combined treatment group, 59% achieved complete local response compared to 41% in the radiation therapy alone group. Similar to the findings of Perez, results were improved in patients with smaller lesions, as indicated by diameter or depth.
Other studies have reported conflicting results. For example, Emami and colleagues reported negative results in a study that randomized 173 patients with persistent or recurrent superficial tumors to receive either interstitial radiation therapy alone, or radiation combined with hyperthermia. (4) In this study, the hyperthermia was administered interstitially, primarily as a technique to provide more uniform heat to the target lesion. There was no difference between the complete response rates in the 2 groups.
There are inadequate data to permit scientific conclusions regarding the use of whole body hyperthermia as an adjunct to either radiation or chemotherapy, and inadequate data regarding the use of local hyperthermia in conjunction with chemotherapy alone.
A literature search of the MedLine database targeted at clinical articles published between 1995 and 2003, found citations describing technical feasibility studies and a few Phases I, II and III studies, but there were no controlled studies reporting on patient outcomes. (5-8) No additional studies were noted that focused on the use of local hyperthermia alone, with chemotherapy or whole body hyperthermia as an adjunct to either radiation or chemotherapy.
A literature search of the MedLine database targeted at clinical articles published between 2002 and 2007 was completed. No studies were found that would alter the position of this policy.
The Radiation Trials Oncology Group (RTOG) has published guidelines outlining quality control criteria for adequate hyperthermia treatment. (8) When the investigators compared these criteria to their data, they found that only 1 patient met the criteria for adequate hyperthermia sessions. The issue of quality assurance and reproducible parameters for delivering hyperthermia has been identified as an obstacle by other authors as well. (2, 9) Identification of the optimal parameters for hyperthermia have also been researched. The majority of the clinical trials describe 8 to12 hyperthermia regimens delivered twice weekly, or every 72 hours. These schedules recognize the phenomenon of thermotolerance, a transient resistance to subsequent heat treatment.
A search of peer reviewed literature through June 2013 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.
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