A joint clinical trial of hyperthermia using a newly developed 8-MHz radiofrequency (RF) capacitive heating device (Thermotron RF-8; developed in cooperation with Yamamoto Vinyter Co. of Osaka) was performed under collaboration of seven institutions. Radiation with 4 Gy twice a week for a total of 40 Gy or 2 Gy five times a week for a total of 50 Gy was delivered. After irradiation, hyperthermia at 42.5 degrees C +/- 0.5 degree C for 40 to 60 minutes was given twice a week for a total of 10 times. Tumors examined in this trial were located in various depths in the body, and included those which were considered refractory to conventional treatments or radioresistant such as malignant melanoma and soft tissue tumors. Of the 63 tumors treated, 52.4% showed complete regression (CR); 19.0% more than 80% regression (PRa); 20.6%, 80% to 50% regression (PRb); and 8.0% no regression (NR). Our joint clinical trial demonstrated that hyperthermia with the use of the Thermotron RF-8 is safe and effective in the treatment of radioresistant tumors located in superficial, subsurface, and in some cases deep regions, if the surface cooling is properly managed by the temperature-controlled saline pad and electrodes of appropriate size are paired.

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Multi-institutional studies on clinical hyperthermia of deep-seated tumours were undertaken using 8 MHz radiofrequency capacitive heating devices (Thermotron RF-8) at seven institutions. Each institute was designated to treat specific organs. This paper contains the accumulations of the results obtained at different institutions charged for different tumours. Deep-seated tumours in the lung, stomach, pancreas, liver, urinary bladder and rectum were treated. A total of 177 cases examined from January 1985 to December 1988 included 96 cases (54%) treated with radiotherapy plus hyperthermia, among which 14 cases were pre-operative. Of 177 cases, 81 (46%) were treated with chemotherapy plus hyperthermia. Complete response (CR) and partial response (PR) were obtained in 80% of the cases with lung cancer, 39% with stomach cancer, 56% with liver cancer, 35% with pancreas cancer, 71% with urinary bladder cancer, 100% with primary rectal cancer, and 47% with recurrent rectal cancer. Thermometry was performed using two techniques; one is direct measurement of intratumour temperature in lung and liver cancers, the other is indirect measurement of intracavitary temperature for stomach, pancreas, urinary bladder and rectal cancers. Intratumour temperatures were measured in 30 of the 43 tumours of the lung and liver. The maximum tumour temperature was greater than 42 degrees C in 23 (77%) of the 30 tumours. Intracavitary temperatures were measured in 133 (99%) of the 134 tumours of stomach, pancreas, urinary bladder and rectum. An intracavitary temperature greater than 42 degrees C was obtained in 98 (73.7%) of the 133 tumours. The contribution of hyperthermia in improving the quality of life of patients under terminal care was also investigated. It was indicated that hyperthermia was one of the most effective treatment techniques for advanced or inoperable cases. In this study local control rate (LCR) was mainly discussed because the period of follow-up was only 3 years. Side-effects were observed in 37 cases (21%); main side-effects were fatty induration, pain during treatment and burn. However, no side-effects were severe enough to interrupt therapy.

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The combination therapy of urinary bladder cancer with radiation and hyperthermia with bleomycin was investigated. Immediately following daily external irradiation (40 Gy/4 weeks), patients were irrigated with a solution of warmed saline (intravesical temperature, 42-43 degrees C) containing 30 micrograms/ml bleomycin. Of a total of 56 patients, complete responses were observed in 25, and partial responses in 21. Among T2-T3 cases, an 84% response rate was noted in combination therapy, whereas a 56% response rate was observed after radiation alone (50-70 Gy). The side-effects of the combination therapy were limited to reversible bladder irritation, and bladder capacity could be maintained within normal limits. These results suggest that combination therapy represents an effective conservative therapy for the management of bladder cancer.