Phase I/II trial of preoperative thermoradiotherapy in the treatment of urinary bladder cancer
ABSTRACT
Between April 1984 and September 1988, preoperative radiotherapy or thermoradiotherapy was administered to 49 patients with bladder cancer (T1-4N0M0; UICC classification, 1987). Twenty-one patients were preoperatively treated by radiotherapy alone, with 4 Gy per fraction and three fractions per week to a total dose of 24 Gy (TDF = 53, group 1). The other 28 patients were treated by the same radiotherapy regimen in combination with hyperthermia (group 2). Regional hyperthermia was administered for 35-60 min immediately after irradiation (two sessions per week to a total of four sessions) using an 8 MHz RF capacitive heating device. Group 2 was divided into group 2 (high), in which the average intravesical temperature (T(av)) was > 41.5 degrees C, which was the mean value, and group 2 (low) with a T(av) < 41 x 5 degrees C. Group 2 (high) showed a significantly higher incidence of down-staging and tumour degeneration than both group 1 and group 2 (low). In addition, the local recurrence rate was lower and survival time was longer in group 2 than in group 1, although not significantly so. In particular, the patients with T3-4 or grade 3 bladder cancer in group 2 had a longer average survival than those in group 1, although the difference was not significant. The toxicity associated with hyperthermia was pain during treatment, and complications were not serious.