PHASE-II TRIAL OF WEEKLY LOCOREGIONAL HYPERTHERMIA AND CISPLATIN IN PATIENTS WITH A PREVIOUSLY IRRADIATED RECURRENT CARCINOMA OF THE UTERINE CERVIX

BACKGROUND. The biologic rationale for combining cisplatin with locore gional hyperthermia (HT) relates to the potentiating effect of HT on c isplatin cytotoxicity. METHODS. Patients with recurrent cervical carci noma, who had a pelvic recurrence after radiotherapy, were treated wit h weekly cycles of locoregional HT (using the 70-megahertz, 4 antenna- phased array system for 1 hour and cisplatin, 50 mg/m(2) intravenously [i.v.], for a maximum of 12 cycles.) RESULTS. Twenty-three patients w ere entered in this study. A total of 169 cycles were given. Responses were observed in 12 of 23 patients, a response rate of 52% (95% confi dence interval, 31-73%). Salvage surgery became possible in 3 of 12 re sponding patients, whose tumors were previously considered unresectabl e. The median duration of response was 9.5(+) months, the median overa ll survival was 8(+) months, and the 1-year survival was 42%. No corre lation was found between treatment outcome and clinical parameters suc h as age, weight, performance status, and histology. Thermal parameter s such as T20, T50, and T90 were higher in responding patients, but we re not significantly different from nonresponding patients. Overall to xicity was moderate. Subcutaneous fatty necrosis due to HT occurred in 10% of the cycles, whereas 2 patients developed skin burns. Squamous cell carcinoma antigen proved to be a valuable tool for the evaluation of response and detection of progression. CONCLUSIONS. Weekly locoreg ional HT and cisplatin, 50 mg/m(2) i.v., for a maximum of 12 cycles wa s effective treatment in patients with a previously irradiated recurre nt carcinoma of the uterine cervix. (C) 1997 American Cancer Society.