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 locoregional hyperthermia (HT) relates to the potentiating effect of HT on cisplatin cytotoxicity.


METHODS
Patients with recurrent cervical carcinoma, who had a pelvic recurrence after radiotherapy, were treated with weekly cycles of locoregional HT (using the 70-megahertz, 4 antenna-phased array system for 1 hour and cisplatin, 50 mg/m2 intravenously [i.v.], for a maximum of 12 cycles.)


RESULTS
Twenty-three patients were 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% confidence interval, 31-73%). Salvage surgery became possible in 3 of 12 responding patients, whose tumors were previously considered unresectable. The median duration of response was 9.5+ months, the median overall survival was 8+ months, and the 1-year survival was 42%. No correlation was found between treatment outcome and clinical parameters such as age, weight, performance status, and histology. Thermal parameters such as T20, T50, and T90 were higher in responding patients, but were not significantly different from nonresponding patients. Overall toxicity 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 locoregional HT and cisplatin, 50 mg/ m2 i.v., for a maximum of 12 cycles was effective treatment in patients with a previously irradiated recurrent carcinoma of the uterine cervix.
Rietbroek
R C
RC
Department of Medical Oncology, University of Amstersam, Academic Medical Center, The Netherlands.
Schilthuis
M S
MS
Bakker
P J
PJ
van Dijk
J D
JD
Postma
A J
AJ
González González
D
D
Bakker
A J
AJ
van der Velden
J
J
Helmerhorst
T J
TJ
Veenhof
C H
CH
D000951:Antigens, Neoplasm / Q000032:analysis; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000276:immunology / Q000628:therapy*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local; D015843:Serpins; D016019:Survival Analysis; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy / Q000276:immunology / Q000628:therapy*
D000951:Antigens, Neoplasm; D015843:Serpins; C051072:squamous cell carcinoma-related antigen; D002945:Cisplatin