Electrochemotherapy, a new antitumor treatment. First clinical phase I-II trial.
BACKGROUND
Electrochemotherapy is a new antitumor treatment consisting of electrical pulses administered to the tumor several minutes after intravenous injection of bleomycin. In mice, important antitumor effects were observed on subcutaneously transplanted tumors and on spontaneously occurring mammary carcinomas. Cures were obtained after one single treatment combining bleomycin and electric pulses. In humans, permeation nodules seemed an adequate oncologic situation to assay this new procedure. The authors report the first Phase I-II trial of electrochemotherapy.


METHODS
Eight patients with 40 permeation nodules of head and neck squamous cell carcinomas were treated with 10 mg/m2 bleomycin intravenous bolus, followed by four or eight short (100 microseconds) and intense (1300 V/cm) pulses administered through two external electrodes located on each side of the treated nodule.


RESULTS
An instantaneous painless contraction of the underlying muscles was regularly observed. Neither local nor general side effects were observed, and electrochemotherapy was well tolerated. In addition, a clear local antitumor efficacy was found: 23 (57%) nodules were in clinical complete response within a few days.


CONCLUSIONS
The absence of toxicity, the good tolerance by the patients, and the net antitumor effects observed are encouraging for additional electrochemotherapy developments in clinical oncology.
Belehradek
M
M
Department of Head and Neck Oncology, Institut Gustave-Roussy, Villejuif, France.
Domenge
C
C
Luboinski
B
B
Orlowski
S
S
Belehradek
J
J
Mir
L M
LM
D000328:Adult; D000368:Aged; D001761:Bleomycin / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D003131:Combined Modality Therapy; D004599:Electric Stimulation Therapy / Q000379:methods*; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010539:Permeability
D001761:Bleomycin