Efficacy trial of topically administered interferon gamma-1 beta gel in comparison to laser treatment in cervical intraepithelial neoplasia.
OBJECTIVE
Dose dependent response of cervical intraepithelial neoplasia (CIN) to topically administered interferon (IFN) gamma was assessed and compared with conventional laser therapy.


METHODS
33 women were included in a randomized phase II trial which was double blinded for IFN dosages. Twenty-four patients received IFN gamma-1 beta gel and a control group of nine patients was treated with laser surgery. 18 patients had smears suggesting CIN II and 15 patients had smears suggesting CIN III. The response was assessed 6 months after starting of IFN gamma-1 beta treatment or having laser surgery.


RESULTS
Topical IFN gamma-1 beta treatment gave a cure rate of 42% independent of IFN dosage as compared to an 89% cure rate with laser therapy (P = 0.02). Patients with CIN II responded better compared with patients with CIN III. Current smokers showed a significantly lower cure rate whereas use of oral contraceptives (OC) did not influence response. High viral load with high risk types of human papillomaviruses (HPV) was associated with a better response.
Schneider
A
A
Department of Obstetrics and Gynecology, University of Ulm, Germany.
Grubert
T
T
Kirchmayr
R
R
Wagner
D
D
Papendick
U
U
Schlunck
G
G
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D007371:Interferon-gamma / Q000008:administration & dosage*; D053685:Laser Therapy; D009367:Neoplasm Staging; D027383:Papillomaviridae; D030361:Papillomavirus Infections / Q000473:pathology / Q000628:therapy*; D011994:Recombinant Proteins; D012907:Smoking / Q000009:adverse effects; D016896:Treatment Outcome; D014412:Tumor Virus Infections / Q000473:pathology / Q000628:therapy*; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000628:therapy*; D002578:Uterine Cervical Dysplasia / Q000473:pathology / Q000628:therapy*
D005782:Gels; D011994:Recombinant Proteins; D007371:Interferon-gamma