Prevention of local relapses and new localisations of oral leukoplakias with the synthetic retinoid fenretinide (4-HPR). Preliminary results.
This paper analyses preliminary results of a randomised chemoprevention trial in patients surgically treated for oral leukoplakia started in 1988 at the Istituto Nazionale Tumori of Milan with the synthetic retinoid N-(4-hydroxyphenyl)-retinamide (4-HPR). To date 115 patients have been randomised, after surgical excision of oral leukoplakia, to receive 200 mg 4-HPR daily for 52 weeks versus no intervention. 80 patients completed the 1-year intervention, 41 in the control group and 39 in the 4-HPR group. During this period 12 local relapses or new lesions occurred in the control group and three in the 4-HPR group. Only 5 patients interrupted the intervention because of toxicity. No impaired dark adaptation was observed. It is concluded that 4-HPR is well tolerated and seems efficacious in preventing relapses and new localisations during the treatment period. This promising trend needs further confirmation.
Chiesa
F
F
Head and Neck Surgical Oncology Department, Istituto Nazionale Tumori, Milano, Italy.
Tradati
N
N
Marazza
M
M
Rossi
N
N
Boracchi
P
P
Mariani
L
L
Clerici
M
M
Formelli
F
F
Barzan
L
L
Carrassi
A
A
D000328:Adult; D000368:Aged; D005260:Female; D017313:Fenretinide / Q000627:therapeutic use*; D006801:Humans; D007972:Leukoplakia, Oral / Q000517:prevention & control* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D011182:Postoperative Care
D017313:Fenretinide