Pilot phase IIA study for evaluation of the efficacy of folic acid in the treatment of laryngeal leucoplakia.
BACKGROUND
It has been previously observed that patients with head and neck squamous cell carcinoma or with laryngeal leucoplakia present a significant reduction in plasma folate levels. The current Phase IIA pilot study assessed the effectiveness of folic acid as a chemopreventive agent in patients affected by glottic laryngeal leucoplakia.


METHODS
Forty-three untreated patients affected by glottic laryngeal leucoplakia were enrolled in the Ear, Nose, and Throat Department (Universita Cattolica del Saco Cuore, Rome, Italy). Glottic leucoplakia was initially diagnosed by indirect laryngoscopy and successively confirmed by diagnostic direct microlaryngoscopy with a biopsy for histologic assessment. Folic acid (Folina, Schwarz Pharma, Germany) was administered orally (5 mg every 8 hours) for 6 months. Patients were monitored every 30 days by videolaryngoscopy.


RESULTS
Twelve (28%) patients had no response, 19 (44%) had a partial response, and 12 (28%) had a complete response. The mean increase in serum folate levels (10.06 +/- 0.53) and the mean decrease in homocysteine serum (3.65349 +/- 0.85526) at the end of the study were highly significant (P = .0001).


CONCLUSIONS
The larynx is 1 of the sites of major interest and a good model for the development of chemopreventive agents, but so far the proposed agents have shown no clear efficacy on precancerous lesions or on the development of second malignancies.
Almadori
Giovanni
G
Institute of Otolaryngology, Universita Cattolica del Sacro Cuore, Policlinico A. Gemelli, Rome, Italy. almgio@yahoo.it
Bussu
Francesco
F
Navarra
Pierluigi
P
Galli
Jacopo
J
Paludetti
Gaetano
G
Giardina
Bruno
B
Maurizi
Maurizio
M
D000328:Adult; D000368:Aged; D005260:Female; D005492:Folic Acid / Q000097:blood / Q000627:therapeutic use*; D006801:Humans; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000517:prevention & control; D007828:Laryngoscopy; D007971:Leukoplakia / Q000188:drug therapy* / Q000473:pathology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome
D005492:Folic Acid