A phase I trial of topically applied trans-retinoic acid in cervical dysplasia-clinical efficacy

✍ Scribed by Sheldon A. Weiner; Earl A. Surwit; Vivian E. Graham; Frank L. Meyskens

• Publisher: Springer US
• Year: 1986
• Tongue: English
• Weight: 260 KB
• Volume: 4
• Category: Article
• ISSN: 0167-6997
• DOI: 10.1007/bf00179590

✦ Synopsis

Forty-two patients were entered into a phase I trial to evaluate the vitamin A derivative, trans-retinoic acid, in cervical intraepithelial neoplasia. Treatment consisted of four consecutive 24-h applications of retinoids via an inert collagen sponge in a cervical cap. Patients were followed for response at 3-month intervals using cytology, colposcopy, and selected biopsies. Thirty-six patients were evaluable (mild dysplasia, 13; moderate dysplasia, 17; severe dysplasia, 6) with follow-up from 5 to 18 months. Complete regression was seen in 2/14 (14%) patients treated with concentrations of 0.05~ --, 0.1167~ and in 10/22 (45~ patients treated with concentrations of 0.1583 ~ --* 0.484~ (p < 0.05). One patient with negative biopsies at 12 months has subsequently recurred at 18 months.