Isotretinoin for low-grade cervical dysplasia in human immunodeficiency virus-infected women.

Abstract

OBJECTIVE:

To estimate the efficacy of isotretinoin for prevention of progression of low-grade squamous intraepithelial lesions (SIL) of the cervix to high-grade lesions or invasive cervical cancer; to estimate the regression rate of low-grade SIL with isotretinoin and the toxicity of isotretinoin in this setting; and to correlate serum CD4 levels with progression of low-grade SIL.

METHODS:

A randomized, phase III, observation-controlled, multicenter trial was performed in which 117 human immunodeficiency virus (HIV)-positive women with low-grade SIL of the cervix received either oral isotretinoin at 0.5 mg/kg per day for 6 months or observation. Papanicolaou smears and colposcopy/biopsy were done at regular intervals during follow-up. The primary endpoint was progression to high-grade SIL or cervical cancer.

RESULTS:

Twenty-one of 102 women (20.6%) completing follow-up experienced progression to high-grade SIL, 13 in the observation group and eight in the isotretinoin group. This difference was not significant (P =.29). No cases of invasive cancer were seen. Baseline CD4 levels were lower than anticipated (median 329 cells/mm(3)), but not associated with time to progression (P =.36). Most subjects (63 of 102, 61.7%) used highly active antiretroviral therapy. Subjects under age 30 were more likely to progress than those older than 30 (P =.046).

CONCLUSION:

Isotretinoin was not associated with longer time to progression of low-grade SIL. This appears to be a chronic condition in HIV-positive women, with a low risk of progression and significant rate of resolution. As in the general population, observation without excisional therapy may be appropriate for HIV-positive women with low-grade SIL.

• Authors: William R Robinson, Janet Andersen, Teresa M Darragh, Michelle A Kendall, Rebecca Clark, Mitchell Maiman
• Journal: Obstetrics and gynecology (Obstet Gynecol) Vol. 99 Issue 5 Pt 1 Pg. 777-84 (May 2002) ISSN: 0029-7844 [Print] United States
• PMID: 11978287 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Isotretinoin

Topics

• Adult
• CD4 Lymphocyte Count
• Disease Progression
• Female
• HIV Infections (complications, immunology)
• Humans
• Isotretinoin (adverse effects, therapeutic use)
• Uterine Cervical Neoplasms (complications, drug therapy, pathology)
• Uterine Cervical Dysplasia (complications, drug therapy, pathology)