Randomized clinical trial of imiquimod: An adjunct to treating cervical dysplasia

Deirdre R. Pachman, Debra L. Barton, Amy C. Clayton, Renee M. McGovern, John A. Jefferies, Paul J. Novotny, Jeff A. Sloan, Charles L. Loprinzi, Bobbie S. Gostout

Research output: Contribution to journalArticle

22 Scopus citations

Abstract

Human papillomavirus (HPV) infection is a major risk factor for cervical cancer. Imiquimod is a topical medication that enhances the immune response to HPV-induced genital warts. This study evaluated cervical application of imiquimod as an adjunct to standard treatment for cervical dysplasia. Fifty-six patients were randomized to standard excisional/ablative treatment vs applications of imiquimod followed by standard treatment. The primary endpoint was dysplasia recurrence within 2 years. There were no differences in dysplasia recurrence between the 2 groups. Treatment was well tolerated, with side effects being mild but significantly worse in women receiving imiquimod for, chills, fatigue, fever, headache, myalgias, and vaginal discharge. This trial does not support the hypothesis that imiquimod, as used in this trial, has an impact on recurrence of cervical dysplasia, but the adequacy of findings are limited by sample size. The trial does support the feasibility and acceptability of the use of imiquimod on the cervix.

Original languageEnglish (US)
Pages (from-to)42.e1-42.e7
JournalAmerican journal of obstetrics and gynecology
Volume206
Issue number1
DOIs
StatePublished - Jan 2012

Keywords

  • cervical dysplasia
  • human papillomavirus
  • imiquimod
  • loop electrosurgical excision procedure

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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    Pachman, D. R., Barton, D. L., Clayton, A. C., McGovern, R. M., Jefferies, J. A., Novotny, P. J., Sloan, J. A., Loprinzi, C. L., & Gostout, B. S. (2012). Randomized clinical trial of imiquimod: An adjunct to treating cervical dysplasia. American journal of obstetrics and gynecology, 206(1), 42.e1-42.e7. https://doi.org/10.1016/j.ajog.2011.06.105