A pilot study of topical imiquimod therapy for the treatment of recurrent extramammary Paget's disease

Gynecol Oncol. 2016 Jul;142(1):139-143. doi: 10.1016/j.ygyno.2016.04.028. Epub 2016 May 5.

Abstract

Objective: The objective of this prospective pilot study was to assess the clinical and histologic effects of topical imiquimod therapy on recurrent extramammary Paget's disease of the vulva.

Methods: Patients with biopsy-proven recurrent extramammary Paget's disease presenting to the gynecology outpatient services at two participating institutions were recruited for conservative treatment with 5% imiquimod cream from 2007 to 2011. The topical cream was to be applied 3 times per week for 12weeks. Punch biopsy and photography were performed at baseline and at the 12-week time point.

Results: Eight patients from two institutions were enrolled. Complete clinical and histologic response was achieved in 6 (75%) patients by the 12-week follow-up appointment. Of the two remaining patients, one had a complete clinical response but no significant histologic response; the other patient was removed from the study protocol secondary to intolerable local irritation. Two patients continue to have no evidence of disease after a median follow-up of 35months. Five are alive with disease. No patients progressed to invasive cancer while receiving therapy.

Conclusion: Topical 5% imiquimod cream is a safe and feasible option for women suffering from recurrent extramammary Paget's disease of the vulva, and should be considered as a viable alternative to surgical management. Given the rare nature of this disease, additional multi-institutional prospective studies should be conducted to explore the efficacy of this treatment regime.

Keywords: Extramammary Paget's disease; Imiquimod; Vulvar cancer.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / adverse effects
  • Administration, Topical
  • Aged
  • Aminoquinolines / administration & dosage*
  • Aminoquinolines / adverse effects
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Female
  • Humans
  • Imiquimod
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy*
  • Neoplasm Recurrence, Local / pathology
  • Paget Disease, Extramammary / drug therapy*
  • Paget Disease, Extramammary / pathology
  • Pilot Projects

Substances

  • Adjuvants, Immunologic
  • Aminoquinolines
  • Antineoplastic Agents
  • Imiquimod