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


CONCLUSIONS
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.
Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA.
Renee A
RA
Cowan
Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA.
Destin R
DR
Black
Gynecology Service, Department of Pathology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA.
Lien N
LN
Hoang
Gynecology Service, Department of Pathology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA.
Kay J
KJ
Park
Gynecology Service, Department of Pathology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA; Weill Cornell Medical College, 1300 York Avenue, New York, NY 10065, USA.
Robert A
RA
Soslow
Department of Gynecologic Oncology, The James Cancer Hospital and Solove Research Institute, Ohio State University Medical Center, 460 West 10(th) Avenue, Columbus, OH 43210, USA.
Floor J
FJ
Backes
Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA; Weill Cornell Medical College, 1300 York Avenue, New York, NY 10065, USA.
Ginger J
GJ
Gardner
Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA; Weill Cornell Medical College, 1300 York Avenue, New York, NY 10065, USA.
Nadeem R
NR
Abu-Rustum
Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA; Weill Cornell Medical College, 1300 York Avenue, New York, NY 10065, USA.
Mario M
MM
Leitao
Department of Gynecologic Oncology, The James Cancer Hospital and Solove Research Institute, Ohio State University Medical Center, 460 West 10(th) Avenue, Columbus, OH 43210, USA.
Eric L
EL
Eisenhauer
Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA; Weill Cornell Medical College, 1300 York Avenue, New York, NY 10065, USA. Electronic address: chid@mskcc.org.
Dennis S
DS
Chi
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000287:Administration, Topical; D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D010145:Paget Disease, Extramammary / Q000188:drug therapy* / Q000473:pathology; D010865:Pilot Projects
D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod
Extramammary Paget's disease; Imiquimod; Vulvar cancer