Treatment of carcinoma in situ of the glans penis with topical chemotherapy agents

Eur Urol. 2012 Nov;62(5):923-8. doi: 10.1016/j.eururo.2012.02.052. Epub 2012 Mar 8.


Background: The use of topical agents in the treatment of carcinoma in situ (CIS) of the penis has been well described in the literature. Previous studies have been limited by small sample size and imprecise end points.

Objective: Establish the response rate of 5-fluorouracil (5-FU) and imiquimod (IQ) in the treatment of penile CIS in a large contemporary series in a supranetwork centre.

Design, setting, and participants: Retrospective review of all primary and recurrent cases of penile CIS treated with 5-FU and IQ identified from a prospective database over a 10-yr period. Therapy was standardised in all cases with application to the lesion for 12h every 48 h for 28 d.

Intervention: 5-FU was the first-line therapy, and IQ was the second-line topical agent.

Outcome measurements and statistical analysis: The primary end point was defined as complete response (CR; i.e., resolution of lesion), partial response (PR; i.e., lesion reduced in size and or visibility), or no response (NR; ie, no improvement in lesion size and or visibility). The secondary end points included local toxicity and adverse events. No statistical analysis or software was used.

Results and limitations: A total of 86 patients were diagnosed with CIS of the penis over the 10-yr period. Forty-four (51%) received topical chemotherapy. The mean follow-up was 34 mo. CR to topical chemotherapy was seen in 25 (57%), PR was seen in 6 (13.6%), and NR was seen in the remaining 13 (29.5%) patients. Local toxicity was experienced by 10% of patients, and 12% had an adverse event following application of 5-FU. The retrospective design and short follow-up were the major limitations of this study.

Conclusions: Topical chemotherapy agents are moderately effective first-line therapy in the treatment of penile CIS. Toxicity and adverse events were few with our treatment protocol. The issues of long-term surveillance and assessment of partial responders remain a challenge. Topical chemotherapy should remain a first-line treatment option for penile CIS.

MeSH terms

  • Administration, Cutaneous
  • Aged
  • Aminoquinolines / administration & dosage*
  • Aminoquinolines / adverse effects
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Carcinoma in Situ / drug therapy*
  • Carcinoma in Situ / pathology
  • Fluorouracil / administration & dosage*
  • Fluorouracil / adverse effects
  • Humans
  • Imiquimod
  • Male
  • Middle Aged
  • Penile Neoplasms / drug therapy*
  • Penile Neoplasms / pathology
  • Retrospective Studies
  • Time Factors
  • Treatment Outcome


  • Aminoquinolines
  • Antineoplastic Agents
  • Imiquimod
  • Fluorouracil