Topical treatment of cutaneous metastases of malignant melanoma using combined imiquimod and 5-fluorouracil

Invest New Drugs. 2012 Aug;30(4):1641-5. doi: 10.1007/s10637-011-9717-2. Epub 2011 Jul 13.

Abstract

Background: Despite multiple available options, the treatment of cutaneous melanoma metastases is often unsuccessful. Based on the hypothesis that imiquimod and 5-fluorouracil have synergistic antitumor properties, we used this topical combination to treat several patients.

Aim: Our objective was to investigate the treatment combination in a small cohort of patients with surgically non-resectable melanoma metastases.

Methods: The lesions of 5 patients with multiple cutaneous metastases were treated topically, 5 days per week, with 5-fluorouracil in the morning and imiquimod at night.

Results: 45 lesions were treated. A clinical response was seen in 44 lesions, with a complete response in 19 lesions and a partial response in 25. Stable disease was confirmed in the 1 remaining lesion. No patients developed new lesions during treatment. However, one patient had a recurrence 6 months after treatment discontinuation, followed by a partial response when rechallenged.

Conclusions: The imiquimod and 5-fluorouracil combination is effective. That patients did not develop new, distant lesions suggests the achievement of locoregional control, probably by the induction of antitumor immune response.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Administration, Topical
  • Aged
  • Aged, 80 and over
  • Aminoquinolines / administration & dosage
  • Aminoquinolines / therapeutic use*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / therapeutic use*
  • Humans
  • Imiquimod
  • Melanoma / complications
  • Melanoma / drug therapy*
  • Melanoma / pathology
  • Neoplasm Metastasis
  • Skin Neoplasms / complications
  • Skin Neoplasms / drug therapy*
  • Skin Neoplasms / pathology
  • Skin Ulcer / complications
  • Skin Ulcer / drug therapy
  • Skin Ulcer / pathology
  • Treatment Outcome

Substances

  • Aminoquinolines
  • Antineoplastic Agents
  • Imiquimod
  • Fluorouracil