title: Imiquimod 5% cream for treatment of HIV-negative Kaposi's sarcoma skin lesions: A phase I to II, open-label trial in 17 patients.
abstract: BACKGROUND
  Kaposi's sarcoma (KS), a virus-associated neoplasm, can be treated locally or systemically with interferon alfa. Therefore, imiquimod, an immune response modifier able to induce interferon-alpha secretion in situ, could prove a good local treatment for KS skin lesions.
  
  
  OBJECTIVE
  We sought to determine the efficacy and safety of imiquimod 5% cream for the topical treatment of classic or endemic KS skin lesions in patients who are HIV negative.
  
  
  METHODS
  We conducted a prospective, open-label, single center, phase II clinical trial. Imiquimod cream was applied under occlusion 3 times a week for 24 weeks. The main efficacy end points were the safety of topical imiquimod and the overall clinical response in patients evaluated on the basis of modified AIDS Clinical Trials Group criteria at 36 weeks. The statistical analysis was based on the intent-to-treat data set.
  
  
  RESULTS
  Seventeen patients were enrolled. Eight (47%) presented objective overall clinical response (2 complete and 6 partial responses). Tumor progression was noted in 6 patients. The most frequent side effects were local itching and erythema, seen in 9 patients (53%).
  
  
  CONCLUSIONS
  This was not a randomized placebo-controlled study and was restricted to a small number of patients.
  
  
  CONCLUSIONS
  Topical imiquimod 5% cream had antitumor activity in about half the patients with classic and endemic KS and was generally well tolerated.
authors: Department of Dermatology 2, Hôpital Saint Louis AP-HP, Paris, France. noel.schartz@noos.fr
authors: Noël Emile
authors: NE
authors: Célestin Schartz
authors: Sylvie
authors: S
authors: Chevret
authors: Carolina
authors: C
authors: Paz
authors: Delphine
authors: D
authors: Kerob
authors: Olivier
authors: O
authors: Verola
authors: Patrice
authors: P
authors: Morel
authors: Céleste
authors: C
authors: Lebbé
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000287:Administration, Topical; D000368:Aged; D000634:Aminoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D018023:HIV Seronegativity; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D012514:Sarcoma, Kaposi / Q000188:drug therapy*; D012878:Skin Neoplasms / Q000188:drug therapy*
chemical_list: D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000077271:Imiquimod