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Treatment of classic Kaposi sarcoma with a nicotine dermal patch: a phase II clinical trial

  1. Author:
    Goedert, J. J.
    Scoppio, B. M.
    Pfeiffer, R.
    Neve, L.
    Federici, A. B.
    Long, L. R.
    Dolan, B. M.
    Brambati, M.
    Bellinvia, M.
    Lauria, C.
    Preiss, L.
    Boneschi, V.
    Whitby, D.
    Brambilla, L.

  2. Author Address

    Goedert, J. J.; Pfeiffer, R.; Dolan, B. M.] NCI, Viral Epidemiol Branch, Div Canc Epidemiol and Genet, Rockville, MD 20852 USA. [Goedert, J. J.; Pfeiffer, R.; Dolan, B. M.] NCI, Biostat Branch, Div Canc Epidemiol and Genet, Rockville, MD 20852 USA. [Scoppio, B. M.; Federici, A. B.; Brambati, M.; Bellinvia, M.; Boneschi, V.; Brambilla, L.] Regina Elena Fdn, IRCCS Fdn Maggiore Policlin Hosp, Dept Med & Med Specialties, Angelo Bianchi Bonomi Hemophilia Thrombosis Ctr, Milan, Italy. [Scoppio, B. M.; Federici, A. B.; Brambati, M.; Bellinvia, M.; Boneschi, V.; Brambilla, L.] Regina Elena Fdn, IRCCS Fdn Maggiore Policlin Hosp, Dept Med & Med Specialties, Inst Dermatol Sci, Milan, Italy. [Neve, L.; Long, L. R.] Natl Lib Med, Commun Engn Branch, Bethesda, MD USA. [Lauria, C.] Lega Italiana Lotta Contro I Tumori RG, Ragusa, Italy. [Preiss, L.] RTI Int, Rockville, MD USA. [Preiss, L.] RTI Int, Buenos Aires, DF, Argentina. [Whitby, D.] NCI, SAIC Frederick, AIDS Vaccine Program, Viral Oncol Sect, Frederick, MD 21701 USA.
    1. Year: 2008
  2. Journal: Journal of the European Academy of Dermatology and Venereology
    1. 22
    2. 9
    3. Pages: 1101-1109
  4. Type of Article: Article
  1. Abstract:

    Background Kaposi sarcoma (KS), a malignancy of dermal endothelial cells that is caused by human herpesvirus 8 (HHV8) infection, is sensitive to perturbations of immunity. Nicotine might be effective against KS because of its immunologic and vascular effects and because smoking is associated with a low risk of KS. Objective and study design We conducted a masked, randomized phase 2 clinical trial of transdermal nicotine and placebo patches to assess the safety and efficacy of nicotine against classic KS (cKS). Subjects and methods Three cKS lesions, predominantly nodules, in each of 24 non-smoking patients were randomly assigned to 15 weeks continuous treatment with nicotine patch (escalated to 7 mg), identical masked placebo patch or no patch. Changes in lesion area and elevation from baseline through six follow-up visits, by direct measurement and by two independent readers using digital photographs of the lesions, were compared using non-parametric and regression methods. Changes in longitudinal levels of HHV8 antibodies and DNA in blood cells were similarly assessed. Results There were no systemic or serious adverse events, and compliance was good. One patient resumed smoking and discontinued patches, and two patients withdrew at week 12 for unrelated indications. Six (29%) of the remaining 21 suspended use of patches to relieve local skin irritation, four of these six completed the trial at reduced dose. Treatment assignment was not associated with significant or consistent changes in cKS lesion area or elevation, HHV8 viral load or antibodies. Conclusion Transdermal nicotine and placebo patches caused no serious toxicities but had no demonstrable effect on nodular cKS lesions or HHV8 levels.

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External Sources

  1. PMID: 18384551

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