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

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

Research output: Contribution to journalArticle

10 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1101-1109
Number of pages9
JournalJournal of the European Academy of Dermatology and Venereology
Volume22
Issue number9
DOIs
Publication statusPublished - Sep 2008

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Tobacco Use Cessation Products
Human Herpesvirus 8
Phase II Clinical Trials
Kaposi's Sarcoma
Skin
Placebos
Nicotine
Smoking
Viral Antibodies
Herpesviridae Infections
Therapeutics
Viral Load
Compliance
Blood Vessels
Immunity
Blood Cells
Endothelial Cells
Clinical Trials
Safety
Antibodies

Keywords

  • Drug delivery systems
  • Kaposi sarcoma
  • Smoking

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

Cite this

Goedert, J. J., Scoppio, B. M., Pfeiffer, R., Neve, L., Federici, A. B., Long, L. R., ... Brambilla, L. (2008). Treatment of classic Kaposi sarcoma with a nicotine dermal patch: A phase II clinical trial. Journal of the European Academy of Dermatology and Venereology, 22(9), 1101-1109. https://doi.org/10.1111/j.1468-3083.2008.02720.x

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

In: Journal of the European Academy of Dermatology and Venereology, Vol. 22, No. 9, 09.2008, p. 1101-1109.

Research output: Contribution to journalArticle

Goedert, JJ, Scoppio, BM, Pfeiffer, R, Neve, L, Federici, AB, Long, LR, Dolan, BM, Brambati, M, Bellinvia, M, Lauria, C, Preiss, L, Boneschi, V, Whitby, D & Brambilla, L 2008, 'Treatment of classic Kaposi sarcoma with a nicotine dermal patch: A phase II clinical trial', Journal of the European Academy of Dermatology and Venereology, vol. 22, no. 9, pp. 1101-1109. https://doi.org/10.1111/j.1468-3083.2008.02720.x
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. / Treatment of classic Kaposi sarcoma with a nicotine dermal patch : A phase II clinical trial. In: Journal of the European Academy of Dermatology and Venereology. 2008 ; Vol. 22, No. 9. pp. 1101-1109.
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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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T1 - Treatment of classic Kaposi sarcoma with a nicotine dermal patch

T2 - A phase II clinical trial

AU - Goedert, J. J.

AU - Scoppio, B. M.

AU - Pfeiffer, R.

AU - Neve, L.

AU - Federici, A. B.

AU - Long, L. R.

AU - Dolan, B. M.

AU - Brambati, M.

AU - Bellinvia, M.

AU - Lauria, C.

AU - Preiss, L.

AU - Boneschi, V.

AU - Whitby, D.

AU - Brambilla, L.

PY - 2008/9

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N2 - 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.

AB - 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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