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Updated: Jul 6, 2026
An In Vitro Model for Studying Cellular Transformation by Kaposi Sarcoma Herpesvirus
Published on: August 25, 2017
Treatment of classic Kaposi sarcoma with a nicotine dermal patch: a phase II clinical trial
J J Goedert1, B M Scoppio, R Pfeiffer
1Viral Epidemiology Branch and Biostatistics Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD 20852, USA. goedertj@mail.nih.gov
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.
Insights
Transdermal nicotine patches were tested for classic Kaposi sarcoma (cKS) treatment. The study found no significant effect on cKS lesions or human herpesvirus 8 (HHV8) levels, with good safety and tolerability.
Area of Science:
- Oncology
- Dermatology
- Virology
Background:
- Kaposi sarcoma (KS) is a malignancy linked to human herpesvirus 8 (HHV8) and immune status.
- Nicotine's potential therapeutic role in KS is suggested by its immunologic and vascular effects, and the association between smoking and reduced KS risk.
Purpose of the Study:
- To evaluate the safety and efficacy of transdermal nicotine in treating classic Kaposi sarcoma (cKS).
- A masked, randomized phase 2 clinical trial was designed to compare nicotine patches against placebo and no treatment.
Main Methods:
- 24 non-smoking patients with cKS lesions were randomized to receive nicotine patches, placebo patches, or no patch for 15 weeks.
- Lesion size and elevation were measured, and digital photographs were analyzed. HHV8 antibody and DNA levels were also monitored.
Main Results:
- No serious adverse events were reported; compliance was good.
- Treatment with nicotine or placebo patches did not result in significant changes in cKS lesion size or elevation.
- No consistent effects on HHV8 viral load or antibody levels were observed.
Conclusions:
- Transdermal nicotine and placebo patches were safe and well-tolerated in patients with cKS.
- Neither nicotine nor placebo patches demonstrated a significant therapeutic effect on nodular cKS lesions or HHV8 levels.
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