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Isolated Hepatic Perfusion as a Treatment for Liver Metastases of Uveal Melanoma
Published on: January 25, 2015
A randomized, double-blind, placebo-controlled phase II clinical trial of lovastatin for various endpoints of
Kenneth G Linden1, Sancy A Leachman, Jonathan S Zager
1Department of Dermatology and The Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, 101 The City Drive, Orange, CA 92868. kglinden@uci.edu.
Abstract:
On the basis of large cardiovascular clinical trials of lipid-lowering agents that showed a considerable decrease in the incidence of primary melanomas in the active agent arm, we have carried out a randomized, double-blind clinical trial examining the impact of lovastatin on various biomarkers of melanoma pathogenesis. Subjects with at least two clinically atypical nevi were randomized to receive oral lovastatin or placebo for a 6-month period. Clinical, histopathologic, and molecular biomarkers were evaluated for change in the two groups. Eighty subjects were randomized, evaluable, and included in the analyses. Lovastatin showed no benefit in comparison with placebo in the primary endpoint of decreasing the level of histopathologic atypia, nor in any of the secondary endpoints of decreasing clinical atypia, impact on nevus number, nor in showing significant changes in any of the molecular biomarkers. There were no significant differences in adverse event profiles for lovastatin compared with placebo. The lovastatin arm did show a significant and considerable decrease in total serum cholesterol and serum low-density lipoprotein (LDL) levels compared with placebo, an expected result. This finding bolsters confidence in subject compliance. Given the results of this trial, it is concluded that if lovastatin were to lower the incidence of melanoma, it would appear not to be doing so by reversing atypia of precursor atypical nevi over the 6-month time frame studied. Further research into the pathogenesis of melanoma and in other potential chemopreventive agents is needed.
Insights
Lovastatin did not reduce melanoma precursor atypia in a clinical trial. This cholesterol-lowering drug did not impact clinical, histopathologic, or molecular melanoma biomarkers over six months.
Area of Science:
- Dermatology
- Oncology
- Pharmacology
Background:
- Cardiovascular clinical trials noted fewer melanomas with lipid-lowering agents.
- Melanoma pathogenesis involves various biomarkers.
- Atypical nevi are considered precursor lesions for melanoma.
Purpose of the Study:
- To investigate the effect of lovastatin on melanoma pathogenesis biomarkers.
- To determine if lovastatin can reverse atypia in precursor nevi.
Main Methods:
- Randomized, double-blind, placebo-controlled trial.
- 80 subjects with atypical nevi received oral lovastatin or placebo for 6 months.
- Evaluated clinical, histopathologic, and molecular biomarkers.
Main Results:
- Lovastatin did not decrease histopathologic or clinical atypia compared to placebo.
- No significant changes observed in nevus count or molecular biomarkers.
- Lovastatin effectively lowered serum cholesterol and LDL levels, confirming compliance.
- Adverse event profiles were similar between groups.
Conclusions:
- Lovastatin does not appear to reverse atypia in precursor nevi within a 6-month timeframe.
- The mechanism by which lipid-lowering agents might reduce melanoma incidence remains unclear.
- Further research is needed on melanoma pathogenesis and chemopreventive agents.
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