A Cochrane Collaboration systematic review of melanoma incidence in randomized controlled trials of lipid-lowering agents

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Dellavalle R, Drake A, Graber M, Hester E, McNealy K, Morelli J, Schillin L

Recent clinical trial, in-vitro, and animal study data suggest that lipid-lowering medications may be useful for the prevention and/or adjuvant therapy of melanoma. To further investigate this hypothesis, we have initiated a systematic review of melanoma outcomes in randomized controlled trials of statin and fibrate medicines in collaboration with the Cochrane Collaboration Skin Group. Inclusion criteria for candidate trials are: 1) random allocation of study participants to the experimental and placebo or on-placebo control groups, 2) statins or fibrates used in isolation in the experimental group, and 3) therapy occurring for at least 4 years. The databases MEDLINE, Cochrane Central Register of Controlled Trials, CANCERLIT, EMBASE and Web of Science were searched using both generic and trade drug names and Chemical Abstract Service registry numbers for all known fibrate and statin medications. One or more authors reviewed all article titles for applicability, and two reviewers critiqued each applicable abstracts/article to determine whether the study met the inclusion criteria. Melanoma outcome data was requested from the principal investigator of all qualifying studies and included melanoma incidence and characteristics (e.g. Breslow depth, ulceration, sentinel node status, and staging). Out of the 5671 article titles examined, 23 trials qualified for inclusion in the meta-analysis: 11 statin trials and 12 fibrate trials. Seven on-going trials may meet the inclusion criteria and melanoma outcome data will be requested upon trial completion. Melanoma incidence was stated in published articles of four trials: AFCAPS (14 incident melanomas in experimental group: 27 incident melanomas in placebo group), CARE (4:3), Helsinki Heart Study (1:0) and the VA-HIT (1:9). To date, fourteen trials have supplied melanoma-related data (BIP, CARE, Coronary Drug Project, WHO Cooperative trial, the Heart Protection Study, WOSCOPS, LEADER, LIPID, PREVEND-IT, 4S, VA-HIT, WHO, New Castle, and MAAS). Final analysis of this review will be completed and presented at the colloquium.