Changes to This Summary (05/16/2013)
The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.
Added Risk Factors as a new subsection.
Revised text to state that identification of activating mutations in the mitogen-activated protein (MAP) kinase pathway has led to the definition of molecular subtypes of melanoma and provided potential drug targets.
Revised text to state that prospective, randomized, controlled trials with both agents have not shown an increase in overall survival (OS) when compared with observation (cited Kirkwood et al. and Eggermont et al. as references 9 and 10, respectively.) Also added text about therapies that have impacted OS in patients with recurrent or metastatic disease that are now being tested as adjuvant therapy in clinical trials, including NCT01274338, NCT01667419, and NCT01682083.
Added text to state that these single agents are rarely curative, but the trials that incorporate these agents are testing combinations in an attempt to prevent development of drug resistance. Also added text about clinical trials that are testing targeted therapies in the smaller patient subsets.
Added text to state that prospective, randomized, multicenter treatment trials have demonstrated that high-dose interferon alpha-2b and pegylated interferon do not improve OS and agents that have demonstrated improved OS in patients with recurrent or metastatic disease are now being tested in clinical trials of adjuvant therapy in patients at high risk for relapse after surgical resection of tumor. These trials include: NCT01274338, NCT01667419, and NCT01682083.
Added text to include checkpoint inhibitors in the treatment options list.
Revised text to state that although melanoma that has spread to distant sites is rarely curable, two approaches have demonstrated clinical benefit by prolonging OS in randomized trials: immunotherapy and inhibition of the MAP kinase pathway, adding that both ipilimumab and vemurafenib were approved by the U.S. Food and Drug Administration in 2011. Also added that although neither appears to be curative when used as a single agent, clinical trials are currently testing combinations of these and similar agents to prevent the development of resistance; additionally, ipilimumab and vemurafenib are available to newly diagnosed and previously treated patients.
Added Anti-PD-1 and PD-L1 as a new subsection.
Added text to state that combination therapy to address other mechanisms of resistance are in early-phase trials.
Added Hauschild et al. and Flaherty et al. as references 33 and 34, respectively.
This summary is written and maintained by the PDQ Adult Treatment Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ NCI's Comprehensive Cancer Database pages.