CURRENTS TARGETING MELANOMA ducted two small cohort studies aimed at evaluating safety as DECISION ON INVESTIGATIONAL well as a potential administration schedule for further clini- MELANOMA AGENT DELAYED cal development. In the second study, the authors observed The FDA decision on GlaxoSmithKline’s investigational elevations in aminotransferase levels in some patients within melanoma treatment trametinib has been extended to three weeks after starting ipilimumab. In addition, two September 2013. GSK originally submitted a New Drug patients (one in each cohort) had elevations of grade 2 or 3 Application in August 2012, but the recent extension in the total bilirubin level with concomitant grade 3 eleva- came after the company submitted additional manu- tions in aminotransferase levels. The authors noted that all facturing data for review. The proposed indication for hepatic adverse events in the two cohorts were asymptomatic trametinib is for treatment of unresectable or metastatic and reversible with either temporary discontinuation of the melanoma with BRAF V600 mutations as detected by an study drugs or administration of glucocorticoids. However, FDA-approved test. they also observed other toxic effects during the concomitant vemurafenib and ipilimumab phase, such as grade 2 temporal Indoor Tanners Exhibit Psychiatric and arteritis (in one patient) and grade 3 rash (in two patients), all Addictive Symptoms in the first cohort. Upon closing the study to further patient Indoor tanning dependence among young women in par- accrual, the investigators observed that their findings rein- ticular has recently been associated with symptoms of anxiety forced the need for carefully conducted trials of new com- and addiction. A new study examined 306 female university bination therapies, even when both agents have regulatory students between the ages of 18 and 25 and found that 46 per- approval and distinct mechanisms of action. cent of the sample reported a history of indoor tanning, with — N Engl J Med. 2013; 368: 1365-6 25 percent being classified as tanning dependent. Multivariate logistic regression analyses showed that indoor tanning was NEW SKIN CANCER AWARENESS CAMPAIGN: significantly associated with symptoms of alcohol use disorders, OUTRUN THE SUN generalized anxiety, and not having social anxiety. The authors “Outrun the Sun in May” is a new community outreach noted that these findings suggest that young women with campaign running throughout Melanoma Awareness certain psychological problems may seek relief from their symp- Month that encourages individuals to be both proac- toms by indoor tanning. Moreover, the study concludes that tive—and active—in terms of skin cancer prevention. indoor tanners may benefit from health behavior and other People worldwide are invited to register online and then psychosocial interventions. either run or walk any day in May (from any location) in —Am J Health Promot. 2013; Apr 26 support of skin cancer education and melanoma research. Participants take a sun safety pledge and receive impor- Combining Melanoma Therapies Could Pose tant sun safety and skin cancer prevention information. Increased Safety Risks They may gather teams, running clubs, or participate in The notion of combining the only two approved agents honor of someone undergoing melanoma treatment. for the treatment of melanoma—vemurafenib (Zelboraf, Partnering with the campaign are the Dermatology Nurses’ Genentech) and ipilimumab (Yervoy, Bristol-Myers Squibb)— Association, American College of Mohs Surgery, USA for potentially improved survival deserves more careful Track & Field, and the Road Runners Club of America. scrutiny, according to a recent editorial in The New England Registration information is available now at www.outrun- Journal of Medicine. Exploring the rationale to investigate thesun.org. n combined therapy with the two agents, the authors con- 24 PRACTICAL DERMATOLOGY MAY 2013.