April 2014 | Volume 13 | Issue 4 | Feature | 505 | Copyright © 2014
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
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FDA Approves First Combo Therapy for Advanced Melanoma
The FDA has approved trametinib (Mekinist, GlaxoSmithKline) in combination with dabrafenib (Tafinlar, GlaxoSmithKline) to treat patients with advanced melanoma that is unresectable or metastatic. The safety and effectiveness of Mekinist in combination with Tafinlar were demonstrated in a clinical trial of 162 participants with unresectable or metastatic melanoma with the BRAF V600E or V600K mutation, most of who had not received prior therapy. Results showed that 76% of participants treated with Mekinist in combination with Tafinlar had their cancers shrink or disappear, an objective response lasting an average of 10.5 months. Fever, chills, fatigue, rash, nausea, vomiting, diarrhea, abdominal pain, peripheral edema, cough, headache, joint pain, night sweats, decreased appetite, constipation, and muscle pain were the most common side effects reported by participants receiving Mekinist in combination with Tafinlar.
Long-Term Efficacy and Safety of Alemtuzumab in Advanced Primary Cutaneous T-Cell Lymphomas
The British Journal of Dermatology (Vol. 170 Issue 2) has published a study designed to assess the efficacy and safety of alemtuzumab in the treatment of advanced CTCL. The study was a multicenter retrospective analysis of 39 patients with advanced CTCL treated with alemtuzumab between 2003 and 2013. Twenty-three of the patients had Sézary syndrome while sixteen had advanced mycosis fungoides. All patients received alemtuzumab 30 mg 2 to 3 times a week for a median duration of 12 weeks. Fifteen patients received maintenance therapy for a median duration of 24 weeks. Eleven patients (28%) had transformed disease. After a median follow-up of 24 months, 8 patients (21%) were still alive. The overall response rate was 51% in the whole study group, 70% in patients with Sézary syndrome and 25% in patients with mycosis fungoides. The median time to progression was 3.4 months. Six patients remained progression-free for more than 2 years. Five patients experienced cutaneous large T-cell transformation during alemtuzumab treatment and 1 patient developed primary cutaneous large B-cell lymphoma. Twenty-four patients (62%) had a grade 3 or higher infectious adverse event and 10 (26%) a hematologic toxicity that led to treatment discontinuation in 17 cases (44%) and death in 2 (5%).
The study authors concluded that Alemtuzumab may induce long-term remissions in Sézary syndrome but does not seem effective in mycosis fungoides and transformed CTCL.
Cutaneous Delayed-Type Hypersensitivity in Patients With Atopic Dermatitis to Surfactants
A recent study by Cristin N. Shaughnessy, BS, Dana Malajian, BA, Donald V. Belsito, MD sought to assess whether atopic patients were more likely than nonatopic patients to patch test positive to the surfactants cocamidopropyl betaine (CAPB) and cocamide diethanolamide (DEA), or to the surfactant precursor amidoamine. Patients with atopic dermatitis (AD) have abnormalities in skin barrier function, and are predisposed to developing cutaneous delayed-type hypersensitivity. Soap and detergents are known to exacerbate the breakdown of the skin barrier.
The study looked at 1674 patients who underwent patch testing to the North American Contact Dermatitis Group standard screening series. The incidence of positive patch test results to CAPB, cocamide DEA, and amidoamine among patients with AD (n = 242) and without AD (n = 1422) was assessed. The data show that AD was associated with contact hypersensitivity to CAPB, but not to cocamide DEA or amidoamine. The study authors concluded that patients with AD should avoid the use of skincare products containing the surfactant CAPB.
Tazarotene in Patients With Basal Cell Nevus Syndrome
A recent report by Y. Tang, Albert S. Chiou, Julian M. Mackay- Wiggan, Michelle Aszterbaum, Anita M Chanana, Wayne Lee, Joselyn Lindgren, Maria Acosta Raphael, Bobbye J. Thompson, David R. Bickers, and Ervin Epstein discusses the results of a randomized, double-blind, vehicle-controlled study in basal cell nevus (Gorlin) syndrome patients evaluating the efficacy of topically applied tazarotene for basal cell carcinoma chemoprevention (N=34 subjects), along with an open-label trial evaluating tazarotene’s efficacy for chemotherapy of BCC lesions (N=36 subjects) for a maximum follow-up period of 3 years. The authors of the study found that only 6% of patients had a chemopreventive response and that only 6% of treated BCC target lesions were clinically cured. The study also provided no evidence for either chemopreventive or chemotherapeutic effect of tazarotene against BCCs in patients with BCNS. The authors hypothesize that the discrepancy between the efficacy seen in Ptch1+/- mice as compared to that seen in PTCH1+/-, BCNS patients, may relate to the superior barrier function of human skin and the greater depth of human BCCs.