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Vemurafenib (Zelboraf) received FDA approval on August 17, 2011, for treatment of metastatic or unresectable melanoma, based on the results of the phase III BRIM3 trial.1 BRIM3 compared vemurafenib to dacarbazine in 675 untreated patients with the BRAF V600E mutation. Vemurafenib targets the...
In this introductory installment of In the Clinic, The ASCO Post provides an overview of two new melanoma agents recently approved by FDA, with discussion on pivotal data leading to approval, dosage and administration, and managing drug-related toxicities. Watch for more on clinical use of novel...
At the Best of ASCO® Miami meeting, Omid Hamid, MD, The Angeles Clinic and Research Institute (www.theangelesclinic.org), Los Angeles, California, reviewed abstracts that received a great deal of attention at this year’s Annual Meeting—the new treatments for metastatic melanoma. He also described...
The first-in-class Hedgehog pathway inhibitor vismodegib appears to be a successful treatment for advanced basal cell carcinoma, a disfiguring and debilitating disease, according to a pivotal multicenter nonrandomized trial presented as a Best Abstract at a Presidential Session during the recent...
Researchers at the University of Pittsburgh Cancer Institute have documented the molecular activity through which the Merkel cell polyomavirus contributes to 80% of cases of Merkel cell carcinoma—a finding that holds promise for future therapies. The researchers are now working on testing more than ...
Vismodegib is a small-molecule, orally active hedgehog pathway inhibitor that has shown considerable promise in treating basal cell carcinoma and is currently being evaluated alone and in combination in early-phase trials in medulloblastoma and a long list of other cancers.1 Owing to its...
Physician-based screening leads to detection of thinner melanomas that were less likely to have negative prognostic attributes such as ulceration and dermal mitosis, according to a retrospective review of patient records and biopsy logs from 394 patients diagnosed with cutaneous melanoma. The...
When sentinel lymph node biopsy for the regional staging of melanoma was first introduced, it was recommended for any patient with a melanoma 1.0 mm in Breslow thickness or greater. Patients with thin melanomas were not thought to have a sufficiently high risk to warrant the additional cost and...
Patients with a previously diagnosed cancer have an increased risk of developing cutaneous melanoma, with the highest risk among patients who have had a prior diagnosis of melanoma, according to a report published in the Archives of Dermatology.1 Key Findings Using Surveillance, Epidemiology, and...
The FDA has approved ingenol mebutate (Picato) gel for the topical treatment of actinic keratosis. At a concentration of 0.015%, the gel is used once daily on the face and scalp for 3 consecutive days, whereas a 0.05% dosage form is used once daily on the trunk and extremities for 2 consecutive...
The FDA has approved vismodegib (Erivedge) to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients with metastatic...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication Peginterferon alfa-2b (PegIntron, Sylatron) was recently ...
“The development of nonmelanoma skin cancers secondary to RAF inhibitor treatment has been recognized since 2005, having been seen initially with sorafenib (Nexavar),” noted Mario E. Lacouture, MD, of Memorial Sloan-Kettering Cancer Center. Commenting on recently published studies in this setting,...
Keratoacanthomas and cutaneous squamous cell carcinomas are frequently observed in patients receiving the RAF inhibitor vemurafenib (Zelboraf) for treatment of BRAF-mutated melanoma. As discussed by Lacouture and colleagues in a recent Journal of Clinical Oncology article, these effects appear to...
The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology have become the most widely used guidelines in oncology practice. The Guidelines cover 97% of all patients with cancer and are continually updated by expert panels. The 2012 Guidelines include some completely...
In advanced melanoma, combination therapy with two investigational drugs—one targeting BRAF and the other the MEK pathway—achieved a median progression-free survival of 7.4 months, which rose to 10.8 months in patients who were optimally dosed, reported Jeffrey S. Weber, MD, PhD, Director of the...
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. The MEK inhibitor trametinib...
Metastatic melanoma was long considered untreatable and incurable. The FDA approval of ipilimumab (Yervoy) and vemurafenib (Zelboraf) ushered in a new era for this disease, and now additional treatment options are in late stages of clinical development. Dabrafenib, a novel oral BRAF inhibitor, and...
Delcath Systems, Inc, announced that it has submitted a New Drug Application (NDA) to the FDA, seeking approval for its chemosaturation system (CHEMOSAT) for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The system is designed to...
I first became interested in treating skin issues associated with cancer about 10 years ago, during my dermatology residency training at the University of Chicago. Many of the agents under clinical development at the time, such as cetuximab (Erbitux) or sorafenib (Nexavar), were causing...
“This is a very exciting time in melanoma,” said Michael Sabel, MD, of the University of Michigan, Ann Arbor. “For years, we chugged along with few options for systemic therapy. Then in 2010 and 2011, we saw melanoma data presented at ASCO plenary sessions. At ASCO 2012, we expanded in these areas...
The likelihood of developing basal cell carcinoma was approximately 40 times higher among participants of the Childhood Cancer Survivor Study (CCSS) who received a dose of 35 Gy or more to the skin from radiation therapy than survivors who were not treated with radiation, according to a study...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In January 2012, vismodegib (Erivedge) was approved...
Two late-breaking studies presented at the 2012 European Society for Medical Oncology (ESMO) Congress highlight the promising potential of combining dual BRAF and MEK inhibitors for the treatment of BRAF-mutated metastatic melanoma. A phase II study showed that combining full doses of the BRAF...
Multikinase inhibitors (sorafenib [Nexavar], sunitinib [Sutent], pazopanib [Votrient], axitinib [Inlyta], regorafenib [Stivarga]) block various proteins including vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR). They have been approved by...
Tremelimumab did not produce a statistically significant advantage in overall survival compared to first-line standard-of-care chemotherapy in a phase III randomized trial reported in the Journal of Clinical Oncology. At final analysis, median overall survival by intent to treat was 12.6 months...
Mutational activation of BRAF is the most prevalent genetic alteration in melanoma, with ≥ 50% of tumors expressing the BRAF(V600E) oncoprotein. Vemurafenib (Zelboraf) produces tumor regression and improved survival in patients with late-stage BRAF-mutated melanoma. However, most patients relapse...
In a multicenter phase II study, trametinib showed “significant clinical activity” in a cohort of BRAF inhibitor–naive patients with BRAF-mutant cutaneous melanoma previously treated with chemotherapy and/or immunotherapy. Only minimal clinical activity, however, was observed among a cohort of...
At the recent American Academy of Dermatology 71st Annual Meeting in Miami Beach, researchers presented interesting findings regarding melanoma and other skin cancers. The ASCO Post brings you the following news briefs on these topics. Melanoma Incidence Decreases among Adolescents and Children An...
The FDA has approved technetium Tc 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Tilmanocept is an imaging drug that...
At the recent American Academy of Dermatology Annual Meeting in Miami, researchers presented interesting findings regarding melanoma and other skin cancers, as well as dermatologic effects of cancer agents. The following is a summary of one such study. While alopecia is a common side effect of many ...
Is sentinel node biopsy in melanoma an essential component of care? Despite a large multinational trial and recently published or updated guidelines, the question is still a thorny one according to experts who debated the issue at the recent meeting of the Society of Surgical Oncology in...
When sentinel node biopsy was shown to predict whether early melanoma had spread to regional lymph nodes, it revolutionized care. Before that, dissection of all regional lymph nodes was the norm for most patients. After that, the standard of care became a sentinel node biopsy and then—only if the...
A prospective study by researchers at Brigham and Women’s Hospital observed an association between risk of second primary cancer and history of nonmelanoma skin cancer in white men and women. The researchers found that people with a history of nonmelanoma skin cancer had a modestly increased risk...
Dermatologic Events in Oncology is guest edited by Mario E. Lacouture, MD, an Associate Member in the Division of Dermatology, Department of Medicine, at Memorial Sloan-Kettering Cancer Center, New York. He is a board-certified dermatologist with a special interest in dermatologic conditions that...
Merck has announced that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting the programmed death receptor (PD-1) that...
Patients with inflammatory bowel disease are at higher risk of melanoma, reported researchers at Mayo Clinic. Researchers found that inflammatory bowel disease is associated with a 37% greater risk for the disease. The findings were presented at the Digestive Disease Week 2013 conference in...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On May 29, 2013, trametinib (Mekinist) was approved by...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On May 29, 2013, dabrafenib (Tafinlar) was approved for ...
The U.S. Food and Drug Administration (FDA) recently approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma. Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene...
For the first time, a drug has proven effective in the treatment of uveal (ocular) melanoma that has metastasized, according to a randomized multicenter phase II study presented at the 2013 ASCO Annual Meeting.1 “This study is the first to demonstrate an improved clinical outcome with any systemic...
For metastatic melanoma, the activity of ipilimumab can be boosted by the addition of granulocyte-macrophage colony-stimulating factor (GM-CSF, Leukine), according to a phase II study that found the combination improved overall survival, vs ipilimumab alone. The results were presented at the 2013...
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Much of the news about immunotherapy ...
Dermatologic Events in Oncology is guest edited by Mario E. Lacouture, MD, an Associate Member in the Division of Dermatology, Department of Medicine, at Memorial Sloan-Kettering Cancer Center, New York. He is a board-certified dermatologist with a special interest in dermatologic conditions that...
New treatments for melanoma and cervical cancer were cited as the most important subjects of new clinical information presented at the 2013 ASCO Annual Meerting, according to the second annual ASCO Impact Report released recently by Encuity Research. New treatments for melanoma, with an emphasis...
Attendees at the ASCO Annual Meeting are faced with a major challenge of trying to attend as many important sessions as they can over a 4-day period. Our challenge is to feature the major news in The ASCO Post. In addition to our regular comprehensive coverage of key presentations, the following...
Lambrolizumab produced a high rate of sustained tumor regression when tested among 135 patients with advanced melanoma in a multi-institutional, international, phase I expansion study reported in The New England Journal of Medicine. At a median follow-up of 11 months, responses were durable in the...
An “alarming difference” in survival outcomes between young, non-Hispanic white males and females with primary invasive melanoma “highlights the urgent need for both behavioral interventions to promote early detection strategies in young men and further investigation of the biological basis for the ...
Researchers at Moffitt Cancer Center suggest secondary cancers seen in melanoma patients who are being treated for a BRAF gene mutation may require new strategies, such as enhanced surveillance and combining BRAF inhibitor therapy with other inhibitors, especially as they become more widely used....
Merkel cell carcinoma is a rare but aggressive skin cancer with poor outcomes and suboptimal therapeutic options. With a 46% mortality rate, it is three times more lethal than melanoma, and its reported incidence is rising. “Merkel cell carcinoma is a nasty cancer and we have zero FDA-approved...