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Ipilimumab: A First-in-Class??T-Cell Potentiator for Metastatic Melanoma

DOI: 10.1155/2013/423829

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Abstract:

Ipilimumab, a fully human anti-cytotoxic T-lymphocyte antigen-4 monoclonal antibody that potentiates antitumor T-cell responses, has demonstrated improved survival in previously treated and treatment-na?ve patients with unresectable stage III/IV melanoma. Survival benefit has also been shown in diverse patient populations, including those with brain metastases. In 2011, ipilimumab (3?mg/kg every 3 weeks for 4 doses) was approved by the Food and Drug Administration for unresectable or metastatic melanoma. Ipilimumab can induce novel response patterns for which immune-related response criteria have been proposed. irAEs are common but are usually low grade; higher grades can be severe and life-threatening. irAEs are usually manageable using established guidelines emphasizing vigilance and prompt intervention. This agent provides an additional therapeutic option in metastatic melanoma, and guidelines for management of adverse events facilitate clinical implementation of this new agent. 1. Introduction The incidence of melanoma has more than tripled in the Caucasian population during the last 20 years, and melanoma currently is the sixth most common cancer in the United States [1]. Recent estimates indicate that approximately 70,230 Americans (40,010 men and 30,220 women) developed invasive cutaneous melanoma in 2011, and 53,360 cases of melanoma in situ will be reported [1]. Although melanoma accounts for only 4% of all skin cancers, it is responsible for approximately 80% of all skin cancer deaths [2] with an estimated 8790 deaths from melanoma in 2011 [3]. For the majority of patients, the diagnosis of melanoma occurs at an early stage; 84% are diagnosed with localized disease. In contrast, for the small percentage of patients with a first diagnosis of unresectable stage III or stage IV or for those who recur with advanced disease, the associated clinical burden is significant and the prognosis is poor. For the 8% of patients diagnosed with stage III disease, 5-year relative survival is 62% [4]. For the 4% of patients diagnosed with unresectable stage III or IV (advanced) disease, historical benchmark data from a recent meta-analysis estimates a 25% 1-year survival [5], falling to approximately only 15% by 5 years [4, 5]. In addition to poor survival, patients diagnosed with advanced melanoma have limited treatment options: dacarbazine remains the only chemotherapy approved for use in the United States [6]. However, dacarbazine is associated with modest response rates (7–12%) and has never been tested in a randomized clinical trial setting for the

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