Palifermin (Kepivance™) for the treatment of oral mucositis in patients with hematologic malignancies requiring hematopoietic stem cell support

Abstract

Objective. To provide a comprehensive review of the clinical use of the recombinant biological agent, palifermin, with particular reference to its use in its approved indication, oral mucositis resulting from high dose chemotherapy and radiation in patients with hematologic malignancies requiring hematopoietic stem cell support. Data Sources. A MEDLINE search was conducted using the terms ‘palifermin’ and ‘Kepivance.’ All data available from MEDLINE were reviewed. The reference lists from retrieved articles were reviewed and other relevant papers were identified. Data Summary. Keratinocyte growth factor (KGF) is a growth factor that acts specifically on epithelial cells playing a role in proliferation, migration, and morphogenesis. Palifermin is a recombinant human form of KGF. Because of its ability to cause proliferation of the oral mucosa and to protect against mucosal injury, palifermin is a treatment option for patients who are at high risk for oral mucositis, specifically patients with hematological malignancies receiving stem cell transplantation (SCT). In a phase III study of these patients, the overall incidence of World Health Organization (WHO) grade 3 or 4 oral mucositis was significantly reduced in the palifermin group (palifermin=63% versus placebo=98%, P B0.001). Among the patients who experienced WHO grade 3 or 4 oral mucositis the average duration of this grade of mucositis in the palifermin group was six days compared with nine days in the placebo group (P B0.001). Common adverse effects of palifermin include pruritis, erythema, mouth and tongue disorders, and taste alterations.