Update to mucositis guidelines issued

"Palifermin is a recombinant form of human keratinocyte growth factor [KGF]," said Robert J. Ignoffo, Pharm.D., clinical oncology specialist and professor emeritus of clinical pharmacy at the University of California San Francisco School of Pharmacy. Palifermin binds to the KGF receptor on the cell surface, acting as both a growth factor and a survival factor by stimulating epithelial-cell proliferation, differentiation, and migration in addition to upregulating cytoprotective mechanisms, he explained. "In essence, this drug promotes mucosal tissue healing. It is used for protecting against chemotherapy-induced mucositis."

According to the guidelines, palifermin should be administered at a dose of 60 mcg/kg per day for three days prior to conditioning treatment and for three days post-transplantation for the prevention of oral mucositis. This regimen is recommended for hematologic malignancies being treated with high-dose chemotherapy and total body irradiation with autologous stem cell transplantation. According to experts, nearly all patients undergoing myeloablative therapy for stem cell or bone marrow transplantation experience oral mucositis.

Experts estimate that hundreds of thousands of patients are affected by mucositis worldwide every year, causing pain and dysphagia which can even result in depression in some patients. These complications often lead to extended hospital stays and increased costs. "Mucositis affects quality of life substantially, especially those patients receiving high-dose chemotherapy and chronic radiation therapy," Ignoffo pointed out. "Prevention strategies are more desirable than treatment of mucositis, since they minimize the occurrence of mouth pain and maintain nutritional status." Preventive oral care regimens recommended by the panel include flossing, brushing, and using moisturizers and bland rinses. For bowel care, the group suggested maintenance of adequate hydration and prevention of the effects of lactose intolerance. Cryotherapy should be used to prevent oral mucositis in patients receiving high-dose melphalan.

Thirty guideline panelists who specialize in mucositis developed the consensus statement using the criteria of the American Society of Clinical Oncology and literature published between January 2002 and May 2005. In addition to adding new recommendations, the group also included guidance against certain practices. Due to its severe toxicity, systemic glutamine is not recommended for prevention of gastrointestinal mucositis. Both sucralfate and antimicrobial lozenges are also ill-advised for radiation-induced oral mucositis due to lack of proven benefit. Also, granulocyte-macrophage colony-stimulating factor mouthwashes are not recommended for prevention of oral mucositis due to lack of efficacy in several trials.

The Mucositis Study Group cited the need for a better understanding of the pathobiology of mucositis, as well as the genetic-based risk and long-term toxicity. If clinicians could predict which patients would develop mucositis, they said, targeted treatment with the newer, more expensive therapies might then be more cost-effective. The panel plans to publish updates to the guide every two to three years following literature review to incorporate results of ongoing studies.