Researchers from Germany have reported that Kepivance® (palifermin, keratinocyte growth factor) reduces the incidence and severity of oral mucositis associated with high-dose methotrexate. The details of this study were reported in the September issue of the Annals of Oncology.¹ 

Oral mucositis is a frequent clinical problem in patients receiving chemotherapy and/or radiation therapy. Mucositis can be a severe dose-limiting toxicity, especially in patients receiving high-dose chemotherapy. Mucositis can also be dose-limiting in patients receiving conventional doses of chemotherapy. Although oral mucositis is the most obvious manifestation of mucosal injury from chemotherapy and radiation therapy, the damage extends throughout the oropharynx, esophagus, and perirectal areas. Damaged mucosa is also the portal of entry of bacteria and fungi, and mucositis is associated with febrile neutropenia.

Although many specific and non-specific prophylactic and therapeutic treatments have been evaluated, there is no proven therapy for the prevention or treatment of mucositis. Prior to the approval of Kepivance, there were no FDA-approved systemic drugs for the treatment or prevention of mucositis due to chemotherapy or radiation therapy. Currently, Kepivance is approved by the FDA for preventing mucositis in the transplant setting. However, a recent randomized multicenter trial demonstrated that Kepivance given before chemotherapy reduced the incidence of severe oral mucositis in patients receiving 5-FU/leucovorin for metastatic colorectal cancer.

The current study evaluated the effects of Kepivance in preventing oral mucositis in 10 patients undergoing treatment with sequential cycles of high-dose methotrexate. Kepivance was administered on alternate cycles, and each patient served as his own control for this study. These authors reported that severe mucositis (Grade III=IV) occurred after all 10 cycles without Kepivance. However, severe mucositis occurred in only two of 10 patients after receiving Kepivance. All 10 cycles of high-dose methotrexate given without Kepivance prophylaxis were associated with infection compared with only four of 10 cycles given with Kepivance. There was also a two-day reduction in the duration of mucositis in patients receiving Kepivance who developed severe mucositis. These authors concluded that Kepivance reduced the incidence and severity of high-dose methotrexate-induced oral mucositis.

Comments: These data are consistent with those generated in patients receiving 5-FU and suggest that Kepivance could play a supportive care role in patients receiving conventional-dose chemotherapy.

Related News:

Kepivance® May Decrease Oral Mucositis Following High-Dose Chemotherapy (01/08/2007)

Kepivance® Decreases Oral Mucositis in Patients with Metastatic Colorectal Cancer. (11/27/2006)

Kepivance® Reduces Mucositis After Allogeneic Stem Cell Transplantation Without Impact on Acute GVHD (11/09/2006)

Kepivance™ Improves Patient-Assessed Oral Mucositis Following Autologous Stem Cell Transplantation (04/21/2006)

Reference:

¹ Schmidt E, Thoennissen NH, Rudat A, et al. Use of palifermin for the prevention of high-dose methotrexate-induced oral mucositis. Annals of Oncology. 2008;19:1644-1649.