Kepivance® Decreases Oral Mucositis in Patients with Metastatic Colorectal Cancer.
The results of a randomized multicenter trial demonstrate that Kepivance (palifermin, keritinocyte growth factor) given before chemotherapy reduces the incidence of severe oral mucositis in patients receiving 5-FU/leucovorin for metastatic colorectal cancer. The details of this study appeared in the November 20, 2006, issue of the Journal of Clinical Oncology.
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. At the present time, Kepivance is approved for preventing mucositis in the transplant setting.
In the current study, 64 patients with metastatic colorectal cancer were randomly allocated to receive Kepivance or placebo on three consecutive days prior to each of two cycles of 5-FU/leucovin. Tables 1 shows the main observations after cycle 1 and cycle 2 of chemotherapy.
Table 1: Cycles 1 and 2 of 5FU/Leucovorin
| Kepivance | Placebo |
Number of Patients | 28 | 36 |
Grade 2 or Higher Oral Mucositis (Cycle 1) | 29% | 61% |
No Mucositis (Cycle 1) | 46% | 17% |
Grade 2 or Higher Oral Mucositis (Cycle 2) | 11% | 47% |
No Mucositis (Cycle 2) | 63% | 31% |
Dose Reduction of 10% or more (Cycle 2) | 14% | 31% |
Grade 2 Diarrhea (cycle 1) | 18% | 20% |
Grade 2 Diarrhea (cycle 2) | 19% | 13% |
Patient reported observations were reported to be similar to investigator observations for both diarrhea and mucositis. There was no apparent impact on time to disease progression or survival. These authors suggest that Kepivance should be tested in other mucositis inducing regimens.
Comments: These are the first data showing that Kepivance is effective in preventing mucositis in the non-transplant setting.
Reference: Rose LS, Abdi E, Davis ID, et al. Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with flouracil-based chemotherapy. Journal of Clinical Oncology 2006;24:5194-5200.
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