Palifermin Use in Lymphoma Patients Undergoing Autologous BEAM Transplants

Background: Palifermin is a human recombinant keratinocyte growth factor. It was approved by the FDA in 2004 for decreasing the incidence and duration of oral mucositis in patients receiving high dose chemotherapy and stem cell rescue. Approval followed two randomized, placebo-controlled, multicenter trials conducted in patients with hematologic malignancies undergoing myeloablative conditioning with TBI. After approval, palifermin use was extended to non-TBI based conditioning regimens. In 2008, our institution began use of palifermin in lymphoma patients undergoing BEAM conditioning and ASCT. Our goal in this study was to assess the efficacy of such a strategy in a non-TBI based transplant group. Methods: From 1/2008 through 6/2013 we performed 75 BEAM/ASCT on lymphoma patients using palifermin. We compared this group to the preceding 75 lymphoma patients who received BEAM auto-conditioning without it. The two cohorts were compared for incidence of fever, positive blood cultures, positive urine cultures, TPN use, PCA use, and length of stay (LOS). Data was collected retrospectively. Results: Results are summarized in the table below. Of note,  there was a statistically significant difference (p<0.05) of fewer febrile episodes in the palifermin group and TPN use.  However there were no statistically significant differences in positive blood cultures, urine cultures, PCA use, or LOS. Conclusion: Mucositis has been associated with increased incidence of fever. Inflammation rather than infection has been postulated as the mechanism for mucosotis fever. Significantly fewer patients developed fevers in the palifermin group though there was no difference in the incidence of positive cultures. Palifermin reduced the use of fever workups and the empiric use of antibiotics. TPN use was also curtailed by palifermin administration. Despite its mechanism of action of decreasing mucositis, neither PCA use nor LOS differed substantially between the groups. It may be that mucositis is not a major rate-limiting step to discharge as symptoms often tend to resolve shortly after engraftment. Further analysis comparing time to engraftment with length of stay may help answer this question. Important future studies should include pharmacoeconomic analysis of the relationship between palifermin, TPN antibiotics, and growth factor use as well as overall cost and outcomes of performing BEAM/ASCT with and without palifermin. A CIBMTR retrospective study with additional data collection analyzing palifermin use in BEAM auto-patients may be an expeditious way to answer many of these questions.  

TABLE:

Characteristic	Palifermin (N=75)	No Palifermin (N=75)	P-value
Fever	46	72	<0.05
Positive Blood Cultures	5	11	NS
Positive Urine Cultures	11	5	NS
TPN	17	58	<0.05
PCA	52	56	NS
Mean LOS	21	22	NS
Median LOS	21	21	NS
Range for LOS	12-36	12-37	N/A

  NS: Not statistically significant (using P value of <0.05)