Analysis of the Clinical Impact of the Use of Palifermin in Patients Undergoing Autologous Peripheral Blood Progenitor Cell Transplantation for Multiple Myeloma and Relapsed Lymphoma

Severe mucositis remains a serious complication of autologous PBPC transplantation. Keratinocyte growth factor/KGF (Palifermin) is a 28kd heparin-binding glycoprotein that specifically binds the KGF receptor resulting in a range of biological events including increased mucosal epithelial thickness. Administration of palifermin to patients undergoing TBI-based autologous PBPC transplantation has been shown to reduce the incidence and duration of severe mucositis. In the current study we retrospectively evaluated the use of palifermin in patients with myeloma and relapsed lymphoma undergoing non-TBI autologous PBPC transplantation with high-dose melphalan and BEAM (BCNU, etoposide, cytarabine, melphalan) conditioning regimens respectively. Palifermin was given at a dose of 60 mcg/kg/day on days −5 to −3 in patients with myeloma, days −10 to −8 in patients with lymphoma, and days 0 to +2 in all patients. Depending on clinical status and distance from our centre, patients had the opportunity of early discharge on day +1 with outpatient follow-up. G-CSF was administered (5 mcg/kg/day) starting on day +5 in all patients. Of a total of 81 patients, 32 patients received palifermin (23 myeloma, 9 lymphoma) and were compared to a concurrent non-palifermin treated population of 49 patients (27 myeloma, 22 lymphoma). Patients were comparable with respect to age (overall mean 54.5 years), except that patients with myeloma receiving palifermin were slightly older (mean 60 vs. 55 y, p=0.04), and the numbers of infused CD34 positive cells per kg were similar. There were 46 male and 35 female patients. Administration of palifermin was safe and generally well tolerated with 97% of patients receiving all scheduled doses; rash was seen in 32% of cases. The use of palifermin did not influence engraftment of leukocytes or platelets in either myeloma or lymphoma patients. Analysis of length of stay (LOS) following reinfusion in the entire group suggested a difference of 2 days favouring the palifermin group (mean 11.8 vs 13.8 days), but this was not statistically significantly different. There were also no statistically detectable differences in LOS in palifermin treated or untreated patients with myeloma (mean 13.5 vs 10.5 days) or lymphoma (mean 7.7 vs 17.9 days) respectively, although the number of patients with lymphoma receiving palifermin was small. Patients with myeloma appeared to have higher rates of significant mucositis compared with lymphoma (74% vs 48%, p=0.03) but this was not significant in an exploratory logistic regression analysis when age, gender, underlying disease, administration of palifermin and infused number of PBPC were included in the analysis. We conclude that palifermin can be safely administered to patients undergoing non-TBI high dose therapy and autologous PBPC transplantation. Although there was a suggestion of some improvements in LOS with palifermin, the small numbers of patients limit the strength of such conclusions. Further prospective studies in non-TBI conditioning regimens will help to further define the potential benefits of palifermin in reducing mucositis and its consequences.