Prevention of mucositis with KGF in patients undergoing allogeneic stem cell transplantation.

Abstract

6543 Background: Prospective studies have shown that palifermin (keratinocyte growth factor, KGF) reduces the duration and severity of oral mucositis after auto hematopoietic stem cell transplant (HSCT). Methods: To test the hypothesis that KGF reduces mucositis following ablative allogeneic (allo)-HSCT, we conducted a retrospective study on 251 consecutive adult patients with hematologic malignancies who had a T cell depleted allo-HSCT from 2004-2009. 154 patients received KGF (TBI=77, chemo=77) and 97 patients did not receive KGF (TBI=44, chemo=53). The number of days of PCA and TPN use and length of hospital stay (LOS) were evaluated as clinical surrogates for mucositis severity. Outcomes were compared between KGF and non-KGF recipients using the Wilcoxon rank-sum test. Adjusting for age, ATG use and conditioning regimen, linear regression models evaluated the effect of KGF on each of these outcomes. Results: In the entire cohort, KGF was significantly associated in univariate and multivariate analysis with fewer days on PCA and TPN, and shorter LOS (Table). While the same significant association between KGF and outcomes was noted in recipients of TBI-based allo-HSCT, KGF did not affect mucositis severity in recipients of a chemo-based allo-HSCT. KGF did not affect overall survival, event-free survival, engraftment or acute graft-versus-host disease. Conclusions: Our data demonstrate that KGF decreases mucositis severity in recipients of TBI-based but not chemo-based allo-HSCT. We cannot exclude a benefit of KGF in other chemotherapy regimens. Prospective studies evaluating KGF’s impact on mucositis following allo-HSCT should preferentially focus on patients who receive TBI-based transplants. KGF P value Yes Median (range) No Median (range) Wilcoxon rank sum Adjusted test Entire cohort PCA days 2 (0-78) 7 (0-106) 0.002 0.023 TPN days 12 (0-53) 15 (0-63) 0.003 0.006 LOS 31 (11-89) 33 (15-128) 0.001 0.014 TBI regimens PCA days 5 (0-45) 11 (0-106) 0.011 0.033 TPN days 11 (0-51) 17 (0-32) <0.001 <0.001 LOS 31 (24-72) 37 (16-106) <0.001 0.001 Chemo regimen (busulfan/melphalan/fludarabine) PCA days 0 (0-78) 5 (0-34) 0.032 0.288 TPN days 12 (0-53) 13 (0-63) 0.573 0.490 LOS 31 (11-89) 32 (15-128) 0.696 0.459