The Impact Of Palifermin Use On Hematopoietic Cell Transplant Outcomes In Children.

The Impact Of Palifermin Use On Hematopoietic Cell Transplant Outcomes In Children.

Biol Blood Marrow Transplant. 2016 Apr 15;

Authors: Saber W, Zhang MJ, Steinert P, Chen M, Horowitz MM

Abstract
PURPOSE: Clinical trials evaluating palifermin have enrolled few pediatric patients precluding safety analyses in large groups of children. We compared hematopoietic cell transplant (HCT) outcomes among pediatric patients from a large database who did or did not receive palifermin as a preventive treatment for oral mucositis.
PATIENTS AND METHODS: Pediatric patients and controls, matched for HCT and donor type, disease, disease status and age, were selected from the Center for International Blood and Marrow Transplant Research (CIBMTR) database and a 1:3 matched cohort analysis was performed. Stratified Cox proportional hazards models were built and propensity score adjustments were used to compare overall and disease-free survival outcomes between palifermin-treated and untreated patients.
RESULTS: Three controls were identified for 90% of palifermin recipients. The remaining cases were matched with two (8%) or one (2%) controls, for a total of 210 palifermin-treated patients matched with 606 controls. Median follow-up was 31 months in cases and 36 months in controls. 57% of patients underwent allogeneic HCT, mostly for acute leukemia, and 43% underwent autologous HCT, mostly for solid tumors. In univariate analyses, two-year survival and disease-free survival rates after allogeneic HCT (58% vs 66%, P = .109; 49% vs 60%, P = .060) and after autologous HCT (73% vs 77%, P = .474; 60% vs 64%, P = .637) were similar between palifermin-treated patients and matched controls. In multivariate analysis, palifermin treatment did not significantly increase the risk of mortality (relative risk [RR] 1.20, 95% CI 0.87-1.66) or relapse (RR 1.12, 95% CI 0.78-1.62) compared with matched controls. No significant differences in rates of acute or chronic graft-vs-host disease (GVHD) were observed between palifermin-treated patients and matched controls.
CONCLUSION: Among the pediatric patients undergoing HCT, overall survival, disease-free survival, neutrophil recovery, and GVHD rates were similar between palifermin-treated patients and matched controls.

PMID: 27090960 [PubMed - as supplied by publisher]

from #ENT via xlomafota13 on Inoreader http://ift.tt/1WF04Dg
via IFTTT