A COMPARISON OF CLINICAL EFFICACY AND SAFETY OF PERIPHERAL BLOOD STEM CELL TRANSPLANTATION AFTER MOBILIZATION WITH LENOGRASTIM AND FILGRASTIM

Author(s)

Pankiewicz O1, Rogoz A1, Rys P1, Lis J2, Gierczynski J2, Plisko R1, Wladysiuk M11HTA Consulting, Krakow, Poland, 2Sanofi-Aventis, Warsaw, Poland

OBJECTIVES: This study compared efficacy and safety of allogenic peripheral blood stem cell transplantation (PBSCT) after mobilization with either lenograstim or filgrastim. METHODS: Comparison was based on randomized controlled trials (RCT) identified by means of systematic review, carried out according to the Cochrane Collaboration guidelines. The most important medical databases were searched (EMBASE, MEDLINE, CENTRAL). Two reviewers independently selected trials, assessed their quality and extracted data. Since head-to-head trials were not found, indirect comparison using Bucher’s method was performed. RESULTS: The results of 2 RCTs for PBSCT after lenograstim mobilization and 7 for PBSCT with filgrastim were included. In all trials PBSCT was compared with bone marrow transplantation (BMT). No significant differences between lenograstim and filgrastim were found in mortality rate (RR = 0.84 [0.49; 1.42]) and relapse rate (RR=0.69 [0.19; 2.49]). PBSCT after mobilization with lenograstim comparing to BMT does not increase the risk of acute graft versus host disease (GvHD) (RR=1.06 [0.73; 1.53]) whereas PBSCT after filgrastim use is associated with higher risk of acute GvHD than BMT (RR=1.19 [1.03; 1.37]). However indirect comparison results in similar incidence of acute GvHD (RR= 0.89 [0.60; 1.32]. The was also no difference between lenograstim and filgrastim in respect to chronic GvHD (RR=1.33 [0.84; 2.11]. Lenograstim and filgrastim in PBSCT resulted in similar mortality rate due to GvHD (RR=0.55 [0.19; 1.59]), treatement realted mortality (RR=1.11 [0.60; 2.04]). No differences in hospital admissions for donors mobilized with lenograstim and filgrastim were identified (RR=1.04 [ 0.60; 1.79]). CONCLUSIONS: Indirect comparisons indicate similar efficacy and safety of PBSCT after mobilization with lenograstim and PBSCT after mobilization with filgrastim. Acknowledgements: This analysis was supported by Sanofi-Aventis.

Conference/Value in Health Info

2009-10, ISPOR Europe 2009, Paris, France

Value in Health, Vol. 12, No. 7 (October 2009)

Code

PCN7

Topic

Clinical Outcomes, Epidemiology & Public Health

Topic Subcategory

Comparative Effectiveness or Efficacy, Safety & Pharmacoepidemiology

Disease

Oncology

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