Therapeutic efficacy and safety of photochemically treated apheresis platelets processed with an optimized integrated set.
Fiche publication
Date publication
septembre 2005
Auteurs
Membres identifiés du Cancéropôle Est :
Dr LIOURE Bruno
Tous les auteurs :
Janetzko K, Cazenave JP, Kluter H, Kientz D, Michel M, Beris P, Lioure B, Hastka J, Marblie S, Mayaudon V, Lin L, Lin JS, Conlan MG, Flament J
Lien Pubmed
Résumé
BACKGROUND: This multicenter, randomized, controlled, double-blind Phase III clinical study evaluated the therapeutic efficacy and safety of apheresis platelets (PLTs) photochemically treated (PCT) with amotosalen and ultraviolet A light (INTERCEPT Blood System, Baxter Healthcare Corp.) compared with conventional apheresis PLTs (reference). STUDY DESIGN AND METHODS: Forty-three patients with transfusion-dependent thrombocytopenia were randomly assigned to receive either PCT or reference PLT transfusions for up to 28 days. RESULTS: The mean 1- and 24-hour corrected count increments were lower in response to PCT PLTs (not significant). When analyzed by longitudinal regression analysis, the estimated effect of treatment on 1-hour PLT count was a decrease of 7.2 x 10(9) per L (p = 0.05) and on 24-hour PLT count a decrease of 7.4 x 10(9) per L (p = 0.04). Number, frequency, and dose of PLT transfusions; acute transfusion reactions; and adverse events were similar between the two groups. There was no transfusion-associated bacteremia. Four PCT patients experienced clinical refractoriness; however, only one exhibited lymphocytotoxicity assay seroconversion. Antibodies against potential amotosalen-related neoantigens were not detected. CONCLUSION: PCT PLTs provide effective and safe transfusion support for thrombocytopenic patients.
Référence
Transfusion. 2005 Sep;45(9):1443-52.