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2. Improving survival with deferiprone treatment in patients with thalassemia major: A prospective multicenter randomised clinical trial under the auspices of the Italian Society for Thalassemia and Hemoglobinopathies

Author

Michele Rizzo, Crocetta Argento, Angela Vitrano, Pietro Violi, R. Malizia, Domenico Giuseppe D'Ascola, Carmelo Magnano, Aurelio Maggio, Marcello Capra, Saveria Campisi, Francesco Cantella, Francesca Valeria Commendatore, Francesco Gagliardotto, Liana Cuccia, Giovanni Giugno, Rocca Cingari, Carmelo Fidone, Maria Antonietta Romeo, Paolo Rigano, Luciano Prossomariti, Anna Meo, Paolo Cianciulli, Gaetano Roccamo, Aldo Filosa, Maria Concetta Galati, Gaetano Giuffrida, Vincenzo Caruso, Turi Lombardo, Angela Ciancio, Calogera Gerardi, Maggio, A, Vitrano, A, Capra, M, Cuccia, L, Gagliardotto, F, Filosa, A, Magnano, C, Rizzo, M, Caruso, V, Gerardi, C, Argento, C, Campisi, S, Cantella, F, Commendadore, F, D’Ascola, DG, Fidone, C, Ciancio, A, Galati, MC, Giuffrida, G, Cingari, R, Giugno, G, Lombardo, T, Prossomariti, L, Malizia, R, Meo, A, Roccamo, G, Romeo, MA, Violi, P, Cianciulli, P, and Rigano, P

Subjects
Male, Thalassemia, Kaplan-Meier Estimate, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, Cause of Death, Neoplasms, Deferiprone, Prospective Studies, Child, Cause of death, Hazard ratio, Hematology, Middle Aged, Combined Modality Therapy, Survival Rate, Thalassemia, survival, chelation, treatment, trial, thalassemia major, Combination, Splenectomy, Molecular Medicine, Drug Therapy, Combination, Female, Adult, medicine.medical_specialty, Adolescent, Pyridones, Deferoxamine, Iron Chelating Agents, Young Adult, Drug Therapy, Internal medicine, medicine, Humans, Blood Transfusion, Chelation Therapy, Heart Failure, Kaplan-Meiers Estimate, Proportional Hazards Models, beta-Thalassemia, Molecular Biology, Survival rate, Survival analysis, business.industry, Proportional hazards model, Cell Biology, medicine.disease, Surgery, chemistry, business
Abstract

The prognosis for thalassemia major has dramatically improved in the last two decades. However, many transfusion-dependent patients continue to develop progressive accumulation of iron. This can lead to tissue damage and eventually death, particularly from cardiac disease. Previous studies that investigated iron chelation treatments, including retrospective and prospective non-randomised clinical trials, suggested that mortality, due mainly to cardiac damage, was reduced or completely absent in patients treated with deferiprone (DFP) alone or a combined deferiprone-deferoxamine (DFP-DFO) chelation treatment. However, no survival analysis has been reported for a long-term randomised control trial. Here, we performed a multicenter, long-term, randomised control trial that compared deferoxamine (DFO) versus DFP alone, sequential DFP-DFO, or combined DFP-DFO iron chelation treatments. The trial included 265 patients with thalassemia major, with 128 (48.3%) females and 137 (51.7%) males. No deaths occurred with the DFP-alone or the combined DFP-DFO treatments. One death occurred due to graft versus host disease (GVHD) in a patient that had undergone bone marrow transplantation; this patient was censored at the time of transplant. Only one death occurred with the DFP-DFO sequential treatment in a patient that had experienced an episode of heart failure one year earlier. Ten deaths occurred with the deferoxamine treatment. The main factors that correlated with an increase in the hazard ratio for death were: cirrhosis, arrhythmia, previous episode of heart failure, diabetes, hypogonadism, and hypothyroidism. In a Cox regression model, the interaction effect of sex and age was statistically significant (p-value

Published
2009

3. Improving survival with deferiprone treatment in patients with thalassemia major: a prospective multicenter randomised clinical trial under the auspices of the Italian Society for Thalassemia and Hemoglobinopathies.

Author

Maggio A, Vitrano A, Capra M, Cuccia L, Gagliardotto F, Filosa A, Magnano C, Rizzo M, Caruso V, Gerardi C, Argento C, Campisi S, Cantella F, Commendatore F, D'Ascola DG, Fidone C, Ciancio A, Galati MC, Giuffrida G, Cingari R, Giugno G, Lombardo T, Prossomariti L, Malizia R, Meo A, Roccamo G, Romeo MA, Violi P, Cianciulli P, and Rigano P

Subjects
Adolescent, Adult, Blood Transfusion, Cause of Death, Child, Combined Modality Therapy, Deferiprone, Deferoxamine administration & dosage, Deferoxamine therapeutic use, Drug Therapy, Combination, Female, Heart Failure etiology, Heart Failure mortality, Humans, Iron Chelating Agents administration & dosage, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasms complications, Neoplasms mortality, Proportional Hazards Models, Prospective Studies, Pyridones administration & dosage, Splenectomy, Survival Rate, Young Adult, beta-Thalassemia complications, beta-Thalassemia mortality, beta-Thalassemia therapy, Chelation Therapy, Iron Chelating Agents therapeutic use, Pyridones therapeutic use, beta-Thalassemia drug therapy
Abstract

The prognosis for thalassemia major has dramatically improved in the last two decades. However, many transfusion-dependent patients continue to develop progressive accumulation of iron. This can lead to tissue damage and eventually death, particularly from cardiac disease. Previous studies that investigated iron chelation treatments, including retrospective and prospective non-randomised clinical trials, suggested that mortality, due mainly to cardiac damage, was reduced or completely absent in patients treated with deferiprone (DFP) alone or a combined deferiprone-deferoxamine (DFP-DFO) chelation treatment. However, no survival analysis has been reported for a long-term randomised control trial. Here, we performed a multicenter, long-term, randomised control trial that compared deferoxamine (DFO) versus DFP alone, sequential DFP-DFO, or combined DFP-DFO iron chelation treatments. The trial included 265 patients with thalassemia major, with 128 (48.3%) females and 137 (51.7%) males. No deaths occurred with the DFP-alone or the combined DFP-DFO treatments. One death occurred due to graft versus host disease (GVHD) in a patient that had undergone bone marrow transplantation; this patient was censored at the time of transplant. Only one death occurred with the DFP-DFO sequential treatment in a patient that had experienced an episode of heart failure one year earlier. Ten deaths occurred with the deferoxamine treatment. The main factors that correlated with an increase in the hazard ratio for death were: cirrhosis, arrhythmia, previous episode of heart failure, diabetes, hypogonadism, and hypothyroidism. In a Cox regression model, the interaction effect of sex and age was statistically significant (p-value<0.013). For each increasing year of age, the hazard ratio for males was 1.03 higher than that for females (p-value<0.013). In conclusion, the results of this study show that the risk factors for predicting mortality in patients with thalassemia major are deferoxamine-treatment, complications, and the interaction effect of sex and age.

Published
2009
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