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Impact of the type of anthracycline and of stem cell transplantation in younger patients with acute myeloid leukaemia: Long-term follow up of a phase III study
Authors:Frédéric Baron  Fabio Efficace  Laura Cannella  Petra Muus  Silvia Trisolini  Constantijn J M Halkes  Paola Fazi  Marco Vignetti  Jean-Pierre Marie  Patrizia Chiusolo  Walter van der Velden  Edoardo La Sala  Umberto Vitolo  Xavier Thomas  Francois Lefrère Sr  Francesco Di Raimondo  Jean-Henri Bourhis  Giorgina Specchia  José E Guimarães  Bernardino Allione  Radovan Vrhovac  Felicetto Ferrara  Marian Stevens-Kroef  Liv Meert  Theo de Witte  Roelof Willemze  Sergio Amadori  Stefan Suciu
Institution:1. GIGA-I3 and CHU, University of Liège, Liège, Belgium;2. Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy;3. Radboud University Medical Center, Nijmegen, Netherlands;4. Sapienza University, Rome, Italy;5. Leiden University Medical Center, Leiden, Netherlands;6. Saint-Antoine Hospital, Paris, France;7. Gemelli Hospital, Rome, Italy;8. Candiolo Cancer Institute-IRCCS, Torino, Italy;9. Lyon-Sud University Hospital, Lyon, France;10. Assistance Publique-Hôpitaux de Paris, Necker Children's Hospital, Paris, France;11. Universita di Catania, Catania, Italy;12. Gustave Roussy cancer campus Grand Paris, Villejuif, France;13. Giovanni XXIII- University Hospital, Bari, Italy;14. Hospital S. João, Porto, Portugal;15. University Hospital Centre Zagreb, Zagreb, Croatia;16. Cardarelli Hospital, Naples, Italy;17. EORTC Headquarters, Brussels, Belgium;18. University Tor Vergata, Rome, Italy
Abstract:We provide a long-term evaluation of patients enrolled in the EORTC/GIMEMA AML-10 trial which included a total of 2157 patients, 15-60 years old, randomized to receive either daunorubicin (DNR, 50 mg/m2), mitoxantrone (MXR, 12 mg/m2), or idarubicin (IDA, 10 mg/m2) in addition to standard-dose cytarabine and etoposide for induction chemotherapy and intermediate dose cytarabine for consolidation. Younger patients who reached complete remission with complete (CR) or incomplete (CRi) recovery were then scheduled to receive an allogeneic hematopoietic stem cell transplantation (HSCT). That was if they had a HLA-identical sibling donor; in all other cases, an autologous HSCT had to be administered. At an 11-year median follow-up, the 5-year, 10-year and 15-year overall survival (OS) rates were 33.2%, 30.1% and 28.0%, respectively. No significant difference between the three randomized groups regarding OS was observed (P = .38). In young patients, 15-45 years old, no treatment difference (P = .89) regarding OS was observed, while in patients 46-60 years old, MXR and IDA groups had a trend for a longer OS as compared to the DNR group (P = .029). Among younger patients without a favorable MRC cytogenetic risk subgroup who achieved a CR/CRi after induction chemotherapy, those with a HLA-identical sibling donor had higher 10-year and 15-year OS rates than those without. In older patients who reached CR/CRi, the long-term outcomes of those with or without a donor was similar. In conclusion, long-term outcomes of the study confirmed similar OS in the three randomized groups in the whole cohort of patients.
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