TY - JOUR
T1 - GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia
AU - Venditti, Adriano
AU - Piciocchi, Alfonso
AU - Candoni, Anna
AU - Melillo, Lorella
AU - Calafiore, Valeria
AU - Cairoli, Roberto
AU - De Fabritiis, Paolo
AU - Storti, Gabriella
AU - Salutari, Prassede
AU - Lanza, Francesco
AU - Martinelli, Giovanni
AU - Luppi, Mario
AU - Mazza, Patrizio
AU - Martelli, Maria Paola
AU - Cuneo, Antonio
AU - Albano, Francesco
AU - Fabbiano, Francesco
AU - Tafuri, Agostino
AU - Chierichini, Anna
AU - Tieghi, Alessia
AU - Fracchiolla, Nicola Stefano
AU - Capelli, Debora
AU - Foà, Robin
AU - Alati, Caterina
AU - Sala, Edoardo La
AU - Fazi, Paola
AU - Vignetti, Marco
AU - Maurillo, Luca
AU - Buccisano, Francesco
AU - Del Principe, Maria Ilaria
AU - Irno-Consalvo, Maria
AU - Ottone, Tiziana
AU - Lavorgna, Serena
AU - Voso, Maria Teresa
AU - Lo-Coco, Francesco
AU - Arcese, William
AU - Amadori, Sergio
PY - 2019/9/19
Y1 - 2019/9/19
N2 - We designed a trial in which postremission therapy of young patients with de novo acute myeloid leukemia (AML) was decided combining cytogenetics/genetics and postconsolidation levels of minimal residual disease (MRD). After induction and consolidation, favorable-risk patients (FR) were to receive autologous stem cell transplant (AuSCT) and poor-risk patients (PR) allogeneic stem cell transplant (AlloSCT). Intermediate-risk patients (IR) were to receive AuSCT or AlloSCT depending on the postconsolidation levels of MRD. Three hundred sixty-one of 500 patients (72%) achieved a complete remission, 342/361 completed the consolidation phase and were treatment allocated: 165 (48%) to AlloSCT (122 PR, 43 IR MRD-positive) plus 23 rescued after salvage therapy, for a total of 188 candidates; 150 (44%) to AuSCT (115 FR, 35 IR MRD-negative) plus 27 IR patients (8%) with no leukemia-associated phenotype, for a total of 177 candidates. Overall, 110/177 (62%) and 130/188 (71%) AuSCT or AlloSCT candidates received it, respectively. Two-year overall (OS) and disease-free survival (DFS) of the whole series was 56% and 54%, respectively. Two-year OS and DFS were 74% and 61% in the FR category, 42% and 45% in the PR category, 79% and 61% in the IR MRD-negative category, and 70% and 67% in the IR MRD-positive category. In conclusion, AuSCT may still have a role in FR and IR MRD-negative categories. In the IR MRD-positive category, AlloSCT prolongs OS and DFS to equal those of the FR category. Using all the available sources of stem cells, AlloSCT was delivered to 71% of the candidates
AB - We designed a trial in which postremission therapy of young patients with de novo acute myeloid leukemia (AML) was decided combining cytogenetics/genetics and postconsolidation levels of minimal residual disease (MRD). After induction and consolidation, favorable-risk patients (FR) were to receive autologous stem cell transplant (AuSCT) and poor-risk patients (PR) allogeneic stem cell transplant (AlloSCT). Intermediate-risk patients (IR) were to receive AuSCT or AlloSCT depending on the postconsolidation levels of MRD. Three hundred sixty-one of 500 patients (72%) achieved a complete remission, 342/361 completed the consolidation phase and were treatment allocated: 165 (48%) to AlloSCT (122 PR, 43 IR MRD-positive) plus 23 rescued after salvage therapy, for a total of 188 candidates; 150 (44%) to AuSCT (115 FR, 35 IR MRD-negative) plus 27 IR patients (8%) with no leukemia-associated phenotype, for a total of 177 candidates. Overall, 110/177 (62%) and 130/188 (71%) AuSCT or AlloSCT candidates received it, respectively. Two-year overall (OS) and disease-free survival (DFS) of the whole series was 56% and 54%, respectively. Two-year OS and DFS were 74% and 61% in the FR category, 42% and 45% in the PR category, 79% and 61% in the IR MRD-negative category, and 70% and 67% in the IR MRD-positive category. In conclusion, AuSCT may still have a role in FR and IR MRD-negative categories. In the IR MRD-positive category, AlloSCT prolongs OS and DFS to equal those of the FR category. Using all the available sources of stem cells, AlloSCT was delivered to 71% of the candidates
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UR - http://www.scopus.com/inward/citedby.url?scp=85072508914&partnerID=8YFLogxK
U2 - 10.1182/blood.2018886960
DO - 10.1182/blood.2018886960
M3 - Article
C2 - 31395600
AN - SCOPUS:85072508914
VL - 134
SP - 935
EP - 945
JO - Blood
JF - Blood
SN - 0006-4971
IS - 12
ER -