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GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia

Blood, 2019-09, Vol.134 (12), p.935-945 [Peer Reviewed Journal]

2019 American Society of Hematology ;2019 by The American Society of Hematology. ;ISSN: 0006-4971 ;EISSN: 1528-0020 ;DOI: 10.1182/blood.2018886960 ;PMID: 31395600

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Title:
GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia
Author: Venditti, Adriano ; Piciocchi, Alfonso ; Candoni, Anna ; Melillo, Lorella ; Calafiore, Valeria ; Cairoli, Roberto ; de Fabritiis, Paolo ; Storti, Gabriella ; Salutari, Prassede ; Lanza, Francesco ; Martinelli, Giovanni ; Luppi, Mario ; Mazza, Patrizio ; Martelli, Maria Paola ; Cuneo, Antonio ; Albano, Francesco ; Fabbiano, Francesco ; Tafuri, Agostino ; Chierichini, Anna ; Tieghi, Alessia ; Fracchiolla, Nicola Stefano ; Capelli, Debora ; Foà, Robin ; Alati, Caterina ; La Sala, Edoardo ; Fazi, Paola ; Vignetti, Marco ; Maurillo, Luca ; Buccisano, Francesco ; Del Principe, Maria Ilaria ; Irno-Consalvo, Maria ; Ottone, Tiziana ; Lavorgna, Serena ; Voso, Maria Teresa ; Lo-Coco, Francesco ; Arcese, William ; Amadori, Sergio
Subjects: Adolescent ; Adult ; Age Factors ; Combined Modality Therapy ; Consolidation Chemotherapy - methods ; Cytogenetics ; Female ; Hematopoietic Stem Cell Transplantation - methods ; Humans ; Induction Chemotherapy - methods ; Leukemia, Myeloid, Acute - diagnosis ; Leukemia, Myeloid, Acute - genetics ; Leukemia, Myeloid, Acute - pathology ; Leukemia, Myeloid, Acute - therapy ; Male ; Middle Aged ; Molecular Targeted Therapy - methods ; Neoplasm, Residual ; Precision Medicine - methods ; Prognosis ; Remission Induction - methods ; Risk Assessment ; Young Adult
Is Part Of: Blood, 2019-09, Vol.134 (12), p.935-945
Description: 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.This trial was registered at www.clinicaltrials.gov as #NCT01452646 and EudraCT as #2010-023809-36. •A risk-adapted, MRD-driven transplant strategy is a feasible approach for the treatment of younger adults with AML.•Pretransplant MRD positivity should not contraindicate delivery of an allogeneic stem cell transplant. [Display omitted]
Publisher: United States: Elsevier Inc
Language: English
Identifier: ISSN: 0006-4971
EISSN: 1528-0020
DOI: 10.1182/blood.2018886960
PMID: 31395600
Source: GFMER Free Medical Journals
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GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia

2019 American Society of Hematology ;2019 by The American Society of Hematology. ;ISSN: 0006-4971 ;EISSN: 1528-0020 ;DOI: 10.1182/blood.2018886960 ;PMID: 31395600

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