A prognostic model for survival after salvage treatment with FLAG-Ida +/- gemtuzumab-ozogamicine in adult patients with refractory/relapsed acute myeloid leukaemia.
The combination of fludarabine, cytarabine, idarubicin, and granulocyte colony-stimulating factor (FLAG-Ida) is widely used in relapsed/refractory acute myeloid leukaemia (AML). We retrospectively analysed the results of 259 adult AML patients treated as first salvage with FLAG-Ida or FLAG-Ida plus Gentuzumab-Ozogamicin (FLAGO-Ida) of the Programa Español de Tratamientos en Hematología (PETHEMA) database, developing a prognostic score system of survival in this setting (SALFLAGE score). Overall, 221 patients received FLAG-Ida and 38 FLAGO-Ida; 92 were older than 60 years. The complete remission (CR)/CR with incomplete blood count recovery (CRi) rate was 51%, with 9% of induction deaths. Three covariates were associated with lower CR/CRi: high-risk cytogenetics and t(8;21) at diagnosis, no previous allogeneic stem cell transplantation (allo-SCT) and relapse-free interval <1 year. Allo-SCT was performed in second CR in 60 patients (23%). The median overall survival (OS) of the entire cohort was 0·7 years, with 22% OS at 5-years. Four independent variables were used to construct the score: cytogenetics, FLT3-internal tandem duplication, length of relapse-free interval and previous allo-SCT. Using this stratification system, three groups were defined: favourable (26% of patients), intermediate (29%) and poor-risk (45%), with an expected 5-year OS of 52%, 26% and 7%, respectively. The SALFLAGE score discriminated a subset of patients with an acceptable long-term outcome using FLAG-Ida/FLAGO-Ida regimen. The results of this retrospective analysis should be validated in independent external cohorts.
Department of Haematology, Hospital San Pedro de Alcántara, Cáceres, Spain.
Juan M
JM
Bergua
Department of Haematology, University Hospital La Fe, Valencia, Spain.
Pau
P
Montesinos
Department of Haematology, University Hospital La Fe, Valencia, Spain.
David
D
Martinez-Cuadrón
Department of Haematology, General Hospital Alicante, Alicante, Spain.
Pascual
P
Fernández-Abellán
Department of Haematology, Hospital Reina Sofia, Córdoba, Spain.
Josefina
J
Serrano
Department of Haematology, Hospital Doctor Peset, Valencia, Spain.
María J
MJ
Sayas
Department of Haematology, Hospital San Pedro de Alcántara, Cáceres, Spain.
Julio
J
Prieto-Fernandez
Department of Haematology, General Hospital Castellón, Castellón, Spain.
Raimundo
R
García
Department of Haematology, Central Hospital of Asturias, Oviedo, Spain.
Ana J
AJ
García-Huerta
Department of Haematology, Hospital Carlos Haya, Málaga, Spain.
Manuel
M
Barrios
Department of Haematology, Clinic Hospital, Madrid, Spain.
Celina
C
Benavente
Department of Haematology, Clinic Hospital, Santiago de Compostela, Spain.
Manuel
M
Pérez-Encinas
Department of Haematology, Hospital Povisa, Vigo, Spain.
Adriana
A
Simiele
Department of Haematology, Hospital Gregorio Marañon, Madrid, Spain.
Gabriela
G
Rodríguez-Macias
Department of Haematology, Hospital Ramón y Cajal, Madrid, Spain.
Pilar
P
Herrera-Puente
Department of Haematology, University Hospital La Fe, Valencia, Spain.
Rebeca
0000-0003-2139-8540
R
Rodríguez-Veiga
Department of Haematology, Hospital 12 de Octubre, Madrid, Spain.
María P
MP
Martínez-Sánchez
Department of Haematology, Hospital Montecelo, Pontevedra, Spain.
María L
ML
Amador-Barciela
Department of Haematology, Hospital Severo Ochoa, Leganés, Spain.
Rosalía
R
Riaza-Grau
Department of Haematology, University Hospital La Fe, Valencia, Spain.
Miguel A
MA
Sanz
D000293:Adolescent; D000328:Adult; D000368:Aged; D064591:Allografts; D000617:Aminoglycosides / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage; D000079982:Gemtuzumab; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D015470:Leukemia, Myeloid, Acute / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D011379:Prognosis; D012074:Remission Induction; D012189:Retrospective Studies; D018570:Risk Assessment; D016879:Salvage Therapy / Q000379:methods*; D016019:Survival Analysis; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives; D055815:Young Adult
D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; D000079982:Gemtuzumab; D014740:Vidarabine; D015255:Idarubicin
FLAG-Ida; genetic risk; prognostic factors; relapsed-refractory acute myeloid leukaemia; salvage treatment