A randomised comparison of FLAG‐Ida versus daunorubicin combined with clofarabine in relapsed or refractory acute myeloid leukaemia: Results from the UK NCRI AML17 trial. (6th April 2022)

• Record Type: Journal Article
• Authors: Russell, Nigel H.; Hills, Robert K.; Kjeldsen, Lars; Clark, Richard E.; Ali, Sahra; Cahalin, Paul; Thomas, Ian F.; Burnett, Alan K.
• Is Part Of: British journal of haematology. Volume 198:Number 3(2022)
• Page Start: 528
• Page End: 534
• Publication Date: 2022-04-06
• Subjects: chronic lymphocytic leukaemia -- morphology -- CLL lymphocytes; Hematology -- Periodicals; Blood -- Diseases -- Periodicals; 616.15
• DOI: 10.1111/bjh.18195
• Languages: English
• ISSNs: 0007-1048

Abstract

Summary: The prognosis for younger patients with relapsed acute myeloid leukaemia (AML) is generally dismal. Allogeneic stem cell transplantation is the preferred therapy for these patients. As part of the UK NCRI AML17 trial, daunorubicin/clofarabine (DClo) was compared with fludarabine, cytarabine, granulocyte colony‐stimulating factor with idarubicin (FLAG‐Ida) in 311 patients designated high‐risk following course one of induction therapy, which has previously been reported. We now report the results of the same randomisation in patients who were refractory to two induction courses or subsequently relapsed. A total of 94 relapsed or refractory AML patients, usually less than 60 years of age and with mainly favourable or intermediate‐risk cytogenetics, were randomised to receive up to three courses of DClo or FLAG‐Ida, with the aim of proceeding to transplant. Complete remission was achieved in 74% of patients with no difference between the arms. Overall, 57% of patients received a transplant with no difference between the arms, likewise overall survival at five years showed no significant difference (21% for DClo vs. 22% for FLAG‐Ida). No patient who did not receive a transplant survived beyond 21months. A stratified analysis including the 311 post course 1 high‐risk patients who underwent the same randomisation showed a consistent treatment benefit for FLAG‐Ida.