Reduced-intensity conditioning reduces toxicity associated with allogeneic hematopoietic cell transplantation (HCT) for acute myeloid leukemia (AML) without affecting long-term outcomes, show results from the first randomized trial of this treatment.
The findings published in The Lancet Oncology confirm the reported benefits of a fludarabine-based reduced-intensity conditioning over standard treatment, potentially allowing curative treatment of older AML patients and those with comorbidity unsuitable for conventional conditioning.
Despite being halted early due to slow patient accrual, the trial demonstrated that the 99 patients given reduced-intensity and the 96 patients given standard conditioning did not significantly differ with regards to relapse at 3 years (28 vs 26%), disease-free survival at 3 years(58 vs 56%), or overall survival (61 vs 58%).
All patients assigned to receive the reduced-intensity regimen were discharged from hospital, whereas there were eight early in-hospital deaths in the standard regimen arm, a significant difference.
Furthermore, per-protocol analysis showed that the reduced-intensity regimen was associated with a small but significant decrease in nonrelapse mortality at 1 year compared with standard treatment (8 vs 17%; hazard ratio=0.42). This benefit was found to have occurred in patients aged 41 to 60 years only.
Patients in the reduced-intensity group were significantly less likely to develop grade 3 to 4 oral mucositis (50 vs 73 patients), although no significant difference was found for other toxicity markers.
"Patients aged 18-60 years with AML in first complete remission who are candidates for allogeneic [HCT] should be advised on the equivalent efficacy of reduced-intensity conditioning versus standard conditioning in terms of overall outcome and early toxic effects and mortality," recommend Martin Bornhauser (Medizinische Klinik und PoliklinikI, Dresden, Germany) and co-authors.
"Physicians and patients should know that reduced intensity conditioning is an alternative for patients with AML in first complete remission, especially when the tolerability of intensive conditioning is in question."
The open-label trial was conducted in patients aged 18 to 60 years with cytogenetically defined intermediate- or high-risk AMLwho were in first remission.
The reduced-intensity regimen consisted of total body irradiation in four 2 Gy doses plus fludarabine 150 mg/m2 versus six 2 Gy doses of radiation with cyclophosphamide 120 mg/kg. Both patient groups also received ciclosporin and methotrexate.
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