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Reduced Intensity transplantation vs chemotherapy in CR1. A prospective, pseudorandomized study in 50-70 year old AML
Mats Brune1, Thomas Kiss2, Harald Anderson3
1Section of Hematology and Coagulation, Department of Specialist Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.
Insights
This study found that reduced-intensity conditioning (RICT) allogeneic hematopoietic stem cell transplantation (HCT) with unrelated donors (URD) showed improved survival in older AML patients compared to those with related donors (RD). Elderly related donors are not recommended for RICT-HCT in first complete remission.
Area of Science:
- Hematology
- Oncology
- Transplantation Immunology
Background:
- Acute Myeloid Leukemia (AML) in patients aged 50-70 with intermediate- or high-risk disease presents treatment challenges.
- Allogeneic hematopoietic stem cell transplantation (HCT) is a potential curative option, but donor selection is critical.
Purpose of the Study:
- To compare reduced-intensity conditioning (RICT) allogeneic HCT versus standard-of-care chemotherapy in older AML patients.
- To evaluate the efficacy of related donor (RD) versus unrelated donor (URD) HCT in this patient population.
Main Methods:
- A prospective, international, multicenter, pseudorandomized study involving 360 registered AML patients (50-70 years).
- Part 1: Patients with potential related donors (RD). Part 2: Patients without sibling donors, initiating unrelated donor (URD) search.
- Comparison of overall survival (OS) between RICT HCT groups and a control group receiving standard chemotherapy.
Main Results:
- No significant difference in OS between RD-HCT and controls (3-year OS: 41% vs. 49%).
- In Part 2, URD-HCT showed a trend towards improved OS compared to controls (3-year OS: 60% vs. 37%).
- Transplanted patients in Part 2 demonstrated significantly higher 3-year OS for URD-HCT versus RD-HCT (67% vs. 42%).
Conclusions:
- RICT allogeneic HCT using unrelated donors may offer survival benefits for older AML patients in first complete remission.
- The study does not support the use of elderly, HLA-identical related donors for RICT allogeneic HCT in this patient group.
Abstract:
The aim of this prospective, international multicenter, pseudorandomized study comparing RICT HCT to standard-of-care chemotherapy in intermediate- or high-risk AML patients 50-70 years using the donor versus no-donor concept. Part 1 included only patients with potential family donors (RD) at the date of HLA-typing of the first potential sibling or CR-date, if later. Part 2 allowed the inclusion of patients without a possible sibling donor using the start of an unrelated donor (URD) search as inclusion date. 360 patients were registered and 309 analyzed. The median follow-up was 47 months (1-168). There was no difference in overall survival (OS) between the RD (n = 124) and the Control (n = 77) groups (p = 0.50, 3-year OS RD: 0.41(95% CI; 0.32-0.50); Controls: 0.49 (95% CI; 0.37-0.59)). The main cause of death was relapse (67% RD; 88% Controls). In Part 2, the 3-year OS was 0.60 (95% CI 0.50-0.70) for URD-HCT (n = 86) and 0.37 (95% CI 0.13-0.62) for Controls (n = 20), respectively (p = 0.10). When analyzing transplanted patients (Part 2), the OS at 3-years was higher for URD-HCT than RD-HCT (0.67 (0.55-0.76) vs. 0.42 (0.26-0.57; p = 0.005). This study doesn't support elderly HLA-identical siblings as donors for older AML patients undergoing a RICT allogeneic HCT in first CR.
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