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Multicenter Study
. 2024 Dec;59(12):1676-1682.
doi: 10.1038/s41409-024-02408-x. Epub 2024 Sep 2.

Reduced Intensity transplantation vs chemotherapy in CR1. A prospective, pseudorandomized study in 50-70 year old AML patients

Mats Brune #  1 , Thomas Kiss #  2 , Harald Anderson  3 , Malin Nicklasson  1 , Robert Delage  4 , Jürgen Finke  5 , Tobias Gedde-Dahl  6 , Josée Hébert  2 , Martin Höglund  7 , Ain Kaare  8 , Vladimir Lazarevic  9 , Lars Möllgård  1 , Kari Remes  10 , David Ritchie  11 , Alexandros Spyridonidis  12 , Mitchell Sabloff  13 , Ruth Spearing  14 , Elisabeth Wallhult  1 , Per Ljungman  15
Affiliations
Multicenter Study

Reduced Intensity transplantation vs chemotherapy in CR1. A prospective, pseudorandomized study in 50-70 year old AML patients

Mats Brune et al. Bone Marrow Transplant. 2024 Dec.

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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Conflict of interest statement

Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Study flow chart including reasons for exclusion from analysis.
Flow chart describing patient inclusion and reasons for exclusions from analysis in the two different study periods.
Fig. 2
Fig. 2. Overall survival from study inclusion in RD vs Controls.
Kaplan-Meier estimates of 3-year survival in RD and control groups (study parts 1 and 2).
Fig. 3
Fig. 3. Overall survival from study inclusion in patients without potential sibling donor vs. controls.
Kaplan-Meier estimated 3-year survival in patients without potential sibling donor (only study part 2).
Fig. 4
Fig. 4. Overall survival in patients transplanted from unrelated or sibling donors.
Kaplan-Meier estimates of 3-year survival in patients transplanted from URD or RD (only study period 2).
See this image and copyright information in PMC

References

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