Table 3.

Risk of disease relapse and survival associated with biomarker status and patient characteristics

VariablesPositive, N (%)RelapseDeath
Sample sourceMethodHR95% CIPHR95% CIP
MRD persistence at 1 mo          
 ctDNA Serum ddPCR 20/47 (42.6) 7.89 2.22-28.10 .0014** 8.24 1.77-38.37 .0072** 
 Mutation BM ddPCR 19/38 (50.0) 8.03 1.79-35.96 .0065** 4.75 1.00-22.45 .0494* 
 MC BM PCR/FISH 11/45 (24.4) 3.25 1.20-8.80 .0202* 1.22 0.33-4.53 .7631 
 FC BM Flow cytometry 11/44 (25.0) 0.33 0.07-1.48 .1475 0.23 0.03-1.83 .1650 
MRD persistence at 3 mo          
 ctDNA Serum ddPCR 14/44 (31.8) 15.04 3.33-67.96 .0004** 8.04 1.66-38.88 .0095** 
 Mutation BM ddPCR 5/26 (19.2) 13.03 2.36-72.04 .0032** 17.66 1.81-172.20 .0135* 
 MC BM PCR/FISH 5/38 (13.2) 6.22 1.47-26.26 .0129* 5.78 0.95-35.06 .0577 
 FC BM Flow cytometry 20/38 (52.6) 0.91 0.25-3.45 .9005 1.16 0.19-7.03 .8751 
ctDNA kinetics          
 Increasing Serum ddPCR 6/40 (15.0) 28.47 5.59-145.00 .0001** 17.35 3.21-93.68 .0009** 
 Decreasing/stable Serum ddPCR 11/40 (27.5) 4.15 0.76-22.65 .0868 1.04 0.09-11.44 .977 
 Both negative Serum ddPCR 23/40 (57.5) 1.00   1.00   
Adverse prognostic variables          
 Complex karyotype BM G-BAND 15/51 (29.4) 2.41 0.90-6.46 .0794 1.73 0.53-5.52 .3575 
 −7/del7q karyotype BM FISH/G-BAND 8/51 (15.7) 0.67 0.15-2.97 .6010 1.05 0.23-4.82 .9494 
 FLT3-ITD BM/PB PCR/NGS 12/51 (23.5) 2.47 0.89-6.85 .0813 2.69 0.84-8.58 .0953 
 TP53 mutation BM/PB NGS 6/51 (11.8) 2.28 0.65-8.05 .1999 3.27 0.88-12.12 .0761 
 RAS pathway mutation BM/PB NGS 19/51 (37.3) 2.59 0.96-6.99 .0605 1.84 0.59-5.74 .2911 
 Age > 65 y   8/51 (15.7) 1.21 0.27-5.39 .8040 2.81 0.74-10.75 .1308 
 Male   29/51 (56.9) 0.69 0.26-1.85 .4601 0.68 0.22-2.11 .5037 
 Relapsed or refractory disease at alloSCT   25/51 (49.0) 1.91 0.71-5.63 .2049 3.23 0.96-14.55 .0584 
VariablesPositive, N (%)RelapseDeath
Sample sourceMethodHR95% CIPHR95% CIP
MRD persistence at 1 mo          
 ctDNA Serum ddPCR 20/47 (42.6) 7.89 2.22-28.10 .0014** 8.24 1.77-38.37 .0072** 
 Mutation BM ddPCR 19/38 (50.0) 8.03 1.79-35.96 .0065** 4.75 1.00-22.45 .0494* 
 MC BM PCR/FISH 11/45 (24.4) 3.25 1.20-8.80 .0202* 1.22 0.33-4.53 .7631 
 FC BM Flow cytometry 11/44 (25.0) 0.33 0.07-1.48 .1475 0.23 0.03-1.83 .1650 
MRD persistence at 3 mo          
 ctDNA Serum ddPCR 14/44 (31.8) 15.04 3.33-67.96 .0004** 8.04 1.66-38.88 .0095** 
 Mutation BM ddPCR 5/26 (19.2) 13.03 2.36-72.04 .0032** 17.66 1.81-172.20 .0135* 
 MC BM PCR/FISH 5/38 (13.2) 6.22 1.47-26.26 .0129* 5.78 0.95-35.06 .0577 
 FC BM Flow cytometry 20/38 (52.6) 0.91 0.25-3.45 .9005 1.16 0.19-7.03 .8751 
ctDNA kinetics          
 Increasing Serum ddPCR 6/40 (15.0) 28.47 5.59-145.00 .0001** 17.35 3.21-93.68 .0009** 
 Decreasing/stable Serum ddPCR 11/40 (27.5) 4.15 0.76-22.65 .0868 1.04 0.09-11.44 .977 
 Both negative Serum ddPCR 23/40 (57.5) 1.00   1.00   
Adverse prognostic variables          
 Complex karyotype BM G-BAND 15/51 (29.4) 2.41 0.90-6.46 .0794 1.73 0.53-5.52 .3575 
 −7/del7q karyotype BM FISH/G-BAND 8/51 (15.7) 0.67 0.15-2.97 .6010 1.05 0.23-4.82 .9494 
 FLT3-ITD BM/PB PCR/NGS 12/51 (23.5) 2.47 0.89-6.85 .0813 2.69 0.84-8.58 .0953 
 TP53 mutation BM/PB NGS 6/51 (11.8) 2.28 0.65-8.05 .1999 3.27 0.88-12.12 .0761 
 RAS pathway mutation BM/PB NGS 19/51 (37.3) 2.59 0.96-6.99 .0605 1.84 0.59-5.74 .2911 
 Age > 65 y   8/51 (15.7) 1.21 0.27-5.39 .8040 2.81 0.74-10.75 .1308 
 Male   29/51 (56.9) 0.69 0.26-1.85 .4601 0.68 0.22-2.11 .5037 
 Relapsed or refractory disease at alloSCT   25/51 (49.0) 1.91 0.71-5.63 .2049 3.23 0.96-14.55 .0584 

CI, confidence interval; FISH, fluorescence in situ hybridization; FLT3-ITD, fms-like tyrosine kinase 3–internal tandem duplication.

*

P < .05; **P < .01.

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