Among patients with acute myeloid leukemia (AML) who were treated with intensive chemotherapy on clinical trials from the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), Black race was found to be an independent predictor of inferior survival, with outcomes not being explained by cytogenetic risk. These findings from a retrospective analysis were presented at the 2025 American Society of Hematology (ASH) Annual Meeting & Exposition.¹

Black–White racial disparities in survival outcomes for AML have been seen to reflect multiple factors, including inequities in access to aggressive therapy and clinical trials, as well as biologic differences in the prevalence and impact of oncogenic drivers, according to population registries and the Alliance Co-Operative Group database. But, because of the limited number of Black patients with genomic data, there have been limitations in the generalizability of these findings.

We saw that Black race was an independent predictor of inferior survival in patients with AML treated on clinical trials with intensive chemotherapy.

— SHELLA SAINT FLEUR-LOMINY, MD, PhD

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“This study represents one of the largest race-based comparisons of cytogenetic abnormalities and clinical outcomes in prospective trials of intensive chemotherapy in AML,” commented presenting author Shella Saint Fleur-Lominy, MD, PhD, Associate Professor, University of Maryland School of Medicine, Baltimore, and colleagues. “Our data confirm the independent prognostic relevance of race in AML survival and validate the predictive ability of the ELN [European LeukemiaNet] 2017 cytogenetic risk score for overall survival across racial groups.”

Study Details

The investigators focused on 3,469, 184, and 156 patients with newly diagnosed AML who self-reported as White, Black, and other races, respectively, from 10 phase II and III ECOG-ACRIN interventional trials with accrual between 1984 and 2019.

Descriptive statistics were used to summarize baseline characteristics, with comparisons performed using the Wilcoxon rank-sum test for continuous variables and Fisher’s exact test for categorical variables. The investigators used multivariable Cox proportional hazards regression models, stratified by protocol and adjusted for relevant clinical factors—including age, blood counts (ie, hemoglobin, platelet, and white blood cell levels), blast percentage, performance status, and ELN cytogenetic risk score—to assess the association between race and survival outcomes. Subgroup analyses of overall and disease-free survival were conducted using Kaplan-Meier curves stratified by race, with differences assessed using log-rank tests.

Key Findings

Demographic and clinical characteristics were evaluated across racial groups, including age at presentation, which was lower among minority patients compared with their White counterparts (Black vs White: mean, 47.9 vs 53.5 years, P < .001; other: mean, 44.2 years). The proportion of patients aged younger than 60 years appeared to further highlight this difference (Black vs White: 65.8% vs 54.8%, P = .004; other: 75.6%). “There were no significant differences in other characteristics,” Dr. Saint Fleur-Lominy added.

Black vs White race was found to independently predict inferior overall (hazard ratio [HR] = 1.21, 95% confidence interval [CI] = 1.01–1.45; P = .0383) and disease-free (HR = 1.31, 95% CI = 1.05–1.64; P = .017) survival. However, in this multivariable analysis, no such differences were observed between patients of other races and White patients (overall survival: HR = 1.06, 95% CI = 0.87–1.30; disease-free survival: HR = 1.14, 95% CI = 0.87–1.50). “As you would expect,” said Dr. Saint Fleur-Lominy, “variables like cytogenetics were also independent predictors of survival.”

Based on these findings, the investigators focused exclusively on Black–White differences, aiming to understand the reasons for the observed survival disparities. The complete remission (58.2% vs 57.5%; P = .879), 30-day mortality (7.1% vs 8.9%; P = .504), and overall bone marrow transplantation (19.0% vs 20.2%; P = .89) rates did not seem to significantly differ between these racial groups. However, among those who underwent transplantation, the investigators observed that a significantly higher proportion of White (48.5% [vs Black: 37.1%]) patients received allogeneic transplants (P < .001).

Complete cytogenetic results were available for 117 Black patients and 2,162 White patients, with ELN 2017 cytogenetic risk groups showing a similar predictive value for overall survival in both racial groups. However, NPM1 mutations—typically associated with favorable outcomes, according to Dr. Saint Fleur-Lominy—were linked to inferior overall survival in Black vs White patients (8.9 vs 19.1 months; P = .0095). This ancestry-based attenuation of benefit “underscores the need to tailor the current treatment approach to NPM1-mutated AML based on race,” the investigators remarked.

Dr. Saint Fleur-Lominy concluded, “In this large study, we saw that Black race was an independent predictor of inferior survival in patients with AML treated on clinical trials with intensive chemotherapy. Poorer survival of [Black vs White patients] was independent of cytogenetics…, as the ELN 2017 risk group was equally predictive of overall survival across races. But while that was true for the ELN cytogenetic classification, NPM1 mutation itself failed to confer favorable outcomes in Black patients, suggesting that race can modify the effect of certain somatic mutations. We also noticed that access to allogeneic transplant is a persistent inequity, even in patients with sufficient social support to be enrolled on clinical trials.”

Looking forward, she stated, “We think there is a need for analysis of large representative AML datasets with integration of ancestry, social factors, and comprehensive genomic profiling of AML cells to elucidate the interaction between race and outcome disparities in AML.”

DISCLOSURE: Dr. Saint Fleur-Lominy has served as a consultant (including giving expert testimony) for AstraZeneca.

REFERENCE

1. Saint Fleur-Lominy S, Chen L, Sun Z, et al: Inferior survival in black AML patients treated with intensive chemotherapy in ECOG-ACRIN clinical trials is independent of cytogenetic profiles. 2025 ASH Annual Meeting & Exposition. Abstract 290. Presented December 6, 2025.

EXPERT POINT OF VIEW

Brian A. Jonas, MD, PhD, FACP, Professor of Medicine and Chief of the Division of Malignant Hematology/Cellular Therapy and Transplantation, and Guneet Kaleka, MD, MPA, Hematology/Oncology Fellow, both at the University of California Davis School of Medicine in Sacramento, commented in an interview with The ASCO Post on the retrospective analysis of ECOG-ACRIN cytogenetic and outcomes data from newly diagnosed patients with acute myeloid leukemia (AML) treated on intensive chemotherapy–based clinical trials over 3 decades.¹

Brian A. Jonas, MD, PhD, FACP

Guneet Kaleka, MD, MPA

“Inferior treatment outcomes among Black patients with AML, compared with their White counterparts, have previously been reported in both population-based registry studies and clinical trial cohorts.^2,3,4 Dr. Fleur-Lominy’s study provides additional insight into factors contributing to survival variations among patients with AML receiving intensive chemotherapy on ECOG-ACRIN trials.

In this retrospective analysis of 3,469 White and 184 Black patients with AML treated across 10 ECOG-ACRIN phase II/III clinical trials conducted between 1984 and 2019, Dr. Fleur-Lominy’s team again identified race as an independent adverse prognostic factor with inferior overall survival (hazard ratio [HR] = 1.21, 95% confidence interval [CI] = 1.01–1.45) and disease-free survival (HR = 1.31, 95% CI = 1.05–1.64) in Black patients as compared with White patients.

Specifically, this study provides deeper insight into the cytogenetic characteristics of AML in Black patients. An analysis of 117 Black and 2,162 White patients highlighted the need to refine ELN [European LeukemiaNet] risk stratification to better account for racial differences. While the study validated ELN 2017 risk categories in predicting overall survival in both race groups, it also demonstrated limitations in its ability to predict disease-free survival in Black patients. Notably, Black patients classified within the favorable-risk group experienced significantly inferior disease-free survival. In addition, Black patients harboring NPM1 mutations had worse overall survival compared with their White counterparts.

Differences in rates of allogeneic stem cell transplantation were also observed, with 37% of Black patients undergoing allogeneic stem cell transplantation compared to 48.5% of White patients. Although differences in transplantation are frequently linked to access-to-care barriers, the discrepancies observed in this study where all patients were enrolled in a clinical trial indicate that additional factors may also contribute to the lower allogeneic stem cell transplantation rates among Black patients. In the setting of comparable cytogenetic profiles, complete remission rates, and early mortality between racial groups, the inferior overall survival and disease-free survival observed in Black patients may reflect a combination of reduced allogeneic stem cell transplantation utilization, differences in somatic mutation biology, and limitations of ELN risk stratification in guiding disease-free survival–related treatment decisions for Black patients.

Collectively, these findings underscore intrinsic differences in disease biology, prognostic factors, and barriers to allogeneic stem cell transplantation that influence treatment outcomes in Black patients with AML. Incorporating ancestry-related considerations into ELN risk stratification—which plays a critical role in prognostication and therapeutic decision-making—may help reduce racial disparities in outcomes. In addition, comprehensive analyses of mutational profiles, including co-occurring mutations and their interactions in Black patients, along with improved characterization of measurable residual disease–driven depth of response, may further inform treatment strategies and contribute to more equitable outcomes in AML.”

DISCLOSURE: Dr. Jonas has held a consulting or advisory role with AbbVie, BMS, Daiichi Sankyo, Genentech, Gilead, Kura, Rigel, Schrödinger, Syndax, and Treadwell. Dr. Kaleka reported no conflicts of interest.

REFERENCES

1. Saint Fleur-Lominy S, Chen L, Sun Z, et al: Inferior survival in black AML patients treated with intensive chemotherapy in ECOG-ACRIN clinical trials is independent of cytogenetic profiles. 2025 ASH Annual Meeting & Exposition. Abstract 290. Presented December 6, 2025.

2. Bhatnagar B, Zhao Q, Fisher JL, et al: Poor treatment outcomes of young (< 60 years) African American patients diagnosed with acute myeloid leukemia (Alliance). 2020 ASH Annual Meeting & Exposition. Abstract 6. Presented December 6, 2020.

3. Larkin KT, Nicolet D, Kelly BJ, et al: High early death rates, treatment resistance, and short survival of Black adolescents and young adults with AML. Blood Adv 6: 5570–5581, 2022.

4. Shah AK, Shah R, Mandal D, et al: Racial disparities and survival outcomes in secondary acute myeloid leukemia: A SEER-based analysis. J Clin Oncol 43: e18540, 2025.