Mild renal impairment in African Americans does not affect OS in AML

Overall survival of acute myeloid leukaemia (AML) patients with mild renal dysfunction did not differ from patients with normal renal function. Given that African Americans in this study had significantly higher creatinine levels when compared with Caucasians, the investigators postulated that reduced renal function effectively selects against people of African descent to participate in clinical trials, even though survival is not affected.

Dr Abby Statler (Cleveland Clinic, USA) and colleagues included 1,040 AML patients who received chemotherapy at Cleveland Clinic between 2003 and 2019 [1]. Approximately 10% of that cohort was African American, whereas 90% was Caucasian. Renal function was tested at every blood draw and assessed retrospectively for association with AML outcome.

A total of 63% of African Americans with acute myeloid leukaemia (AML) presented with an abnormal renal function measurement, compared with 56% in the overall cohort (P=0.002). However, analysis of outcomes data suggested that renal function abnormalities were not strongly associated with decreased survival in African Americans. Race did not affect median overall survival: 13.7 months for African-American patients versus 14.9 months for Caucasians (P=0.89).

Renal function was then split into mild (≤1.5 fold Upper Limits of Normal [ULN]), moderate (1.5-3.0 ULN), and severe (≥3.0 ULN) groups, with the largest group with mild renal dysfunction showing no difference in overall survival (P=0.97). However, it should be noted that the groups with moderate and severe renal impairment were associated with significantly decreased survival (P=0.01 and P=0.02, respectively).

In conclusion, while African Americans had significantly higher kidney disease levels, only the more severe forms in the minority of patients affected overall survival. These results have implications for the design of clinical trials that exclude patients because of comorbidities. Dr Statler stated, "If we are able to liberalise renal function eligibility criteria [...] this may reduce racial disparities in clinical trial enrolment, which might be a major step in improving the diversity of cancer patient populations."

1. Statler A, et al. Abstract 381, ASH 2019, 7-10 December, Orlando, USA.

Posted on 5 March, 202031 March, 2021