No Decreased Survival in Blacks With AML Compared With Whites

Andrew D. Bowser

December 08, 2019

ORLANDO, Florida — While African Americans with acute myeloid leukemia were more likely to have evidence of abnormal kidney function, the excess of this comorbidity didn't affect overall survival, compared with whites, according to a study of more than 1,000 patients.

A total of 63% of African Americans with acute myeloid leukemia (AML) presented with a renal function abnormality that could have excluded them from a clinical trial, compared with 56% in the overall cohort; however, analysis of outcomes data suggested that renal function abnormalities were not associated with decreased survival in African Americans versus whites, said Abby Statler, PhD, MPH, of the Cleveland Clinic.

The findings may have implications for the design of clinical trials that might exclude patients on the basis of comorbidities that don't actually affect survival, according to Dr. Statler.

"If we're able to liberalize renal function eligibility criteria...this may reduce racial disparities in clinical trial enrollment, which might be a major step in improving the diversity of cancer patient populations," Dr. Statler said in a press conference at the annual meeting of the American Society of Hematology.

Overly restrictive criteria could be a significant barrier to clinical trial enrollment among minority patient populations, according to Dr. Statler.

Eligibility criteria are generally biased toward "fit" patient populations, which means they may discriminate against less-fit groups, such as African Americans who, compared with whites, have higher rates of comorbidities and report poorer overall health, according to Dr. Statler.

Laura Michaelis, MD, who chaired the press conference, said these findings suggest current clinical trial designs may be "too restrictive."

"Once it's published and validated, [these] data should definitely make us think twice about when you limit a patient's enrollment in a trial," Dr. Michaelis said in an interview.

Restrictive eligibility criteria may not only limit access to minority populations, but also may slow clinical trial accrual and completion, and make it harder to generalize clinical trial findings to the overall population, said Dr. Michaelis, associate professor of medicine in the division of hematology and oncology, Medical College of Wisconsin, Milwaukee.

The study by Dr. Statler and colleagues included 1,040 AML patients who received chemotherapy at Cleveland Clinic between 2003 and 2019. About 10% of the patients in the analysis were African American and 90% were white.

Median overall survival was not significantly different by race, at 13.7 months for African Americans and 14.9 months for whites (P = 0.89), according to results published in the study abstract.

Mild creatinine elevation did not appear to affect survival in this study, according to the investigator. Survival was not significantly different between patients with normal creatinine and those with creatinine up to 1.5 times the upper limit of normal. However, higher levels of creatinine were significantly associated with worse survival, Dr. Statler said.

Further analyses showed that these survival findings by creatinine level held up specifically in the African American subgroup as well, Dr. Statler said in the press conference.

Dr. Statler provided no disclosures related to the presentation. Study coauthors described disclosures related to Amgen, SimulStat, Bristol-Myers Squibb, Takeda, Pfizer, Novartis, Celgene Corporation, AbbVie, and Incyte, among others.

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Source: Statler A et al. American Society of Hematology (ASH) 2019, Abstract 381.