Nino Balanchivadze, MD, FACP

Nino Balanchivadze, MD, FACP, senior administrative fellow of the Hematology and Oncology Fellowship Program at Henry Ford Cancer Institute, discusses the rationale for evaluating toxicity based on race in the KEYNOTE-189 study (NCT02578680).

The phase 3 study was created to determine the differences in the rate of renal toxicity based on race in patients with non-squamous non-small cell lung cancer (NSCLC). A total of 134 patients with a median age of 66.5 years and a large percentage made of males (48.5%) were examined. Additionally, 24% of the patients were Black, and the other 75.4% were White.

retrospective analysis of the KEYNOTE-189

 study showed that patients with nonsquamous NSCLC who were treated with platinum-based pemetrexed combined with pembrolizumab (Keytruda), resulted in acute kidney injury (AKI) and death in more Black American patients compared with White American patients.

 Prior studies have shown that compared to White Americans, Black Americans are at higher risk of morbidity and mortality associated with chronic kidney diseases. Black patients are at a 3 to 4 times higher risk of developing kidney failure compared to White patients, irrespective of cancer. Data regarding renal impairment with platinum pemetrexed and pembrolizumab treatment in Black patients is lacking.

The main driver for our study is to investigate if there was more renal toxicity observed in Black Americans compared to white Americans that were treated with a company coming up to therapy.

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Nino Balanchivadze, MD, FACP, discusses the rationale for evaluating toxicity based on race in the KEYNOTE-189 study.

Differences in Toxicity Based on Race in Nonsquamous NSCLC 

Nino Balanchivadze, MD, FACP, senior administrative fellow of the Hematology and Oncology Fellowship Program at Henry Ford Cancer Institute, discusses the results of an analysis investigating renal toxicity in patients with nonsquamous non–small cell lung cancer treated in the KEYNOTE-189 study (NCT02578680).

The retrospective analysis looked at acute kidney injury (AKI) as an adverse event of pemetrexed (Alimta) combined with pembrolizumab (Keytruda) in the phase 3 KEYNOTE-189 clinical trial. Though Black Americans have previously been found to be at a higher risk of morbidity and mortality from chronic kidney disease (CKD), the study found no correlation between AKI in Black patients compared with White patients.

The study, recently presented during the 2021 European Society for Medical Oncology Annual Congress, analyzed a total of 134 patients, 33 of whom (24.6%) identified as non-Hispanic Black, and 101 (75.4%) who identified as non-Hispanic White. The mean age of patients was 66.5 years. Investigators observed that 8.1% of patients developed AKI, with a median time to development of 4.5 months.

Of the 10 patients who experienced AKI, 3 were Black and 7 were White 

 .57), showing no correlation between race and AKI development.

The median overall survival of all patients was 15.2 months. Black ethnicity was not associated with increased mortality in this patient population (HR, 1.21

 = .46), and development of AKI was also not associated with increased mortality (HR, 1.13; 95% CI, 0.45-2.86).

Other conditions such as hypertension, diabetes mellitus, cardiovascular disease, or CKD were not associated with AKI in these patients. However, patients with CKD were more likely to have a reduced glomerular filtration rate (GFR).

 We found we had a total of 134 patients that were included in the analysis. The mean age of patients was 66.5 years, and about 48.5% patients were men. A total of 33 patients, or 24.6% of our patients were non-Hispanic Black, and 75.4% of patients were non-Hispanic White. There were 10 patients who developed AKI and with the median time to development of kidney injury was 4.5 [months], with no margin of [patients of] black or white race with AKI. And the odds of developing AKI was not increased in patients with a history of hypertension, diabetes mellitus, cardiovascular disease, or CKD. We also found that a total of 17, or 13.4% of patients, had significantly reduced GFR, and patients that had a history of CKD were more likely to have reduced GFR.

Nino Balanchivadze, MD, FACP, discusses the results of an analysis investigating renal toxicity in patients with nonsquamous non–small cell lung cancer in relation to the race of patients.

Nino Balanchivadze, MD, FACP | Authors

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Differences in Toxicity Based on Race in Nonsquamous NSCLC

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