Doubling in KIM-1 plasma concentrations was associated with an increased risk of developing renal cell cancer (RCC) and poorer survival, according to results from a case-control study.1

“This is the first blood test to show relevance in kidney cancer,” Rapul Bhatt, MD, PhD, an associate professor of medicine at Harvard Medical School and a clinical fellow in hematology-oncology at Beth Israel Deaconess Medical Center in Boston, Massachusetts, and an author on the study, told Cancer Therapy Advisor.

KIM-1 is normally expressed at low levels by normal cells, but is upregulated in the kidney when renal tubules are injured. Prior studies demonstrated that KIM-1 levels are much higher than that of normal cells at the diagnosis of clear cell RCC. Furthermore, KIM-1 levels decreased post nephrectomy. “Our preliminary data and data from others show that KIM-1 is a marker that is elevated in people who have kidney cancer,” explained Dr Bhatt. “So our question was, can this potentially be looked at earlier prior to diagnosis?”

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Dr Bhatt noted that this study “is part of a very important set of studies that will validate KIM-1, and the goal is to eventually have a biomarker for kidney cancer.” She said that another goal is to better apply plasma KIM-1 to patients who already have kidney cancer, such as following patients during therapy or to predict recurrence after nephrectomy.

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Study Results

The study included 190 patients with RCC and 190 controls within the population-based European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. All cases included in this study donated blood up to 5 years prior to their RCC diagnosis. Controls were matched to each incident RCC case as it was diagnosed. Dr Bhatt noted that “KIM-1 is also elevated in people with benign kidney disease, such as renal failure, but that was probably matched between our 2 cohorts.”

At baseline, 52% of subjects were male and 42% were never smokers. Most of the RCC cases were of clear cell histology. KIM-1 was detected in 93% of cases with a median concentration of 149 pg/mL and in 70% of controls with a median concentration of 59 pg/mL.