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Patients with CKD underrepresented in trials for cancer therapies
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According to a research letter in the Journal of the American Medical Association, patients with chronic kidney disease are underrepresented in trials for cancer therapies.
Abhijat Kitchlu , MD, FRCPC, and colleagues performed a systematic search of MEDLINE for randomized trials of drugs for the five most common solid cancers. They searched six high-profile general medicine and oncology journals and excluded trials of surgery, radiation and supportive care. They also excluded nonrandomized studies and pooled analyses from their review.
Of the 310 eligible articles, investigators concluded that 85% of recent trials excluded patients with CKD, writing: “This finding is concerning because it was estimated that 32% of deaths among patients with CKD in 2005 [to] 2009 were attributable to malignancy.”
It was noted that serum creatinine threshold values, which data demonstrate are suboptimal measures of kidney function in cancer patients, were the most common exclusion criteria at 62%. They found 5% of trials used eGFR thresholds for exclusion, despite being a more accurate and validated method for estimating kidney function.
“The exclusion of patients based on kidney function is appropriate when CKD is severe and prognosis-limiting or when concerns exist regarding potential nephrotoxicity or adverse events due to bioaccumulation of renally cleared drugs,” the investigators wrote. “However, this review suggests that patients with CKD with only mild to moderate kidney dysfunction are often excluded, and frequently from trials of interventions (eg, biologics or immunotherapies) for which there may be no pharmacologic basis for renal exclusions.” – by Jake Scott
Disclosures: Kitchlu reports no relevant financial disclosures. Please see the research letter for all other authors’ relevant financial disclosures.
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Kitchlu A, et al. JAMA. 2018;319(23):2437-2439.
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