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Imprecise Kidney Function Thresholds in Cancer Clinical Trials and the Potential for Harm

Edwin Wang1, Jessica K Paulus2, Douglas Hackenyos3

  • 1Tufts University School of Medicine, Boston, MA.

JNCI Cancer Spectrum
|July 31, 2019
PubMed

Insights

Cancer clinical trials frequently use inconsistent kidney function criteria, potentially harming patients. Current standards should be adopted to ensure accurate drug dosing and patient eligibility for cancer treatments.

Area of Science:

  • Nephrology
  • Oncology
  • Clinical Pharmacology

Background:

  • Current medical guidelines recommend using glomerular filtration rate (GFR) for assessing kidney function and guiding drug dosing.
  • Serum creatinine (Scr) alone or creatinine clearance are often used but are less precise than GFR.

Purpose of the Study:

  • To evaluate the definitions of kidney function thresholds used for eligibility in cancer clinical trials.
  • To identify the prevalence of GFR versus Scr or creatinine clearance in defining these thresholds.

Main Methods:

  • A random sample of 465 active Phase I-III trials involving cisplatin and 74 studies in cancer patients with decreased kidney function were analyzed.
  • Data were sourced from clinicaltrials.gov to assess defined kidney function criteria.

Main Results:

  • Kidney function thresholds were defined by Scr alone or a composite including Scr or creatinine clearance in 46% of cisplatin trials.
  • Only 2% of cisplatin trials and 14% of trials for decreased kidney function utilized GFR.
  • A significant discrepancy exists in the methods used to define kidney function eligibility across cancer trials.

Conclusions:

  • Imprecise and inconsistent kidney function thresholds are commonly used in cancer clinical trials.
  • These inconsistent criteria may lead to patient harm through drug toxicity or reduced treatment efficacy.
  • Adoption and harmonization of recommended GFR standards are crucial for improving cancer trial design and patient safety.

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