CKD Patients Often Excluded From Cancer Trials
Even patients with mild chronic kidney disease were prevented from participating in clinical trials of drugs for bladder, breast, colorectal, lung, and prostate cancers.
Eighty-five percent of randomized trials investigating drugs for the 5 most common solid cancers (i.e., bladder, breast, colorectal, lung, and prostate) that were published in 6 high-impact journals excluded patients with chronic kidney disease (CKD), according to new research published in JAMA.
Abhijat Kitchlu, MD, of Toronto General Hospital in Canada, and colleagues found that cancer trials frequently excluded those with mild to moderate CKD without an apparent pharmacologic rationale, such as nephrotoxicity or drug bioaccumulation. Trials of biologics or immunotherapies often excluded CKD patients, whereas trials of endocrine-based therapies were more welcoming.
Excluding patients with severe CKD is appropriate. Most trials used serum creatinine or creatinine clearance to assess renal function, which is less accurate than estimated glomerular filtration rate.
“This finding is concerning because it was estimated that 32% of deaths among patients with CKD in 2005–2009 were attributable to malignancy,” Dr Kitchlu and the team wrote. “As a result of trial underrepresentation, patients with CKD may not be considered for cancer therapies that have potential to improve morbidity and mortality.” They urged broadening of eligibility criteria so more CKD patients can benefit from novel cancer therapies.
Kitchlu A, Shapiro J, Amir E, et al. Representation of patients with chronic kidney disease in trials of cancer therapy. JAMA. [Published online June 19, 2018]