Improving cancer care for patients with chronic kidney disea
Chemotherapeutic agents used to treat cancer generally have narrow therapeutic indices along with potentially serious adverse toxicities. Many cancer drugs are at least partially excreted through the kidney and, thus, the availability of accurate data on safe and effective dosing of these drugs in chronic kidney disease (CKD) patients is essential to guide treatment decisions. Typically during drug development, initial clinical studies only include patients with normal or only mildly impaired kidney function. In subsequent preregistration studies, a limited number of patients with more severe kidney dysfunction are included. Data obtained from patients with either severe kidney dysfunction (here defined as an estimated glomerular filtration rate < 30 mL/min or stage 4G CKD), and end-stage kidney disease (ESKD) requiring kidney replacement treatment are particularly limited before drug registration and only a minority of new drug applications to the Food and Drug Administration include data from this population. Unfortunately, limited data and/or other safety concerns may result in a manufacturer statement that the drug is contraindicated in patients with advanced kidney disease, which hinders access to potentially beneficial drugs for these patients. This systematic exclusion of CKD patients from cancer trials remains an unsolved problem, which prevents provision of optimal clinical care for these patients raising questions of inclusion, diversity, and equity. In addition, with the aging of the population there are increasing numbers of patients with CKD and cancer who face these issues.