Abstract
colorectal cancer, CKD, chronic kidney disease, CKD‐, lung cancer, prostate, breast, lung, or colorectal cancer, prostate cancer
COLORECTAL CANCER, BREAST CANCER, METASTATIC DISEASE, LUNG CANCER, CHRONIC KIDNEY DISEASE (CKD), CHRONIC KIDNEY DISEASE, PROSTATE CANCER
The objective of this study was to determine the proportion of phase 3 clinical trials investigating a systemic therapy for patients with prostate, breast, lung, or colorectal cancer that excluded patients with Chronic Kidney Disease (CKD) and the exclusion criteria chosen, if any. A search was conducted using the The majority of clinical trials restrict enrollment of patients with chronic kidney disease (CKD) and the exclusion criterion is undefined in most trials. Patients with CKD have therefore little access to innovation in oncology but solutions can be proposed to allow their inclusion in clinical trials.
Chronic kidney disease (CKD), as defined by the KDIGO Consensus Conference (Glomerular Filtration Rate [GFR] < 60 mL/min/1.73 mA search was conducted in December 2021, using the Of 268 included trials, 125 (47%) were conducted in lung cancer, 81 (30%) in breast cancer, 42 (16%) in prostate cancer and 20 (7%) in colorectal cancer (Table Trial factors associated with exclusion of patients with kidney diseaseAbbreviations: mAB, monoclonal antibody; MD, metastatic disease; TKI, tyrosine kinase inhibitor. The majority of phase 3 clinical trials for patients with prostate, breast, lung, or colorectal cancer restricted enrollment of patients with CKD. Moreover, the exclusion criterion was undefined in most trials. However, according to recommendationsCommon barriers to including patients with CKD in clinical trials‐ Include patients with stable CKD‐ Establish criteria for determining the stability of CKD‐ Stratify on CKD‐ Choose a method to estimate GFR and use it consistently across the research process‐ Establish dose‐modification strategies in early phase trials‐ Perform drug assays‐ Adapt the GFR thresholds leading to exclusion to the mode of elimination (renal or not) of the drug‐ Detail the list of contraindicated drugs‐ Plan a pharmacological follow‐upAbbreviations: CKD, chronic kidney disease; GFR, glomerular filtration rate.Our research was only based on data reported on clinical 