Scope and consistency of cancer outcomes reported in randomized trials in kidney transplant recipients
Eric H. Au, Germaine Wong, Allison Tong, Armando Teixeira-Pinto, Anita van Zwieten, Ellen Dobrijevic, Curie Ahn, Christopher D. Blosser, Bianca Davidson, Anna Francis, Kenar D. Jhaveri, Jolanta Malyszko, Alejandra Mena-Gutierrez, Kenneth A. Newell, Sarah Palmer, Nicole Scholes-Robertson, Helio Tedesco Silva Junior, Jonathan C. Craig
Kidney International Reports. DOI: https://doi.org/10.1016/j.ekir.2022.10.032
Abstract
Background Cancer is an important outcome in kidney transplantation, but the scope and consistency of how cancer is defined and reported in trials involving kidney transplant recipients has not been evaluated. This study aimed to assess the range and variability of cancer outcomes in trials involving kidney transplant recipients. Methods The ClinicalTrials.gov database was searched from February 2000 to July 2021 to identify all randomized controlled trials in adult kidney transplant recipients, and which included cancer as a specified outcome. The definition of cancer, types of cancer (if any), timepoint(s) of measurement and method of aggregation were extracted for each cancer outcome. Results Of the 819 trials in kidney transplantation, only 84 (10%) included one or more cancer outcomes. Of these, 72 (86%) trials included cancer as a secondary outcome and 12 (14%) considered cancer as a primary outcome. The most frequent description of cancer was “malignancy” (n=44, 43%), without reference to diagnostic criteria, histology, grade, or stage. The two most common cancer types were post-transplant lymphoproliferative disorder (n=20, 20%) and non-melanoma skin cancer (n=10, 10%). Several methods of aggregation were identified, including incidence/rate (n=47, 46%), frequency/proportion (n=30, 29%), and time to event (n=5, 5%). Approximately half the cancer outcomes were measured at a single time point (n=44, 52%). Conclusion Cancer is an infrequently reported outcome and is inconsistently defined in trials of kidney transplant recipients. Consistent reporting of cancer outcomes using standardized definitions would provide important information on the impact of cancer in patients after kidney transplantation.
