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Published on: April 12, 2021
Scope and Consistency of Cancer Outcomes Reported in Randomized Trials in Kidney Transplant Recipients
Eric H Au1,2,3, Germaine Wong1,2,3, Allison Tong1,2
1Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Introduction:
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 (RCTs) 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 1 or more cancer outcomes. Of these, 72 of 84 (86%) trials included cancer as a secondary outcome and 12 of 84 (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 2 most common cancer types were posttransplant lymphoproliferative disorder (PTLD) (n = 20, 20%) and nonmelanoma skin cancer (n = 10, 10%). Several methods of aggregation were identified, including incidence or rate (n = 47, 46%), frequency or 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.
Insights
Cancer outcomes are inconsistently reported in kidney transplant trials. Standardized definitions are needed to improve understanding of cancer in these patients.
Area of Science:
- Nephrology
- Oncology
- Clinical Trials Methodology
Background:
- Cancer is a significant concern for kidney transplant recipients.
- The reporting and definition of cancer outcomes in clinical trials for these patients lack evaluation.
Purpose of the Study:
- To assess the variability and scope of cancer outcome definitions and reporting in randomized controlled trials (RCTs) involving kidney transplant recipients.
Main Methods:
- A systematic search of ClinicalTrials.gov (February 2000 - July 2021) identified RCTs in adult kidney transplant recipients with cancer as a specified outcome.
- Data extracted included cancer definitions, types, measurement timepoints, and aggregation methods.
Main Results:
- Only 10% of kidney transplantation trials (84/819) reported cancer outcomes, mostly as secondary endpoints (86%).
- The term "malignancy" was most common (43%), often without specific diagnostic criteria.
- Post-transplant lymphoproliferative disorder (PTLD) and non-melanoma skin cancer were the most frequent types reported.
Conclusions:
- Cancer is infrequently and inconsistently reported in kidney transplant trials.
- Standardized definitions and reporting of cancer outcomes are crucial for better understanding cancer's impact post-transplantation.
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