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Kidney Week

Abstract: PO2472

Spectrum and Consistency of Cancer Outcomes in Randomized Trials in Kidney Transplant Recipients: A Systematic Review

Session Information

Category: Transplantation

  • 1902 Transplantation: Clinical

Authors

  • Au, Eric Hoi Kit, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia
  • Tong, Allison, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia
  • Wong, Germaine, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia
  • Craig, Jonathan C., Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia
Background

Cancer is an important cause of morbidity and mortality in kidney transplant recipients. Despite being established as a critically important outcome by patients, caregivers and health professionals, inconsistency in how cancer outcomes are defined and reported in trials of kidney transplant recipients may limit decision-making. The aim of this study was to assess the spectrum and consistency of cancer outcomes in trials involving kidney transplant recipients.

Methods

ClinicialTrials.gov was searched from inception to October 2019 to identify all randomized controlled trials (RCTs) in adult kidney transplants recipients which included cancer as a pre-defined outcome. We extracted the details of all primary and secondary cancer outcomes, including type, timepoint and definition of cancer (histology, grade and stage).

Results

Among the 71 RCTs included, there was a total of 87 cancer outcomes. The majority of trials (n = 61, 86%) included cancer as a secondary outcome only, with 8 trials (11%) including cancer as a primary outcome and 2 (3%) including cancer as part of a composite primary outcome measure. The most common descriptions of cancer in these outcome measures was “malignancy” without specific reference to diagnostic criteria, histology, grade or cancer stage (40, 46%) or “cancer” without specific clarification (8, 9%). Some trials included mention of specific cancer types, with post-transplant lymphoproliferative disorder (13, 15%), non-melanoma skin cancer (10, 11%) and skin cancer (in general) (5, 6%) being the most common, but these were not defined. A range of timepoints were used, with a single timepoint at the end of the primary trial being the most frequent (38, 44%); 13 studies included measurement at several timepoints during the trial (15%). A range of metrics for measuring cancer outcomes were used, including cancer incidence (53, 61%), proportion with cancer (9, 10%), and time-to-event (5, 6%). No measurement metric was specified in 18 (21%) cancer outcome measures.

Conclusion

Cancer is one of the most important outcomes for patients post-transplantation, but cancer outcomes are very poorly defined and highly variable in RCTs. A core outcome for cancer for all trials in kidney transplant recipients should be developed that is consistent and meaningful to patients and clinicians.

Funding

  • Government Support - Non-U.S.