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How do I report on patients treated with CAR T-cells to the EBMT Registry? (part 4)

Cellular Therapy & Immunobiology Working Party (CTIWP)

Part 4: Reporting of (contributory) cause of death

Death is a multifactorial event, related to different factors, acting together in patients with severe diseases or complications related to the treatments. Capturing the main cause of death and contributory causes of death is important for the analysis of treatment outcomes. It is recommended to report only one main cause of death. If disease recurrence occurs and patient subsequently dies, relapse is the main cause of death, and any contributory causes of death should be captured.

Example 1: a patient treated for diffuse large B-cell lymphoma (DLBCL) receives chemotherapy to treat relapse after CAR T-cell therapy and develops infections or hemorrhage and then dies. In this example, the disease recurrence is the main cause of death and the infections/hemorrhage should be reported as contributory causes of death, even if these conditions are not indicated as complications. 

Also, for patients not experiencing disease relapse or progression/persistent disease, all the events occurring must be listed, indicating the main cause of death (i.e. cellular therapy-related), and the other contributory conditions which could occur at the same time (i.e. pulmonary toxicity, infections (viral, fungal, parasitic, bacterial and/or unknown), cardiac toxicity). The main contributory causes should be discussed with the physician before data reporting, according to the clinical course of the patient. 

For patients in which cytokine release syndrome (CRS) is determined as the main cause of death and no other cause is the principle factor leading to this outcome, CRS should be reported as grade 5 CRS (according to the ASTCT Consensus Grading, Lee et al. 2019 (read part 2: Capturing essential information on the cytokine release syndrome (CRS) and Immune Cells Associated Neurotoxicity Syndrome (ICANS).

Example 2: a patient develops CRS after a CAR T-cell treatment and the patient dies due to CRS. In this example, if CRS is the main cause of death, the main cause of death should be reported as cellular therapy-related, and the contributing cause of death would be captured as CRS. Additionally, the maximum grade for the CRS complication would be grade 5 (death due to CRS).  

In case the main and/or contributory cause of death is unclear, consult with a physician to determine the appropriate (contributory) cause of death. 

The EBMT community thanks you for your contribution to progresses in this innovative field.