All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional.
Introducing
Now you can personalise
your GvHD Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe GvHD Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the GvHD Hub cannot guarantee the accuracy of translated content. The GvHD Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
Bookmark this article
The overall response rate (ORR) of clinical symptoms at Day 28 is a validated replacement for non-relapse mortality (NRM) and has been accepted as the primary endpoint for clinical trials of acute graft-versus-host disease (GvHD) treatment.1 Physicians typically modify immunosuppression earlier than Day 28 for patients who do not respond to treatment; therefore, measuring ORR at Day 28 may not be as effective.1 A further limitation of using Day 28 ORR is that it does not account for the distinct treatment goals required for patients with high- and low-risk GvHD.1
Here, we summarize an article by Spyros et al.1 published in Transplantation and Cellular Therapy, which evaluates Day 14 endpoint models for acute GvHD (aGvHD) as predictors of long-term outcomes.
Figure 1. Quantitative comparison of Day 28 and Day 14 models for competing risks with NRM as outcome*
AUC, area under the curve; GvHD, graft-versus-host disease; NRM, non-relapse mortality; MAGIC, Mount Sinai Acute GvHD International Consortium.
*Data from Spyrou, et al.1
Table 1. Model characteristics at the 12-month post-treatment NRM endpoint*
Model |
Sensitivity |
Specificity |
Youden’s index |
NPV |
Day 14 standard criteria (ORR) |
0.54 |
0.77 |
0.31 |
0.88 |
Day 28 standard criteria (ORR) |
0.54 |
0.87 |
0.41 |
0.89 |
Day 14 Mount Sinai model |
0.57 |
0.90 |
0.47 |
0.90 |
Day 14 MAGIC model |
0.71 |
0.85 |
0.56 |
0.92 |
GvHD, graft-versus-host disease; MAGIC, Mount Sinai Acute GvHD International Consortium; NPV, negative predictive values; NRM, non-relapse mortality; ORR, overall response rate. |
Key learnings |
|
Subscribe to get the best content related to GvHD delivered to your inbox