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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 |
GvHD, graft-versus-host disease; MAGIC, Mount Sinai Acute GvHD International Consortium; NPV, negative predictive values; NRM, non-relapse mortality; ORR, overall response rate. |
||||
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 |
Key learnings |
|
References
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