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M.L. MacMillan et al.
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haematologica | 2020; 105(2)
into SR-GvHD and HR-GvHD groups to define our refined acute Minnesota GvHD Risk Score.1 As measured by the net reclassification index, our refined definition of GvHD improved both the true-positive and false-positive rates among our study population.1
In the current report including an independent contem- porary cohort, even though with some differences in clin- ical characteristics, we now validate this Minnesota GvHD Risk Score, demonstrating prognostic utility that remains reliable in the new cohort. While biomarkers can associate with later outcomes, their assay takes time and requires measurement accuracy of a variety of reported indicators. Our clinical risk score should be the immedi- ate and initial step in tailoring GvHD therapy, as it can be performed in real time.
The approach of stratification by this Minnesota GvHD Risk Score and later adjustment by biomarkers was used prospectively for the first time to establish eligibility cri- teria in the BMT CTN Protocol 1501, a randomized, phase II trial evaluating sirolimus versus prednisone in patients with SR GvHD.17 Of 122 patients classified by the Minnesota Risk Score at enrollment as having SR acute GvHD, only 4 patients (3%) were deemed high risk by the biomarkers. Thus, we confirmed the accuracy of
the Minnesota Risk Score using bedside GvHD risk assessment.
Further prospective trials using the Minnesota GvHD Risk Score along with informative and reliable biomarker results if available quickly are needed to better explore the GvHD risk. Additional studies using clinical classifiers supplemented with biomarkers may be of interest. A tai- lored approach to upfront acute GvHD therapy based upon the Minnesota GvHD Risk Score should be consid- ered in order to improve outcomes in patients with acute GvHD. It may also improve risk stratification for future trials of initial GvHD therapy.
Acknowledgments
The authors thank the nurses, nurse coordinators, pharmacists and physicians who cared for these patients and their families. In addition, we gratefully acknowledge the nurses and research staff whose dedicated efforts facilitated the prospective collection of the GvHD data. The authors also thank the patients and the fami- lies for participating in the clinical research trials.
Funding
This study was supported in part by the National Institutes of Health, National Cancer Institute grant P01 CA065493-20.
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