期刊
THERAPEUTIC ADVANCES IN HEMATOLOGY
卷 10, 期 -, 页码 -出版社
SAGE PUBLICATIONS LTD
DOI: 10.1177/2040620719891358
关键词
acute graft-versus-host disease; biomarkers; liquid biopsy; surrogate endpoints; responses; FDA-NIH BEST
类别
资金
- National Cancer Institute [P01CA03942, P30CA196521]
- National Center for the Advancement of Translational Science of the National Institutes of Health [TL1 TR001434]
Hematopoietic cell transplantation (HCT) is a potentially curative therapy for hematologic malignancies that relies on the graft-versus-leukemia (GVL) effect to eradicate malignant cells. GVL is tightly linked to graft-versus-host disease (GVHD) however, in which donor T cells damage healthy host tissues. Acute GVHD occurs in nearly 50% of patients receiving HCT, and damages the skin, liver, and gastrointestinal (GI) tract. The organ stages are totaled in an overall grade (I-IV), and severe (grade III/IV) GVHD has a high mortality rate (50-70%). In the past decade, serum biomarkers have emerged as an additional potential measurement of acute GVHD severity. The discovery and validation of GVHD biomarkers is a principal objective of the Mount Sinai Acute GVHD International Consortium (MAGIC), a group of 25 HCT centers conducting GVHD research. MAGIC has validated an algorithm that combines two GI biomarkers (ST2 and REG3 alpha) into a single value that estimates the probability of 6 month nonrelapse mortality (NRM) for individual patients, known as the MAGIC algorithm probability (MAP). The MAP reflects GI crypt damage and serves as a 'liquid biopsy' of the lower GI tract; it also predicts response to treatment and maximum GVHD severity and is now commercially available and widely used among scores of centers in clinical practice. The MAP is the focus of this review, with consideration of the categorization of types of biomarkers as defined by the United States National Institutes of Health (NIH) and Food and Drug Administration (FDA).
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