title: NIH Consensus development project on criteria for clinical trials in chronic graft-versus-host disease: II. The 2014 Pathology Working Group Report.
abstract: The 2005 National Institute of Health (NIH) Consensus Conference outlined histopathological diagnostic criteria for the major organ systems affected by both acute and chronic graft-versus-host disease (GVHD). The 2014 Consensus Conference led to this updated document with new information from histopathological studies of GVHD in the gut, liver, skin, and oral mucosa and an expanded discussion of GVHD in the lungs and kidneys. The recommendations for final histological diagnostic categories have been simplified from 4 categories to 3: no GVHD, possible GVHD, and likely GVHD, based on better reproducibility achieved by combining the previous categories of "consistent with GVHD" and "definite GVHD" into the single category of "likely GVHD." Issues remain in the histopathological characterization of GVHD, particularly with respect to the threshold of histological changes required for diagnostic certainty. Guidance is provided for the incorporation of biopsy information into prospective clinical studies of GVHD, particularly with respect to biomarker validation.
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors: Howard M
authors: HM
authors: Shulman
authors: Department of Pathology, Duke University Medical Center, Durham, North Carolina.
authors: Diana M
authors: DM
authors: Cardona
authors: Department of Pathology, University of Michigan, Ann Arbor, Michigan.
authors: Joel K
authors: JK
authors: Greenson
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Departments of Pediatrics, Gastroenterology and Pathology, University of Washington, Seattle, Washington; Seattle Children's Hospital, Seattle, Washington.
authors: Sangeeta
authors: S
authors: Hingorani
authors: Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts.
authors: Thomas
authors: T
authors: Horn
authors: Institute of Pathology, University of Regensburg, Regensburg, Germany.
authors: Elisabeth
authors: E
authors: Huber
authors: Institute of Pathology, University Medical Center Mainz, Mainz, Germany.
authors: Andreas
authors: A
authors: Kreft
authors: Institute of Pathology, University Hospital RWTH Aachen, Aachen, Germany.
authors: Thomas
authors: T
authors: Longerich
authors: Departments of Pediatrics, Gastroenterology and Pathology, University of Washington, Seattle, Washington.
authors: Thomas
authors: T
authors: Morton
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Department of Pathology, University of Washington, Seattle, Washington.
authors: David
authors: D
authors: Myerson
authors: Department of Pathology, University of Texas M.D. Anderson Cancer Center, Houston, Texas.
authors: Victor G
authors: VG
authors: Prieto
authors: Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
authors: Avi
authors: A
authors: Rosenberg
authors: Division of Oral Medicine and Dentistry, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.
authors: Nathaniel
authors: N
authors: Treister
authors: Department of Pathology, Microbiology and Immunology, Vanderbilt University, Nashville, Tennessee.
authors: Kay
authors: K
authors: Washington
authors: Department of Dermatology, University Hospital of Leipzig, Leipzig, Germany.
authors: Mirjana
authors: M
authors: Ziemer
authors: Experimental Transplantation and Immunology Branch, National Cancer Institute, Bethesda, Maryland.
authors: Steven Z
authors: SZ
authors: Pavletic
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors: Stephanie J
authors: SJ
authors: Lee
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors: Mary E D
authors: ME
authors: Flowers
authors: Department of Pediatrics, BC Children's Hospital/University of British Columbia, Vancouver, British Columbia.
authors: Kirk R
authors: KR
authors: Schultz
authors: Division of Hematology-Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.
authors: Madan
authors: M
authors: Jagasia
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors: Paul J
authors: PJ
authors: Martin
authors: Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors: Georgia B
authors: GB
authors: Vogelsang
authors: Department of Pathology, University of Texas M.D. Anderson Cancer Center, Houston, Texas. Electronic address: kleinerd@mail.nih.gov.
authors: David E
authors: DE
authors: Kleiner
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D002986:Clinical Trials as Topic; D005260:Female; D006086:Graft vs Host Disease / Q000378:metabolism / Q000473:pathology; D006801:Humans; D007410:Intestinal Diseases / Q000378:metabolism / Q000473:pathology; D008107:Liver Diseases / Q000378:metabolism / Q000473:pathology; D008297:Male; D009059:Mouth Diseases / Q000378:metabolism / Q000473:pathology; D012871:Skin Diseases / Q000378:metabolism / Q000473:pathology
chemical_list: D015415:Biomarkers
keywords: Allogeneic hematopoietic cell transplantation; Chronic graft-versus-host disease; Consensus; Diagnosis; Histology; Pathology
references: Pediatr Blood Cancer. 2007 May;48(5):561-6
references: 16862539
references: Rheumatology (Oxford). 2007 May;46(5):833-41
references: 17255134
references: Histopathology. 2007 May;50(6):727-38
references: 17493237
references: Blood. 2007 Aug 15;110(4):1388-96
references: 17452515
references: Biol Blood Marrow Transplant. 2007 Sep;13(9):1116-7
references: 17697974
references: Clin J Am Soc Nephrol. 2006 Jul;1(4):685-94
references: 17699273
references: Biol Blood Marrow Transplant. 2003 Nov;9(11):683-8
references: 14652851
references: Biol Blood Marrow Transplant. 2003 Dec;9(12):760-5
references: 14677115
references: BMC Gastroenterol. 2003 Mar 27;3:5
references: 12697049
references: Br J Dermatol. 2004 Sep;151(3):579-86
references: 15377343
references: J Am Acad Dermatol. 2004 Oct;51(4):543-6
references: 15389188
references: Transplant Proc. 1974 Dec;6(4):367-71
references: 4155153
references: Gastroenterology. 1980 Apr;78(4):764-71
references: 6986319
references: Am J Med. 1980 Aug;69(2):204-17
references: 6996481
references: Gastroenterology. 1980 Dec;79(6):1178-91
references: 7002704
references: Hum Pathol. 1981 Nov;12(11):1022-30
references: 7033104
references: Arch Ophthalmol. 1983 Apr;101(4):580-4
references: 6340648
references: Arch Ophthalmol. 1983 Apr;101(4):585-90
references: 6340649
references: Transplantation. 1991 May;51(5):1004-10
references: 1851580
references: Aust N Z J Ophthalmol. 1991 Aug;19(3):187-91
references: 1958361
references: Gastroenterology. 1993 Feb;104(2):595-603
references: 8425703
references: Ann Intern Med. 1994 Jun 15;120(12):993-8
references: 8185148
references: Am J Surg Pathol. 2013 Apr;37(4):539-47
references: 23211294
references: Biol Blood Marrow Transplant. 2013 May;19(5):784-91
references: 23395601
references: Biol Blood Marrow Transplant. 2013 Jun;19(6):973-80
references: 23562737
references: J Dtsch Dermatol Ges. 2013 Jun;11(6):477-95
references: 23721594
references: Blood. 2013 Aug 22;122(8):1505-9
references: 23760615
references: J Hematother Stem Cell Res. 2000 Jun;9(3):299-306
references: 10894351
references: J Formos Med Assoc. 2000 Jun;99(6):503-6
references: 10925558
references: Hepatology. 2000 Dec;32(6):1265-71
references: 11093733
references: Am J Pathol. 2001 Apr;158(4):1379-90
references: 11290556
references: Bone Marrow Transplant. 2001 Dec;28(11):1047-51
references: 11781615
references: Blood. 2002 Apr 15;99(8):3033-40
references: 11929797
references: Int J Hematol. 2002 Apr;75(3):332-4
references: 11999366
references: Lancet. 2002 Jun 15;359(9323):2078-83
references: 12086762
references: Clin Nephrol. 2002 Sep;58(3):231-7
references: 12356194
references: Blood. 2002 Dec 1;100(12):3903-7
references: 12393729
references: Biol Blood Marrow Transplant. 2003 Jan;9(1):46-51
references: 12533741
references: Invest Ophthalmol Vis Sci. 2003 May;44(5):1888-96
references: 12714620
references: Blood. 2003 Nov 15;102(10):3822-8
references: 12869516
references: Int J Surg Pathol. 2003 Oct;11(4):295-302
references: 14615824
references: J Invest Dermatol. 1994 Aug;103(2):206-10
references: 8040611
references: Arch Dermatol. 1995 Aug;131(8):964-5
references: 7632078
references: Biomed Pharmacother. 1995;49(3):117-24
references: 7647282
references: Gastroenterology. 1996 Jul;111(1):193-8
references: 8698199
references: J Heart Lung Transplant. 1996 Jan;15(1 Pt 1):1-15
references: 8820078
references: Hum Pathol. 1997 Nov;28(11):1310-2
references: 9385940
references: Am J Clin Pathol. 1998 Jan;109(1):101-9
references: 9426525
references: Hepatology. 1988 May-Jun;8(3):463-70
references: 3131226
references: Arch Pathol Lab Med. 1989 Aug;113(8):932-4
references: 2757495
references: Arch Ophthalmol. 1989 Sep;107(9):1343-8
references: 2675805
references: Gastroenterology. 1990 Jan;98(1):223-5
references: 2293582
references: Transplantation. 1991 Mar;51(3):642-6
references: 2006521
references: Blood. 2011 Mar 17;117(11):3214-9
references: 21263156
references: Rheumatology (Oxford). 2011 Jun;50(6):1168-9
references: 21454306
references: Blood. 2011 Jun 16;117(24):6714-20
references: 21493797
references: Blood. 2011 Aug 11;118(6):1685-92
references: 21636856
references: N Engl J Med. 2011 Sep 1;365(9):815-24
references: 21879899
references: Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56
references: 16338616
references: Biol Blood Marrow Transplant. 2006 Jan;12(1):31-47
references: 16399567
references: Am J Surg Pathol. 2006 Apr;30(4):444-9
references: 16625089
references: Biol Blood Marrow Transplant. 2006 May;12(5):506-10
references: 16635785
references: Blood. 2006 Jul 15;108(2):749-55
references: 16537799
references: Bone Marrow Transplant. 2006 Sep;38(5):371-6
references: 16915225
references: Am J Surg Pathol. 2006 Sep;30(9):1085-90
references: 16931952
references: Gastroenterology. 2006 Sep;131(3):713-8
references: 16952540
references: Biol Blood Marrow Transplant. 2006 Nov;12(11):1101-13
references: 17085303
references: Virchows Arch. 2006 Nov;449(5):539-45
references: 17024424
references: Bone Marrow Transplant. 2013 Nov;48(12):1525-9
references: 23892328
references: Bone Marrow Transplant. 2013 Nov;48(12):1574-7
references: 23892332
references: Virchows Arch. 2014 Feb;464(2):175-90
references: 24385287
references: Bone Marrow Transplant. 2014 Mar;49(3):403-9
references: 24317123
references: Bone Marrow Transplant. 2014 Apr;49(4):539-44
references: 24419519
references: N Engl J Med. 2014 May 8;370(19):1820-8
references: 24806161
references: Transplantation. 2014 May 15;97(9):965-71
references: 24827766
references: Biol Blood Marrow Transplant. 2014 Jul;20(7):1008-13
references: 24704386
references: Biol Blood Marrow Transplant. 2014 Jul;20(7):1048-55
references: 24704387
references: J Eur Acad Dermatol Venereol. 2014 Jul;28(7):915-24
references: 23906476
references: Biol Blood Marrow Transplant. 2014 Oct;20(10):1493-500
references: 24813168
references: Biol Blood Marrow Transplant. 2014 Oct;20(10):1592-8
references: 24954547
references: J Am Acad Dermatol. 2014 Oct;71(4):745-53
references: 24993601
references: Clin J Am Soc Nephrol. 2015 Jan 7;10(1):12-20
references: 25388519
references: Am J Surg Pathol. 2015 Feb;39(2):212-20
references: 25517948
references: Biol Blood Marrow Transplant. 2015 Mar;21(3):531-8
references: 25498923
references: Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1
references: 25529383
references: J Eur Acad Dermatol Venereol. 2015 May;29(5):948-54
references: 25265987
references: Blood. 1998 Nov 1;92(9):3098-104
references: 9787144
references: Bone Marrow Transplant. 1999 Jan;23(1):99-101
references: 10037059
references: Gastrointest Endosc. 1999 May;49(5):612-21
references: 10228260
references: Am J Clin Pathol. 2004 Dec;122(6):919-25
references: 15539384
references: Histopathology. 2004 Dec;45(6):648-51
references: 15569061
references: Hepatology. 2005 Feb;41(2):345-52
references: 15660388
references: Am J Kidney Dis. 2005 Apr;45(4):780-5
references: 15806483
references: Liver Transpl. 2005 May;11(5):525-31
references: 15838886
references: Blood. 2005 May 15;105(10):3802-11
references: 15687239
references: J Oral Pathol Med. 2005 Sep;34(8):486-93
references: 16091116
references: Biol Blood Marrow Transplant. 2005 Sep;11(9):721-31
references: 16125643
references: Biol Blood Marrow Transplant. 2005 Oct;11(10):773-80
references: 16182178
references: Biol Blood Marrow Transplant. 2005 Oct;11(10):805-13
references: 16182181
references: Transplant Proc. 2005 Sep;37(7):3213-5
references: 16213351
references: Clin J Am Soc Nephrol. 2007 Sep;2(5):1014-23
references: 17702721
references: Am J Hematol. 2007 Oct;82(10):881-6
references: 17570511
references: Pediatr Dev Pathol. 2007 Sep-Oct;10(5):351-7
references: 17929993
references: Int J Hematol. 2008 Mar;87(2):225-30
references: 18264743
references: Am J Gastroenterol. 2008 Apr;103(4):982-9
references: 18028511
references: Am J Surg Pathol. 2008 Sep;32(9):1367-72
references: 18763324
references: Bone Marrow Transplant. 2008 Oct;42(7):461-7
references: 18604240
references: Biol Blood Marrow Transplant. 2009 Mar;15(3):370-6
references: 19203729
references: Mod Pathol. 2009 Jun;22(6):737-43
references: 19329937
references: PLoS One. 2009;4(7):e6203
references: 19587802
references: Am J Surg Pathol. 2009 Sep;33(9):1355-63
references: 19542873
references: Muscle Nerve. 2009 Oct;40(4):643-7
references: 19670319
references: Blood. 2009 Oct 1;114(14):3113-6
references: 19643987
references: Transpl Immunol. 2010 May;23(1-2):77-80
references: 20230895
references: Biol Blood Marrow Transplant. 2010 Jul;16(7):985-93
references: 20167280
references: Biol Blood Marrow Transplant. 2010 Oct;16(10):1362-9
references: 20353829
references: Transplant Proc. 2010 Nov;42(9):3591-3
references: 21094821
references: Biol Blood Marrow Transplant. 2011 Apr;17(4):486-96
references: 20870026
references: Clin Transplant. 2011 Sep-Oct;25(5):E552-7
references: 21919962
references: Blood. 2011 Dec 15;118(25):6702-8
references: 21979939
references: Semin Hematol. 2012 Jan;49(1):73-82
references: 22221787
references: Bone Marrow Transplant. 2012 Mar;47(3):430-8
references: 21706064
references: Biol Blood Marrow Transplant. 2012 Aug;18(8):1281-6
references: 22326632
references: Int J Hematol. 2012 Sep;96(3):386-9
references: 22903864
references: Bone Marrow Transplant. 2012 Oct;47(10):1343-9
references: 22388280
references: Haematologica. 2012 Nov;97(11):1674-7
references: 22689672
references: Biol Blood Marrow Transplant. 2013 Jan;19(1):22-7
references: 23041600
references: Cardiovasc Hematol Agents Med Chem. 2013 Mar;11(1):67-76
references: 23016546
references: Indian J Pathol Microbiol. 2012 Oct-Dec;55(4):506-8
references: 23455789
references: Bone Marrow Transplant. 2013 Sep;48(9):1249-52
references: 23749110
references: Pediatr Blood Cancer. 2013 Nov;60(11):1798-800
references: 23775774
references: Am J Surg Pathol. 2013 Sep;37(9):1319-28
references: 24076772