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SUPPLEMENTARY DATA
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for
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Prognostic factors and outcomes of severe gastrointestinal graft-versus-host disease after
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allogeneic hematopoietic cell transplantation
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Cristina Castilla-Llorente MD1*; Paul J. Martin, MD1,2; George B. McDonald, MD1,2; Barry E.
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Storer, PhD1,2; Frederick R. Appelbaum, MD1,2; H. Joachim Deeg, MD1,2; Marco Mielcarek,
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MD1,2; Howard Shulman, MD1,2; Rainer Storb, MD1,2; Richard A. Nash, MD1,2**
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Supplementary Table 1. Data collected for this study*
Parameter
Description
Stages/Grades
Gut GVHD stage
A peak stage was assigned based on volume
Stage 0 - ≤500 ml;
of diarrhea and clinical signs.
Stage 1 - 500-1000 ml;
Stage 2 - 1000-1500 ml;
Stage 3 - >1500 ml;
Stage 4 - severe abdominal pain
(cramps)† or melena.
Skin GVHD stage
A peak stage was assigned based on the
Stage 0 - No involvement;
extent and severity of the rash.
Stage 1 - <25%;
Stage 2 - 25-50%;
Stage 3 - >50%; Stage 4 Generalized erythema with
bullae.
Liver GVHD
A peak stage was assigned based on the level Stage 0 - <2 mg/dl;
stage
of serum bilirubin and exclusion of other
Stage 1 - 2.0-3.0 mg/dl;
causes of abnormalities in serum bilirubin.
Stage 2 - 3.1-6.0 mg/dl;
Stage 3 - 6.1-15 mg/dl;
Stage 4 - >15 mg/dl
Upper GI
Presence or absence of any of anorexia,
symptoms
nausea or vomiting.
Gastrointestinal
Presence or absence of frank red blood or
bleeding
melena in the stools.
Endoscopic grades
Endoscopic grading was based on the visual
Grades 0 - normal appearance;
of GVHD in upper
findings at endoscopy previously
Grade 1 - edematous or
and lower
described16,40
erythematous changes; no
gastrointestinal
ulcerations or erosions;
tract
Grade 2 - friable mucosa, focal
erosions or ulcerations;
Grade 3 - extensive confluent
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Parameter
Description
Stages/Grades
erosions or ulcerations.
Histopathological
As previously described16,26,41 if more than
Grade 0 - normal mucosa; Grade 1 -
grades of upper
one endoscopy was performed in the same
presence of apoptosis without crypt
and lower
14-day interval, the highest grade for GVHD
(or basilar gland) loss;
gastrointestinal
histology was assigned.
Grade 2 - individual crypt (or basilar
GVHD
gland) loss;
Grade 3 - contiguous areas of crypt
(or basilar gland) loss with or
without presence of focal
regenerative hyperplasia;
Grade 4 - complete loss of crypts (or
basilar glands).
Grade of GVHD
The grades were based on the extent of
Grade 0 - Normal; Grade 1 -
based on
involvement.
Regional wall thickening in either
abdominal CT
the small or large intestine;
imaging
Grade 2 - Extensive wall thickening in
both the small and large intestine 38.
Infections
Infections of the gastrointestinal tract
confirmed by cultures or biopsy including
cytomegalovirus, C. Difficile or other
infections.
GVHD treatment:
Immunosuppressive agents used for treating
GVHD were noted for each of the 14-day
intervals including any relevant change in the
dose of corticosteroids or the addition of
other systemic therapies. Data on the use of
topical therapies was not collected.
Serum albumin
The nadir of serum albumin was noted for
each consecutive 14-day interval (mg/L).
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Parameter
Description
Stages/Grades
RBC transfusion
Number of red blood cell units transfused for
each 14-day interval.
Total parenteral
The number of days on TPN in each 14-day
nutrition (TPN)
interval.
Hospitalization
The number of days for which hospitalization
was required for supportive care.
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*Each parameter was collected as either presence/absence or peak/nadir values for each 14-day
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interval from 14 days before onset of stages 3-4 gut GVHD.
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†
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Cramps were defined as abdominal pain requiring intravenous narcotics.
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Supplementary Table 2. Survival at 6 and 12 months according to the number of risk factors
Number of
Risk Factors*
Number of
Patients
6 Month Overall
Survival (%)
12 Month Overall
Survival (%)
0 or 1
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83
72
2
30
73
57
3
35
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4
33
0
0
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*Risk factors for overall survival were identified in the multivariate analysis and are: 1) serum
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bilirubin >3.0 mg/dL, 2) corticosteroid-resistant, 3) patient >18 years of age at transplant and 4)
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gastrointestinal bleeding. Overall survival decreases as the number of risk factors for poor
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outcome are increased.
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