Table 1.
Patient and cGVHD Characteristics at Study Enrollment
| Characteristics | n (%) or (range) |
|---|---|
| Total number of patients | 187 |
| Total number of oral cGVHD patients | 44 (23.5%) |
| Age (median, range, in yrs) | 45.6 (3.7-69.8) |
| Gender | |
| Male | 103 (55%) |
| Female | 85 (45%) |
| Disease | |
| ALL/AML/MDS | 79 (46%) |
| Lymphoma/CML/MM | 71 (41%) |
| CLL | 12 (7%) |
| Aplastic Anemia/PNH | 6 (4%) |
| Other non-malignant | 3 (2%) |
| Conditioning regimen | |
| Myeloablative | 106 (57%) |
| Total Body Irradiation (TBI) | 72 (39%) |
| Donor relationship | |
| Unrelated | 72 (39%) |
| Related | 113 (61%) |
| Cell source | |
| Bone marrow | 35 (19%) |
| Peripheral blood | 146 (79%) |
| Cord blood | 4 (2%) |
| HLA match | |
| Yes | 148 (82%) |
| No | 32 (18%) |
| cGVHD onset type | |
| Progressive | 70 (38.5%) |
| Quiescent | 52 (28.6%) |
| De novo | 60 (33.45) |
| Number of organs involved | 5 (1-8) |
| Eye | 148 (80.4%) |
| Skin | 145 (78.8%) |
| Lung | 141 (77%) |
| Joint or fascia | 115 (62.5%) |
| Liver | 96 (52.5%) |
| Gastrointestinal tract | 84 (45.6%) |
| Genital | 42 (50%) |
| Activity by therapeutic intent | |
| Active | 79 (53.4%) |
| Not active | 69 (46.6%) |
| Intensity of immunosuppression a | |
| None/mild | 46 (25.1%) |
| Moderate | 62 (33.9%) |
| Severe | 75 (41.0%) |
| NIH average score | 1.03 (0-2.33) |
| Median number of mos from transplant to enrollment | 50.6 (4-258.2) |
For all values in this Table, continuous variables are shown as median values with ranges, and categorical variables are shown as frequencies with percentages.
Abbreviations: ALL, acute lymphoblastic leukemia; AML, acute myelogenous leukemia; MDS, myelodysplastic syndrome; CML, chronic myeloid leukemia; CLL, chronic lymphocytic leukemia; MM, multiple myeloma; PNH, paroxysmal nocturnal hemoglobinuria; M, male; F, female; HLA, human leukocyte antigen.
a
Intensity of immunosuppression: Mild, single agent prednisone < 0.5; Moderate, prednisone < 0.5 mg/kg/day and/or any single agent/modality; High, 2 or more agents/modalities ± prednisone < 0.5 mg/kg/day.