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Chronic GvHD, PRO and health status
time since transplant, and variables from the patient-self-reported survey: severity of chronic GVHD, and presence of any of four comorbidities (pulmonary disease, avascular necrosis, adrenal insufficiency or diabetes) previously associated with QOL.19
Work or school status was categorized as: (i) work, school or homemaking full or part time, or retired by choice; (ii) not working, not in school or retired due to health problems, and unemployed.
Because of multiple comparisons, P-values less than 0.01 were considered statistically significant.
Results
The survey was sent to 3027 recipients surviving one or more years after allogeneic HCT and 1377 responded (overall response rate 45%). The median age of the respon- dents was 54 years [interquartile range (IQR) 42-63 years] and 55.2% were male. Non-respondents were younger (mean age 48.5 versus 56.4, P<0.001), more likely to have received bone marrow (55.9% versus 45.7%, P<0.001), myeloablative conditioning (86.6% versus 78.5%, P<0.001), or high dose total body irradiation (44.5% versus 34.7%, P<0.001) and to have survived longer since their transplant (mean 15.8 versus 13.8 years, P<0.001) than respondents. The median time since HCT was 11 years (IQR 4-20) for all respondents whose chronic GvHD status was known and 6 years (IQR 2-13) for those with current chronic GvHD.
Table 1 shows the characteristics of the groups of patients divided according to their self-reported current chronic GvHD status, excluding the 328 who responded to the survey but did not answer the chronic GvHD ques- tions. There were 377 who had never had chronic GvHD and 280 whose chronic GvHD had resolved by the time of the survey. Of those with current chronic GvHD, mild involvement was reported by 257, moderate involvement by 110, and severe involvement by 25. Overall, the groups were significantly different for all characteristics examined except for age. Patients who had never had chronic GvHD or whose chronic GvHD had resolved were more likely to have had matched related donors, myeloablative condi- tioning, high dose total body irradiation and to have sur- vived longer since HCT. They were less likely to have received peripheral blood as the source of their graft.
Because of these cohort differences, all of these factors were included in the multivariate models. Starting in 1992, the database captures date last seen at FHCRC. Among the 1043 patients who had a date of last visit recorded, the median time since last being seen at FHCRC was 9.9 years (IQR 2.8-22.2) for patients with no chronic GvHD, 13.3 (IQR 7.0-20.9) for those whose GvHD had resolved, 1.2 (IQR 0.3-8.4) for mild, 0.8 (IQR 0.2-4.8) for moderate and 0.7 (IQR 0.2-9.5) for severe chronic GvHD.
Table 2 shows the raw scores of the different instru- ments for the chronic GvHD subgroups, as well as the comparisons between never versus resolved chronic GvHD and, for those with active chronic GvHD, between self- identified mild, moderate, and severe chronic GvHD. Patients whose chronic GvHD had resolved reported scores similar to those who reported never having had chronic GvHD on nearly all subscales. Exceptions were seen with the LSS in which patients with resolved chronic GvHD still reported more mouth, eye and nutritional symptoms and had higher summary scores than those never affected by chronic GvHD, although none of these differences was considered clinically meaningful (i.e., all <0.5 standard deviations). Patients with mild chronic GvHD had statistically significant worse scores than patients with resolved chronic GvHD in many domains (data not shown) but these differences were not considered clinically significant by virtue of the 0.5 standard deviation criterion. In contrast, among patients with current chronic GvHD, scores varied as expected between those with self- reported mild and those with moderate and severe chronic GvHD for all scales. Patients with moderate or severe chronic GvHD reported scores in multiple physical, mental and symptom domains that were both statistically and clinically worse than those of patients whose chronic GvHD had resolved, as shown by the bold values in Table 2. However, we did not detect any statistically significant differences between patients with moderate and severe chronic GvHD (data not shown).
A similar pattern was seen for the physical functioning scales of the SF-36 and PROMIS Global Health (Figure 1A), the mental functioning scales of the SF-36 and PROMIS Global Health (Figure 1B) and the physical and social sub- scales of the PROMIS-29 (Figure 1C).
Presence and severity of Chronic GvHD remained pre-
Table 1. Population characteristics.
Never (n=377)
Resolved (n=280)
135 (48.2)
58.8 (12.3)
136(48.6) 19 (6.8) 7 (2.5) 81 (28.9) 33 (11.8) 4 (1.4) 0
110 (39.3) 242 (86.4) 131 (46.8) 17.5 (8.4)
Mild (n=257)
113 (44.0)
57.2 (12.6)
88 (34.2) 4 (1.6) 10 (3.9) 114 (44.4) 31 (12.1) 9 (3.5) 1 (0.4)
187 (72.8) 172 (66.9) 59 (23.0) 8.4 (7.5)
Moderate (n=110)
49 (44.5)
58.3 (10.8)
40 (36.4) 1 (0.9) 2 (8.1) 54 (49.1) 13 (11.8) 0
0
97 (88.2) 64 (58.2) 18 (16.4) 7.2 (5.8)
Severe (n=25)
9 (36.0)
57.6 (15.0)
7 (28.0) 1 (4.0) 1 (4.0) 11 (44.0) 4 (16.0) 0
0
20 (80.0) 14 (56.0) 3 (12.0) 9.0 (8.1)
P-value 0.02
<0.001 <0.001
<0.001 <0.001 <0.001 <0.001
Female, n (%)
Age, mean years (SD)
Matched related Mismatched related Haplo-identical related Matched unrelated Mismatched unrelated Cord blood
Syngeneic
Peripheral blood, n (%) Myeloablative, n (%)
High dose TBI, n (%)
Years since HCT, mean, (SD)
209 (55.4)
53.9 (13.5)
212 (56.2) 16 (4.2) 11 (2.9) 95 (25.2) 17 (4.5) 19 (5.0) 6 (1.6)
150 (39.8) 309 (82.0) 133 (35.3) 14.9 (11.3)
TB: total body irradiation; HCT: hematopoietic cell transplant.
haematologica | 2018; 103(9)
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