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Real-world QOL survey for patients with acute and chronic GvHD post allo-SCT in 5 European countries

May 24, 2021
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Graft-versus-host disease (GvHD) is a major limitation and complication after allogeneic stem cell transplantation (allo-SCT). Acute GvHD (aGvHD) is associated with a high symptom burden including pain and reduced quality of life (QOL). Chronic GvHD (cGvHD) occurs in 30−70% of patients and is a leading cause of morbidity and nonrelapse mortality post allo-SCT. Due to GvHD-associated symptom burden, the majority of patients score low on QOL measures.

The impact of aGvHD and cGvHD severity and steroid response on the QOL of patients post allo-SCT was recently studied in real-world cross-sectional surveys, which were conducted by Hammad et al. (aGvHD) and Lachance et al. (cGvHD).1,2

Methods

To assess the QOL of GvHD, data on disease severity and its impact on patients were collected from hematology-oncologists. Patients were also required to fill in the information using the EQ-5D-5L assessment tool. The EQ-5D-5L form consisted of a descriptive questionnaire and a visual analog scale (VAS) where patients could rate their QOL on a 7-point scale ranging from very good to very poor, and reported their current symptoms. These responses were analyzed by GvHD grade as per National Institutes of Health (NIH) criteria, and steroid response as reported by the physicians. An outline of the study method is presented in Figure 1.

Figure 1. An outline of the methods used for data collection from patients and physicians, and analysis using the EQ-5D-5L assessment tool*

cGvHD, chronic graft-versus-host disease; aGvHD, acute graft-versus-host disease; QOL, quality of life; VAS, visual analog scale.
*Adapted from Hammad et al.1 and Lachance et al.2
Data was collected from five European countries: France, Germany, Italy Spain, and UK.

 Patient demographics

Table 1 below depicts the patient demographics in the study.

Table 1. Patient demographics*

Patients

Age, median (range), years

Gender, %

Median time since diagnosis, days

Responsive

Refractory

M

F

cGvHD
              All patients
              (n = 143)


54 (21−76)


65.7


34.3


269


65


35

aGvHD
              All patients
              (n = 68)


53 (12−73)


66.2


33.8


45


77.9


22.1

cGvHD severity
              Mild (n = 85)
              Moderate (n = 42)
              Severe (n = 16)


54 (21−76)
50 (24−72)
53 (30−69)


69.4
59.5
62.5


30.6
40.5
37.5


246
220
554


78.8
54.8
18.8


21.2
45.2
81.3

aGvHD severity
              Mild (n = 41)
              Moderate (n = 17)
              Severe (n = 10)


53 (13−73)
52 (12−72)
53.5 (20−64)


61.0
70.6
80.0


39.0
29.4
20.0


52
29
46


69.8
24.5
5.7


26.7
26.7
46.7

cGvHD
              Responsive (n = 93)
              Refractory dependent (n = 50)


54 (21−76)
53.5 (24−72)


67.7
62.0


32.3
38.0


230.5
317.0





aGvHD
              Responsive (n = 53)
              Refractory dependent (n = 15)


55 (21−73)
51 (20−61)


62
80


38
20


43
96





aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease.
*Adapted from Hammad et al.1 and Lachance et al.2

 

Results:

  • Results from both components of EQ-5D-5L indicated that patients with aGvHD or cGvHD had a decrease in the QOL.
  • Patients with Grade 3 and 4 aGvHD/cGvHD had substantially worse QOL (48.5 and 43.9, respectively), as shown in Figure 2. For reference, the mean score in the general population aged 55−64 was in the range of 0.86 to 0.89.

Figure 2. Patient QOL decreased with an increase in GvHD severity*

 aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease; QOL, quality of life; VAS, visual analogue scale.
*Data derived from Hammad et al.1 and Lachance et al.2

  •  Almost 90% of patients with cGvHD and aGvHD were rated with poor overall QOL (which included ratings of very poor, poor or somewhat poor).
  • Steroid-responsive patients had overall better QOL compared with patients who were steroid-dependent or refractory when assessed via the EQ-5D-5L tool; the scores for steroid responsive vs steroid refractory were 0.79 vs 0.69 for cGvHD, and 0.83 vs 0.53 for aGvHD, respectively.
  • Nevertheless, based on the outcomes obtained via the EQ-5D-5L VAS, the difference between the score of the steroid responsiveness group and the steroid-refractory group was not great; the scores were 67.3 vs 57 for cGvHD, and 63.8 vs 55.0 for aGvHD, respectively.
  • In the analysis of the impact of the GvHD on the five dimensions of EQ-5D-5L, more than 25% of patients with cGvHD and 50% of patients with aGvHD had problems in three dimensions such as ‘pain/discomfort’, ‘anxiety/depression’, and ‘usual activities’ (Table 2).

Table 2. EQ-5D-5L responses by individual dimension*

Problem score

None,
%

Slight,
%

Moderate,
%

Severe,
%

Extreme,
%

cGvHD
              Mobility
              Self-care
              Usual activities
              Pain/discomfort
              Anxiety/depression


51.4
63.8
38.0
21.0
26.8


26.8
30.4
37.2
46.4
42.8


19.6
5.1
16.8
27.5
23.9


2.2
0.7
7.3
5.1
5.8


0.0
0.0
0.7
0.0
0.7

aGvHD
              Mobility
              Self-care
              Usual activities
              Pain/discomfort
              Anxiety/depression


64.1
62.5
39.1
23.4
35.9


18.8
21.9
34.4
50.0
37.5


10.9
10.9
18.8
17.2
21.9


6.3
4.7
6.3
9.4
4.7


0.0
0.0
1.6
0.0
0.7

aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease.
*Adapted from Hammad et al.1 and Lachance et al.2

 

  • The mean number of reported symptoms increased progressively with disease severity. There was no difference on symptom burden between the steroid-responsive group and steroid-refractory group in cGvHD patients. On the other hand, the symptom burden was twice as high in the steroid-refractory group compared with the steroid-responsive group in the aGvHD patients.
  • The mean total symptom score worsened as the severity of GvHD increased; the symptom burden almost doubled for patients with severe disease compared with those with mild GvHD (Figure 3). A total of 21 symptoms were reported, and the ranges for total symptoms were 0−53 in cGvHD and 1−55 in aGvHD.
  • Patients in the highest grade of cGvHD experienced severe symptoms including dry skin, dry mouth, muscle weakness, and shortness of breath. In the aGvHD group, steroid-dependent/refractory patients experienced more severe individual symptoms such as diarrhea, indigestion, weight loss, and decreased libido.

Figure 3. Symptom burden increased with GvHD severity*

aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease.
*Data derived from Hammad et al.1 and Lachance et al.2

  • The number of psychosocial problems also increased with an increase of aGvHD/cGvHD grade, and with the mean number of problems reported. The mean total problem scores also increased with GvHD severity; the burden almost doubled for those with severe disease compared with those with mild GvHD. In aGvHD, patients with inadequate steroid response had the highest mean psychosocial problem score, as well as highest mean number of reported problems (Table 3).

Table 3. Mean number of reported psychosocial problems and mean score of total problems in cGvHD and aGvHD patients*

Severity

Mean number of reported problems

Mean total problem score

cGvHD

aGvHD

cGvHD

aGvHD

Mild
Moderate
Severe
Steroid responsive
Steroid refractory

7.1
8.4
9.4
7.7
7.8

6.8
7.0
9.7
6.7
9.2

8.1
11.2
15.8
9.2
11.1

9.1
14.8
19.6
10.2
18.9

aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease.
*Adapted from Hammad et al.1 and Lachance et al.2
Total number of symptoms: 12
Problem score range 0−29 for cGvHD, and 0−53 for aGvHD.

  • The most severe psychosocial problems reported by cGvHD patients included feeling trapped and activity impairment, whereas fatigue, loss of appetite, and feelings of hopelessness and embarrassment were the most common severe psychosocial problems in the aGvHD cohort.
  • Activity impairment also increased with increased GvHD severity (Figure 4), including the ability to do regular activities such as childcare, shopping, and exercising. Also, activity impairment was higher in patients with inadequate response to steroid therapy compared with the steroid-responsive group.
  • It was observed that hospitalization, healthcare professional (HCP) visits, and testing also increased with both disease severity and inadequate response to steroids, adding further to the disease burden in cGvHD patients.

Figure 4. Activity impairment for cGvHD and aGvHD patients as per severity of the disease and steroid response*

aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease.
*Data derived from Hammad et al.1 and Lachance et al.2

Conclusion

This study captures the real-life experiences of patients with aGvHD and cGvHD. In both disease states, the QOL is impaired for these patients along with an increase in symptom burden and cost of treatment. These results highlight the need for better symptom control with improved first- and second-line treatments.

  1. Hammad A, de Courcy J, Rowaichi L, et al. Patient reported outcomes in acute graft-vs-host disease: Quality of life findings in a real-world study. Oral abstract #OS8-8. 47th Annual Meeting of the EBMT; March 14, 2021; Virtual.
  2. Lachance S, Hamad N, de Courcy J, et al. Impact of chronic GvHD severity and steroid response on the quality of life in patients following allogeneic stem cell transplantation: Findings from a real-world study. Oral abstract #OS8-5. 47th Annual Meeting of the EBMT; March 14, 2021; Virtual.

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