Table 2 Linear mixed-effects model for repeated measures (MMRM) of the domains and functional scales of health-related quality of life questionnaires in patients with advanced urothelial carcinoma treated with immune checkpoint inhibitors.

From: Longitudinal assessment of health-related quality of life in Japanese patients with advanced urothelial carcinoma receiving immune check point inhibitors

Questionnaire

Domains and functions

(abbreviation)

Second-line or later pembrolizumab (n = 19)

Maintenance avelumab (n = 13)

Adjuvant nivolumab (n = 10)

Baseline

MID#

Estimated mean change per a month (standard error)

P value##

Baseline

MID#

Estimated mean change per a month (standard error)

P value##

Baseline

MID#

Estimated mean change per a month (standard error)

P value##

EORTC QLQ-C30

             
 

Global health status/QoL

54 ± 21

± 10

1.31 (0.56)

0.022

62 ± 26

± 10

-0.63 (0.94)

0.51

63 ± 19

± 10

0.27 (0.60)

0.66

 

Physical functioning (PF)

72 ± 24

± 10

1.02 (0.41)

0.015

77 ± 18

± 10

0.20 (0.59)

0.73

74 ± 20

± 10

0.50 (0.37)

0.18

 

Role functioning (RF)

72 ± 24

± 10

1.18 (0.43)

0.007

83 ± 16

± 10

-0.15 (0.48)

0.76

83 ± 18

± 10

0.12 (0.31)

0.69

 

Emotional functioning (EF)

75 ± 24

± 10

0.81 (0.43)

0.06

81 ± 20

± 10

-0.34 (0.37)

0.36

79 ± 23

± 10

0.57 (0.47)

0.23

 

Cognitive functioning (CF)

72 ± 24

± 10

0.25 (0.44)

0.56

72 ± 18

± 10

0.34 (0.57)

0.56

77 ± 24

± 10

0.44 (0.58)

0.46

 

Social functioning (SF)

82 ± 21

± 10

-0.62 (0.47)

0.19

85 ± 20

± 10

-0.85 (0.62)

0.18

78 ± 22

± 10

0.42 (0.26)

0.11

FACT-G

             
 

Physical well-being (PWB)

22 ± 5.5

± 2.8

0.28 (0.10)

0.005

22 ± 4.3

± 2.2

0.09 (0.11)

0.42

21 ± 4.7

± 2.4

0.29 (0.11)

0.012

 

Social/family well-being (SWB)

14 ± 6.7

± 3.4

-0.27 (0.11)

0.017

12 ± 6.3

± 3.2

-0.43 (0.22)

0.056

13 ± 4.9

± 2.5

0.26 (0.18)

0.15

 

Emotional well-being (EWB)

16 ± 4.5

± 2.3

0.14 (0.09)

0.120

17 ± 4.1

± 2.2

0.35 (0.15)

0.019

18 ± 4.7

± 2.4

0.26 (0.14)

0.064

 

Functional well-being (FWB)

16 ± 5.5

± 2.8

0.39 (0.13)

0.005

14 ± 8.8

± 4.4

-0.82 (0.32)

0.014

16 ± 6.9

± 3.5

-0.19 (0.19)

0.32

 

FACT-G total score

68 ± 13

± 6.5

0.56 (0.22)

0.011

64 ± 17

± 8.5

-0.94 (0.44)

0.14

68 ± 16

± 8.0

0.53 (0.35)

0.14

SF-8

             
 

Physical function (PF)

41 ± 12

± 6.0

0.52 (0.20)

0.011

45 ± 7.6

± 3.8

-0.19 (0.28)

0.51

42 ± 12

± 6.0

-0.16 (0.20)

0.43

 

Role physical (RP)

41 ± 11

0.59 (0.21)

± 5.5

 

0.007

46 ± 8.5

± 4.3

-0.32 (0.26)

0.22

43 ± 13

± 6.5

0.09 (0.17)

0.58

 

Bodily pain (BP)

48 ± 10

± 5.0

0.71 (0.23)

0.002

56 ± 7.6

± 3.8

-0.59 (0.27)

0.34

50 ± 7.5

± 3.8

-0.02 (0.29)

0.95

 

General health (GH)

45 ± 8.0

± 4.0

0.68 (0.19)

< 0.001

51 ± 8.0

± 4.0

-0.24 (0.27)

0.39

48 ± 6.9

± 3.5

0.03 (0.15)

0.86

 

Vitality (VT)

47 ± 7.2

± 3.6

0.55 (0.17)

0.002

51 ± 8.3

± 4.2

-0.48 (0.25)

0.061

48 ± 7.8

± 3.9

0.37 (0.16)

0.035

 

Social functioning (SF)

44 ± 11

± 5.5

-0.62 (0.47)

0.16

50 ± 9.1

± 4.6

-0.43 (0.27)

0.077

44 ± 13

± 6.5

-0.10 (0.21)

0.63

 

Role emotional (RE)

43 ± 9.2

± 4.6

0.44 (0.17)

0.009

49 ± 7.7

± 3.9

-0.51 (0.28)

0.28

45 ± 8.7

± 4.4

0.01 (0.19)

0.93

 

Mental health (MH)

46 ± 8.0

± 4.0

0.50 (0.15)

0.001

52 ± 6.9

± 3.5

-0.40 (0.22)

0.078

47 ± 9.4

± 4.7

0.10 (0.18)

0.60

 

Physical component summary (PCS)

42 ± 10

± 5.0

0.64 (0.21)

0.003

47 ± 7.5

± 3.8

-0.34 (0.25)

0.18

44 ± 10

± 5.0

-0.04 (0.17)

0.82

 

Mental component summary (MCS)

46 ± 8.2

± 4.1

0.32 (0.16)

0.055

50 ± 6.4

± 3.2

-0.33 (0.25)

0.18

46 ± 7.8

± 3.9

0.12 (0.18)

0.51

  1. Data are expressed by means ± standard deviations. A higher score indicates a higher level of quality of life.
  2. EORTC QLQ-C30 the European organization for research and treatment of cancer quality of life questionnaire - core 30, FACT-G functional assessment of cancer therapy-general, SF-8 8-Item short form survey, MID minimally important difference.
  3. #Minimally important difference (MID) of each scale are defined ± 10 points in the EORTC QLQ-C30, and half a standard deviation of the baseline score in the FACT-G and SF-8 prior to the end of treatment.
  4. ##The linear mixed-effects model for repeated measures was used to detect statistically significant changes during the treatment. groups.