Supplementary table 1 EORTC QLQ-C30 global quality of life and functional mean scores at all time points by treatment group and changes between baseline and assessment point.
Global health
Physical
Role
Emotional
Cognitive
Social
Global health
Physical
Role
Emotional
Cognitive
Social
Treatment
Group
CRT
CRT + C
Baseline
Mean 95% CI
67.8 (63.3 72.3)
83.2 (79.5 87.0)
77.9 (72.5 83.2)
76.1 (71.9 80.4)
85.7 (81.9 89.5)
76.9 (71.8 81.9)
68.3 (64.9 71.8)
85.7 (82.4 88.9)
83.5 (79.4 87.6)
77.1 (73.3 81.0)
85.5 (82.6 88.4)
82.1 (78.1 86.1)
7 weeks
Mean 95% CI CH
62.2 (58.4 66.1) -5.6
76.0 (71.8 80.3) -7.2
68.4 (62.5 74.4) -9.5
81.1 (76.8 85.4) 5.0
83.0 (79.1 87.0) -2.7
73.4 (68.4 78.5) -3.5
58.7 (54.3 63.1) -9.6
73.2 (68.7 77.7) -12.5
63.4 (56.6 70.3) -20.1
72.0 (67.1 77.0) -5.1
74.7 (69.9 79.5) -10.8
67.7 (61.7 73.8) -14.4
CRT = chemoradiotherapy
CRT + C = chemoradiotherapy plus cetuximab
CI = confidence intervals
CH =mean difference between time point and baseline
High score is equivalent to a better quality of life
13 weeks
Mean 95% CI CH
45.3 (40.2 50.4) – 22.5
59.3 (54.0 64.7) -23.9
45.3 (38.5 52.1) -32.6
74.5 (70.0 79.1) -1.6
74.8 (70.0 79.7) -10.9
54.4 (47.7 61.2) -22.5
45.2 (39.8 50.7) -23.1
58.1 (52.3 63.9) -27.6
42.8 (35.6 50.1) -40.7
69.2 (63.4 75.0) -7.9
69.8 (64.0 75.5) -15.7
57.8 (50.4 75.5) -24.3
26 weeks
Mean 95% CI CH
65.4 (60.4 70.5) -2.4
74.7 (69.8 79.5) -8.5
67.8 (60.9 74.6) -10.1
76.3 (70.9 81.1) 0.2
79.8 (74.3 85.3) 5.9
71.9 (65.3 78.5) -5.0
68.1 (63.4 72.8) -0.2
76.3 (71.4 81.2) -9.4
72.4 (65.8 78.9) -11.1
77.4 (72.2 82.6) 0.3
79.5 (74.5 84.5) -6.0
80.3 (74.6 86.0) -1.8
52 weeks
Mean 95% CI CH
71.5 (66.4 76.6) 3.7
78.6 (73.9 83.3) -4.6
75.9 (69.6 82.2) -2.0
80.6 (74.8 86.4) 4.5
84.7 (80.1 89.3) -1.0
78.2 (71.6 84.7) 1.3
72.6 (67.7 77.6) 4.3
76.9 (71.2 82.5) -8.8
77.2 (69.8 84.6) -6.3
77.9 (72.0 83.8) 0.8
82.3 (77.5 87.1) -3.2
81.0 (73.9 88.1) -1.1
104 weeks
Mean 95% CI CH
68.5 (61.4 75.7) 0.7
74.8 (68.3 81.3) -8.4
72.0 (62.8 81.2) -5.9
80.8 (74.0 87.7) 4.7
82.0 (76.0 87.9) -3.7
79.9 (71.6 88.3) 3.0
71.7 (63.4 79.9) 3.4
76.4 (67.4 85.4) -9.3
77.9 (66.6 89.3) -5.6
80.7 (71.1 87.8) 3.6
81.0 (71.8 90.1) -4.5
85.7 (75.7 95.7) 3.6
Supplementary table 2a Proportion of ‘severe’ symptoms for EORTC QLQ-C30 symptoms scales and items at all time points by treatment group and changes between baseline and assessment point.
Fatigue
Nausea/vomiting
Pain
Dyspnoea
Insomnia
Appetite loss
Constipation
Diarrhoea
Financial difficulty
Fatigue
Nausea/vomiting
Treatment
Group
CRT
CRT + C
Baseline
% (95% CI)
18.3 (12.4 26.2)
5.7 (2.8 11.4)
10.6 (6.3 17.2)
7.4 (3.9 13.4)
14.8 (9.5 22.1)
22.5 (15.9 30.8)
12.3 (7.6 19.3)
4.9 (2.3 10.3)
16.4 (10.9 24.0)
24.0 (17.2 32.3)
4.8 (2.2 10.2)
7 weeks
% (95% CI) CH
20.2 (13.5 29.2) 3.9
5.8 (2.7 12.1) 0.1
1.9 (0.5 6.8) -8.7
9.8 (5.4 17.1) 2.4
22.5 (15.5 31.6) 7.7
22.5 (15.5 31.6) 0.0
8.0 (4.1 15.0) -4.3
5.0 (2.1 11.1) 0.1
15.8 (10.0 24.2) -0.6
18.5 (11.9 27.6) -5.5
5.4 (2.3 12.1) 0.6
Pain
Dyspnoea
Insomnia
Appetite loss
Constipation
Diarrhoea
Financial difficulty
8.1 (4.4 14.2)
13.0 (8.2 20.1)
16.9 (11.4 24.5)
26.6 (19.6 35.0)
15.3 (10.0 22.7)
2.4 (0.8 06.9)
12.1 (7.5 19.0)
6.4 (3.0 13.2) -1.7
12.0 (6.8 20.2) -1.0
28.0 (19.9 37.8) 11.1
37.4 (28.1 47.6) 10.8
24.7 (17.1 34.4) 9.4
5.4 (2.3 12.1) 3.0
15.1 (9.2 23.7) 3.0
High scores represent a higher proportion of patients with severe symptoms
CI = Confidence interval
CH = difference between baseline score and the score at the defined time point,
CRT = Chemoradiotherapy
CRT + C = Chemoradiotherapy plus cetuximab
13 weeks
% (95% CI) CH
45.9 (36.4 55.8) 27.6
22.2 (15.2 31.4) 16.5
25.0 (17.5 34.3) 14.4
23.2 (16.0 32.5) 15.8
23.7 (16.4 33.1) 8.9
59.4 (49.4 68.7) 36.9
21.2 (14.3 30.3) 8.9
7.2 (3.5 14.2) 2.3
24.7 (17.2 34.2) 8.3
38.1 (28.4 48.8) 14.1
16.3 (10.0 25.5) 11.5
20.9 (13.7 30.7) 12.8
31.8 (22.8 42.3) 18.8
31.3 (22.4, 41.9) 14.4
58.1 (47.6 68.0) 31.5
26.2 (18.0 36.5) 10.9
8.7 (4.3 17.0) 6.3
12.3 (6.8 21.3) 0.2
26 weeks
% (95% CI) CH
28.4 (20.0 38.6) 9.6
7.9 (3.9 15.4) 2.2
15.6 (9.5 24.4) 5.0
21.3 (14.1 31.0) 13.9
18.2 (11.5 27.5) 3.4
14.8 (8.8 23.7) -7.7
8.9 (4.6 16.6) -3.4
2.2 (0.6 7.8) -2.7
14.6 (8.7 23.4) 1.8
22.4 (14.8 32.3) 11.9
2.4 (0.6 8.2) -2.4
10.6 (5.7 18.9) 2.5
7.1 (3.3 14.7) -5.9
15.3 (9.2 24.4) -1.6
15.5 (9.3 24.7) -11.1
6.0 (2.6 13.3) -9.3
1.2 (0.2 6.5) -1.2
14.5 (8.5 23.6) 2.4
52 weeks
% (95% CI) CH
17.6 (10.6 27.8) 2.8
4.1 (1.4 11.3) -1.6
12.2 (6.5 21.5) 1.6
13.5 (7.5 23.1) 6.1
16.2 (9.7 26.2) 1.4
13.5 (7.5 23.1) 9.0
8.3 (3.9 17.0) -4.0
1.4 (0.2 7.4) -3.5
6.8 (3.0 15.1) -9.6
20.0 (12.1 31.3) 9.5
1.5 (0.3 8.2) -3.3
9.2 (4.3 18.7) 1.1
15.4 (8.6 26.1) 2.4
23.1 (14.5 34.6) 6.2
9.4 (4.4 19.0) 17.2
7.8 (3.4 17.0) -7.5
1.6 (0.3 8.3) -0.8
9.4 (4.4 19.0) -2.7
104 weeks
% (95% CI) CH
24.0 (14.3 37.4) 9.2
2.0 (0.4 10.5) -3.7
8.0 (3.2 18.8) -2.6
12.2 (5.7 24.2) 4.8
16.0 (8.3 28.5) -1.2
10.0 (4.3 21.4) -12.5
10.2 (4.4 21.8) -2.1
4.1 (1.1 13.7) -0.8
10.4 (4.5 22.2) -6.0
17.6 (8.3 33.5) 7.1
2.9 (0.5 14.9) -1.9
11.4 (4.5 26.0) 3.3
17.6 (8.3 33.5) 4.6
17.6 (8.3 33.5) 0.7
8.8 (3.0 23.0) -17.8
0.0 (0.0 9.9) -15.3
0.0 (0.0 9.9) -2.4
0.0 (0.0 10.2) -12.1
Supplementary table 2b Proportion of ‘severe’ symptoms for EORTC QLQ-OES18 symptoms scales and items at all time points by treatment group and changes between baseline and assessment point.
Dysphagia
Eating
Reflux
Pain
Trouble saliva
Choking
Dry mouth
Trouble with taste
Trouble coughing
Trouble talking
Dysphagia
Eating
Reflux
Pain
Trouble saliva
Choking
Dry mouth
Trouble with taste
Trouble coughing
Trouble talking
Treatment
Group
CRT
CRT + C
Baseline
% (95% CI)
18.3 (12.4,26.2)
36.4 (28.3 45.4)
9.2 (5.2 15.7)
10.0 (5.8 16.7)
15.0 (9.7 22.5)
12.1 (7.3 19.2)
17.5 (11.7 25.3)
11.0 (6.6 17.9)
11.7 (7.1 18.6)
3.3 (1.3 8.3)
24.0 (17.2,32.3)
30.8 (23.3 39.6)
6.6 (3.4 12.5)
10.7 (6.4 17.5)
15.7 (10.3 23.2)
12.4 (7.7 19.4)
15.8 (10.4 23.4)
10.7 (6.4 17.5)
9.1 (5.2 15.5)
4.1 (1.8 09.3)
7 weeks
% (95% CI) CH
20.2 (13.5, 29.2) 1.9
20.2 (13.5 29.2 -16.2
9.9 (5.5 17.3) 0.7
6.9 (3.4 13.6) -3.1
11.9 (6.9 19.6) -3.1
9.2 (4.9 16.5) -2.9
21.0 (14.2 30.0) 3.5
24.2 (16.9 33.5) 13.2
7.0 (3.4 13.7) -4.7
5.9 (2.8 12.4) 2.6
18.5 (11.9, 27.6) 5.5
29.3 (21.0 39.3) -1.5
7.6 (3.7 14.9) 1.0
6.5 (3.0 13.5) -4.2
7.8 (3.8 15.2) -7.9
9.9 (5.3 17.7) -2.5
38.0 (28.8 48.3) 22.2
39.1 (29.8 49.3) 28.4
8.7 (4.5 16.2) -0.4
8.7 (4.5 16.2) 4.6
13 weeks
% (95% CI) CH
45.9 (36.4,55.8) 27.6
45.3 (35.6 55.3) 8.9
11.3 (6.5 19.2) 2.1
20.8 (13.9 30.0) 10.8
19.4 (12.8 28.3) 4.4
8.2( 4.2 15.4) -3.9
25.5 (17.9 35.0) 5.0
46.3 (36.6 56.3) 35.3
24.5 (17.0 33.9) 12.8
5.2 (2.2 11.5) 1.9
38.1 (28.4,48.8) 24.1
53.0 (42.4 63.4) 22.2
8.3 (4.1 16.2) 1.7
16.7 (10.2 26.1) 6.0
16.7 (10.2 26.1) 1.0
6.2 (2.7 13.6) -6.2
38.1 (28.4 48.8) 22.3
48.2 (37.8 58.8) 37.5
34.1( 24.8 44.9) 25.0
8.4 ( 4.1 16.4) 4.3
26 weeks
% (95% CI) CH
11.1 (6.1 19.3) -12.9
17.8 (11.2 26.9 -18.6
4.4 (1.7 10.9) -4.8
5.6 (2.4 12.4) -4.4
10.0 (5.4 17.9) -5.0
7.8 (3.8 15.2) -4.3
15.6 (9.5 24.4) -1.9
19.1 (12.3 28.5) 8.1
15.6 (9.5 24.4) 3.9
4.4 (1.7 10.9) 1.1
9.8(5.0 18.1) -8.5
13.4 (7.7 22.4) -17.4
6.0 (2.6 13.3) -0.6
8.4 (4.1 16.4)-2.3
6.0 (2.6 13.3) -9.7
4.8 (1.9 11.7) -7.6
10.8 (5.8 19.3) -5.0
12.3 (6.8 21.3) 1.6
12.0 (6.7 20.8) 3.1
2.4 (0.7 8.4) -1.7
52 weeks
% (95% CI) CH
15.7 (9.0 26.0)-8.3
15.1(8.6 25.3)-21.3
4.1 (1.4 11.5) -5.1
6.8 (3.0 15.1) -3.2
9.7 (4.8 18.7) -5.3
9.7 (4.8 18.7)-2.4
17.8 (10.7 28.1) 0.3
6.9 (3.0 15.2) -4.1
13.7 (7.6 23.4) 2.0
4.2 (1.4 11.5) 1.1
9.5 (4.4 19.3) -8.8
10.8 (5.3 20.6) -20.0
7.7 (3.3 16.8) 1.1
4.6 (1.6 12.7) -6.1
9.4 (4.4 19.0) -6.3
10.9 (5.4 20.9) -1.5
13.8 (7.5 24.3) -2.0
9.2 (4.3 18.7) -1.5
21.5 (13.3 33.0) 12.4
9.2 (4.3 18.7) 5.1
104 weeks
% (95% CI) CH
8.0 (1.1 13.5) -16.0
10.0 (4.3 21.4) -26.4
8.0 (3.2 18.8) -1.2
2.0 (0.4 10.5) -8.0
4.0 (1.1 13.5) -11.0
4.0 (1.1 13.5) -8.1
14.0 (7.0 26.2) -3.5
8.0 (3.2 18.8) -3.0
14.0 (7.0 26.2) 2.3
6.0 (2.1 16.2) 2.7
11.4 (4.5 26.0) -3.8
14.3 (6.3 29.4) -16.5
8.6 (3.0 22.4) 2.0
8.6 (3.0 22.4) -2.1
11.8 (4.7 26.6) -3.9
11.4 (4.5 26.0) -1.0
14.3 (6.3 29.4) -1.5
14.3 (6.3 29.4) 3.6
14.3 (6.3 29.4) 5.2
17.1 (8.1 32.7) 13.0
High scores represent a higher proportion of patients with severe symptoms
CI = Confidence interval
CH = difference between baseline score and the score at the defined time point,
CRT = Chemoradiotherapy
CRT + C = Chemoradiotherapy plus cetuximab
DLQI overall score$
DLQI Scales
Symptoms#
Daily activities#
Leisure#
Work & school@
Personal relationships#
Treatment@
DLQI overall score$
DLQI Scales
Symptoms#
Daily activities#
Leisure#
Work & school@
Personal relationships#
Treatment@
Supplementary table 3 Mean Dermatology Life Quality Index (DLQI) scores at all time points by treatment group and changes in scores between baseline and assessment point.
Treatment
Group
CRT
Baseline
Mean 95% CI
1.92 (1.76 2.08)
0.17 (0.06 0.27)
0.01 (0.00 0.03)
0.02 (0.00 0.05)
1.63 (1.54 1.72)
0.04 (0.01 0.08)
0.01 (0.00 0.03)
7 weeks 13 weeks 26 weeks 52 weeks
Mean 95% CI CH Mean 95% CI CH Mean 95% CI CH Mean 95% CI CH
2.62 (2.11 3.13) 0.70 2.93 (2.32 3.54) 1.01 2.41 (2.06 2.75) 0.49 1.94 (1.72 2.16) 0.02
0.58 (0.37 0.79) 0.41
0.21 (0.06 0.36) 0.20
0.12 (0.00 0.25) 0.10
1.61 (1.51 1.71) -0.02
0.06 (0.00 0.13) 0.02
0.09 (0.00 0.18) 0.08
0.82 (0.59 1.04) 0.65
0.25 (0.11 0.39) 0.24
0.21 (0.03 0.38) 0.19
1.46 (1.35 1.56) -0.17
0.08 (0.00 0.17) 0.04
0.14 (0.06 0.23) 0.13
0.55 (0.34 0.75) 0.38
0.08 (0.01 0.15) 0.07
0.05 (0.00 0.10) 0.03
1.62 (1.51 1.72) -0.01
0.06 (0.00 0.13) 0.02
0.05 (0.00 0.10) 0.04
0.36 (0.14 0.58) 0.19
0.07 (0.00 0.17) 0.06
0.00 (0.00 0.00) -0.02
1.57 (1.45 1.69) -0.06
0.01 (0.00 0.04) 0.03
0.00 (0.00 0.00) 0.01
104 weeks
Mean 95% CI CH
2.93 (1.54 4.32) 1.01
0.65 (0.26 1.03 ) -0.48
0.25 (0.00 0.53) 0.24
0.15 (0.00 0.41) 0.13
1.64 (1.48 1.79) 0.01
0.13 (0.00 0.38) 0.09
0.10 (0.00 0.24) 0.09
CRT + C
2.12 (1.83 2.41)
0.29 (0.17 0.41)
0.08 (0.00 0.15)
0.01 (0.00 0.03)
1.63 (1.53 1.72)
0.05 (0.00 0.10)
0.04 (0.00 0.10)
4.59 (3.86 5.33) 2.47
1.69 (1.40 1.98) 1.40
0.62 (0.36 0.87) 0.54
0.48 (0.26 0.71) 0.47
1.59 (1.48 1.70) -0.04
0.24 (0.10 0.39) 0.19
0.24 (0.13 0.36) 0.20
5.70 (4.60 6.81) 3.58
1.99 (1.63 2.35) 1.7
0.89 (0.57 1.20) 0.81
0.55 (0.28 0.81) 0.54
1.54 (1.40 1.67) -0.09
0.29 (0.09 0.48) 0.24
0.43 (0.27 0.60) 0.39
2.51 (2.07 2.94) 0.39
0.49 (0.27 0.70) -0.2
0.14 (0.04 0.25) 0.06
0.10 (0.00 0.21) 0.09
1.65 (1.54 1.75) -0.02
0.02 (0.00 0.06) -0.03
0.07 (0.01 0.14) 0.03
2.72 (2.20 3.23) 0.60
0.66 (0.35 0.98) 0.37
0.18 (0.02 0.34) 0.10
0.08 (0.00 0.18) -0.07
1.62 (1.49 1.74) -0.01
0.05 (0.01 0.11) 0.00
0.10 (0.00 0.22) 0.06
2.63 (1.85 3.42) 0.51
0.58 (0.22 0.93) 0.29
0.20 (0.00 0.42) 0.12
0.11 (0.00 0.30) -0.10
1.54 (1.37 1.72) 0.09
0.00 (0.00 0.00) 0.05
0.09 (0.00 0.23) -0.05
High scores represent greater problems.
$ = worse (maximum) score 30,
# = worse (maximum) score 6,
@ = worse (maximum) score 3
CI = Confidence interval
CRT = Chemoradiotherapy
CRT + C = Chemoradiotherapy plus cetuximab
CH Change from baseline