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Table 1 Patient characteristics

From: Nivolumab-induced thyroid dysfunction lacking antithyroid antibody is frequently evoked in Japanese patients with malignant melanoma

 

Total

n = 24

Thyroid irAE n = 7

No Thyroid irAE

n = 17

P Value

Sex

Male

11

2

9

0.39

Female

13

5

8

Age

Median

61.5 ± 17.4

57.0 ± 19.0

63.0 ± 17.1

0.57

Range

(50–75)

(37–76)

(51–75)

 

≤40 ≤ 40

3

2

1

 

> 40

21

5

16

 

Tumor staging

II

1

0

1

0.91

III

2

1

1

IV

21

6

15

Metastasis stage

M1a

2

0

2

0.7

M1b

9

3

6

M1c

10

3

7

Response to nivolumab

PR

2

1

1

0.68

SD

10

4

6

PD

6

2

4

NA

6

0

6

History of previous thyroid disorder

YES

2

1

1

0.51

NO

22

6

16

Administration durationb, week

27.5 ± 25.4

54.4 ± 24.1

16.4 ± 17.9

0.0045

Administration duration including rest periodb, week

32.1 ± 31.4

59.9 ± 26.8

20.6 ± 26.2

0.0075

Number of administrationb

9.5 ± 7.2

16.7 ± 5.4

6.6 ± 5.7

0.0016

TSHb, μU/mL

1.94 ± 1.30

2.22 ± 1.21

1.82 ± 1.35

0.51

fT4b, ng/dL

1.25 ± 0.19

1.19 ± 0.13

1.27 ± 0.21

0.3

fT3b, pg/mL, n

2.93 ± 0.48, 11

3.20 ± 0.23, 3

2.80 ± 0.51, 8

0.063

Elevated anti-Tg Ab, case/total (%)

2/17 (12%)

1/4 (25%)

1/13 (8%)

0.47

Elevated anti-TPO Ab, case/total (%)

0/17 (0%)

0/4 (0%)

0/13 (0%)

1.0

Elevated TRAb, case/total

1/4

0/0

1/4

NA

  1. Reference laboratory values are as follows: TSH, 0.27–4.20 μU/L; fT4, 1.0–1.8 ng/dL; fT3, 2.2–4.4 pg/mL; anti-TPO Ab, < 30 IU/L; anti-Tg Ab, < 30 IU/L; TRAb, < 2 IU/L.aValues are presented as median ± standard deviation (SD). bValues are presented as mean ± SD and represent administration duration, including rest period; number of administrations; and TSH, fT4, and fT3 levels. Significant differences are indicated in bold font
  2. Abbreviations: irAEs, immune-related adverse events; fT4 free thyroxine, fT3 free triiodothyronine, TSH thyroid-stimulating hormone, anti-TPO Ab antithyroid peroxidase antibody, anti-Tg Ab antithyroglobulin antibody, TRAb TSH receptor antibody, PR partial response, SD stable disease, PD progressive disease; NA, not applicable