Table 1.
Patient characteristics
| 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 | |
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
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