Table 2.
Thyroid Function During Treatment
| Sorafenib | Sunitinib | P Value | |
|---|---|---|---|
| Patients Without a History of Hypothyroidism | |||
| No. (%) patients developing hypothyroidism | 6/22 (27) | 15/34 (44) | .16 |
| Hazard ratio for hypothyroidism | 0.38 (sorafenib/sunitinib) (95% CI, 0.14–0.97 | .04 | |
| Patients with hypothyroidism, median peak TSH level (range), mIU/L | 12.3 (5.5–28.13) | 34.8 (5.87–162.64) | .10 |
| No. (%) patients required thyroid replacement | 3/22 (13.6) | 12/34 (35.3) | .07 |
| Median thyroid replacement dose (range), µg | 50 (25–150) | 75 (50–175) | .56 |
| Survival function with estimated median time to development of hypothyroidism, mo | 20 | 11 | .038a |
| Patients With a History of Hypothyroidism | |||
| No. (%) patients with a history of hypothyroidism develop thyroid dysfunction | 2/6 (33) | 8/11 (73) | .16 |
| Patients with hypothyroidism, median peak TSH (range), mIU/L | 25.8 (7.9–43.8) | 28.9 (7.5–72.43) | .99 |
| Survival function with estimated median time to development, mo | 8 | 6 | .3a |
| Median thyroid replacement dose increase required (range), µg | 43.8 (50–37.5) | 37.5 (25–50) | .69 |
| All Patients | |||
| Average baseline TSH level | 2.10 | 2.12 | .97 |
| Average peak TSH level | 6.23 | 18.12 | .04 |
| No. (%) patients with peak TSH between 5 and 10 mIU/L | 4 (14.3) | 4 (8.9) | .52 |
| No. (%) patients with peak TSH level >10 mIU/L | 4 (14.3) | 19 (42.2) | .06 |
| No. (%) patients with hypothyroidism or worsening thyroid dysfunction | 8/28 (28.6) | 23/45 (51.1) | .058 |
| Survival function with estimated median time to development, mo | 20 | 10 | .01a |
| Hazard ratio for hypothyroidism | 0.38 (sorafenib as compared to sunitinib) (95% CI, 0.17–0.86) | .03 | |
Abbreviation: TSH = thyroid-stimulating hormone.
a
Log-rank test for the difference in survival function between the 2 drugs.