Table 1.
Demographic and clinical characteristics (intention-to-treat population)
| Sorafenib (n=207) |
Placebo (n=210) |
|
|---|---|---|
| Female, n (%) | 103 (49·8) | 115 (54·8) |
| Age (years) | ||
| Median (range) | 63 (24–82) | 63 (30–87) |
| ≥60 years, n (%) | 127 (61·4) | 129 (61·4) |
| Ethnicity, n (%) | ||
| White | 123 (59·4) | 128 (61·0) |
| Asian | 47 (22·7) | 52 (24·8) |
| Black | 6 (2·9) | 5 (2·4) |
| Hispanic | 2 (1·0) | 2 (1·0) |
| Not reported | 29 (14·0) | 23 (11·0) |
| Region, n (%) | ||
| Europe | 124 (59·9) | 125 (59·5) |
| North America | 36 (17·4) | 36 (17·1) |
| Asia | 47 (22·7) | 49 (23·3) |
| Metastases, n (%) | ||
| Locally advanced | 7 (3·4) | 8 (3·8) |
| Distant | 200 (96·6) | 202 (96·2) |
| Time from diagnosis, months | ||
| Median (range) | 66·2 (3·9–362·4) | 66·9 (6·6–401·8) |
| ECOG performance status, n (%) | ||
| 0 | 130 (62·8) | 129 (61·4) |
| 1 | 69 (33·3) | 74 (35·2) |
| 2 | 7 (3·4) | 6 (2·9) |
| Histology by central review,a n (%) | ||
| Papillary | 118 (57·0) | 119 (56·7) |
| Follicular | 50 (24·2) | 56 (26·7) |
| Poorly differentiated | 24 (11·6) | 16 (7·6) |
| Well differentiated | 2 (1·0) | 1 (0·5) |
| Nonthyroid | 0 | 1 (0·5) |
| Medullary | 0 | 1 (0·5) |
| Oncocytic carcinoma | 2 (1·0) | 0 |
| Carcinoma, not otherwise specified | 0 | 3 (1·4) |
| Missing/nondiagnostic | 13 (6·3) | 14 (6·7) |
| Most common metastatic lesion sites, n (%) | ||
| Lung | 178 (86·0) | 181 (86·2) |
| Lymph nodes | 113 (54·6) | 101 (48·1) |
| Bone | 57 (27·5) | 56 (26·7) |
| Pleura | 40 (19·3) | 24 (11·4) |
| Head and neck | 33 (15·9) | 34 (16·2) |
| Liver | 28 (13·5) | 30 (14·3) |
| Baseline FDG uptake | ||
| Positive | 161 (77·8) | 159 (75·7) |
| Negative | 14 (6·8) | 15 (7·1) |
| Missing | 32 (15·5) | 36 (17·1) |
| Prior therapy | ||
| Median cumulative radioiodine activity, mCi | 400 | 376 |
| Any prior systemic anticancer therapy, n (%) | 7 (3·4) | 6 (2·9) |
| Any prior radiotherapy, n (%) | 83 (40·1) | 91 (43·3) |
FDG, 2-[18F] fluoro-2-deoxy-D-glucose; ECOG, Eastern Cooperative Oncology Group
a
All patients had differentiated thyroid cancer as per investigator assessment.