Table 2.
Characteristics of patients included in the phase 1 dose-escalation study per dosage cohort
| 0.09 mg/kg (n = 3) |
0.13 mg/kg (n = 10) |
0.18 mg/kg (n = 6) |
Total (n = 19) |
|
|---|---|---|---|---|
| General characteristics | ||||
| Female sex—no. (%) | 1 (33.3) | 6 (60.0) | 3 (50.0) | 10 (52.6) |
| Male sex—no. (%) | 2 (66.7) | 4 (40.0) | 3 (50.0) | 9 (47.4) |
| Age, years—median (IQR) | 70.0 (69.0–n/a) | 58.5 (46.8–72.3) | 52.5 (32.5–66.8) | 62.0 (46.0–72.0) |
| Weight, kg—median (IQR) | 84.0 (77.0–n/a) | 89.0 (77.3–100.8) | 75.0 (69.3–85.6) | 84.0 (75.0–94.0) |
| Indication | ||||
| First presentation—no. (%) | 1 (33.3) | 8 (80.0) | 6 (100) | 15 (78.9) |
| Recurrent disease—no. (%) | 2 (66.6) | 2 (20.0) | 0 | 4 (21.1) |
| Thyroid surgery | ||||
| None—no. (%) | 2 (66.6) | 2 (20.0) | 0 | 4 (21.1) |
| Hemithyroidectomy—no. (%) | 0 | 1 (10.0) | 1 (16.7) | 2 (10.5) |
| Total thyroidectomy—no. (%) | 1 (33.3) | 7 (70.0) | 5 (83.3) | 13 (68.4) |
| Lymph node dissections | ||||
| CLND | ||||
| None—no. (%) | 1 (33.3) | 1 (10.0) | 0 | 2 (10.5) |
| Unilateral—no. (%) | 1 (33.3) | 1 (10.0) | 3 (50.0) | 5 (26.3) |
| Bilateral—no. (%) | 1 (33.3) | 8 (80.0) | 3 (50.0) | 12 (63.2) |
| Lateral neck dissection | ||||
| None—no. (%) | 2 (66.7) | 4 (40.0) | 4 (66.7) | 10 (52.6) |
| Selective unilateral—no. (%) | 1 (33.3) | 1 (10.0) | 0 | 2 (10.5) |
| Unilateral—no. (%) | 0 | 3 (30.0) | 1 (16.6) | 4 (21.1) |
| Bilateral—no. (%) | 0 | 2 (20.0) | 1 (16.6) | 3 (15.8) |
| T-stage | ||||
| pT1—no. (%) | 1 (33.3) | 3 (30.0) | 2 (33.3) | 6 (31.6) |
| pT2—no. (%) | 0 | 0 | 4 (66.7) | 4 (21.1) |
| pT3—no. (%) | 0 | 3 (30.0) | 0 | 3 (15.8) |
| pT4—no. (%) | 0 | 2 (20.0) | 0 | 2 (10.5) |
| Not applicable – no. (%) | 2 (66.7) | 2 (20.0) | 0 | 4 (21.1) |
| N-stage | ||||
| pN0—no. (%) | 1 (33.3) | 1 (10.0) | 2 (33.3) | 4 (21.1) |
| pN1a—no. (%) | 1 (33.3) | 3 (30.0) | 2 (33.3) | 6 (31.6) |
| pN1b—no. (%) | 1 (33.3) | 6 (60.0) | 2 (33.3) | 9 (47.4) |
| Grossed lymph nodes | ||||
| PTC nodal metastases—no. (%) | 3 (21.4) | 41 (14.2) | 32 (28.3) | 76 (18.3) |
| Normal lymph nodes—no. (%) | 11 (78.6) | 248 (85.8) | 81 (71.7) | 340 (81.7) |
Staging was performed according to the 8th edition of the American Joint Committee on Cancer staging system. Abbreviations: CLND, central compartment lymph node dissection; IQR, interquartile range; N-stage, nodal stage; PTC, papillary thyroid cancer; T-stage, tumor stage