Table 2.
Patient demographics and baseline disease characteristics for phase II patients with osteosarcoma
| Parameter | Phase II expansion cohorta Lenvatinib 14 mg/m2 (N = 31) |
|---|---|
| Age, years, median (range) | 15 (9-22) |
| Sex, male, n (%) | 13 (41.9) |
| Lansky play score/Karnofsky performance score, n (%)b | |
| 60 | 1 (3.2) |
| 70 | 3 (9.7) |
| 80 | 5 (16.1) |
| 90 | 15 (32.3) |
| 100 | 7 (22.6) |
| Site of lesion, n (%) | |
| Bone only | 1 (3.2) |
| Lung only | 15 (48.4) |
| Lung and bone | 14 (45.2) |
| Prior radiotherapy, n (%)c | 10 (32.3) |
| For primary tumor | 5 (16.1) |
| For metastases | 5 (16.1) |
| Procedures before study entry, n (%) | 29 (93.5) |
| Resection | 28 (90.3) |
| Ablation | 3 (9.7) |
| Biopsy | 9 (29.0) |
| Number of prior systemic anticancer therapies, n (%) | |
| 1 | 7 (22.6) |
| 2 | 15 (48.4) |
| ≥3 | 9 (29.0) |
| Median Range |
2 1-6 |
| Previous systemic anticancer agents used by >20% of patients, n (%) | |
| Cisplatin | 31 (100.0) |
| Doxorubicin | 30 (96.8) |
| Methotrexate | 30 (96.8) |
| Ifosfamide | 27 (87.1) |
| Etoposide | 19 (61.3) |
| Docetaxel | 10 (32.3) |
| Gemcitabine | 11 (35.5) |
| Mifamurtide | 7 (22.6) |
| Previous anti-VEGF therapyd, n (%) | 4 (12.9) |
Clinical cut-off date: 2 August 2018.
Percentages based on total number of patents within relevant treatment group in the full analysis set.
VEGF, vascular endothelial growth factor.
a
Due to dose capping, eight patients received a lower dose than the planned dose of lenvatinib 14 mg/m2.
b
Lansky play scores for patients ≥1 to <16 years of age, Karnofsky performance scores for patients ≥16 years of age.
c
Patients received radiotherapy to lungs, abdomen/pelvis, extremities, and skull/spine/thorax/pelvis.
d
Bevacizumab (n = 2), pazopanib (n = 2).