Table 1.
Baseline characteristics | Control (n = 26) |
Mifamurtide (n = 23) |
p |
---|---|---|---|
Gender M/F (%) | 15 (58%)/11 (42%) | 15 (65%)/8 (35%) | 0.770 |
Age mean ± SD | 14.1 ± 4.4 | 13.8 ± 4.3 | 0.824 |
Histology (%) | ~1.0† | ||
Conventional osteoblastic | 17 (65%) | 15 (65%) | |
High-grade other | 7 (27%) | 7 (31%) | |
Periosteal | 2 (8%) | 1 (4%) | |
Site | 0.653† | ||
Femur | 11 | 6 | |
Tibia or fibula | 5 | 8 | |
Lower limb – other | 2 | 0 | |
Humerus | 2 | 5 | |
Upper limb – other | 3 | 2 | |
Skull/axial | 3 | 2 | |
Lung unspecific nodules (%) | 7 (27%) | 11 (48%) | 0.151 |
surgery | |||
Resection‡ R0/R1 (%) | 19 (76%)/6 (24%) | 20 (87%)/3 (13%) | 0.466 |
Limb‡ sparing/amputation (%) | 20 (80%)/5 (20%) | 23 (100%)/0 (0%) | 0.051 |
Good/poor response* (%) | 14 (64%)/8 (36%) | 14 (70%)/6 (30%) | 0.750 |
Follow-up | |||
Median [months] | 73.2 | 42.7 | |
Events (progression/toxicity/death) | 12/0/8 | 1/1/2 |
p: statistical significance.
4 or 3 patients underwent surgical resection before administration of chemotherapy thus their histologic response was not evaluable.
Categories were appropriately grouped to enable valid testing.
Surgery was not possible in one patient.