Table 1 Clinical and pathologic characteristics of accrued patients
Accrued patients (n = 23) | Per-protocol population (n = 21) | |
|---|---|---|
Median age (Range) | 49 (20–74) | 57 (20–74) |
Gender | ||
Male | 13 (57%) | 12 (57%) |
Female | 10 (43%) | 9 (43%) |
Histology | ||
Leiomyosarcoma | 5 (22%) | 5 (24%) |
Others | 18 (78%) | 16 (76%) |
ECOG | ||
0 | 10 (43%) | 10 (48%) |
1 | 13 (57%) | 11 (52%) |
Extension at diagnosis | ||
Localized | 13 (57%) | 11 (52%) |
Locally advanced | 6 (26%) | 6 (29%) |
Metastatic | 4 (17%) | 4 (19%) |
Extension at baseline | ||
Locally advanced | 2 (9%) | 2 (9%) |
Metastatic | 21 (91%) | 19 (90%) |
Location | ||
Somatic | 15 (65%) | 13 (62%) |
Visceral | 8 (35%) | 8 (38%) |
Median primary size (range; mm) | 95 (12–230) | 95 (12–230) |
Median previous surgery (range) | 1 (0–13) | 1 (0–13) |
Median previous chemotherapy (range) | 2 (1–5) | 2 (1–5) |
Median previous radiotherapy (range) | 0 (0–4) | 0 (0–4) |
Median previous systemic (range) | 3 (1–5) | 3 (1–5) |
Dose reduction | 2 (9%) | 2 (9%) |
Treatment delay | 5 (22%) | 4 (19%) |
Best response | ||
SD | 13 (57%) | 13 (62%) |
PD | 8 (35%) | 8 (38%) |
Non-evaluable | 2 (9%) | – |