Table 1:
Patient characteristics
Vaccine + OPT-821 (N=68) | OPT-821 (N=68) | |
---|---|---|
Age (years) | ||
n | 68 | 68 |
Mean (SD) | 49.8 (13.25) | 52.5 (15.24) |
Sex - n (%) | ||
Male | 39 (57.4) | 32 (47.1) |
Female | 29 (42.6) | 36 (52.9) |
Race - n (%) | ||
American Indian or Alaska Native | 1 (1.5) | 0 |
Asian | 4 (5.9) | 3 (4.4) |
Black or African American | 1 (1.5) | 3 (4.4) |
White | 62 (91.2) | 61 (89.7) |
Other | 0 | 1 (1.5) |
Ethnicity - n (%) | ||
Hispanic or Latino | 3 (4.4) | 2 (2.9) |
Not Hispanic or Latino | 65 (95.6) | 66 (97.1) |
ECOG Performance Status– n (%) | ||
0 | 57 (83.8) | 48 (70.6) |
1 | 11 (16.2) | 20 (29.4) |
Number of Metastases – n (%) | ||
1 to 3 | 60 (88.2) | 57 (83.8) |
4 or more | 8 (11.8) | 11 (16.2) |
Primary Tumor Grade - n (%) | ||
High | 62 (91.2) | 56 (82.4) |
Intermediate | 5 (7.4) | 9 (13.2) |
Low | 1 (1.5) | 3 (4.4) |
Primary Site of Original Disease – n (%) | ||
Soft Tissue | 35 (51.5%) | 32 (47.1%) |
Other | 18 (26.5%) | 20 (29.4%) |
Bone | 8 (11.8%) | 6 (8.8%) |
Abdomen | 4 (5.9%) | 7 (10.3%) |
Lungs | 1 (1.5%) | 2 (2.9%) |
Kidney | 1 (1.5%) | 1 (1.5%) |
Head and Neck | 1 (1.5%) | 0 |
Metastatic Disease at time of Original Diagnosis – n (%) | ||
Yes | 13 (19.1%) | 11 (16.2%) |
No | 55 (80.9%) | 57 (83.8%) |
Most Recent Disease-free Interval – n (%) | ||
< 12 months | 34 (50.0%) | 33 (48.5%) |
>= 12 months | 28 (41.2%) | 28 (41.2%) |
Number of Relapses – n (%) | ||
1 | 34 (50.0%) | 36 (52.9%) |
> 1 | 28 (41.2%) | 25 (36.8%) |
Prior Radiotherapy - n (%) | ||
Yes | 35 (51.5%) | 34 (50.0%) |
No | 33 (48.5%) | 34 (50.0%) |
Prior Chemotherapy – n (%) | ||
Yes | 35 (51.5%) | 37 (54.4%) |
No | 33 (48.5%) | 31 (45.6%) |
Tumor Histology - n (%) | ||
Leiomyosarcoma (n=45) | 17 (25%) | 28 (41%) |
Spindle Cell Sarcoma (n=19) | 12 (18%) | 7 (10%) |
Pleomorphic Sarcoma (n=18) | 9 (13%) | 9 (13%) |
Osteosarcoma (n=14) | 7 (10%) | 7 (10%) |
Liposarcoma (n=12) | 6 (9%) | 6 (9%) |
Synovial Sarcoma (n=12) | 5 (7%) | 7 (10%) |
Other (n=16) | 12 (18%) | 4 (6%) |