Table 1.
Patients' baseline characteristics of cross-sectional population for QoL analysis.
| Demographic items | Eribulin (n = 223) |
DAC (n = 219) |
Total (n = 442) |
p value[1] |
|---|---|---|---|---|
| Age (years) | ||||
| n | 223 | 219 | 442 | 0.263 |
| Mean (SD) | 55.5 (11.09) | 55.7 (10.46) | 55.6 (10.77) | |
| Median | 56.0 | 56.0 | 56.0 | |
| Min, Max | 28.0, 83.0 | 24.0, 83.0 | 24.0, 83.0 | |
| Gender | ||||
| Male | 65 (29.1%) | 79 (36.1%) | 144 (32.6%) | 0.120 |
| Female | 158 (70.9%) | 140 (63.9%) | 298 (67.4%) | |
| Race | ||||
| White | 158 (70.9%) | 164 (74.9%) | 322 (72.9%) | 0.865 |
| Black or African American | 6 (2.7%) | 6 (2.7%) | 12 (2.7%) | |
| Japanese | 1 (0.4%) | 0 (0.0%) | 1 (0.2%) | |
| Chinese | 2 (0.9%) | 1 (0.5%) | 3 (0.7%) | |
| Other Asian | 15 (6.7%) | 15 (6.8%) | 30 (6.8%) | |
| Native Hawaiian or other Pacific Islander | 1 (0.4%) | 0 (0.0%) | 1 (0.2%) | |
| Other | 6 (2.7%) | 4 (1.8%) | 10 (2.3%) | |
| Missing | 33 (15.2%) | 29 (13.2%) | 63 (14.3%) | |
| Region | ||||
| USA and Canada | 85 (38.1%) | 84 (38.4%) | 169 (38.2%) | 0.998 |
| Western Europe, Australasia, and Israel | 104 (46.6%) | 102 (46.6%) | 206 (46.6%) | |
| Eastern Europe, Latin America, and Asia | 34 (15.2%) | 33 (15.1%) | 67 (15.2%) | |
| ECOG PS | ||||
| n | 223 | 219 | 442 | 0.661 |
| Mean (SD) | 0.5 (0.53) | 0.7 (0.58) | 0.6 (0.56) | |
| Median | 1.0 | 1.0 | 1.0 | |
| Min, Max | 0.0, 2.0 | 0.0, 2.0 | 0.0, 2.0 | |
| NYHA | ||||
| Class I | 144 (64.6%) | 130 (59.4%) | 274 (62.0%) | 0.353 |
| Class II | 15 (6.7%) | 19 (8.7%) | 34 (7.7%) | |
| Prior regimens | ||||
| Number of prior regimens for advanced STS: 2 | 120 (53.8%) | 120 (54.8%) | 240 (54.3%) | 0.836 |
| Number of prior regimens for advanced STS: >2 | 103 (46.2%) | 99 (45.2%) | 202 (45.7%) | |
| Histology/cytology | ||||
| Liposarcoma | 70 (31.4%) | 71 (32.4%) | 140 (31.9%) | 0.816 |
| Leiomyosarcoma | 153 (68.6%) | 148 (67.6%) | 301 (68.1%) |
CSP, cross-sectional population; DAC, dacarbazine; ECOG PS, Eastern Cooperative Oncology Group Performance Status; NYHA, New York Heart Association; SD, standard deviation; STS, soft tissue sarcoma.
Of note, of the 452 patients randomized, only 442 patients (223 patients in the eribulin treatment arm and 219 patients in the DAC treatment arm) were included in the cross-sectional population (defined as any full analysis set patient with at least one item of QLQ-C30 or EQ-5D questionnaire at the time of randomization).
[1]From t-test on continuous variable or Chi-square test on categorical variables.