Table 1.
Baseline Characteristics
| n (%) | |
|---|---|
| Total, n | 540 |
| Age, mean [SD], y | 63.2 [11.49] |
| Race | |
| White | 434 (80.4) |
| Black or African American | 82 (15.2) |
| Othera | 24 (4.4) |
| Ethnicity | |
| Hispanic or Latino | 34 (6.3) |
| Not Hispanic or Latino | 497 (92.0) |
| Unknown | 9 (1.7) |
| ECOG performance status | |
| 0 | 315 (58.3) |
| 1 | 225 (41.7) |
| BMI, mean [SD], kg/m2 | 29.9 [7.02] |
| BMI, groups | |
| Underweight: <18.5 kg/m2 | 6 (1.1) |
| Normal: 18.5 to <25 kg/m2 | 132 (24.4) |
| Overweight: 25 to <30 kg/m2 | 160 (29.6) |
| Obese: ≥30 kg/m2 | 242 (44.8) |
| BMI 30–34.9 kg/m2 | 126 (52.1) |
| BMI ≥35 kg/m2 | 116 (47.9) |
| Menopausal status | |
| Premenopausal | 21 (3.9) |
| Postmenopausal | 519 (96.1) |
| Study arm | |
| Entinostat | 270 (50.0) |
| Placebo | 270 (50.0) |
| Visceral disease | |
| No | 215 (39.8) |
| Yes | 325 (60.2) |
| Prior chemotherapy | |
| No | 226 (41.9) |
| Yes | 314 (58.1) |
| Prior chemotherapy setting | |
| Adjuvant | 173 (54.9) |
| Metastatic | 94 (29.8) |
| Both adjuvant/metastatic | 48 (15.2) |
| Muscle mass | |
| N | 540 |
| Mean skeletal muscle index [SD] | 43.6 [7.6] |
| LMM | 212 (39.3) |
| Muscle attenuation | |
| N | 539 |
| Mean HU [SD] | 32.5 [9.74] |
| LMA | 301 (55.8) |
Abbreviations: BMI, body mass index; HU, Hounsfield unit; LMA, low muscle attenuation; LMM, low muscle mass.
a
Includes Asian, American Indian, Alaskan Native, Native Hawaiian, and Pacific Islander.