Table 1.
Demographics and clinical characteristics of patients
| Placebo |
Enobosarm 1 mg |
Enobosarm 3 mg |
||||
|---|---|---|---|---|---|---|
| Safety (n=52) | Efficacy (n=34) | Safety (n=53) | Efficacy (n=32) | Safety (n=54) | Efficacy (n=34) | |
| Mean age, years (range) | 66 (41 to 83) | 65 (41 to 81) | 66 (43 to 87) | 63 (43 to 87) | 66 (39 to 82) | 71 (39 to 81) |
| Sex | ||||||
| Men | 35 (67%) | 21 (62%) | 34 (64%) | 16 (50%) | 34 (63%) | 21 (62%) |
| Women | 17 (33%) | 13 (38%) | 19 (36%) | 16 (50%) | 20 (37%) | 13 (38%) |
| Race | ||||||
| White | 47 (90%) | 32 (94%) | 45 (85%) | 26 (81%) | 51 (94%) | 32 (94%) |
| Other* | 5 (10%) | 2 (6%) | 8 (15%) | 6 (19%) | 3 (6%) | 2 (6%) |
| Cancer type | ||||||
| NSCLC | 21 (40%) | 10 (29%) | 21 (40%) | 8 (25%) | 19 (35%) | 13 (38%) |
| Stage II; III; IV | 1; 5; 15 | 1; 3; 6 | 0; 9; 12 | 0; 5; 3 | 3; 7; 9 | 2; 6; 5 |
| Colorectal | 21 (40%) | 15 (44%) | 21 (40%) | 17 (53%) | 20 (37%) | 12 (35%) |
| Stage II; III; IV | 3; 5; 13 | 3; 4; 8 | 3; 6; 12 | 3; 4; 10 | 1; 7; 12 | 0; 3; 9 |
| Other† | 10 (19%) | 9 (26%) | 11 (21%) | 7 (22%) | 15 (28%) | 9 (26%) |
| Chemotherapy with CRF | ||||||
| n | 39 | 26 | 36 | 24 | 44 | 31 |
| Chemotherapy on study | 31 (79%) | 24 (92%) | 31 (86%) | 24 (100%) | 36 (82%) | 26 (84%) |
| Weight change‡ | ||||||
| kg | –7·4 (5·3) | –6·5 (4·9) | –7·2 (4·0) | –7·4 (4·4) | –5·6 (3·2) | –5·8 (3·6) |
| % | –9·4 (6·0) | –7·9 (4·8) | –9·7 (5·1) | –10·2 (5·6) | –7·4 (3·9) | –7·5 (4·3) |
| BMI (kg/m2) | 24·1 (4·6) | 24·8 (4·9) | 23·5 (4·8) | 23·6 (4·6) | 24·0 (3·9) | 24·1 (4·1) |
| Lean body mass (kg) | 47·2 (27·7 to 72·1) | 46·6 (27·7 to 72·1) | 44·9 (27·0 to 63·6) | 41·6 (27·0 to 63·6) | 44·8 (28·4 to 68·4) | 46·3 (30·6 to 68·4) |
| Stair climb power§ | ||||||
| n | 52 | 36 | 53 | 31 | 53 | 28 |
| Stairs 1–12 (watts) | 137·6 (48·8–442·3) | 150·2 (72·8–442·3) | 127·9 (25·3–375·5) | 116·4 (43·9–375·5) | 154·4 (16·6–413·3) | 154·5 (16·6–286·9) |
| Grip strength | ||||||
| n | 52 | 34 | 53 | 30 | 54 | 33 |
| kg | 27·0 (6·4–56·3) | 26·5 (6·4–56·3) | 25·5 (2·3–85·0) | 24·1 (2·3–85·0) | 26·0 (8·0–95·6) | 26·0 (8·0–95·6) |
Data are n (%), mean (SD), or median (range) unless otherwise specified. Efficacy=patients for whom efficacy data was available, no adjustment for missing data. NSCLC=non-small-cell lung cancer. CRF=cancer-related fatigue. BMI=body-mass index.
*
Hispanic, black, and Native American or Alaskan.
†
Non-Hodgkin lymphoma, chronic lymphocytic leukaemia, and breast cancer.
‡
Weight change in the previous 6 months.
§
Not all patients had a baseline value.