TABLE 3.
Adjusted Mixed-Effect Models Derived Estimates of the Differences in Mean Scores of Efficacy Endpoints (SOSGOQ, SF-36v2, EQ-5D, and Pain NRS) by Time Measurement and Analysis Group Adjusted for Baseline ECOG
| Short survival | Long survival | Short survival/long survival | |||||||
|---|---|---|---|---|---|---|---|---|---|
| n | Mean (95% CI) | Change (95% CI) | Adj. P valuea | n | Mean (95% CI) | Change (95% CI) | Adj. P valuea | P valueb | |
| Pain NRS | |||||||||
| Baseline | 32 | 7.1 (6.2; 8.0) | 202 | 6.2 (5.8; 6.6) | .606 | ||||
| 6 wk | 15 | 5.7 (4.6; 6.9) | –1.4 (–3.4; 0.6) | .415 | 163 | 3.6 (3.2; 3.9) | –2.7 (–3.3; –2.0) | <.001 | .010 |
| 12 wk | 3 | 6.1 (3.9; 8.3) | –1.0 (–4.6; 2.6) | .990 | 155 | 3.2 (2.8; 3.6) | –3.0 (–3.8; –2.3) | <.001 | .164 |
| 26 wk | 127 | 3.3 (2.9; 3.7) | –3.0 (–3.7; –2.2) | <.001 | |||||
| EQ-5D (3 L) | |||||||||
| Baseline | 30 | 0.32 (0.23; 0.41) | 197 | 0.45 (0.42; 0.49) | .089 | ||||
| 6 wk | 15 | 0.48 (0.38; 0.57) | 0.16 (–0.03; 0.35) | .146 | 160 | 0.61 (0.57; 0.64) | 0.15 (0.09; 0.22) | <.001 | .189 |
| 12 wk | 3 | 0.37 (0.20; 0.54) | 0.06 (–0.23; 0.34) | .999 | 152 | 0.68 (0.65; 0.71) | 0.23 (0.17; 0.29) | <.001 | .009 |
| 26 wk | 126 | 0.66 (0.63; 0.70) | 0.21 (0.14; 0.28) | <.001 | |||||
| SF-36v2 PCS | |||||||||
| Baseline | 32 | 26.8 (23.7; 29.8) | 199 | 28.7 (27.3; 30.1) | .935 | ||||
| 6 wk | 12 | 27.0 (22.5; 31.6) | 0.3 (–7.4; 8.0) | 1.000 | 156 | 30.4 (29.0; 31.8) | 1.7 (–0.6; 3.9) | .345 | .866 |
| 12 wk | 3 | 25.6 (17.0; 34.2) | –1.2 (–14.8; 12.4) | 1.000 | 149 | 32.6 (31.0; 34.1) | 3.8 (1.4; 6.3) | <.001 | .757 |
| 26 wk | 124 | 34.6 (32.9; 36.4) | 5.9 (2.9; 8.9) | <.001 | |||||
| SF-36v2 MCS | |||||||||
| Baseline | 32 | 40.8 (36.6; 45.1) | 199 | 44.0 (42.0; 45.9) | .875 | ||||
| 6 wk | 12 | 39.4 (33.1; 45.7) | –1.5 (–11.3; 8.4) | 1.000 | 156 | 46.2 (44.2; 48.2) | 2.3 (–0.6; 5.1) | .239 | .453 |
| 12 wk | 3 | 39.6 (29.2; 50.0) | –1.2 (–17.7; 15.2) | 1.000 | 149 | 48.0 (46.1; 49.9) | 4.0 (1.0; 7.0) | .001 | .761 |
| 26 wk | 124 | 48.3 (46.2; 50.5) | 4.4 (1.0; 7.8) | .003 | |||||
| SOSGOQ2.0 Total | |||||||||
| Baseline | 30 | 46.3 (40.2; 52.4) | 197 | 50.8 (48.1; 53.4) | .870 | ||||
| 6 wk | 14 | 48.1 (39.1; 57.1) | 1.8 (–13.3; 16.9) | 1.000 | 158 | 61.4 (58.5; 64.4) | 10.7 (6.1; 15.3) | <.001 | .101 |
| 12 wk | 3 | 48.7 (31.8; 65.5) | 2.4 (–24.5; 29.2) | 1.000 | 149 | 66.2 (63.3; 69.1) | 15.4 (10.7; 20.1) | <.001 | .465 |
| 26 wk | 125 | 68.9 (65.9; 71.8) | 18.1 (13.4; 22.8) | <.001 | |||||