Table 2.
Mean FACT-NTX, Functional Status, and Fatigue Scores at 12 and 24 Weeks
| Analysis | Observed Baseline |
Observed |
Fitted |
P* | |||
|---|---|---|---|---|---|---|---|
| Mean | Range | Mean | Range | Mean | Range | ||
| FACT-NTX† | |||||||
| Week-12 analysis (n = 372)‡ | .17 | ||||||
| ALC (n = 191) | 40.6 | 40.1-41.1 | 35.4 | 34.3-36.4 | 35.4 | 34.1-36.7 | |
| Placebo (n = 181) | 40.8 | 40.2-41.5 | 36.4 | 35.4-37.4 | 36.3 | 35.0-37.6 | |
| Week-24 analysis (n = 347)§ | .01 | ||||||
| ALC (n = 174) | 40.6 | 40.0-41.1 | 35.3 | 34.1-36.5 | 35.5 | 34.2-36.9 | |
| Placebo (n = 173) | 41.1 | 40.5-41.6 | 37.5 | 36.6-38.5 | 37.3 | 36.0-38.7 | |
| Functional status† | |||||||
| Week-12 analysis (n = 372)‡ | .92 | ||||||
| ALC (n = 191) | 99.3 | 97.4-101.3 | 91.9 | 89.5-94.2 | 92.1 | 89.3-94.9 | |
| Placebo (n = 181) | 99.9 | 97.7-102.1 | 92.5 | 90.1-95.0 | 92.3 | 89.4-95.1 | |
| Week-24 analysis (n = 347)§ | .03 | ||||||
| ALC (n = 174) | 100.0 | 98.0-102.0 | 95.1 | 92.5-97.7 | 95.2 | 92.2-98.3 | |
| Placebo (n = 173) | 100.1 | 98.0-102.3 | 98.9 | 96.5-101.2 | 98.7 | 95.7-101.8 | |
| Fatigue† | |||||||
| Week-12 analysis (n = 371)‡ | .20 | ||||||
| ALC (n = 191) | 37.3 | 35.7-38.9 | 36.4 | 34.9-37.9 | 36.6 | 34.7-38.6 | |
| Placebo (n = 180) | 37.9 | 36.2-39.5 | 35.5 | 33.9-37.1 | 35.3 | 33.4-37.3 | |
| Week-24 analysis (n = 348)§ | .51 | ||||||
| ALC (n = 174) | 37.6 | 35.9-39.3 | 39.3 | 37.9-40.7 | 39.5 | 37.6-41.3 | |
| Placebo (n = 174) | 38.1 | 36.4-39.8 | 40.3 | 38.7-41.8 | 40.1 | 38.2-42.0 | |
Abbreviations: ALC, acetyl-L-carnitine; FACT-NTX, neurotoxicity component of Functional Assessment of Cancer Therapy–Taxane scale.
*
From multivariate analysis adjusting for age, baseline FACT-NTX, and planned taxane treatment.
†
Higher scores reflect less neurotoxicity, better functional status, and less fatigue, respectively.
‡
Among patients with week-12 scores only.
§
Among patients with week-24 scores only.