Table 3.
Multivariate Analyses Comparing FACT-NTX Scores Between ALC and Placebo Arms at 12 and 24 Weeks
| Linear Regression Analyses*† | Week-12 Analysis (n = 372) |
Week-24 Analysis (n = 347) |
||||
|---|---|---|---|---|---|---|
| Coefficient | 95% CI | P | Coefficient | 95% CI | P | |
| Intercept | 7.26 | 0.38 to 14.14 | .04 | 4.35 | −3.61 to 12.31 | .28 |
| Treatment‡ | −0.91 | −2.21 to 0.39 | .17 | −1.80 | −3.16 to −0.43 | .01 |
| Baseline NTX score | 0.69 | 0.52 to 0.86 | < .001 | 0.82 | 0.62 to 1.01 | < .001 |
| Age (< 60 v ≥ 60 years)§ | −0.78 | −2.25 to 0.69 | .30 | −1.66 | −3.22 to −0.11 | .04 |
| Planned taxane treatment∥ | ||||||
| Paclitaxel once per week for 12 cycles | 0.00 | Referent | 0.00 | Referent | ||
| Paclitaxel every 2 weeks for four cycles | 0.20 | −1.50 to 1.90 | .82 | −0.10 | −1.90 to 1.69 | .91 |
| Paclitaxel every 2 weeks for six cycles | 1.62 | −3.61 to 6.85 | .54 | −0.06 | −5.37 to 5.25 | .98 |
| Docetaxel every 3 weeks for four cycles | 2.17 | 0.43 to 3.91 | .02 | 0.14 | −1.70 to 1.98 | .89 |
| Docetaxel every 3 weeks for six cycles | 2.60 | 0.52 to 4.68 | .02 | 0.41 | −1.79 to 2.61 | .72 |
| Logistic Regression Analyses¶ | Week-12 Analysis (n = 372) |
Week-24 Analysis (n = 347) |
||||
|---|---|---|---|---|---|---|
| OR | 95% CI | P | OR | 95% CI | P | |
| Treatment‡ | ||||||
| Placebo | 1.00 | Referent | 1.00 | Referent | ||
| ALC | 1.48 | 0.96 to 2.29 | .08 | 1.57 | 0.99 to 2.49 | .05 |
| Age, years§ | ||||||
| < 60 | 1.00 | Referent | 1.00 | Referent | ||
| ≥ 60 | 1.15 | 0.71 to 1.87 | .57 | 2.05 | 1.24 to 3.37 | .005 |
| Planned taxane treatment¶ | ||||||
| Paclitaxel once per week for 12 cycles | 1.00 | Referent | 1.00 | Referent | ||
| Paclitaxel every 2 weeks for four cycles | 0.87 | 0.50 to 1.50 | .61 | 1.07 | 0.59 to 1.93 | .84 |
| Paclitaxel every 2 weeks for six cycles | 0.75 | 0.13 to 4.29 | .75 | 0.41 | 0.05 to 3.63 | .42 |
| Docetaxel every 3 weeks for four cycles | 0.57 | 0.32 to 1.02 | .06 | 0.72 | 0.38 to 1.32 | .27 |
| Docetaxel every 3 weeks for six cycles | 0.49 | 0.24 to 0.99 | .05 | 1.02 | 0.50 to 2.06 | .96 |
Abbreviations: ALC, acetyl-L-carnitine; FACT-NTX, neurotoxicity component of Functional Assessment of Cancer Therapy–Taxane scale; NTX, neurotoxicity; OR, odds ratio.
Week-12 linear regression analysis represents planned primary end point analysis.
Separate linear regression models that evaluated interaction of treatment and baseline NTX score resulted in regression coefficients for interaction term of 0.18 (95% CI, −0.14 to 0.51; P = .27) for week-12 analysis and −0.05 (95% CI, −0.42 to 0.32; P = .80) for week-24 analysis.
Coded as placebo = 0; ALC = 1.
Coded as < 60 = 0; ≥ 60 = 1.
Coded as indicator variables, with weekly paclitaxel for 12 weeks as the reference group.
Dependent variable for logistic regression analyses was > 5-point decrease in FACT-NTX score at follow-up assessment time.