Table 2.
Mean estimates of the change in neuropathy outcomes since the beginning of paclitaxel treatment (week 0)
| FACT‐GOG‐NTX‐13 | TNSc | CSAP sural amplitude, μV | Two‐point discrimination, mm | Von Frey, mN | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mean ± SE | 95% CI | Mean ± SE | 95% CI | Mean ± SE | 95% CI | Mean ± SE | 95% CI | Mean ± SE | 95% CI | |
| Wk 0 (n = 83) | 49.4 | (48.7 to 50.1) | 1.2 ± .2 a | (.91 to 1.5) | 18.7 | (16.4 to 20.9) | 8.4 | (7.8 to 9.1) | .37 | (.29 to .45) |
| Wk 6 (n = 77) | −4.1 ± .6 a | (−5.2 to −2.8) | 1.9 ± .2 a | (1.4 to 2.3) | −3.0 ± .8 a | (−4.7 to −1.4) | 0.3 ± .4 | (‐0.5 to 1.0) | .26 ± .16 a | (.14 to .38) |
| Wk 12 (n = 69) | −9.7 ± .9 a | (‐11.5 to −7.9) | 3.6 ± .3 a | (2.9 to 4.2) | −5.7 ± 1.0 a | (−7.7 to −3.8) | 1.6 ± .5 a | (0.7 to 2.5) | .60 ± .21 a | (.18 to 1.0) |
| 3 mo post‐treatment (n = 71) | −5.0 ± .8 a | (‐6.5 to −3.5) | 2.4 ± .3 a | (1.8 to 2.9) | −4.9 ± .9 a | (‐6.7 to −3.1) | 2.2 ± .5 a | (1.3 to 3.1) | .31 ± .14 a | (.04 to .58) |
| 6 mo post‐treatment (n = 68) | −4.8 ± .8 a | (‐6.4 to −3.2) | 1.9 ± .3 a | (1.4 to 2.6) | −3.9 ± 1.1 a | (‐6.1 to −1.8) | 1.7 ± .5 a | (0.8 to 2.5) | .33 ± .21 | (−.08 to .74) |
| 12 mo post‐treatment (n = 55) | −4.8 ± .8 a | (−6.4 to −3.2) | 1.8 ± .2 a | (1.1 to 2.5) | −2.9 ± 1.2 a | (−5.2 to −0.5) | 2.2 ± .5 a | (1.3 to 3.1) | .37 ± .36 | (−.34 to 1.1) |
Mean estimates of change from the predicted mean at week 0, presented with SE and 95% confidence intervals. FACT‐GOG‐NTX‐13: range, 0–52 points. Lower scores associated with greater symptomatic burden. TNSc: range, 0–24 points. Higher scores indicate greater neuropathy severity of neuropathy. CSAP sural amplitude: measured from the sural nerve. Baseline sural amplitude was added a covariate to improve the fit of the model. Two‐point discrimination: larger distance (mm) indicate greater sensory deficit. Von Frey monofilament: Higher force (mN) indicates greater sensory deficit.
Indicates significant the change from week 0 (p < .05). Predicted means for other measured are presented in appendix 1.
Abbreviations: CI, confidence interval; CSAP, compound sensory nerve action potential; FACT‐GOG‐NTX‐13, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group‐Neurotoxicity questionnaire; TNSc, Total Neuropathy Score clinical version.