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J Natl Cancer Inst. 2018 Jun 1;110(6):669-676. doi: 10.1093/jnci/djx259.

Two-Year Trends of Taxane-Induced Neuropathy in Women Enrolled in a Randomized Trial of Acetyl-L-Carnitine (SWOG S0715).

Author information

1
Columbia University Medical Center, New York, NY.
2
SWOG Statistical Center, Seattle, WA.
3
Fred Hutchinson Cancer Research Center, Seattle, WA.
4
Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD.
5
Kaiser Permanente Northern California, Vallejo, CA.
6
Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Decatur, IL.
7
Loma Linda University School of Pharmacy, Loma Linda, CA.
8
AIM Specialty Health, Chicago, IL.
9
Huntsman Cancer Institute, Salt Lake City, UT.
10
Loyola University Chicago Stritch School of Medicine, Cardinal Bernardin Cancer Center, Maywood, IL.

Abstract

Background:

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and disabling side effect of taxanes. Acetyl-L-carnitine (ALC) was unexpectedly found to increase CIPN in a randomized trial. We investigated the long-term patterns of CIPN among patients in this trial.

Methods:

S0715 was a randomized, double-blind, multicenter trial comparing ALC (1000 mg three times a day) with placebo for 24 weeks in women undergoing adjuvant taxane-based chemotherapy for breast cancer. CIPN was measured by the 11-item neurotoxicity (NTX) component of the FACT-Taxane scale at weeks 12, 24, 36, 52, and 104. We examined NTX scores over two years using linear mixed models for longitudinal data. Individual time points were examined using linear regression. Regression analyses included stratification factors and the baseline score as covariates. All statistical tests were two-sided.

Results:

Four-hundred nine subjects were eligible for evaluation. Patients receiving ALC had a statistically significantly (P = .01) greater reduction in NTX scores (worse CIPN) of -1.39 points (95% confidence interval [CI] = -2.48 to -0.30) than the placebo group. These differences were particularly evident at weeks 24 (-1.68, 95% CI = -3.02 to -0.33), 36 (-1.37, 95% CI = -2.69 to -0.04), and 52 (-1.83, 95% CI = -3.35 to -0.32). At 104 weeks, 39.5% on the ALC arm and 34.4% on the placebo arm reported a five-point (10%) decrease from baseline. For both treatment groups, 104-week NTX scores were statistically significantly different compared with baseline (P < .001).

Conclusions:

For both groups, NTX scores were reduced from baseline and remained persistently low. Twenty-four weeks of ALC therapy resulted in statistically significantly worse CIPN over two years. Understanding the mechanism of this persistent effect may inform prevention and treatment strategies. Until then, the potential efficacy and harms of commonly used supplements should be rigorously studied.

PMID:
29361042
PMCID:
PMC6005110
DOI:
10.1093/jnci/djx259
[Indexed for MEDLINE]
Free PMC Article

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