Best of ASCO - 2014 Annual Meeting



Attend this session at the
2017 ASCO Annual Meeting!

Session: Patient and Survivor Care

Type: Poster Session

Time: Saturday June 3, 1:15 PM to 4:45 PM

Location: Hall A

Two-year trends of taxane-induced neuropathy in women enrolled in a randomized trial of acetyl-l-carnitine (SWOG S0715).

Symptom Management/Supportive Care/Palliative Care

Patient and Survivor Care

2017 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #82)

J Clin Oncol 35, 2017 (suppl; abstr 10093)

Author(s): Dawn L. Hershman, Joseph M. Unger, Katherine D. Crew, Cyrus Ebnesajjad, Heather Greenlee, Louis Fehrenbacher, Carol Moinpour, Lori M. Minasian, Danika L Lew, Siu-Fun Wong, James Lloyd Wade, Michael Fisch, Kathy S. Albain, Norah Lynn Henry; Columbia University Medical Center, New York, NY; Fred Hutchinson Cancer Research Center, Seattle, WA; Fred Huchinson Cancer Research Center, Seatle, WA; NSABP/NRG Oncology, and Kaiser Permanente Northern California, Novato, CA; National Cancer Institute, Rockville, MD; SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA; Chapman University, Orange, CA; Heartland NCORP, Decatur, IL; AIM Specialty Health, Chicago, IL; Loyola University Chicago Stritch School of Medicine, Cardinal Bernardin Cancer Center, Maywood, IL; University of Utah, Ann Arbor, MI

Abstract Disclosures


Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and disabling side effect of taxanes that leads to suboptimal treatment and adversely affects quality of life. Acetyl-L-Carnitine (ALC) was unexpectedly found to increase CIPN in a randomized trial. We investigated the long-term patterns of CIPN among patients enrolled in this trial. Methods: S0715 was a randomized, double-blind, multi-center trial comparing ALC (1000 mg TID) versus placebo for 24 weeks in women with stage I-III breast cancer undergoing taxane-based chemotherapy. The primary objective was to determine if ALC prevents CIPN as measured by the 11-item neurotoxicity (NTX) component of the FACT-Taxane scale at 12 weeks. Additional assessments were conducted at weeks 24, 36, 52 and 104. We examined the reduction of NTX score over 2 years using linear mixed models for longitudinal data, adjusting for stratification factors and the baseline NTX score. Individual assessment time-points were examined using linear regression. Results: SWOG S0715 registered 437 patients, of whom 409 were eligible and evaluable, including 208 assigned to receive ALC and 201 to placebo. Patterns of evaluability were similar over time by arm. The results for the primary outcome of interest, NTX, show a statistically significant (p = 0.01) average difference of -1.39 (95% CI: -2.47 to -0.31) between treatment groups, with the ALC group having lower scores (worse CIPN) on average than the placebo group. These differences were particularly evident at Weeks 24 (p = 0.02), 36 (p = 0.04), and 52 (p = 0.02). A clinically meaningful (≥5 points) reduction in NTX score over baseline was observed more frequently for the ALC vs. control arm (week 24, 41% vs. 34%; week 36, 41% vs. 28%; 1 year, 41% vs. 32%; 2 years, 40% vs. 34%). For both treatment groups 2 year NTX scores were significantly different compared to baseline (p < 0.001). Conclusions: For both groups NTX scores were reduced with taxane-therapy and remained persistently low 2-years following treatment. Twenty-four weeks of ALC therapy resulted in significantly worse CIPN at weeks 24 36 and 52. Understanding the mechanism of this persistent effect may inform prevention and treatment strategies. Clinical trial information: NCT00775645

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