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Acetyl-L-Carnitine
Background. Peripheral neuropathy (PN) is a recognized side effect of microtubule-targeting agents and the most clinically relevant toxicity observed with the epothilone sagopilone (SAG). Studies suggest that acetyl-L-carnitine (ALC) may prevent chemotherapy-induced PN. We conducted a prospective, placebo (PBO)-controlled, double-blind, randomized trial to investigate the safety and efficacy of ALC for the prevention of SAG-induced PN.
Methods. Patients with ovarian cancer (OC) or castration-resistant prostate cancer (CRPC) and no evidence of neuropathy received SAG
(16 mg/m2 intravenously over 3 hours every 3 weeks) with ALC (1,000 mg every 3 days) or placebo (PBO). The primary endpoint was incidence
of PN within six or fewer cycles in both treatment groups.
Results. Overall, 150
patients enrolled (98 OC patients, 52 CRPC patients), with 75 per
treatment arm. No significant difference in
overall PN incidence was observed between
treatment arms. The incidence of grade ≥3 PN was significantly lower in
the ALC
arm in OC patients. Median duration of
neuropathy was similar between treatment arms. The best overall response
(according
to the modified Response Evaluation Criteria in
Solid Tumors), response according to tumor markers, time-to-event
variables,
and discontinuations because of adverse events
(AEs) were comparable between treatment arms.
Conclusion.
Administration of ALC with SAG did not result in a significant
difference in overall PN incidence compared with a PBO. OC
patients in the SAG/ALC arm had a significantly
lower incidence of grade 3 or 4 PN compared with OC patients in the
SAG/PBO
arm.
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