Campone, M., Berton-Rigaud, D., Joly-Lobbedez, F., Baurain, J.-F., Rolland, F., Stenzl, A., . . . Pautier, P. (2013). A double-blind, randomized phase II study to evaluate the safety and efficacy of acetyl-L-carnitine in the prevention of sagopilone-induced peripheral neuropathy. Oncologist, 18, 1190–1191.
To investigate if the addition of acetyl-L-carnitine (ALC) to sagopilone (SAG) in patients with ovarian cancer (OC) and castration-resistant prostate cancer (CRPC) reduced the overall incidence of SAG-induced peripheral neuropathy (PN) compared to SAG and placebo, and to evaluate the safety and efficacy of ALC-SAG compared to SAG-placebo
Patients were randomized to treatment and placebo-controlled arms. All patients received a three-hour infusion every three weeks of SAG 16 mg/m2 either with oral ALC (1000 mg) three times a day or oral placebo three times a day for six treatment cycles. ALC or placebo was continued for 30–33 days after the last SAG treatment. Patients with CRPC received oral prednisone 5 mg every two days as standard of care for quality of life.
Phase-II, prospective, placebo-controlled, double-blind, randomized trial
No difference in the incidence or median duration of PN existed in either arm. No difference existed in best overall response, tumor markers, time-to-event variables (progression free survival or time to progression), or discontinuations because of adverse events in either arm. Slightly more serious adverse events and grade 3–4 adverse events were reported in the SAG-placebo arm. ALC reduced the incidence of grade 3–4 PN in patients in the SAG-ALC arm compared to patients in the the SAG-placebo arm; however, actual statistical results were not reported.
ALC given concurrently with SAG in patients with advanced OC was reported to reduce the incidence of grade 3–4 PN after six cycles of treatment; however, no results showing statistical significance were provided.
ALC concurrently with SAG after six cycles reduced the incidence of grade 3–4 PN in patients with advanced OC. No benefit was observed in patients with CRPC or in reducing the incidence of grade 1–2 for either patients with OC or CRPC. Further randomized, controlled trials are needed to determine the benefits, duration of benefits, and quality of life for ALC-SAG or other neurotoxic regimens in diverse tumor types.