OP1 Adherence to 6-month oral alpha lipoic acid for prevention of platinum-induced polyneuropathy

Abstract

Background: Peripheral neuropathy induced by platinum-containing chemotherapy causes pain, and frequently becomes a dose-limiting factor for cancer treatment. The neurotoxicity appears to be irreversible; therefore prevention of neuropathy is necessary. Our aim was to determine whether a-lipoic acid (ALA, thioctic acid) can prevent peripheral neuropathy for patients receiving platinum. Methods: Adult patients were randomised to receive either 600 mg ALA or placebo three times a day for 24 weeks. Neuropathy was measured by the FACT/GOG-NTX score, and pain was measured by the brief pain inventory (BPI). Findings: Of the 243 patients randomised, 96 completed treatment for 24 weeks. At baseline, the ALA (n = 122) and placebo (n = 121) groups were comparable for age (58 ± 11 and 60 ± 11 years; p = 0.26), gender (51% and 49% male; p = 0.85), prior platinum exposure (p > 0.99), FACT/GOG-NTX score, and BPI score. At 24 weeks, only 43 evaluable patients remained in the ALA group, and 53 evaluable patients in the placebo group. The drop-out rate was 65% for the ALA group and 56% for placebo (p = 0.17). Reasons for drop-out were: withdrew consent (57 of 147, 39%), refused to take medication or non-compliant (35 of 147, 24%), lost to follow-up (2 of 147, 3%), death (2 of 147, 1%), change of chemotherapy regimen (8 of 147, 5%), physician decision (8 of 147, 5%), adverse effects (4 of 147, 3%), or other (31 of 147, 21%). Interpretation: Intensive schedules of oral agents may be particularly challenging in the symptom-prevention setting. Strategies to gauge the pre-enrolment risk of nonadherence, and to monitor adherence, are worthy of further exploration. Funding: YG and MF are supported in part by the National Institutes of Health. The authors declared no conflicts of interest.