Abstract

e19644 Background: This open-label pilot study is aimed to evaluate the efficacy and tolerability of the antidepressant duloxetine, which is effective for diabetic neuropathic pain, in the treatment of chronic oxaliplatin-induced neuropathic pain (OINP). Methods: We enrolled a total of 39 patients with stage III or IV colorectal cancer with chronic OINP. They were treated with duloxetine by increasing the dose from 30 mg/day to 60 mg/day. Patients’ pain intensity was rated at baseline and 12 weeks after duloxetine administration. The severity of neuropathic pain was evaluated using the visual analog scale (VAS) score, and the grade of neuropathy was evaluated with the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3 (NCI-CTCAE v3.0). Results: Nine patients (23.1%) discontinued duloxetine before the end of treatment because of adverse events. Of the remaining 30 patients, 19 patients (63.3%) had a VAS score improvement. Among them, 9 (47.4%) showed a simultaneous grade improvement, and the other 10 patients (52.6%) had a stable grade according to NCI-CTCAE v3.0. Twenty of the 30 patients (66.7%) who completed 12 weeks of duloxetine treatment received concurrent chemotherapy while taking duloxetine, and none of these patients showed abnormalities in the levels of serum creatinine or alanine transaminase during the period of the combination treatment with duloxetine and chemotherapy. The same conditions were also observed in those who were treated with duloxetine without concurrent chemotherapy. Conclusions: Duloxetine was effective in treating chronic OINP with tolerable toxicity at a daily dose of 60 mg/day.

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