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Duloxetine reduced pain from chemotherapy-induced peripheral neuropathy
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Nearly 60% of patients who received an initial course of duloxetine reported reductions in pain associated with chemotherapy-induced peripheral neuropathy, according to study results.
Painful chemotherapy-induced neuropathy occurs in 20% to 40% of patients who receive neurotoxic chemotherapy, such as taxanes, platinums or bortezomib (Velcade, Millennium Pharmaceuticals).
The neuropathy can persist for years after completion of chemotherapy, and prior randomized, controlled trials that evaluated several drugs with diverse mechanisms of action failed to identify an effective treatment, according to background information in the study. However, several phase 3 studies showed duloxetine could be an effective treatment for painful diabetic neuropathy.
Ellen M. Lavoie Smith
Ellen M. Lavoie Smith, PhD, assistant professor in the division of acute, critical and long-term care at the University of Michigan School of Nursing, and colleagues conducted the randomized, double blind, placebo-controlled crossover trial to evaluate the efficacy of 60 mg daily duloxetine in the management of chemotherapy-induced peripheral neuropathy in a cohort of 231 patients.
Eligible patients were aged at least 25 years; had grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events grading scale; and reported at least 4 on a 10-point scale (average neuropathic pain) for at least 3 months after chemotherapy.
Patients had been treated with paclitaxel, other taxanes or oxaliplatin at community and academic settings between April 2008 and March 2011. Stratification was based on chemotherapy drug and comorbid pain risk.
Randomly assigned treatment regimens included duloxetine followed by placebo or placebo followed by duloxetine. The treatment schedule dictated that patients take one 30-mg capsule of the study drug or placebo for the first week, and two capsules of the drug or placebo for 4 weeks.
The primary endpoint of pain management was assessed using the Brief Pain Inventory-Short Form, which is scaled from 0 to 10.
A mean decrease in average pain of 1.06 (95% CI, 0.72-1.40) occurred in patients who took the study drug first vs. a decrease of 0.34 (95% CI, 0.01-0.66) for patients initially treated with placebo (P=.003; effect size, 0.513).
The researchers reported a mean difference in score between the drug and placebo of 0.73 (95% CI, 0.26-1.20). A decrease in pain of any amount occurred in 59% of patients who received duloxetine first and 38% of patients who received placebo first.
“Five weeks of duloxetine treatment was associated with a statistically and clinically significant improvement in pain compared with placebo,” the researchers concluded. “Exploratory analyses raise the possibility that duloxetine may work better for oxaliplatin-induced rather than taxane-induced painful chemotherapy-induced peripheral neuropathy.”
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