Study Shows First Effective Drug for Cancer Patients with Peripheral Neuropathy
Results of a phase III trial (CALGB-170601) show that duloxetine (Cymbalta) effectively treats painful peripheral neuropathy caused by certain types of chemotherapy. The results, from the first randomized clinical trial to show an effective treatment for chemotherapy-induced peripheral neuropathy (CIPN), were presented last week at the American Society of Clinical Oncology annual meeting .
CIPN causes chronic pain, tingling, and numbness—mainly in the hands and feet—that can interfere with a patient’s ability to perform everyday activities and to receive needed doses of chemotherapy. CIPN affects 20 to 30 percent of cancer patients treated with taxane and platinum-based chemotherapy drugs, which can damage nerve cells. CIPN may continue for months or even years after treatment is stopped and may worsen over time.
Dr. Ellen Lavoie Smith of the University of Michigan and her colleagues studied 181 people 18 years old or older who had previously reported high levels of pain from peripheral neuropathy caused by prior treatment with paclitaxel or oxaliplatin. They found that almost 60 percent of patients taking daily duloxetine for 6 weeks reported a decrease in pain, compared with nearly 40 percent of patients taking a placebo. Pain levels increased in 11 percent of duloxetine-treated patients and in 28 percent of those who took the placebo.
The most commonly reported side effect was fatigue, which was significantly higher in patients taking duloxetine than in patients taking the placebo.
“This study is the first to demonstrate statistically significant improvements in established neuropathic pain compared to placebo,” said Dr. Joanna Brell of NCI’s Division of Cancer Prevention. “While duloxetine is approved by the Food and Drug Administration for painful neuropathy caused by diabetes, there are no such treatments for CIPN.” Duloxetine is also approved to treat depression.