化学療法誘発性末梢神経障害に有効な治療 （Abstract # CRA9013）

デュロキセチンは有痛性化学療法誘発性末梢神経障害の第一の有効な治療法である
Duloxetine is first effective treatment for painful chemotherapy-induced peripheral neuropathy
第48回American Society of Clinical Oncology学会で発表された第3相スタディの結果、デュロキセチンは有痛性化学療法誘発性末梢神経障害の治療に有効であること―この発見によりがん診療が変わり、患者にとって重要な新たなQOLの解決法が得られる―が明らかにされた。デュロキセチンは現在米国において、うつ病および有痛性糖尿病性末梢神経障害に対し承認されている。今回のスタディでは、タキサンまたはプラチナ製剤治療による末梢神経障害に基づく高レベルの疼痛を訴えていた患者を、デュロキセチン投与後にプラセボを投与する群とプラセボ投与後にデュロキセチンを投与する群に無作為に割り付けた。参加者らは1日1錠の3mgカプセルを1週間内服した後に1日2カプセル（計60mg）をさらに4週間内服した。参加者らは疼痛に関するアンケートにスタディ開始時およびその後毎週回答した。疼痛が軽減したと回答したのはデュロキセチン内服中患者の59%であり、プラセボ内服群では39%であった。疼痛に変化がなかった割合は同等であった（デュロキセチン群30%対プラセボ群33%）。疼痛が増悪した割合はプラセボ群において高かった（デュロキセチン群11%対プラセボ群28%）。中等度から重度（グレード2以上）の倦怠感の発現率はデュロキセチン群においてプラセボ群よりも高かった（11%対3%）。
Full Text

A phase III study presented at the American Society of Clinical Oncology's 48th Annual Meeting found that duloxetine is effective in treating painful chemotherapy-induced peripheral neuropathy—a finding that will likely change oncology practice and offers an important new quality of life solution for patients. Duloxetine is currently approved in the United States for the treatment of depression and painful diabetic peripheral neuropathy.

Painful peripheral neuropathy affects 20 to 30 percent of cancer patients treated with taxanes and platinum-based chemotherapy and can be very debilitating. There has been no known effective treatment for peripheral neuropathy, which can lower the quality of life of patients during treatment and sometimes last for years afterwards.

"Duloxetine isn't perfect and didn't work for every patient in our study, but it was effective for a majority of people, and this was the first randomized clinical trial to show that any drug is effective for this terrible pain," said lead study author Ellen M. Lavoie Smith, Ph.D., an assistant professor in the School of Nursing at University of Michigan, Ann Arbor, MI. "We now have a treatment that could improve the quality of life for many of our patients."

In the study, 231 patients who had previously reported high levels of pain from peripheral neuropathy due to taxane or platinum treatment were randomized to duloxetine followed by placebo versus placebo followed by duloxetine.

"The participants took one 30mg capsule daily for one week, followed by two capsules daily (60mg total) for four additional weeks. The gradual dosing was important to reduce the side effects of duloxetine, which can include fatigue, dry mouth, sleepiness, and nausea," Dr. Smith said.

Patients completed a pain survey at the beginning of the study and then weekly. Results were as follows:

  • Patients reporting decrease in pain: 59 percent for duloxetine, 39 percent for placebo.
  • Patients reporting no change in pain: 30 percent for duloxetine, 33 percent for placebo.
  • Patients reporting increase in pain: 11 percent for duloxetine, 28 percent for placebo.

The incidence of moderate to severe (grade 2 or greater) fatigue, the most commonly reported side effect, was higher in the duloxetine arm compared to placebo (11 percent vs. 3 percent).