November 29, 2022

CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN). Authors: Ellen M. Lavoie Smith, Herbert Pang, Constance Cirrincione, Stewart Barry Fleishman, et al.

These are the tingling side effects but sometimes lead to dysfunction in everyday activities such as buttoning shirts or blouses or tying shoes and these are an important quality of life concern for our patients and we have a presentation from dr. ellen smith an assistant professor at the school of nursing at the university of michigan on this subject dr. smith thank

You dr. volkow zhang and so i was going to begin with a brief explanation of what is chemotherapy-induced peripheral neuropathy and so you’ve already heard this is a type of nerve damage that can occur as a result of the of the treatment with certain neurotoxic chemotherapeutic agents the symptoms can be painful numbness tingling and electric shock type symptoms

That tend to occur mainly in the feet in the hands the problem is that although these chemotherapeutic agents can definitely prolong the lives of patients and potentially cure patients there are some that end up with this chronic debilitating problem and by chronic i mean that some patients endure this painful neuropathy for months and possibly for as long as

Years following completion of chemotherapy and so it’s chronic it’s very distressing and disabling and then in addition there really is nothing to date that we know is effective in treating this problem and so our study was designed to test whether duloxetine which is an antidepressant at 60 milligrams a day would be effective in decreasing painful neuropathy

Caused by to chemotherapeutic agents specifically paclitaxel and oxalic platon we were also interested in assessing the side effects of duloxetine as well as its effect on functional status and quality of life this slide illustrates some of our results related to two main pane outcomes the blue line in both of these white boxes reflect the data obtained from

The patients who received placebo i’m sorry receive duloxetine and the red line reflects the data from the patients who received placebo in this first white box you can see that the mean pain scores decreased in both groups but decreased to a greater degree in the patients who receive duloxetine in the second white box you can see that again compared to placebo

The duloxetine treated patients had a greater decrease in the amount that pain interfered with some very important things with general activity mood walking normal work relations with people sleep and enjoyment of life this slide illustrates the percentages of people who responded or who didn’t respond to the walks a team as reflected in the red bars you can see

That fifty-nine percent of patients had a decrease in their pain as a result of duloxetine treatment the placebo group also experienced a decrease in pain however to a lesser degree than the duloxetine patients it is generally accepted that a thirty percent decrease in pain is clinically significant meaning that that’s important to patients thirty-three percent

Of patients in the duloxetine group had at least a thirty percent decrease in pain and twenty-one percent of patients had at least a fifty percent decrease in pain unfortunately there is no drug that is completely effective for everyone pain actually increased in eleven percent of duloxetine treated patients or remained unchanged in thirty percent this slide

Illustrates that duloxetine was extremely well tolerated the most common side effects were fatigue which occurred in seven percent of patients insomnia nausea samuel ins and dizziness as indicated by the red bars you can see that the incidence of these side effects in our study were somewhat less than the incidents reported in two other studies where duloxetine

Had been tested for the treatment of diabetic related painful neuropathy most of these side effects were considered to be moderate seven percent of patients reported severe side effects and eleven percent of patients dropped out because of side effects so in conclusion we can say that duloxetine at 60 milligrams a day is the first drug to be shown to be effective

In painful chemotherapy-induced peripheral neuropathy based on the results of a randomized control trial it decreases chronic cip and pain severity and the majority of patients who take it it improves function and quality of life it’s very well tolerated and we can say that there are fewer side effects associated with a lower starting dose what i neglected to say

Is that in our study patients were started on 30 milligrams before ramping up to 60 milligrams which is in contrast to the other two studies where patients were started on 60 milligrams immediately and then lastly i’d like just to say a few words about where we’re thinking we’re going to take this and so as i mentioned not everyone responded to duloxetine because

Duloxetine works by increasing the amount of some pain inhibiting neurotransmitters or chemicals in the brain we think that possibly patients who respond might be patients who have some abnormality and the way their brain processes pain possibly because they may not have as much of these pain and ebony neurotransmitters so our work to date will try to predict or

To identify who might respond so that we can target the use of this drug to the people who are most likely to benefit thank you

Transcribed from video
Ellen M.: CALGB 170601 By Oncoletter