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M. Toumbis



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    P3.01 - Advanced NSCLC (ID 621)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.01-077 - Effectiveness of Methylnaltrexone Bromide in Opioid-Induced Constipation in Advanced NSCLC Patients (ID 7900)

      09:30 - 09:30  |  Author(s): M. Toumbis

      • Abstract

      Background:
      Methylnaltrexone Bromide (MB) is a selective antagonist of opioid binding at the mu-receptor (μ or MOR receptor). Constipation is a quite common side effect in Non-Small-Cell-Lung-Cancer (NSCLC) patients receiving opioids for chronic pain, usually due to skeletal metastases. We set out to investigate if MB is effective in those patients who received opioids and complained of constipation.

      Method:
      Sixty-eight NSCLC patients with a life expectancy of at least three months were recruited for our study after providing written consent. All patients received either fentanyl as a transdermal patch, in its inhaled form or per os. Patients were randomized (1:1) to four weeks of treatment with either MB 12mg/0.6ml (n=22) administered subcutaneously (sc) or a placebo, on alternate days. We recorded the number of patients who defecated within four hours of the MB or placebo injection, and the number of patients needing a second dose of MB or placebo within six hours from the first dose. We recorded the side effects of this treatment. Patients were not allowed to use other laxatives.

      Result:
      In the MB group after one injection, fifty one patients (75%) had a bowel movement within four hours compared to nine placebo patients (13%), p=0.02. Fifteen patients in the MB group had a bowel movement after two or more doses of MB, raising the percentage of patients who responded to MB to 96%. The more severe the constipation, the higher the response with MB. The overall rate of adverse events was similar in the MB (43%) and placebo groups (42%). In the MB group, the most commonly reported adverse events were abdominal pain (16%), flatulence (16%), vomiting (11%), and nausea (13%). Most treatment related adverse events were rated as mild or moderate by the patients. Discontinuation due to adverse events occurred in 5% and 6% of patients in the MB and placebo groups, respectively.

      Conclusion:
      Methylnaltrexone Bromide has been shown to be superior to placebo in achieving defecation within a short time, in NSCLC patients with opioid-induced constipation, The more severe constipation, the higher the response with MB. There were no serious adverse events. We conclude that Methylnaltrexone Bromide is effective, safe and superior to other commonly used laxatives.