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Lung Cancer |

Effectiveness of Methylnaltrexone Bromide as a Treatment for Opioid-Induced Constipation in Non-small Cell Lung Cancer (NSCLC) Patients

Ioannis Dimitroulis, PhD; Sofia Vasileiou, MD; Adamantia Liapikou, MD; Michail Toumbis, PhD
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"Sotiria" Hospital for Thoracic Diseases, Athens, Greece


Chest. 2015;148(4_MeetingAbstracts):593A. doi:10.1378/chest.2225917
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Abstract

SESSION TITLE: Lung Cancer Treatment Posters

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM

PURPOSE: 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 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.

METHODS: Thirty four 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.

RESULTS: In the MB group after one injection, sixteen patients (73%) had a bowel movement within four hours compared with four placebo patients (18%), p=0.02. Six 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 100%. The more severe the constipation, the higher the response with MB. The overall rate of adverse events was similar in the MB (42%) and placebo groups (41%). In the MB group, the most commonly reported adverse events were abdominal pain (16%), flatulence (15%), vomiting (11%), and nausea (12%). 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.

CONCLUSIONS: 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 the constipation, the higher the response with MB. There were no serious adverse events. We conclude that Methylnaltrexone Bromide is effective and safe.

CLINICAL IMPLICATIONS: Doctors often face the problem of major constipation in NSCLC receiving opioids to alleviate pain. The use of MB which does not require hospitalization can prove effective in patients who were previously treated unsuccessfully with another laxative regimen. This has a direct impact on the quality of life of those patients.

DISCLOSURE: The following authors have nothing to disclose: Ioannis Dimitroulis, Sofia Vasileiou, Adamantia Liapikou, Michail Toumbis

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