naloxegol and Cancer-Pain

Topics: Analgesics, Opioid; Cancer Pain; Constipation; Enema; Gastrointestinal Agents; Gastrostomy; Humans; Laxatives; Morphinans; Naltrexone; Piperidines; Polyethylene Glycols; Practice Guidelines as Topic; Quaternary Ammonium Compounds

Topics: Administration, Oral; Analgesics, Opioid; Cancer Pain; Double-Blind Method; Family; Feasibility Studies; Hospice Care; Humans; Morphinans; Narcotic Antagonists; Neoplasms; Opioid-Induced Constipation; Palliative Care; Patient Selection; Polyethylene Glycols

Opioid-induced constipation (OIC) can affect up to 63% of all patients with cancer. The objectives of this study were to assess quality of life as well as efficacy and safety of naloxegol, in patients with cancer with OIC.. An observational study was made of a cohort of patients with cancer and with OIC exhibiting an inadequate response to laxatives and treated with naloxegol. The sample consisted of adult outpatients with a Karnofsky performance status score ≥50. The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) and the Patient Assessment of Constipation Symptoms (PAC-SYM) were applied for 3 months.. A total of 126 patients (58.2% males) with a mean age of 61.3 years (range 34-89) were included. Clinically relevant improvements (>0.5 points) were recorded in the PAC-QOL and PAC-SYM questionnaires (p<0.0001) from 15 days of treatment. The number of days a week with complete spontaneous bowel movements increased significantly (p<0.0001) from 2.4 to 4.6 on day 15, 4.7 after 1 month and 5 after 3 months. Pain control significantly improved (p<0.0001) during follow-up. A total of 13.5% of the patients (17/126) presented some gastrointestinal adverse reaction, mostly of mild (62.5%) or moderate intensity (25%).. Clinically relevant improvements in OIC-related quality of life, number of bowel movements and constipation-related symptoms were recorded as early as after 15 days of treatment with naloxegol in patients with cancer and OIC, with a good safety profile.

Topics: Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Cancer Pain; Cohort Studies; Female; Follow-Up Studies; Humans; Male; Middle Aged; Morphinans; Narcotic Antagonists; Opioid-Induced Constipation; Pain Management; Patient Reported Outcome Measures; Polyethylene Glycols; Quality of Life; Surveys and Questionnaires

Naloxegol, an oral once-daily peripherally acting mu-opioid receptor antagonist, is indicated for the treatment of opioid-induced constipation (OIC) with inadequate response to laxative(s), in cancer and non-cancer patients. This study mainly aimed to assess in real-life conditions the efficacy and safety of naloxegol in cancer pain patients and the evolution of their quality of life.. A non-interventional, 4-week follow-up study was conducted in 24 French oncology and pain centers between 2018 and 2019. Eligible patients were aged ≥ 18 years, treated with opioids for cancer pain, and started naloxegol for OIC with inadequate response to laxatives. The rate of the response to naloxegol (primary criterion) was assessed at W4. The evolution of quality of life was measured using the Patient Assessment of Constipation Quality of Life (PAC-QOL).. A total of 124 patients were included (mean age, 62 ± 12 years; ECOG ≤ 2, 79%; primary cancer, lung 18%, breast 16%, prostate 11%, head and neck 9%, digestive 9%…; metastatic stage, 80%). At inclusion, the median opioid dosage was 60 mg of oral morphine or equivalent. At W4, the response rate was 73.4% (95% CI [63.7-83.2%]), and 62.9% (95% CI [51.5-74.2%]) of patients had a clinically relevant change in quality of life (decrease in PAC-QOL score ≥ 0.5 point). Adverse events related to naloxegol were reported in 8% of patients (7% with gastrointestinal events; one serious diarrhea).. This real-world study shows that naloxegol is effective and well tolerated in cancer pain patients with OIC and that their quality of life improves under treatment.

Topics: Aged; Analgesics, Opioid; Cancer Pain; Constipation; Follow-Up Studies; Humans; Male; Middle Aged; Morphinans; Neoplasms; Opioid-Induced Constipation; Polyethylene Glycols; Quality of Life

Oncologic patients on opioid therapy due to pain may have several side effects, including respiratory depression (in about 1% of cases), pruritus (up to 10% of cases), nausea (in 25-32% of cases), sedation (in 20- 60% of cases); but the most far-reaching side effect (up to 95% of cases) that can occur is constipation. The socalled "opioid-induced constipation" (OIC) can develop at the start of opioid therapy and can last as long as continued use. The OIC is a real change in intestinal habits that occurs when opioid treatment is started; it is noted with a reduced frequency of episodes of defecation, with a development or worsening of the effort to defecation, with a feeling of incomplete emptying and a perception on the part of the patient to live in a stressful way the act of defecation. Also because of this, the OIC can induce to tolerate the dose of opioids routinely causing inadequate pain management. Continuous therapy with opioids lasting at least two weeks and resistance to the treatment of constipation with osmotic laxatives for more than three days in patients with terminal disease (Nota 90 AIFA) allow the prescription of naloxegol, a PEGylated derivative of the naloxone. Naloxegol belongs to the PAMORA family (peripheral mu-opioid receptor antagonists) which does not generally cross the blood-brain barrier and therefore does not interfere with the central nervous system-mediated analgesic efficacy. The reported clinical case tends to show how the use of the drug under examination (naloxegol) solves the problem of the OIC in a oncologic patient, improving her quality of life.

Topics: Analgesics, Opioid; Cancer Pain; Constipation; Female; Humans; Middle Aged; Morphinans; Narcotic Antagonists; Polyethylene Glycols; Quality of Life

Opioid-induced constipation (OIC) is a common gastrointestinal adverse effect of opioids, which can severely affect compliance and adherence to pain medication regimens and quality of life. Naloxegol has demonstrated efficacy against OIC in several studies involving patients with nonmalignant chronic pain. Here we report efficacy and tolerability of naloxegol in a 68-year-old patient with metastatic lung cancer and severe pain, treated with opioids, who presented with OIC resistant to traditional measures. Addition of naloxegol produced rapid improvement in his OIC symptoms and no apparent adverse effects while taking extended-release morphine 130 mg orally every 12 hours.

Topics: Aged; Analgesics, Opioid; Cancer Pain; Constipation; Humans; Lung Neoplasms; Male; Morphinans; Morphine; Narcotic Antagonists; Polyethylene Glycols; Quality of Life

Opioid-induced bowel dysfunction wich comprises several other gastrointestinal complaints; could be highly debilitating, thus significantly deteriorating patients' quality of life. In particular, opioid-induced constipation (OIC) is the most frequent symptom. Therefore patients with haematological malignances need special attention of these disabling symptoms, which should be prevented by a correct evaluation of diet, age, intestinal habits, history of prior bowel disorders as well as constipating effects of other concomitant medication. However the occurrence of OIC during treatment with opioids requires pharmacological interventions. If these measures are not sufficient to regulate intestinal functions, required to pharmacological interventions, can be used osmotic laxatives. New emerging approved agents such as naloxone pegylate (naloxegol) indicated for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to osmotic laxatives for more than 3 days in patients on opioids for at least 2 weeks. Here we report the case of patient treated with this new molecule both to test its efficacy and to dispel any doubt about the possibility of worsening of pain control linked to the use of this new molecule.

Topics: Aged; Analgesics, Opioid; Cancer Pain; Constipation; Hematologic Neoplasms; Humans; Laxatives; Male; Morphinans; Narcotic Antagonists; Polyethylene Glycols; Quality of Life