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Open Access 13.06.2021 | Original Article

Effectiveness of naloxegol in patients with cancer pain suffering from opioid-induced constipation

verfasst von: Antoine Lemaire, Yoann Pointreau, Bérengère Narciso, François-Xavier Piloquet, Viorica Braniste, Jean-Marc Sabaté

Erschienen in: Supportive Care in Cancer | Ausgabe 12/2021

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Abstract

Purpose

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.

Methods

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).

Results

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).

Conclusion

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.

Bruner HC, Atayee RS, Edmonds KP et al (2015) Clinical utility of naloxegol in the treatment of opioid-induced constipation. J Pain Res 8:289–294. https://doi.org/10.2147/JPR.S61326CrossRefPubMedPubMedCentral

Plante GE, Vanitallie TB (2010) Opioids for cancer pain: the challenge of optimizing treatment. Metabolism 59(Suppl 1):S47–S52. https://doi.org/10.1016/j.metabol.2010.07.010CrossRefPubMed

World Health Organization (2019). WHO guidelines for the pharmacological and radiotherapeutic management of cancer pain in adults and adolescents.https://apps.who.int/iris/bitstream/handle/10665/279700/9789241550390-eng.pdf?ua=1

Fallon M, Giusti R, Aielli F et al (2018) Management of cancer pain in adult patients: ESMO Clinical Practice Guidelines. Ann Oncol 29(Suppl 4):iv166–iv191. https://doi.org/10.1093/annonc/mdy152CrossRefPubMed

Lacy BE, Mearin F, Chang L et al (2016) Bowel disorders. Gastroenterology 150:1393–1407. https://doi.org/10.1053/j.gastro.2016.02.031CrossRef

Abramowitz L, Bezlaud N, Labreze L et al (2013) Prevalence and impact of constipation and bowel dysfunction induced by strong opioids: a cross-sectional survey of 520 patients with cancer pain: DYONISOS study. J Med Econ 16(12):1423–1433. https://doi.org/10.3111/13696998.2013.851082CrossRefPubMed

Framer AD, Drewes AM, Chiarioni G et al (2019) Pathophysiology and management of opioid-induced constipation: European expert consensus statement. United European Gastroenterol J 7(1):7–20. https://doi.org/10.1177/2050640618818305CrossRef

Choi YS, Billings JA (2002) Opioid antagonists: a review of their role in palliative care, focusing on use in opioid-related constipation. J Pain Symptom Manage 24:71–90. https://doi.org/10.1016/s0885-3924(02)00424-4CrossRefPubMed

Fallon MT (1999) Constipation in cancer patients: prevalence, pathogenesis, and cost-related issues. Eur J Pain 3:3–7. https://doi.org/10.1016/S1090-3801(99)90169-6CrossRef

10.

Bell TJ, Panchal SJ, Miakowski C et al (2009) The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1). Pain Med 10(1):35–42. https://doi.org/10.1111/j.1526-4637.2008.00495.xCrossRefPubMed

11.

MASCC. (2020). Consensus on the Core Ideology of MASCC.Definition of supportive care. http://www.mascc.org/index.php?option=com_content&view¼article&id=493:mascc-strategic-plan&catid=30:navigation. Accessed 17 July 2020

12.

Kumar L, Barker C, Emmanuel A (2014). Opioid-induced constipation: pathophysiology, clinical consequences, and management. Gastroenterol Res Pract 141737https://doi.org/10.1155/2014/141737

13.

Chey WD, Webster L, Sostek M et al (2014) Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med 370:2387–2396. https://doi.org/10.1056/NEJMoa1310246CrossRefPubMed

14.

Webster L, Chey WD, Tack J et al (2014) Randomised clinical trial: the long-term safety and tolerability of naloxegol in patients with pain and opioid-induced constipation. Aliment Pharmacol Ther 40(7):771–779. https://doi.org/10.1111/apt.12899CrossRefPubMed

15.

Bull J, Bonsignore L, Massie L et al (2019) Challenges in recruiting patients to a controlled feasibility study of a drug for opioid-induced constipation: lessons from the population with advanced cancer. J Pain Symptom Manage 57(5):E5–E8. https://doi.org/10.1016/j.jpainsymman.2018.09.024CrossRefPubMed

16.

European Medecine Agency.Moventig. Summary of product characteristics. https://www.ema.europa.eu/en/documents/product-information/moventig-epar-product-information_en.pdf. Accessed 10 June 2020

17.

Davies A, Tack J, Fernandez A. Observational study of naloxegol for patients with cancer pain diagnosed with opioid induced constipation. NACASY study preliminary results. 11th congress of the European Pain Federation EFIC. 4–7 September 2019; Valencia, Spain [Abstract A-1021–0090–00546]

18.

Cobo Dols M, Beato Zambrano C, Cabezon Gutierrez L, et al (2020). Efficacy of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: a 3-month follow-up analysis. BMJ Support Palliat Care Published Online First: 06 May 2020. https://doi.org/10.1136/bmjspcare-2020-002249

19.

European Medicines Agency.CHMP (2015). Guideline on the evaluation of medicinal products for the treatment of chronic constipation (including opioid induced constipation) and for bowel cleansing. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-medicinal-products-treatment-chronic-constipation-including-opioid-induced_en.pdf

20.

Rentz AM, Yu R, Muller-Lissner S et al (2009) Validation of the bowel function index to detect clinically meaningful changes in opioid-induced constipation. J Med Econ 12(4):371–383. https://doi.org/10.3111/13696990903430481CrossRefPubMed

21.

Frank L, Kleinman L, Farup C et al (1999) Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol 34(9):870–8777. https://doi.org/10.1080/003655299750025327CrossRefPubMed

22.

Marquis P, De La Loge C, Dubois D et al (2005) Development and validation of the patient assessment of constipation quality of life questionnaire. Scand J Gastroenterol 40:540–551. https://doi.org/10.1080/00365520510012208CrossRefPubMed

23.

Yiannakou Y, Tack J, Piessevaux H et al (2017) The PAC-SYM questionnaire for chronic constipation: defining the minimal important difference. Aliment Pharmacol Ther 46(11–12):1103–1111. https://doi.org/10.1111/apt.14349CrossRefPubMedPubMedCentral

24.

Lemaire A (2019) Modeling cancer pain: “the times they are a-changin.” Support Care Cancer 27(8):3091–3093. https://doi.org/10.1007/s00520-019-04832-yCrossRefPubMed

25.

Lemaire A, George B, Maindet C, Burnod A, Allano G, Minello C (2019) Opening up disruptive ways of management in cancer pain: the concept of multimorphic pain. Supportive Care in Cancer 27:3159–70. https://doi.org/10.1007/s00520-019-04831-zCrossRefPubMed

Titel: Effectiveness of naloxegol in patients with cancer pain suffering from opioid-induced constipation
verfasst von: Antoine Lemaire
Yoann Pointreau
Bérengère Narciso
François-Xavier Piloquet
Viorica Braniste
Jean-Marc Sabaté
Publikationsdatum: 13.06.2021
Verlag: Springer Berlin Heidelberg
Erschienen in: Supportive Care in Cancer / Ausgabe 12/2021
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-021-06299-2

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Effectiveness of naloxegol in patients with cancer pain suffering from opioid-induced constipation