Analysis of the efficacy of naloxegol in a real-world 12 weeks of follow-up study, in patients with cancer and opioid-induced constipation with laxative-inadequate response

Abstract

Background: Naloxegol is a peripherally acting, micro-opioid receptor antagonist for treatment of opioid-induced constipation (OIC). The main objective of this study was to analyze the efficacy of naloxegol in patients with cancer in a real-world prospective study. Method(s): An observational, one year of follow-up study was conducted in 16 Spanish centers. Patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control were selected. OIC with inadequate response to treatment with laxative (s) was the main diagnostic. The patients received treatment with naloxegol according to clinical criteria. Efficacy was assessed measuring the response rate and symptoms evolution measured by means of PAC-SYM questionnaire. Data of an intermediate analysis after 12 weeks of treatment are analyzed. Result(s): A total of 126 patients were included in the study and 68 of them in this interim efficacy analysis. About 58.2% were men, with an average age of 61.3 years (34-89). Lung cancer was observed in 35.7%, breast cancer in 15.1% and 8,7% had prostate cancer. About 75.5% had metastases. Naloxegol at doses of 12.5 mg/day was administered to 14.7% and 25 mg/day to 85.3%. Concomitant laxatives were administered to 63.2% of the patients. At 12 weeks, 88.2% of the patients were responders to naloxegol treatment: 80% at doses of 12.5 mg/day, and 89.7% with 25 mg/day. Furthermore, 75% of patients without concomitant laxative treatment were responders with 12.5 mg/day dose of naloxegol and 90.5% were responders with 25 mg/day. A total of 24 adverse reactions appeared in 13.5% of the patients (17/126). Conclusion(s): The results of this first real-world-data study in patients with cancer confirm the efficacy of naloxegol for the treatment of OIC in this group of patients. Naloxegol is safe and well tolerated in oncologic patients. Legal entity responsible for the study: Kyowa Kirin Farmaceutica, S.L.U. Madrid, Spain. Funding(s): Kyowa Kirin Farmaceutica, S.L.U. Disclosure: A.J. Jimenez Lopez: Full / Part-time employment: Kyowa Kirin Farmaceutica, S.L.U. I. Huerta Gonzalez: Full / Part-time employment: Kyowa Kirin Farmaceutica, S.L.U. A. Sanz Yague: Full / Part-time employment: Kyowa Kirin Farmaceutica, S.L.U. B. Soler Lopez: Advisory / Consultancy: Kyowa Kirin Farmaceutica, S.L.U. All other authors have declared no conflicts of interest.Copyright © 2019 European Society for Medical Oncology