Abstract 1868P
Background
Naloxegol is a peripherally acting, μ-opioid receptor antagonist for treatment of opioid-induced constipation (OIC) observed in up to 63% of patients with cancer. The main objective of this study was to analyze the long-term efficacy and safety of naloxegol in patients with cancer in a real-world study.
Methods
A one-year prospective study was completed. Patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky ≥ 50 were selected. OIC with inadequate response to treatment with laxative (s) was the main diagnostic. All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation quality of life questionnaire (PAC QOL), the patient assessment of constipation symptoms (PAC SYM) and the response rate at day 15, and months 1, 3, 6 and 12.
Results
A total of 126 patients (58.7% males) with a mean age of 61.5 years (95%CI 59.4-63.7) were included. PAC-SYM and PAC-QOL total score and all their dimensions improved from baseline (p<0.0001). At 12 months, 77.8% of the patients were responders to naloxegol treatment. Furthermore, response was obtained in 78.5% of patients without concomitant laxative treatment and 77% of patients with any concomitant laxative. A total of 28 adverse reactions, mainly gastrointestinal, were observed in 15.1% of the patients (19/126), being 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) appeared the first 15 days of treatment.
Conclusions
The results of this first long-term and real-world-data study in patients with cancer, confirm the sustained efficacy and safety of naloxegol for the treatment of OIC in this group of patients.
Clinical trial identification
Editorial acknowledgement
We acknowledge the editorial assistance in the writting of the abstract to E-C-BIO, S.L.
Legal entity responsible for the study
KYOWA KIRIN FARMACÉUTICA, S.L.U.
Funding
KYOWA KIRIN FARMACÉUTICA, S.L.U.
Disclosure
I. Huerta González; A. Sanz Yagüe: Full/Part-time employment: KYOWA KIRIN FARMACÉUTICA, S.L.U. B. Soler López: Advisory/Consultancy: KYOWA KIRIN FARMACÉUTICA, S.L.U. All other authors have declared no conflicts of interest.