One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study

Objectives Naloxegol is a peripherally acting µ-opioid receptor antagonist (PAMORA) for treatment of opioid-induced constipation (OIC). The main objective was to analyse the long-term efficacy, quality life (QOL) and safety naloxegol in patients with cancer real-world study. Methods This one-year prospective study included older than 18 years, active oncological disease who were under opioids pain control Karnofsky≥50 OIC inadequate response laxative (s). All received according clinical criteria. efficacy objectives measured by patient assessment QOL questionnaire (PAC-QOL), PAC symptoms (PAC-SYM), rate at day 15, months 1-3-6-12, global (EuroQoL-5D-5L). Results A total 126 (58.7% males) mean age 61.5 years (95% CI 59.4 63.7) included. PAC-SYM PAC-QOL score all their dimensions improved from baseline (p<0.0001). At 12 months, 77.8% responders treatment. Global conserved baseline. 28 adverse reactions, mainly gastrointestinal observed 15.1% (19/126), being 75% (21) mild, 17.9% (5) moderate 7.1% (2) severe. Most reactions (67.9%) appeared first 15 days Conclusion results this real-world-data cancer, showed sustained group patients.