RT Journal Article
T1 One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study
A1 Cobo Dols, Manuel
A1 Beato Zambrano, Carmen
A1 Cabezon-Gutierrez, Luis
A1 Chicas-Sett, Rodolfo
A1 Blancas Lopez-Barajas, Maria Isabel
A1 Garcia Navalon, Francisco Javier
A1 Fírvida Pérez, José Luis
A1 Serrano Bermudez, Gala
A1 Togores Torres, Pilar
A1 Delgado-Mingorance, Juan I.
A1 Giraldo Marin, Alexandra
A1 Libran Oriol, Anna
A1 Paredes Lario, Alfredo
A1 Sanchez Maurino, Pedro
A1 Higuera Gomez, Oliver
A1 Moreno Munoz, Diana
A1 Huerta Gonzalez, Ibone
A1 Sanz-Yague, Almudena
A1 Soler Lopez, Begona
AB Objectives Naloxegol is a peripherally acting mu-opioid receptor antagonist (PAMORA) for treatment of opioid-induced constipation (OIC). The main objective was to analyse the long-term efficacy, quality of life (QOL) and safety of naloxegol in patients with cancer in a real-world study. Methods This one-year prospective study included patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky >= 50 and OIC with inadequate response to treatment with laxative (s). All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation QOL questionnaire (PAC-QOL), the PAC symptoms (PAC-SYM), the response rate at day 15, and months 1-3-6-12, and global QOL (EuroQoL-5D-5L). Results A total of 126 patients (58.7% males) with a mean age of 61.5 years (95% CI 59.4 to 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. Global QOL was conserved from baseline. 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. Conclusion The results of this first long-term and real-world-data study in patients with cancer, showed the sustained efficacy and safety of naloxegol for the treatment of OIC in this group of patients.
PB BMJ Publishing Group
SN 2045-435X
YR 2021
FD 2021-03-11
LK https://hdl.handle.net/20.500.13003/19729
UL https://hdl.handle.net/20.500.13003/19729
LA eng
NO Dols MC, Zambrano CB, Cabezon-Gutierrez L, Chicas-Sett R, Lopez-Barajas MIB, Navalon FJG, et al. One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study. BMJ Support Palliat Care. 2021 Mar 11;0:1-9.
DS Docusalut
RD 7 may. 2026