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ObjectivesOpioid-induced constipation (OIC) can affect up to 63% of all patients with cancer. The objectives of this study were to assess quality of life as well as efficacy and safety of naloxegol, in patients with cancer with OIC.MethodsAn observational study was made of a cohort of patients with cancer and with OIC exhibiting an inadequate response to laxatives and treated with naloxegol. The sample consisted of adult outpatients with a Karnofsky performance status score ≥50. The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) and the Patient Assessment of Constipation Symptoms (PAC-SYM) were applied for 3 months.ResultsA total of 126 patients (58.2% males) with a mean age of 61.3 years (range 34–89) were included. Clinically relevant improvements (>0.5 points) were recorded in the PAC-QOL and PAC-SYM questionnaires (pConclusionsClinically relevant improvements in OIC-related quality of life, number of bowel movements and constipation-related symptoms were recorded as early as after 15 days of treatment with naloxegol in patients with cancer and OIC, with a good safety profile.

The identification of patients with advanced and complex chronic diseases, and the fragmentation of care towards the end of life, requires the drawing up a long-term therapeutic plan. This should take into account the values and preferences of the patients, as well as the vital and functional prognosis. Having an adjustment tool for determining the diagnostic and therapeutic effort is helpful in the continuity of care, as well as in decision-making in the transitions and dynamic changes of patients as they approach the end of life process.

ObjectivesNaloxegol 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 of life (QOL) and safety of naloxegol in patients with cancer in a real-world study.MethodsThis 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).ResultsA 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 (pConclusionThe 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.

e24155 Background: Naloxegol is a peripherally acting, µ-opioid receptor antagonist for treatment of opioid-induced constipation (OIC). The main objective of this study was to analyze the efficacy and safety of naloxegol in patients with cancer in a real-world 12-month follow-up study. Methods: An observational prospective 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 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. Efficacy was measured by the response rate and symptoms evolution measured by means of PAC-SYM questionnaire. Intensity of pain was measured by a 0-10-point visual analogue scale (VAS). Intent to treat last observation carried forward was applied. Results: A total of 126 patients were included in the study. About 58.7% were men, with a mean age of 61.5 years (34-89). Lung cancer was observed in 35.7%, breast cancer in 16.7%, 10.3% digestive cancer and 8.7% had prostate cancer. About 67.5% had metastases. Naloxegol at doses of 25 mg/day was administered to 88.1% and with concomitant laxatives in 48.4%. At 12 months, 77.8% of the patients were responders to naloxegol treatment: 78.6% at doses of 12.5 mg/day, and 78.4% with 25 mg/day. Furthermore, response was observed in 78.5% of patients without concomitant laxative treatment and 77% of patients with any concomitant laxative. PAC-SYM total score and all the dimensions improved from baseline (p < 0.0001). VAS pain intensity was reduced and controlled from baseline onwards (Baseline-12 months: 4.6 to 3.6, p < 0.001). A total of 28 adverse reactions mainly gastrointestinal were observed in 15.1% of the patients (19/126), 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) were observed the first 15 days of treatment with naloxegol. Conclusions: The results of this first real-world-data study in patients with cancer confirm the long-term efficacy of naloxegol for the treatment of OIC in this group of patients. Naloxegol is safe and well tolerated in patients with cancer while maintaining pain control.