Abstract 1866P
Background
This real-world evidence (RWE) treatment study aims to evaluate the use of naloxegol according to usual clinical practice. This preliminary analysis evaluates quality of life (QOL) of naloxegol in patients (pt) with cancer pain diagnosed with opioid-induced constipation (OIC).
Methods
This is a single-arm, open label, multinational, prospective, observational study in adult cancer pts receiving treatment with opioids for at least 4 weeks, diagnosed with OIC, that receive naloxegol in routine clinical practice. Burden of constipation on pt’ functioning and well-being was evaluated by Patient Assessment of Constipation – Quality of Life Questionnaire (PAC-QOL).
Results
One hundred and fifty two pt from 25 European sites were included. Median age was 66 years and 54% were women. Over the 108 pt with at least one PAC-QOL completed after baseline, the improvement in PAC-QOL total score was clinically relevant (≥ 1 point) in 35.2% of the patients. Statistically significant differences were found between last available visit and baseline in PAC-QOL total score and in each of the 5 domains (Table), which indicates improvement in QOL. Most common adverse reactions to naloxegol were abdominal pain (7.9%), diarrhea (2.6%), flatulence (1.3%) and nausea (1.3%), most of them grade 1-2. Only one pt died due to an adverse reaction: intestinal perforation (patient had peritoneal metastases at inclusion). Nine pt had adverse reactions leading to study discontinuation: abdominal pain (5), diarrhea (2), intestinal perforation (1) and fatigue (1). Table: 1866P
Change in PAC-QOL
| Visit 1 | Last visit | Last visit – Visit 1 | |||||
| Mean | SD | Mean | SD | Mean | SD | P-value | |
| Physical discomfort | 2,0 | 1,0 | 1,2 | ,9 | ,8 | 1,0 | < ,001 |
| Psychosocial discomfort | 1,4 | 1,0 | ,7 | ,7 | ,7 | 1,0 | < ,001 |
| Worries and concerns | 2,0 | ,9 | 1,3 | ,8 | ,7 | 1,0 | < ,001 |
| Satisfaction | 2,6 | ,5 | 2,0 | ,6 | ,6 | ,8 | < ,001 |
| Total score | 1,9 | ,7 | 1,3 | ,7 | ,7 | ,8 | < ,001 |
Conclusions
Preliminary results show a clinically and statistically significant improvement in QOL in pts receiving naloxegol in this RWE treatment study in cancer patients during a 4 weeks follow-up period. Naloxegol seems to be generally well tolerated. The most common AEs were gastrointestinal, as expected. Final results will be presented during the congress.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Kyowa Kirin International plc.
Funding
Kyowa Kirin International plc.
Disclosure
A. Fernandez: Full/Part-time employment: Kyowa Kirin International plc. J. Tack: Advisory/Consultancy: AlfaWassermann; Christian Hansen; Danone; Grünenthal; Ironwood; Menarini; Neutec; Noventure; Nutricia; Shionogi; Theravance; Tramedico; Zealand; Advisory/Consultancy, Research grant/Funding (self): Tsumura; Advisory/Consultancy, Speaker Bureau/Expert testimony: Allergan; Janssen; Kiowa Kirin; Mylan; Novartis; Takeda; Truvion; Zeria pharmaceuticals; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Shire; Research grant/Funding (self): Sofar; Speaker Bureau/Expert testimony: Abbott; AstraZeneca; Menarini. A. Davies: Speaker Bureau/Expert testimony, Research grant/Funding (self): Kyowa Kirin. All other authors have declared no conflicts of interest.