2079P - Naloxegol for the treatment of opioid-induced constipation in patients with cancer pain: A pooled analysis of real-world studies (NALOPOOL)

Background

We aimed to evaluate the efficacy and safety of naloxegol for opioid-induced constipation (OIC) in cancer patients in a real-life setting.

Methods

We pooled individual patient data from three multicenter observational studies conducted with naloxegol in cancer population. Efficacy outcomes included: response rate at week 4 (≥3 spontaneous bowel movements [SBM] per week and an increase of ≥1 from baseline); clinically relevant improvement (>0.5 points) in the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) and in the Patient Assessment of Constipation Symptoms (PAC-SYM); and clinically relevant improvement in the Bowel Function Index (BFI ≥ 12 points at the endpoint). All analyses were performed using a visitwise approach. Homogeneity was assessed with Cochran's Q test.

Results

393/427 patients were included in the pooled efficacy/safety analyses, with a median age of 64 years and a slight predominance of males (53%). Lung (25%), breast (18%), prostate (9%) and head & neck (6%) were the most common tumor locations. 66% of the patients had metastases, and 53% were receiving chemotherapy. The most common opioids were fentanyl (43%), oxycodone (39%) and morphine (28%), with a median treatment duration of 8.9 weeks. Most patients (83%) received an initial dose of naloxegol of 25 mg and 86% were receiving laxatives at baseline. Efficacy outcomes are presented in the table. Twenty-six (6%) of the 427 patients discontinued treatment due to adverse reactions and 3 (0.7%) patients reported serious adverse reactions. Table: 2079P

Summary of efficacy results

Conclusions

Treatment with naloxegol for the OIC in patients with cancer pain in the real-world setting resulted in a high proportion of responders in the SBM and consistently relevant improvements in the quality of life and constipation symptoms. Naloxegol was well tolerated and safe.

Clinical trial identification

Editorial acknowledgement

Fernando Rico-Villademoros (Apices).

Legal entity responsible for the study

Kyowa Kirin.

Funding

Kyowa Kirin.

Disclosure

M.D.C. Beato Zambrano: Financial Interests, Institutional, Advisory Board: Servier, Leo Pharma, Kyowa Kirin; Financial Interests, Institutional, Research Grant: BMS. A. Lemaire: Financial Interests, Personal, Advisory Board: Kyowa Kirin, Alfasigma; Financial Interests, Personal, Training: Ethypharm. V. Montesarchio: Financial Interests, Institutional, Advisory Board: Amgen S.p.A, Servier, Leo Pharma; Non-Financial Interests, Institutional, Local PI: BMS, Merck, Amgen. J. Sabate: Financial Interests, Personal, Invited Speaker: Mayoly Spindler, Biocodex, SChär, Servier, Tillots, Norgine, Novozymes/Précision Biotics, Kyowa Kirin; Financial Interests, Personal, Advisory Board: Biocodex, Norgine, Novozymes/Précision Biotics, Kyowa Kirin; Financial Interests, Personal, Speaker, Consultant, Advisor: Biocodex, Norgine, Novozymes/Précision Biotics, Kyowa Kirin. J. Serna i Mont-Ros: Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor: Medtronic. R. Namane: Financial Interests, Personal, Full or part-time Employment: Kyowa Kirin. S. Martín Baccarelli: Financial Interests, Institutional, Research Funding: Kyowa Kirin. F. Rico-Villademoros: Financial Interests, Institutional, Writing Engagement: Kyowa Kirin. All other authors have declared no conflicts of interest.