Efficacy and Safety of Naldemedine Administration for Opioid-Induced Constipation in Cancer Patients with Poor Performance Status

Background: Constipation is a concern among patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 3 and 4.Objectives: To assess naldemedine's efficacy and safety in cancer patients on opioids with poor PS.Design: Multicenter, retrospective study.Setting/Subjects: Japanese cancer patients with ECOG performance status 3 or 4 who received naldemedine.Measurements: Frequency of defecations before/after naldemedine use. Responders were patients whose defecation frequency increased to >= 3 times/week, from baseline >= 1 defecations/week over seven days after naldemedine administration.Results: Seventy-one patients were analyzed; 66.1% were responders (95% confidence interval: 54.5%-76.1%). Defecation frequency increased significantly after naldemedine in the overall population (6 vs. 2, p < 0.0001) and among those who defecated <3 times/week before naldemedine (4.5 vs. 1, p < 0.0001). Diarrhea (38.0%) of all grades was the most common adverse event; 23 (85.2%) events were classified as Grade 1 or 2.Conclusion: Naldemedine is effective and safe among cancer patients with poor PS.

Automated summary

This multicenter retrospective study aimed to assess the efficacy and safety of naldemedine in cancer patients with ECOG performance status 3 and 4. The results showed that 66.1% of patients responded to naldemedine, and there was a significant increase in defecation frequency for most patients. Diarrhea was the most common adverse event, but most cases were mild or moderate.