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

Constipation is a concern among patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 3 and 4. To assess naldemedine's efficacy and safety in cancer patients on opioids with poor PS. Multicenter, retrospective study. Japanese cancer patients with ECOG performance status 3 or 4 who received naldemedine. 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. 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,  < 0.0001) and among those who defecated <3 times/week before naldemedine (4.5 vs. 1,  < 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. Naldemedine is effective and safe among cancer patients with poor PS.