• Yukiyoshi Fujita, Hisao Imai, Eriko Hiruta, Takashi Masuno, Shigeki Yamazaki, Hajime Tanaka, Teruhiko Kamiya, Mitsuru Sandoh, Satoshi Takei, Kazuya Arai, Hiromi Nishiba, Junnosuke Mogi, Shiro Koizuka, Taeko Saito, Kyoko Obayashi, Kyoichi Kaira, and Koichi Minato.
• Divisions of Pharmacy, Gunma Prefectural Cancer Center, Ota, Japan.
• J Palliat Med. 2023 Apr 1; 26 (4): 548553548-553.

AbstractBackground: 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.

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