Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study

Nishiba, Hiromi; Imai, Hisao; Fujita, Yukiyoshi; Hiruta, Eriko; Masuno, Takashi; Yamazaki, Shigeki; Tanaka, Hajime; Kamiya, Teruhiko; Ito, Masako; Takei, Satoshi; Mogi, Junnosuke; Minato, Koichi; Obayashi, Kyoko

doi:10.3390/jcm11092672

Cited by 8 publications

(8 citation statements)

References 19 publications

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“…A multicenter retrospective study previously published by us evaluated the efficacy and safety of naldemedine for OIC in 149 patients with various cancer types (18). With regard to efficacy, the share of responders was 65.7%, with a significant increase in defecation frequency one week before and after naldemedine administration.…”

Section: Discussionmentioning

confidence: 99%

“…Patients who discontinued treatment within a week of naldemedine administration are also important in safety analysis, and even if discontinuation occurred within a week, adverse events and defecation frequency in the week after naldemedine initiation were counted and evaluated as a whole. The data for the 33 patients included in this analysis are part of the data in a previously published study (18). The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013).…”

Section: Methodsmentioning

confidence: 99%

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Efficacy and safety of naldemedine treatment for opioid-induced constipation in gastrointestinal cancer: a retrospective analysis

Nishiba¹,

Imai²,

Fujita³

et al. 2023

Ann Palliat Med

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Background: Gastrointestinal cancers are one of the most common cancer cases worldwide. Cancer treatment is multidisciplinary, which includes opioid pain management. Opioid analgesics cause opioidinduced constipation (OIC) with the onset of effect. Naldemedine, a peripheral opioid receptor antagonist, is an OIC-modifying agent, but no focused efficacy and safety analysis has been conducted for its use in gastrointestinal cancers.Methods: We retrospectively evaluated patients with gastrointestinal cancer treated with naldemedine at ten institutions in Japan from June 2017 to August 2019. Patients with gastrointestinal cancer who initiated treatment with opioids during hospitalization and were treated with naldemedine for the first time were included in the study. The gastrointestinal cancer types included were esophageal, gastric, small bowel, and colorectal cancers. We assessed the defecation frequency before and after the initiation of naldemedine use.Responders were defined as patients who defecated three or more times/week, with an increase from the baseline of one or more bowel movements/week over seven days after starting naldemedine.Results: Thirty-three patients were observed for one week before and after starting naldemedine. Twentyone patients had an increase in defecation frequency of at least three times per week or at least once per week above the baseline. The response rate was 63.6% (95% CI: 46.6-77.9%). The median number of bowel movements for a week before and after the initiation of naldemedine treatment was 3 (range, 0-13) and 7 (range, 1-39), respectively, in the overall population (n=33), with a significant increase in defecation frequency following naldemedine administration (Wilcoxon signed rank test, P<0.005). Diarrhea was the predominant gastrointestinal symptom, with 13 (39.4%) patients experiencing grade 1 and none experiencing grade 3 or grade 4 adverse events. The frequency of other grade 1 adverse events was low abdominal pain in two patients, nausea in two patients, and anorexia in one patient, without any grade 2-4 adverse events.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Efficacy and safety of naldemedine treatment for opioid-induced constipation in gastrointestinal cancer: a retrospective analysis

Nishiba¹,

Imai²,

Fujita³

et al. 2023

Ann Palliat Med

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“…Overall, 34 patients were enrolled in this study ( Figure S1 ). The data of the 34 patients included in this study have been previously published [ 27 , 28 ]. Patient charts were reviewed for data on patient characteristics, response to naldemedine, and adverse events.…”

Section: Methodsmentioning

confidence: 99%

“…However, to date, those studies have been conducted on carefully selected patients with good performance status (PS) scores and adequate organ function, and no data have been reported on the efficacy and tolerability of naldemedine in patients with hepatobiliary pancreatic cancer. Although we previously evaluated the effectiveness and safety of naldemedine in combination with opioids in clinical practice [ 27 , 28 ], we did not adequately investigate its effectiveness in cancer patients with hepatobiliary pancreatic cancer. Furthermore, to date, there have been no reports focusing on the digestive system and hepatobiliary pancreatic cancer.…”

Section: Introductionmentioning

confidence: 99%

A Retrospective Study of the Efficacy and Safety of Naldemedine for Treatment of Opioid-Induced Constipation in Patients with Hepatobiliary Pancreatic Cancer

Kamiya¹,

Imai

Fujita³

et al. 2023

Medicina

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Background and Objectives: Opioid analgesics, which are used for cancer-related pain management, cause opioid-induced constipation (OIC). Naldemedine, a peripheral opioid receptor antagonist, is an OIC-modifying agent, but no focused efficacy and safety analysis has been conducted for its use in hepatobiliary pancreatic cancers. We performed a multi-institutional study on the efficacy and safety of naldemedine in patients with hepatobiliary pancreatic cancer using opioids in clinical practice. Materials and Methods: We retrospectively evaluated patients with hepatobiliary pancreatic cancer (including liver, biliary tract, and pancreatic cancers) treated with opioids and naldemedine during hospitalization at ten institutions in Japan from June 2017 to August 2019. We assessed the frequency of bowel movements before and after the initiation of naldemedine therapy. Responders were defined as patients who defecated ≥3 times/week, with an increase from a baseline of ≥1 defecations/week over seven days after the initiation of naldemedine administration. Results: Thirty-four patients were observed for one week before and one week after starting naldemedine. The frequency of bowel movements increased by one over the baseline frequency or to at least thrice per week in 21 patients. The response rate was 61.7% (95% confidence interval: 45.4–78.0%). The median number of weekly bowel movements before and after naldemedine treatment was 2 (range: 0–9) and 6 (range: 1–17), respectively, in the overall population (n = 34); the increase in the number of bowel movements following naldemedine administration was statistically significant (Wilcoxon signed-rank test, p < 0.0001). Diarrhea was the predominant gastrointestinal symptom, and 10 (29.4%) patients experienced grade 1, grade 2, or grade 3 adverse events. The only other adverse event included fatigue in one patient; grade 2–4 adverse events were absent. Conclusions: Naldemedine is effective, and its use may be safe in clinical practice for patients with hepatobiliary pancreatic cancer receiving opioid analgesics.

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“… 17 However, previous phase III trials included carefully selected participants (e.g., Eastern Cooperative Oncology Group performance status [ECOG‐PS] ≤ 2, and a cancer condition expected to remain stable for the extent of the study), and data on predictive factors or the detailed course of adverse events were lacking for patients with thoracic cancer. We previously conducted a survey on the use of naldemedine in clinical practice, 23 , 24 but there was insufficient evidence of its efficacy in thoracic cancer. Specifically, there are insufficient data from clinical practice involving patients with thoracic cancer who have poor performance status (PS) or those that are elderly.…”

Section: Introductionmentioning

confidence: 99%

A retrospective study of the efficacy and safety of naldemedine for opioid‐induced constipation in thoracic cancer patients

et al. 2022

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Background We conducted a multicenter, retrospective study on the efficacy and safety of naldemedine in thoracic cancer patients using opioids in clinical practice. Methods We retrospectively evaluated thoracic cancer patients treated with naldemedine at 10 institutions in Japan. Clinical data of patients administered naldemedine between June 2017 and August 2019 were extracted from electronic medical records. Inclusion criteria were as follows: (i) patients hospitalized for at least seven days before and after naldemedine administration, and (ii) those whose frequency of defecation was entered in the medical records. Results Forty patients were analyzed, and defecation frequency was observed for at least seven days before and after naldemedine administration. The response rate was 65.0% (95% CI: 50.2%–79.7%). The number of defecations increased significantly after naldemedine administration in the overall population, as well as among only those who defecated <3 times/week before naldemedine administration, and those that were administered ≥30 mg/day of morphine equivalent. Diarrhea was the most common adverse event in all grades, occurring in 11 patients (27.5%), of which 9 (81.8%) were grade 1 or 2. None of the patients experienced grade 4 or higher adverse events. Conclusion The efficacy and safety of naldemedine for thoracic cancer patients in clinical practice were comparable with those of prospective studies, which suggest that naldemedine may be effective and feasible for most thoracic cancer patients.

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Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study

Cited by 8 publications

References 19 publications

Efficacy and safety of naldemedine treatment for opioid-induced constipation in gastrointestinal cancer: a retrospective analysis

Efficacy and safety of naldemedine treatment for opioid-induced constipation in gastrointestinal cancer: a retrospective analysis

A Retrospective Study of the Efficacy and Safety of Naldemedine for Treatment of Opioid-Induced Constipation in Patients with Hepatobiliary Pancreatic Cancer

A retrospective study of the efficacy and safety of naldemedine for opioid‐induced constipation in thoracic cancer patients

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