Patients' Self-Assessment of the Symptoms and Impact of Opioid-Induced Constipation: Results From a Prospective Observational Cohort Study of Japanese Patients With Cancer

Abstract

Context. Many patients who have cancer consider opioid-induced constipation (OIC) to be a burdensome side effect of opioid treatment.Objectives. To evaluate patient-reported outcomes in Japanese patients with cancer pain and OIC.Methods. This prospective observational study evaluated OIC incidence for two weeks in patients with cancer after they initiated strong opioid therapy. Rome IV diagnostic criteria, a physician's diagnosis, spontaneous bowel movements, Bowel Function Index score, and patients' daily self-assessments were used. Changes from baseline in Patient Assessment of Constipation Symptoms and Patient Assessment of Constipation Quality of Life (PAC-QOL) scores were compared between patients with and without OIC. Patients and health care providers (HCPs) completed study-specific questionnaires regarding OIC burden, treatment satisfaction, and patient-provider communications.Results. Among 212 enrolled patients, the incidence of OIC was 47.6% by patients' self-assessments, with a cumulative incidence of 30.2% by Day 3 and 43.5% by Day 7. Patient Assessment of Constipation Symptoms and PAC-QOL overall scores from patients with OIC worsened significantly from baseline compared with patients without OIC by all diagnostic criteria, except for spontaneous bowel movement frequency for PAC-QOL. Patients and HCPs were generally satisfied with OIC treatment; however, 53.5% of patients and approximately 40.0% of HCPs reported that OIC affected pain management. Most patients and HCPs reported that OIC conditions were sufficiently or essentially communicated.Conclusion. After starting opioid therapy, patients recognized OIC onset and its impact on cancer pain management, highlighting the need for effective patient-provider communications, diagnosis, and treatment of OIC to improve QOL for patients with cancer receiving opioid analgesics. J Pain Symptom Manage 2020;59:1043e1051. Ó This article reports patients' self-assessment data from a prospective observational cohort study that evaluated the incidence of OIC in Japanese patients with cancer. The results indicate that patient recognition of OIC occurs rapidly after opioid initiation, and OIC has a negative impact on health-related QOL.

Subcutaneous Methylnaltrexone for Treatment of Opioid-Induced Constipation in Cancer versus Noncancer Patients: An Analysis of Efficacy and Safety Variables from Two Studies

“…In a trial of Japanese patients, quality of life measured 2 weeks after initiation of a strong opioid was significantly reduced among cancer patients with OIC compared with those without OIC. 8 The use of traditional laxatives often fails to adequately manage symptoms associated with OIC because the underlying opioid receptor-mediated mechanism remains untargeted. 2,[9][10][11] OIC occurs as a result of an opioid binding to peripheral μ-opioid receptors in the gastrointestinal tract, leading to abnormal modulation of gastrointestinal secretion and absorption.…”

Opioid-induced constipation in patients with cancer pain in Japan (OIC-J study): a post hoc subgroup analysis of patients with gastrointestinal cancer

“…When using the Rome IV diagnostic criteria, the incidence of OIC was numerically higher in patients with GI cancer (62%), compared with 56% among patients with different cancer types included in the primary OIC-J analysis (n = 212) [10]. In contrast, self-assessed incidence rates of OIC were similar between patient populations: 46% in patients with GI cancer; 48% among patients with different cancer types in the OIC-J study [11].…”

“…The primary results of that study demonstrated that 56% of patients with cancer pain developed OIC within 2 weeks of initiating opioid analgesic therapy, although incidence varied by the type of diagnostic criteria used [10]. A secondary analysis that evaluated patients' self-awareness of OIC found that patients recognized OIC onset after starting opioid analgesic therapy and that OIC affected both pain management and QOL [11]. The OIC-J study enrolled 50 (23.6%) patients with gastrointestinal (GI) cancer (i.e., colon, stomach, or esophageal cancers), providing an opportunity to assess whether tumors of this category have effects on the incidence of OIC [10].…”

Opioid-Induced Constipation in Patients with Cancer Pain in Japan (OIC-J Study): A Post Hoc Analysis

“…In addition, there was a significantly lower incidence of OIC in patients with more bowel movements (BMs; OIC incidence in patients with >7 BMs in the past week vs. 7 BMs vs. 3–5 BMs: 37% vs. 56% vs. 69%, respectively; p = 0.0008) [ 12 ]. Patient self-assessment data in the OIC-J study also demonstrated that Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QOL) scores of patients with OIC worsened significantly from baseline compared with patients without OIC by most diagnostic criteria used [ 13 ]. In addition, 54% of patients and ~40% of HCPs reported that OIC affected pain management; despite this, patients were generally satisfied with their OIC treatment [ 13 ].…”

“…Patient self-assessment data in the OIC-J study also demonstrated that Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QOL) scores of patients with OIC worsened significantly from baseline compared with patients without OIC by most diagnostic criteria used [ 13 ]. In addition, 54% of patients and ~40% of HCPs reported that OIC affected pain management; despite this, patients were generally satisfied with their OIC treatment [ 13 ]. These observations highlight a significant unmet need in the treatment of OIC.…”