Abstract
BackgroundConstipation is a common side effect of opioid therapy. An observational study of opioid-induced constipation (OIC) in Japanese patients with cancer (OIC-J) included 212 patients with various tumor types. This post hoc analysis of OIC-J evaluated a subgroup of patients with gastrointestinal (GI) cancer.MethodsPatients were aged ≥ 20 years, starting strong opioid therapy, had an ECOG PS of ≤ 2, and must have had ≥ 3 bowel movements during the week before enrollment. OIC was evaluated for 2 weeks after opioid initiation using the Rome IV diagnostic criteria for colorectal disorders, as well as physician’s diagnosis, number of spontaneous bowel movements, Bowel Function Index score, and patient’s self-assessment. Relationships between baseline characteristics and OIC incidence, and the effects of OIC on quality of life (QOL) were also explored.ResultsFifty patients from OIC-J who had GI cancer [colon (50%), stomach (28%), and esophageal (22%)] were included. OIC incidence varied by which diagnostic criteria were used (46.0–62.0%) and occurred rapidly after initiating opioid therapy. The use of prophylactic laxatives reduced the overall incidence rate of OIC from 71.0% to 47.4%. No baseline characteristics, except comorbidities, were associated with OIC incidence. Change from baseline to day 15 in PAC-SYM total score was significantly greater for patients with OIC versus those without OIC (0.188 versus −0.362; P = 0.0011).ConclusionsThis post hoc analysis suggests that OIC occurs rapidly in patients with GI cancer after initiating opioid therapy, and negatively impacts QOL. Early and effective intervention strategies may be particularly useful in this group.Additional InformationCoauthor Makio Gamoh is deceased.
Highlights
Patients and MethodsPain is a common and debilitating symptom of cancer that can cause physical and psychological suffering and has a negative impact on quality of life (QOL) [1, 2]
By patients’ self-assessment, the change from baseline to day 15 in Patient Assessment of Constipation Symptoms (PAC-SYM) and in Patient Assessment of Constipation Quality of Life (PAC-QOL) total scores were numerically greater for patients with opioid-induced constipation (OIC) versus those without OIC, they did not reach statistical significance (PAC-SYM, 0.055 versus −0.223; P = 0.1150; PAC-QOL, 0.178 versus −0.047; P = 0.0696) (Supplementary Fig. 1). This is the first report of OIC incidence in patients with GI cancer, providing valuable data for this patient population
The results of this post hoc subgroup analysis of patients with GI cancer from a prospective, observational study demonstrates that the incidence of OIC varied depending on the diagnostic criteria used
Summary
Patients and MethodsPain is a common and debilitating symptom of cancer that can cause physical and psychological suffering and has a negative impact on quality of life (QOL) [1, 2]. The Rome IV diagnostic criteria further defines OIC as new or worsening symptoms of constipation when initiating, changing, or increasing opioid analgesic therapy, and must include two or more of the following symptoms: straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal blockage, use of manual maneuvers to facilitate defecation, and < 3 spontaneous bowel movements (SBMs) per week [8, 9]. Reported estimates for the prevalence of OIC vary widely (22–81%) depending on definitions and diagnostic criteria used and the type of opioid analgesic therapy administered [7] It remains unclear, whether other factors such as cancer type have an impact on the reported incidence of OIC. Conclusions This post hoc analysis suggests that OIC occurs rapidly in patients with GI cancer after initiating opioid therapy, and negatively impacts QOL.
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