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

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ORIGINAL ARTICLE

Opioid‑induced constipation in patients with cancer pain in Japan (OIC‑J study): a post hoc subgroup analysis of patients with gastrointestinal cancer Toshiyuki Harada1 · Hisao Imai2,3 · Soichi Fumita4 · Toshio Noriyuki5 · Makio Gamoh6 · Masaharu Okamoto7 · Yusaku Akashi4 · Yoshiyuki Kizawa8 · Akihiro Tokoro9  Received: 12 May 2020 / Accepted: 17 September 2020 © The Author(s) 2020

Abstract Background  Constipation 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. Methods  Patients 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. Results  Fifty 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). Conclusions  This 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 Information  Coauthor Makio Gamoh is deceased. Keywords  Cancer pain · GI cancer · Observational study · Opioid-induced constipation · OIC-J Electronic supplementary material  The online version of this article (https​://doi.org/10.1007/s1014​7-020-01790​-y) contains supplementary material, which is available to authorized users. * Akihiro Tokoro [email protected] 1



Center for Respiratory Diseases, JCHO Hokkaido Hospital, Sapporo, Japan

2



Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Gunma, Japan

3

Department of Respiratory Medicine, International Medical Center, Comprehensive Cancer Center, Saitama Medical University, Hidaka, Saitama, Japan



4



Department of Medical Oncology, Kindai University Nara Hospital, Nara, Japan

5



Department of Surgery, Onomichi General Hospital, Onomichi, Hiroshima, Japan

6



Department of Medical Oncology, Osaki Citizen Hospital, Miyagi, Ja