Clinical Factors associated with satisfaction of cancer patients for the treatment of opioid-induced constipation: A post hoc analysis utilizing ou...

Date 24 November 2018
Event ESMO Asia 2018 Congress
Session Poster display - Cocktail
Topics Supportive Measures
Palliative Care
Presenter Hiroto Ishiki
Citation Annals of Oncology (2018) 29 (suppl_9): ix129-ix138. 10.1093/annonc/mdy444
Authors H. Ishiki1, E. Satomi1, Y. Tada2, T. Yokota3, H. Sato4, M. Okamoto5, I. Osaka6
  • 1Department Of Palliative Medicine, National Cancer Center, 1040045 - Tokyo/JP
  • 2Biostatistics Center, Shionogi & Co., Ltd, 530-0012 - Osaka/JP
  • 3Global Project Management, Shionogi & Co., Ltd, 530-0012 - Osaka/JP
  • 4Global Medical Affairs, Shionogi & Co., Ltd, 530-0012 - Osaka/JP
  • 5Medical Affairs, Shionogi & Co., Ltd, 530-0012 - Osaka/JP
  • 6Department Of Palliative Medicine, Shizuoka Cancer Center, Shizuoka/JP



Naldemedine (NAL) is an oral peripherally acting μ-opioid receptor antagonist available for treatment of opioid-induced constipation (OIC). A Phase 3 randomized placebo-controlled study in cancer patients with OIC in Japan (COMPOSE-4 study) showed that NAL increased the number of bowel movements (BMs) and improved the symptoms of BMs (eg. feeling of incomplete evacuation, straining), improved patient satisfaction and decreased the number of rescue laxative use. NAL was generally well-tolerated in this study, although diarrhea was a most common adverse event. In this analysis, we explored associated factors of patient satisfaction.


Post hoc analyses were conducted using data from COMPOSE-4 study (JapicCTI-111510). We evaluated the relationship between patients’ satisfaction (satisfaction domain of the Patient Assessment of Constipation-QOL (PAC-QOL)) and changes from baseline in five factors; 1) frequency of BM, 2) frequency of rescue laxative, 3) proportion of complete evacuation, 4) proportion of straining, and 5) proportion of Bristol Stool Scale (BSS) score 6 or 7 (mushy or watery stool), by applying multiple linear regression model adjusted for baseline score of PAC-QOL satisfaction domain to data in both NAL and placebo groups. The level of significance was set at 0.05.


A total of 186 patients (92 in NAL group and 94 in placebo group) were included in this analysis. The increases in the frequency of BM (positive association, partial r2=0.073), the proportion of complete evacuation (positive association, partial r2=0.053) and the proportion of BSS 6 or 7 (negative association, partial r2=0.029) were significantly associated with the improvement in the satisfaction domain score of PAC-QOL. However, there was no statistical significant association with the frequency of rescue laxative use and proportion of straining.


The results suggested that the increase of BM and improvement of incomplete evacuation by NAL could provide positive impact on the patient satisfaction for the treatment of OIC for cancer patients, while the proportion of BSS 6 or 7 had negative association with the satisfaction.

Editorial acknowledgement

Clinical trial identification

JapicCTI-111510 (2011/5/31).

Legal entity responsible for the study

Shionogi & Co., Ltd.


Shionogi & Co., Ltd.


Y. Tada: Employee: Shionogi & Co., Ltd. T. Yokota, H. Sato, M. Okamoto: Employee: Shionogi & Co., Ltd. I. Osaka: Honoraria for lecturing: Sionogi & Co., Ltd. All other authors have declared no conflicts of interest.