Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

1445 - Efficacy and Tolerability of Naldemedine in Patient with Cancer and Opioid-Induced Constipation: A Pooled Subgroup Analysis of 2 Randomized Placebo Controlled Studies

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Topics

Supportive Care and Symptom Management

Tumour Site

Presenters

Eriko Satomi

Citation

Annals of Oncology (2018) 29 (suppl_8): viii603-viii640. 10.1093/annonc/mdy300

Authors

E. Satomi1, H. Ishiki2, T. Yokota3, Y. Tada4, H. Sato5, M. Okamoto6, I. Osaka7

Author affiliations

  • 1 Palliative Medicine, National Cancer center Hospital, 1040045 - Tokyo/JP
  • 2 Palliative Medicine, National Cancer Center Hospital, Tokyo/JP
  • 3 Project Management, SHIONOGI & CO., LTD, Osaka/JP
  • 4 Biostatistics Center, SHIONOGI & CO., LTD, Osaka/JP
  • 5 Medical Affairs, Shionogi & CO., Ltd., 530-0012 - Osaka/JP
  • 6 Medical Affairs, SHIONOGI & CO., LTD, 530-0012 - Osaka/JP
  • 7 Palliative Medicine, Shizuoka Cancer Center Hospital, Tokyo/JP
More

Resources

Abstract 1445

Background

Opioid-Induced Constipation (OIC) is a common side effect of opioid analgesic therapy. Naldemedine (NAL), an orally available peripherally-acting μ-opioid receptor antagonist (PAMORA), has been shown to improve OIC without affecting analgesic effect of opioids across several clinical studies. However, the predictive factors determining the response to OIC treatment have not been elucidated. We conducted a subgroup analysis with the pooled data to explore the predictive factors in patient population for the efficacy and safety of NAL.

Methods

Data were pooled from 2 randomized, double-blinded, placebo (PBO)-controlled studies of NAL 0.2mg QD (Ph2b and Ph3) for cancer patients (JapicCTI-132340, JapicCTI-111510). Subgroup analysis (age, BMI, gender, opioid type or dosage, concomitant laxatives, with or without anti-cancer therapy, with or without possible disruption of blood brain barrier (BBB)) of spontaneous bowel movement (SBM) responder rate (percentage of patients with ≥ 3 SBMs/week and an increase from baseline of ≥ 1 SBM/week) was conducted. Overall safety and the incidence of diarrhea were evaluated. The pain intensity numerical rating scale (NRS) and clinical opiate withdrawal scale (COWS) were also analyzed in the population with or without possible BBB disruption.

Results

SBM responder rate was 73.5% (114 of 155 patients) for the NAL group and 35.5% (54 of 152 patients) for the PBO group for all subjects. The difference between the groups was 38.0% and was statistically significant (P < 0.0001). In the subgroup analysis, the difference of proportion between NAL vs PBO for each efficacy and safety endpoint was consistent across all subgroups (The all point estimates were greater than zero). Although the difference of the incidence of diarrhea between the groups was relatively larger in the possible disruption of BBB group, there was no difference between with or without possible BBB disruption for NRS and COWS.

Conclusions

Overall, this analysis of subgroups supported that the benefits of NAL were observed regardless of background factor, and its safety profile in various subgroups was consistent with that observed in the overall population.

Clinical trial identification

JapicCTI-132340, JapicCTI-111510.

Legal entity responsible for the study

Shionogi & Co., Ltd.

Funding

Shionogi & Co., Ltd.

Editorial Acknowledgement

Disclosure

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

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.