ESMO Asia Virtual Congress 2020

Abstract 293P

Background

OXN PR, a fixed dose combination of opioid and peripherally-acting mu-opioid antagonist, offers analgesia while reducing opioid-induced constipation (OIC). Few have studied OXN vs other strong opioids for impact on bowel function, safety and QoL in patients with CP.

Methods

Systematic review of literature from PubMed and EMBASE that evaluated analgesia, bowel function, adverse events (AE) and QoL after OXN PR or oral oxycodone (OXY)/morphine/tapentadol PR, or transdermal fentanyl, in adults with moderate-severe CP. Data for outcomes were extracted from publications or clinical study reports.

Results

4 RCTs (OXN vs OXY) were found; no RCT compared OXN vs other strong opioids. Analgesia and safety were comparable with OXN or OXY, except for nausea that was less frequent with OXN (Odds ratio: 0.51 [0.26, 0.97]). Most AEs related to OXN and OXY were mild-moderate severity; most common were gastrointestinal disorders. Improved bowel function (BFI, PAC-SYM) was observed with OXN vs OXY (Table). QoL was comparable with OXN or OXY (Global health status, mean difference: 0.5 [-4.7, 5.7]). Table: 293P

Descriptive findings for bowel function

	RCTs	Findings	OXN vs OXY
BFI
Scores over 4 weeks	2	Δ mean (% improvement)^†	RCT 1: -25.1 (39.2%) vs -13.6 (21.7%) RCT 2: -36.0 (50.7%) vs -25.0 (36.8%)
Score comparison at week 4	1	LS mean difference (SE)	-11.1 (4.00)
95% CI^‡	[-19.0, -3.2]
P value^‡	0.006
PAC-SYM
Total score	1	Δ mean (% improvement)^†	-7.0 (40.3%) vs -2.7 (15.1%)
P-value^§	0.0014
Symptom frequency	1	Δ mean (% improvement)^†	-1.1 (41.9%) vs -0.3 (12.9%)
P value^§	<0.001

^†baseline to week 4 ^‡adjusted for baseline using ANCOVA model. ^§between-group difference; derived from summary statistics LS, least squared.

Conclusions

Systematic review found only direct comparisons of OXN vs OXY in RCTs of CP. OXN provided similar analgesia and safety to OXY for CP with less nausea and improved bowel function, in terms of constipation symptoms. OXN is a valuable analgesic option in patients with OIC or nausea from cancer itself or anticancer treatment. Although limited, this meta-analysis confirms existing evidence on OXN’s efficacy and tolerability in patients with moderate-severe CP and highlights that few data on OXN in CP is available.

Clinical trial identification

Editorial acknowledgement

Editorial assistance was provided by Wei Yi Kwok and Geraldine Toh from Tech Observer Asia Pacific Pte Ltd.

Legal entity responsible for the study

Mundipharma Singapore Holding Pte Ltd.

Funding

Mundipharma Singapore Holding Pte Ltd.

Disclosure

S.H. Ahmedzai: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Mundipharma. L. Langenhoven: Advisory/Consultancy, Speaker Bureau/Expert testimony: Mundipharma. C. Minnaert, Y. Hadjiat: Full/Part-time employment: Mundipharma. All other authors have declared no conflicts of interest.