KEY TAKEAWAYS
- The phase II trial aimed to evaluate OXN PR versus OXY PR in cancer patients with OIC, aligning with ESMO OIC reduction guidelines for efficacy.
- The primary efficacy endpoints were BFI and BPI-SF.
- OXN PR showed similar effectiveness to OXY PR, backed by a statistically significant enhancement in bowel function, reinforcing the positive benefit/risk in Asians.
ESMO guidelines highlight opiate/naloxone (OXN) benefits in reducing OIC risk. OXN prolonged-release tablets (PR) offer comparable efficacy and improved bowel function over oxycodone (OXY) PR. Shiying Yu and the other members aimed to evaluate the effectiveness of OXN PR in managing constipation and pain in advanced cancer, aligning with ESMO guidelines.
The primary efficacy endpoints included the Bowel Function Index (BFI) and Brief Pain Inventory-Short Form (BPI-SF). In contrast, key secondary endpoints were laxative usage (bisacodyl tablets), rescue analgesia (morphine sulfate), quality of life (QoL) (EQ-5D), and safety assessments.
About 232 participants were randomly assigned, with 117 in the OXN PR group and 115 in the OXY PR group. After 4 weeks, the average pain measured by BPI-SF was comparable between the OXN PR and OXY PR groups. The difference in average BFI at 4 weeks did not show statistical significance between the two treatment groups (FAP, p=0.482). In the OXN PR group, BFI was reduced after 1 week compared to baseline (13.5 points vs. 8.8 points in the OXY PR group; p=0.039). An exploratory post-hoc analysis confirmed these results, favoring OXN PR regarding BFI difference.
Laxative usage was similar in both groups, but a higher percentage of patients required laxatives in the OXY PR group at all visits compared to the OXN PR group. The average daily dose and the percentage of patients taking rescue analgesia were comparable at 4 weeks. EQ-5D assessment indicated a minor improvement in the OXN PR group and a decline in the OXY PR group, although this difference was not statistically significant. Fewer adverse events were reported in the OXN PR group (17.5% vs. 27.0% in the OXY PR group), and no treatment-related serious adverse events (TRAEs) were reported in the OXN PR group.
The results showed that XN PR has efficacy comparable to OXY PR. Statistical confirmation through a post-hoc analysis (P=0.039) supports the numerical observations of improved bowel function. This study supports the positive benefit/risk profile of OXN PR in the Asian population. Research was sponsored by Mundipharma Research GmbH & Co KG.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/78
Clinical Trial: https://clinicaltrials.gov/study/NCT00513656
Yu S, Xie G, Zhang Q, et al. (2023) ‘’Oxycodone/naloxone in moderate-to-severe cancer pain: A phase III study in China.’’ Presented at ESMO ASIA 2023 (456P).
