Abstract
10089 Background: The prolonged use of opioids is usually associated with the appearance of adverse events as drowsiness, constipation, nausea/vomiting, and dizziness. Some effects are self-limiting over time for the onset of tolerance while others, as constipation, persist. Clinical studies demonstrated that the association oxycodone-naloxone (OXN), reduced the constipation in the presence of unchanged analgesic efficacy. Though, the variability of the analgesic response to OXN is not explained yet. The aim of this study was to evaluate the association between the clinical and genetics factors and analgesics response at OXN. Methods: In this study the cancer patients with moderate to severe pain received OXN and followed for 28 days. At each visit pain intensity modifications of therapy and adverse drug reactions (ADRs) were recorded. The primary efficacy endpoint was the proportion of responders, defined as patients with a decrease of the average pain intensity from baseline to last visit ≥30% and a final average pain score≤4, measured on 0-10 numerical rating scale. Genetic tests to identify SNPs related to opioid response were performed in each patient. Results: 14 centers participated in the study and recruited 206 patients. Among 176 patients analyzed for a primary endpoint the mean age was 68 (SD 10); 56% were male. Average and worst pain intensity decreased from baseline to last visit from 6.2 to 2.9 and from 8.3 to 4.6 respectively. 81% of patients were responders. Digestive system tumors (p = 0.05), concomitant thyroid endocrinopathy (p = 0.023), psychological irritability (p = 0.0029) and breakthrough pain at baseline were found to decrease the risk of positive response. None of the investigated polymorphisms influenced the analgesic response. Moderate to severe intensity ADRs were mainly constipation (26%), drowsiness (19%) and dry mouth (12%). Conclusions: In patients with moderate to severe cancer pain, OXN showed a strong analgesic effect (about 50% pain reduction). In comparison with other studies the induced constipation appears substantially lower. Some clinical factors influence the analgesic response while none genetic polymorphisms modulate the response. Clinical trial information: NCT02293785.
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