Thomas Nolte, Ulf Schutter, Oliver Loewenstein

Strong opioids, including oxycodone, are the most effective analgesics used to combat moderate to severe cancer pain, but opioid-induced bowel dysfunction is a relevant problem associated with the therapy. Clinical studies have demonstrated equivalent analgesic efficacy and improved bowel function in treatment with a fixed combination of prolonged-release (PR) oxycodone and PR naloxone compared to oxycodone alone in patients with nonmalignant pain. Here, we report of a prospective, non-interventional study evaluating the effectiveness and safety of PR oxycodone/PR naloxone in a subgroup of patients with severe cancer pain. Within the non-interventional multicenter study, 1,178 cancer patients with severe chronic pain received PR oxycodone/PR naloxone, dosed according to pain intensity, for 4 weeks. Recorded variables included pain intensity, patient-reported bowel function (Bowel Function Index), and pain-related functional impairment as a measure of quality of life (QoL). During treatment with PR oxycodone/PR naloxone, clinically relevant improvements in pain intensity were observed in opioid-naïve patients and in patients pretreated with weak or strong opioids, as reflected by reductions in pain scores of 51%, 53%, and 33%, respectively. Improvement in analgesia was paralleled by a significant reduction of opioid-induced bowel dysfunction in opioid-pretreated patients. The reductions in the mean Bowel Function Index of -20.5 and -36.5 in patients pretreated with weak and strong opioids, respectively, represent clinically relevant improvements in bowel function. Pain-related functional impairment decreased consistently across all seven domains, which is equivalent to a substantial improvement in QoL. This subgroup analysis of cancer patients within a large non-interventional study demonstrates that treatment with PR oxycodone/PR naloxone provides effective analgesia with minimization of bowel dysfunction and improved QoL. These data extend our knowledge of the effectiveness and tolerability of PR oxycodone/PR naloxone to the population of patients with cancer under real-life conditions.