Amato, F., Ceniti, S., Mameli, S., Pisanu, G., Vellucci, R., Palmieri, V., . . . Pisanu, G.M. (2017). High dosage of a fixed combination oxycodone/naloxone prolonged release: Efficacy and tolerability in patients with chronic cancer pain. Supportive Care in Cancer, 25, 3051–3058.

To evaluate the efficacy and tolerability of high-dose oxycodone-naloxone (OXN-PR) in chronic cancer pain.

Patients aged 18 years or older with chronic cancer pain of moderate to severe intensity on analgesic therapy and/or who were intolerant to pain medications due to gastrointestinal side effects were switched to OXN-PR. Intensity of pain was measured on a 0 to 10 numerical rating scale. Patients were prescribed oral OXN-PR for pain control at the first visit with doses equivalent to morphine dosage. All patients were evaluated by trained clinicians at baseline and after 14, 30, 45, and 60 days. Components of the evaluation included quality of life, symptoms of constipation, and safety evaluations.

• N: 119 entered; 101 final  
• AGE: 28-94 years old (median = 64 years) 
• MALES: 61.3%  
• FEMALES: 38.7% 
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Pulmonary, GI, and GU cancers. 
• OTHER KEY SAMPLE CHARACTERISTICS: 91.6% with metastatic disease; 75.6% with bone involvement.

• SITE: Multi-site (seven pain centers)   
• SETTING TYPE: Outpatient    
• LOCATION: Italy

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care, palliative care

Multicenter, prospective 60-day observation on consecutive patients with cancer with uncontrolled moderate to severe chronic pain or intolerant to other analgesics.

Brief Pain Inventory Short Form 7; Bowel Function Index; 0- to 10-point safety evaluation.

At 60 days, 18 (15.1%) of patients had prematurely discontinued the OXN-PR due to death, disease progression, major side effects, lack of efficacy, or personal reasons. OXN-PR was associated with reduction in acute pain intensity compared to baseline at all measurement intervals (p = 0.009). A lower response rate was found in patients without metastatic disease. Bowel function improved after OXN-PR (p < 0.0001). There was also a significant decline in patients utilizing laxatives/enemas. The number of other side effects, such as nausea, somnolence, dizziness, tremors, or confusion was decreased by nearly 50% (p < 0.001).

OXN-PR agonist-antagonist combination was highly effective in managing cancer-related pain, reduced bowel dysfunction, and minimized opioid side effects.

• Risk of bias (no control group)
• Other limitations/explanation: Relatively small final sample size of 101 patients.

Oxycodone-naloxone is an effective therapy for the management of patients with cancer-related pain who may be intolerable to other therapies.