Fentanyl Buccal Tablet vs. Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Randomized, Crossover, Comparison Study

Fentanyl products have shown superiority to oral opioids for the management of breakthrough cancer pain (BTcP). However, these studies did not use appropriate patient selection, and drugs have been compared by using different rationales. The aim of this randomized, crossover, controlled study was to compare to efficacy and safety of fentanyl buccal tablets (FBT) and oral morphine (OM), given in doses proportional to opioid daily doses. Cancer patients with pain receiving ≥60 mg or more of oral morphine equivalents/day and presenting with ≤3 episodes of BTcP/day were included. In a randomized, crossover manner, patients received FBT or OM at doses proportional to the daily opioid regimen in four consecutive episodes of BTcP. Pain intensity was measured before (T0) and 15 (T15) and 30 minutes (T30), after study drugs. In total, 263 episodes of BTcP were treated. A statistical difference in changes in pain intensity - decrease of ≥33% and ≥50% -- between the two groups was observed at T15 and T30 (P<0.0005). No severe adverse effects after study drug administration were observed. When used in doses proportional to the basal opioid regimen, FBT showed a clear superiority and was well tolerated compared with OM during the first 30 minutes, which is the approximate target for a timely intervention required for a BTcP medication.