Background: The management of breakthrough pain (BTP) in cancer patients is a challenge. It is clinically useful to evaluate the effectiveness of rapid-onset opioid at a starting dose in proportional to the background opioid regimen. This open-label, multicenter, noncomparative study aimed to assess the efficacy and safety of proportional doses of fentanyl buccal soluble film (FBSF) in patients with breakthrough cancer pain. Methods:Thirty patients aged 20 to 70, experiencing 1 to 3 BTP per day, receiving regimens equivalent to 60 to 360mg/day of oral morphine or 25 to 150mg/h of transdermal fentanyl ≥1 week, were prospectively recruited. FBSF was administered proportionally based on their current opioid regimen for baseline pain. The percentage of patients requiring dose titration was evaluated. For each BTP episode, changes in pain intensity at 30 minutes (PID30) after dosing, patientafs satisfaction, the percentage of episodes requiring rescue medication, and adverse events (AEs) were recorded. Results: The percentage of patients who required dose titration was 21.4% (6/28) and 12.0% (3/25) in the full analysis set and perprotocol populations, respectively. The average PID30 was 3.9, and a pain score ≤3 was achieved in 95.1% of the events. Eight out of 367 (2.2%) BTP episodes needed rescue medication. The majority of subjects (75.8%) rated their experience of pain management as good to excellent. A total of 6 drug-related AEs were reported by 3 (10.7%) patients in the safety population. Conclusions: FBSF dose in proportional to the regimen of opioid for baseline pain management is efficacious and well tolerated for the treatment of cancer patients with BTP.
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