Proportional dose of rapid-onset opioid in breakthrough cancer pain management

Abstract

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 360 mg/day of oral morphine or 25 to 150 μg/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, patient's 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 per-protocol 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.

A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan

“…Both the study performed by Yen and colleagues and the present study enrolled a limited number of patients with similar patient characteristics . Unfortunately, the number of patients in the present study was partially limited by the study design.…”

“…Since the fundamental study design was different between the study conducted by Yen and colleagues and the present study, the results, especially the correlation between FBSF and ATC doses, cannot be compared directly. With a starting dose proportional to the basal opioid regimen instead of completing a full titration process, it is logically expected that the FBSF and ATC doses would be highly correlated (r s = 0.8 as reported by Yen et al). By using a standard dose titration process, we found that there was a positive but relatively weaker correlation between the same two variables (r s = 0.56).…”

“…Nevertheless, with large interindividual variability in patients' dose requirements, the study suggested that OTFC should be routinely titrated and separated from the ATC medication. With respect to FBSF, the correlations between effective FBSF dose and ATC dose has only been previously reported by Yen and colleagues . While our study aimed to assess the feasible dose range of FBSF, the study by Yen and colleagues aimed to evaluate the efficacy of proportional doses of FBSF by identifying the percentage of patients requiring dose titration.…”

“…In a recent study conducted by Yen et al, the authors assessed the efficacy of FBSF at a dose proportional to the ATC opioid regimen in Taiwanese patients with BTP. By applying proportional dosing, the number of patients identified with effective dose of 200, 400, 600, 800, and 1200 μg was 15 (60%), three (12%), two (8%), four (16%), and one (4%), respectively.…”

Careful Breakthrough Cancer Pain Treatment through Rapid-Onset Transmucosal Fentanyl Improves the Quality of Life in Cancer Patients: Results from the BEST Multicenter Study

“…This phenomenon, termed as Breakthrough cancer Pain (BTcP), is a very frequent condition as approximately 70% of patients suffering from chronic pain of oncological nature report episodes of BTcP [5]. Typical BTcP episodes are of short duration (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) minutes/episode), moderate to severe intensity and with rapid onset (maximum peak between 3-15 minutes).…”