Journal of Clinical Oncology, Vol 16, 3238-3245, Copyright © 1998 by American Society of Clinical Oncology
Dose-titration, multicenter study of oral transmucosal fentanyl citrate for the treatment of breakthrough pain in cancer patients using transdermal fentanyl for persistent pain
JM Christie, M Simmonds, R Patt, P Coluzzi, MA Busch, E Nordbrock and RK Portenoy
Hospice Institute of Florida Suncoast and University of South Florida, College of Medicine, Department of Anesthesiology, Tampa 33612-4799, USA.
PURPOSE: Supplemental, "as-needed," administration of an opioid is a common
approach to the problem of breakthrough pain in cancer patients. Oral
transmucosal fentanyl citrate (OTFC) is undergoing investigation as a new
treatment for breakthrough pain. The primary purpose of the study was to
demonstrate that a single-unit dose of OTFC can safely and effectively
treat breakthrough pain. A secondary goal was to determine appropriate
dosing guidelines. PATIENTS AND METHODS: This was a multicenter,
randomized, double-blind, dose-titration study in 62 adult cancer patients
using transdermal fentanyl for persistent pain. Consenting patients
provided 2 days of baseline data to evaluate the performance of their usual
breakthrough pain medication. Patients then randomly received 200 microg or
400 microg OTFC in double-blind fashion. (Patients were always assigned,
rather than randomized, to 200 microg if 400 microg represented > 20% of
around-the-clock medication.) Pain intensity (PI), pain relief (PR), and
global satisfaction scores were recorded. OTFC was then titrated until the
patient received adequate PR for each episode using one OTFC unit. Orders
to titrate up were ignored one third of the time to improve the blind. Two
days of baseline data were compared with 2 days of OTFC data after
titration identified an effective dose of OTFC. RESULTS: Most patients
(76%) found a safe and effective dose of OTFC. There was no meaningful
relationship between the around-the-clock opioid regimen and the effective
dose of OTFC. In open-label comparisons, OTFC produced a faster onset of
relief and a greater degree of PR than patients' usual breakthrough
medication. Somnolence, nausea, and dizziness were the most common side
effects associated with OTFC. CONCLUSION: Most patients find a single OTFC
dosage that adequately treats breakthrough pain. The optimal dose is found
by titration and is not predicted by around-the-clock dose of opioids.
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