DOSE-TITRATION, MULTICENTER STUDY OF ORAL TRANSMUCOSAL FENTANYL CITRATE FOR THE TREATMENT OF BREAKTHROUGH PAIN IN CANCER-PATIENTS USING TRANSDERMAL FENTANYL FOR PERSISTENT PAIN

Purpose: Supplemental, ''as needed,'' administration of an opioid is a common approach to the problem of breakthrough pain in cancer patient s. Oral transmucosal fentanyl citrate (OTFC) is undergoing investigati on as a new treatment for breakthrough pain. The primary purpose of th e study wets to demonstrate that ct single-unit dose of OTFC can safel y and effectively treat break through pain. A secondary goal was to de termine appropriate dosing guidelines. Patients and Methods: This was a multicenter, randomized, double-blind,dose-titration study in 62 adu lt cancer patients using transdermal fentanyl for persistent pain. Con senting patients provided 2 days of base line data to evaluate the per formance of their usual breakthrough pain medication. Patients then ra ndomly received 200 mu g or 400 mu g OTFC in double-blind fashion. (Pa tients were always assigned, rather than randomized, to 200 mu g if 40 0 mu g represented > 20% of around-the-clock medication.) Pain intensi ty (PI), pain relief (PR), and global satisfaction scores were recorde d, OTFC was then titrated until the patient received adequate PR for e ach episode using one OTFC unit, Orders to titrate vp were ignored one third of the time to improve the blind. Two days of baseline data wer e compared with 2 days of OTFC data after titration identified an effe ctive dose of OTFC, Results: Most patients (76%) found a safe and effe ctive dose of OTFC, There was no meaningful relationship between the a round-the-clack opioid regimen and the effective dose of OTFC, In open -label comparisons, OTFC produced a faster onset of relief and a great er degree of PR than patients' usual breakthrough medication. Somnolen ce, nausea, and dizziness were the most common side effects associated with OTFC, Conclusion: Most patients find a single OTFC dosage that a dequately treats breakthrough pain. The optimal dose is found by titra tion and is not predicted by around-the-clack dose of opioids, (C) 199 8 by American Society of Clinical Oncology.