Longitudinal follow-up of TTS-fentanyl use in patients with cancer-related pain: Results of a compassionate-use study with special focus on elderly patients

Goals of the work: This open compassionate-use prospective registration study evaluated the tolerability, ease of use and applied doses of transdermal (TTS) fentanyl in adult patients with cancer-related pain requiring strong opioid analgesia. Elderly patients were particularly focussed on. Patients and methods: Previous pain medication was converted to an appropriate dose of TTS-fentanyl. I m mediate-release morphine rescue medication was allowed as needed for breakthrough pain. Dose adjustments of ITS-fentanyl, rescue morphine requirements, the ease of use and side-effects were assessed monthly, with special emphasis paid to the severity of constipation and the use of laxatives. Main results: A total of 663 patients with cancer-related pain, including 8% opioid-naive patients, were enrolled; 661 patients used at least 1 patch of TTS-fentanyl. Of these, 455 subjects were assessed at baseline and at 1 post-baseline visit at least. Individual treatment ranged from a few days to 21/2 years; TTS-fentanyl doses ranged from 25 to. 950 mug/h. The major reason for study termination was non-drug-related death (61%). Approximately 40% of patients reported constipation. The frequency of constipation depended on the rescue morphine dose used, but no dose-relationship was found for TTS-fentanyl. Patient acceptance of the patches was high; around 85% of patents rated convenience as good to excellent. The ease of use and tolerability of TTS-fentanyl in the elderly patents were comparable to that in the total population, except for a slight increase of non-serious adverse events. Conclusions: TTS-fentanyl can be applied as long-term therapy to patients with cancer-related pain, including the elderly.