A CLINICAL-EVALUATION OF TRANSDERMAL THERAPEUTIC SYSTEM FENTANYL FOR THE TREATMENT OF CANCER PAIN

Fentanyl has been incorporated into a transdermal therapeutic system ( TTS) containing a rate-limiting membrane that provides constant releas e of the opioid. TTS fentanyl provides continuous opioid delivery for up to 72 hr without the need for special equipment. After Institutiona l Review Board approval, 53 patients with cancer pain requiring 45 mg or more of oral morphine daily were admitted into an open-label, prosp ective, multicenter evaluation of TTS fentanyl for the relief of pain. After a 1-week stabilization on oral morphine: patients were transfer red from morphine to an appropriate dose of TTS-fentanyl (25, 50, 75, or 100 mu g/hr) administered as a transdermal patch every 3 days. TTS fentanyl was titrated to pain relief, and patients were followed up fo r as long as 3 months. Pain relief and the side effects of the medicat ions were assessed daily. Twenty-six men and 27 women with a mean (+/- SD) age of 61 (+/- 22) years entered the study; 23 patients completed the full 84-day study. The mean duration of TTS fentanyl use was 58 /- 32 days. The mean (+/- SEM) daily morphine dose during the last 2 d ays of stabilization was 189 (+/- 20) mg, and the mean initial fentany l patch dose was 58 (+/- 6) mu g/hr. The mean daily morphine dose take n ''as needed'' for breakthrough pain at study completion was 35 mg. T he mean final fentanyl dosage at study completion was 169 (+/- 29) mu g/hr. Pain relief was rated as good or excellent by 82% of patients du ring the treatment period. When asked to compare pain relief during th e first month of TTS-fentanyl use to that provided by their last analg esic before study entry 63% preferred TTS fentanyl. Side effects consi dered related to the fentanyl patch were nausea (13%), vomiting (8%), skin rash (8%), and drowsiness (4%). Thirty percent of patients report ed adverse experiences related to the fentanyl patch, and 17% had to b e discontinued from the study. We conclude that TTS fentanyl administe red every 3 days for the treatment of cancer pain is effective, safe, and well tolerated by most patients. J Pain Symptom Manage 1998;16:102 -111. (C) Elsevier Science Inc. 1998.