There is emerging data supporting the use of TTS-F (transdermal therapeutic system-fentanyl) in opioid naive patients. Our study examines the safety and efficacy of TTS-F in the long-term control of cancer pain in opioid naive patients and those transferring from oral morphine. Pain was assessed in 589 patients (Group A: 268 opioid naive, Group B: 321 transferring from morphine) using a Visual Analogue Scale (VAS; 0-10), based on selected questions from the Greek Brief Pain Inventory (GBPI). Overall treatment satisfaction was assessed on a 4-point scale. Quality of Life (QOL) and ECOG (0-4) status were also recorded. These were assessed in relation to TTS-F dose, pain type (neuropathic, combined, nociceptive), concomitant use of anti-inflammatory drugs and other demographic data. Of 589 patients, 59 (10%) withdrew as a result of inadequate pain satisfaction or for other reasons. There were no discontinuations due to side effects; no Grade 3-4 events occurred. A total of 530 continued on-study, 211 patients died during study period and 295 departed; all (506; 89%) were satisfied with their pain relief. Analysis of patients at baseline, 28 days, 6 and 12 month time points (n = 153 Group A; n = 214 Group B) with respect to QOL and pain measures indicated a statistically significant (p < 0.001) improvement in all measures across time independent of pain type, or any other patient characteristic(s). In patients with intolerable pain, transfer to TTS-F offers an efficient and safe long-term analgesic option. TTS-F offers durable long-term maintenance of pain relief with acceptable side effects in opioid naive patients. In general, TTS-F as a first line analgesic approach for carefully selected and monitored patients experiencing moderate to severe cancer pain should be considered.
Copyright 2003 Wiley-Liss, Inc.