Pain management of cancer patients with transdermal fentanyl: A study of 1828 step I, II, & III transfers

The aim of this observational study was to examine pain management outcomes and quality of life (QoL) measures in cancer patients with intolerable or chronic severe pain transferring from World Health Organization's step I, II, and III analgesics to the transdermal therapeutic fentanyl system (TTS-F). This study examines the safety and efficacy of TTS-F in long-term pain management, addressing the role of TTS-F in cancer pain. Pain measures were assessed in 1828 patients (step I [naive], 268; step II [codeine], 1239; and step III [morphine], 321) on the basis of selected questions from the Greek-Brief Pain Inventory. Overall treatment satisfaction (scale, 1 to 4), QoL, and European Collaborative Oncology Group (ECOG) status were also recorded. These were assessed in relation to TTS-F dose, stratified by transfer step, primary cancer, metastases, type of pain, and concomitant use of anti-inflammatory drugs. Of 1828 patients, 100 (5.5%) withdrew, and an addition 14 (0.8%) discontinued because of side effects. A total of 1714 continued on study; 744 patients died, and 970 departed during the study period. In total, 93.8% were satisfied with their pain relief, and complete patient satisfaction was obtained within 2 months. Pain, QoL, and treatment satisfaction measures demonstrated statistically significant improvements over time, independent of the step transfer. Although doses of TTS-F were higher for step III > II > I and for metastatic than nonmetastatic, the median dose for all groups remained 50 mug/h throughout the study period. Pain and QoL improvements were independent of patient characteristic(s). Direct transfer to TTS-F for patients with intolerable or chronic moderate to severe cancer pain offers an efficient and safe long-term analgesic option for palliative care patients. Careful selection and follow-up by experienced palliative care specialists are mandatory. TTS-F as a first-line analgesic approach for severe cancer pain should be considered a viable option because of its durable efficacy and low incidences of side effects. Perspective: At a fairly constant dose of 50 mug/h, the transdermal therapeutic fentanyl system offers a safe, well-tolerated pain relief treatment for carefully monitored patients with cancer pain. The authors stress that this includes patients who experience difficulties in their pain management while progressing through the WHO's ladder for pain management. (C) 2004 by the American Pain Society.