Radiotherapy Plus Either Transdermal Fentanyl or Paracetamol and Codeine for Painful Bone Metastases: A Randomised Study of Pain Relief and Quality of Life

Kyriaki Pistevou-Gompaki; Vassilis E. Kouloulias; Charalambos Varveris; Kyriaki Mystakidou; Grigoris Georgakopoulos; Nikos Eleftheriadis; Nikos Gompakis; John Kouvaris


Curr Med Res Opin. 2004;20(2) 

In This Article

Summary and Intrduction

Objective: To compare the effects of providing analgesia with either transdermal fentanyl (TTS-fentanyl) or paracetamol and codeine (P/C) in addition to radiotherapy in patients with metastatic bone pain.
Methods: In a prospective study, 26 patients with radiologically confirmed bony metastases received radiotherapy (R/T). They were randomised to receive either 500 mg paracetamol and 30 mg codeine four times per day (P/C group), or transdermal fentanyl patches delivering 25 µg fentanyl/h (TTS-fentanyl group). Pain was assessed using visual analogue pain ratings (VAS) and the Greek Brief Pain Inventory (G-BPI) questionnaire administered before R/T and after 3 months.
Results: Data were available from 24 eligible patients. Use of TTS-fentanyl was associated with significantly superior pain relief. Mean VAS fell from 7.0 to 1.1 with TTS-fentanyl and from 8.3 to 4.3 with P/C, p < 0.01. The TTS-fentanyl group also showed significantly greater improvements of important G-BPI domains including global quality of life, pain, and physical, cognitive, and role functioning, than the P/C group (p < 0.01). Four patients receiving TTS-fentanyl and three receiving P/C reported severe nausea/vomiting.
Conclusions: Transdermal fentanyl combined with R/T was more effective in reducing metastatic bone pain and resulted in greater improvements in quality of life than paracetamol and codeine.

Pain is one of the most common and feared symptoms associated with cancer, and can have a substantial impact on patient's activities, interpersonal interactions and overall quality of life.[1,2,3,4] Over 70% of patients with cancer have moderate-to-severe pain during their illness and many fear pain more than death itself.[5] Bone is one of the most common sites for metastases and about 70% of patients with such metastases develop pain at some time during the course of their disease.[6,7]

However, cancer pain is often inadequately treated and only a small proportion of patients with malignant pain receive adequate analgesia.[2,5,8] Many analgesic agents, such as opioids, non-steroidal anti-inflammatory drugs, corticosteroids, radiotherapy, radioisotopes, bisphosphonates and orthopaedic interventions, either alone or in combination, have been used in the management of painful bony metastases, but there is little firm evidence about the ideal therapy.[8,9,10,11,12,13,14,15]

Transdermal fentanyl (TTS-fentanyl) (Durogesic*) has been used in the management of cancer pain and especially of metastatic bone pain with promising results.[16,17,18,19] TTS-fentanyl represents a well-tolerated, effective and economical treatment for cancer pain without the need for invasive procedures or special equipment.[21,22,23,24,25,26] However, although the efficacy of TTS-fentanyl has been clearly established in controlled studies, to our knowledge its effects in combination with palliative radiotherapy for bony metastases have not previously been studied.

The present study was designed to compare the analgesic efficacy, safety and adverse effects of TTS-fentanyl with those of paracetamol plus codeine in combination with external radiotherapy for painful bony metastases.

* Durogesic is a registered trade name of Janssen Pharmaceutica NV, Beerse, Belgium


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