Radiotherapy (R/T) is frequently used for
palliative treatment of painful bone
metastases; however, complete alleviation of
pain is not always achieved. This study was designed to evaluate
pain management outcomes and quality of life (QoL) measures in
cancer patients with metastatic bone
pain receiving a combination of R/T and either transdermal therapeutic
fentanyl (TTS-F) patches or
codeine/
paracetamol. A total of 460
palliative care patients with bone
metastases who received R/T were enrolled in this prospective, open-label study. The patients were randomized to initially receive a total dose of 120 mg
codeine/
paracetamol per day or TTS-F patches releasing 25 microg
fentanyl per hour.
Pain measures were assessed 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 status were also recorded. Among the 460 patients, 422 were eligible for evaluation.
Pain measures in the TTS-F group demonstrated statistically significant improvements during the study that were superior to those in the
codeine/
paracetamol group (p < 0.05). Likewise, there was a significantly greater increase (p < 0.05) in the mean satisfaction score for patients in TTS-F group at every visit between baseline and month two. The vast majority (95.8 percent) of patients in the
codeine/
paracetamol group increased their medication dosage until the end of the study, whereas in the TTS-F group the respective percentage was only 6.1. Both treatments were generally well tolerated, with
constipation as the most common side effect followed by sleep disturbances and
nausea. The overall frequencies of side effects were higher in the
codeine/
paracetamol group. The results therefore indicate that TTS-F offers more effective
pain relief than
codeine/
paracetamol, in combination with R/T, in patients with metastatic bone
pain, obtaining complete treatment satisfaction matched by improvements in their QoL.