Comparison of transdermal fentanyl with codeine/paracetamol, in combination with radiotherapy, for the management of metastatic bone pain

Kyriaki Mystakidou, MD, PhD; Emmanuela Katsouda, MD, PhD; Vassilios Kouloulias, MD, PhD; John Kouvaris, MD, PhD; Marinos Tsiatas, MD; Lambros Vlahos, MD, PhD

doi:10.5055/jom.2005.0044

Authors

Kyriaki Mystakidou, MD, PhD
Emmanuela Katsouda, MD, PhD
Vassilios Kouloulias, MD, PhD
John Kouvaris, MD, PhD
Marinos Tsiatas, MD
Lambros Vlahos, MD, PhD

DOI:

https://doi.org/10.5055/jom.2005.0044

Keywords:

bone metastases, pain, radiotherapy, fentanyl, codeine/paracetamol, palliation

Abstract

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 μg 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.

Author Biographies

Kyriaki Mystakidou, MD, PhD

Assistant Professor in Palliative Medicine, Pain Relief and Palliative Care Unit, Department of Radiology, Areteion Hospital, University of Athens School of Medicine, Athens, Greece.

Emmanuela Katsouda, MD, PhD

Pneumonologist, Pain Relief and Palliative Care Unit, Department of Radiology, Areteion Hospital, University of Athens School of Medicine, Athens, Greece.

Vassilios Kouloulias, MD, PhD

Assistant Professor, Radiation Oncologist, Kalergi, Greece.

John Kouvaris, MD, PhD

Associate Professor in Radiotherapy Oncology, Radiology Department, Areteion Hospital, University of Athens School of Medicine, Athens, Greece.

Marinos Tsiatas, MD

Department of Clinical Therapeutics, “Alexandra” Hospital, University of Athens, Athens, Greece.

Lambros Vlahos, MD, PhD

Professor and Director, Radiology Department, Areteion Hospital, University of Athens School of Medicine, Athens, Greece.

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