The efficacy of low-dose transdermal fentanyl in opioid-naïve cancer patients with moderate-to-severe pain

Jung Hun Kang, Sung Yong Oh, Seo Young Song, Hui Young Lee, Jung Han Kim, Kyoung Eun Lee, Hye Ran Lee, In Gyu Hwang, Se Hoon Park, Won Seok Kim, Young Suk Park, Keunchil Park

Research output: Contribution to journalArticlepeer-review

10 Scopus citations


Background/Aims: Little is known about the efficacy of low-dose transdermal fentanyl (TDF) patches in opioid-naïve patients with moderate-to-severe cancer pain.

Methods: This study had an open-label, prospective design, and was conducted between April 2007 and February 2009 in seven tertiary cancer hospitals; 98 patients were enrolled. TDF was started using a low-dose formulation (12.5 μg/ hr), and the dose was adjusted according to the clinical situation of individual patients. Pain intensity, the TDF doses used, and adverse events (AEs) were monitored over 4 weeks. Data were analyzed using the intent-to-treat and per-protocol principles.

Results: Of the 98 patients enrolled, 64 (65%) completed the study. The median pain intensity decreased from 6.0 to 3.0 (p < 0.001) at the follow-up visit. The efficacy of low-dose TDF on pain relief was consistent across groups separated according to gender (p < 0.001), age (p < 0.001), metastasis (p < 0.001), previous treatment (p < 0.001), and baseline pain intensity (p < 0.001). The decrease in pain intensity was significantly greater in the severe group compared with the moderate group (mean ± SD, 5.10 ± 2.48 vs. 2.48 ± 1.56; p < 0.001). TDF dose (27.8 μg/ hr vs. 24.8 μg/hr, p = 0.423) and the mean treatment time (7.5 days vs. 7.9 days, p = 0.740) required for pain control were not different between the two pain-intensity groups. Patients had AEs of only mild or moderate intensity; among these, nausea (38%) was the most common, followed by vomiting (22%) and somnolence (22%).

Conclusions: Low-dose TDF was an effective treatment for patients with cancer pain of moderate-to-severe intensity. Further randomized trials assessing the efficacy of TDF for severe pain and/or optimal starting doses are warranted.

Original languageEnglish
Pages (from-to)88-95
Number of pages8
JournalKorean Journal of Internal Medicine
Issue number1
StatePublished - 1 Jan 2015

Bibliographical note

Publisher Copyright:
© 2015 The Korean Association of Internal Medicine


  • Fentanyl
  • Neoplasms
  • Opioids
  • Pain
  • Transdermal patch


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