The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
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The efficacy of low-dose transdermal fentanyl in opioid-naïve cancer patients with moderate-to-severe pain

  • Kang, Jung Hun (Department of Internal Medicine, Gyeongsang National University School of Medicine) ;
  • Oh, Sung Yong (Department of Internal Medicine, Dong-A University College of Medicine) ;
  • Song, Seo-Young (Department of Internal Medicine, Kangwon National University School of Medicine) ;
  • Lee, Hui-Young (Department of Internal Medicine, Kangwon National University School of Medicine) ;
  • Kim, Jung Han (Department of Internal Medicine, Hallym University College of Medicine) ;
  • Lee, Kyoung Eun (Department of Internal Medicine, Ewha Womans University School of Medicine) ;
  • Lee, Hye Ran (Department of Internal Medicine, Inje University Ilsan Paik Hospital) ;
  • Hwang, In Gyu (Department of Internal Medicine, Chung-Ang University College of Medicine) ;
  • Park, Se Hoon (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Kim, Won Seok (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Park, Young Suk (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Park, Keunchil (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine)
  • Received : 2013.10.29
  • Accepted : 2014.04.07
  • Published : 2015.01.01
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Abstract

Background/Aims: Little is known about the efficacy of low-dose transdermal fentanyl (TDF) patches in opioid-naive 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 ($12.5{\mu}g/hr$), 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 ($mean{\pm}SD$, $5.10{\pm}2.48$ vs. $2.48{\pm}1.56$; p < 0.001). TDF dose ($27.8{\mu}g/hr$ vs. $24.8{\mu}g/hr$, 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.

Keywords

Acknowledgement

Supported by : Janssen Korea

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