Korean J Intern Med.  2015 Jan;30(1):88-95. 10.3904/kjim.2015.30.1.88.

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

• Kang JH
• Oh SY
• Song SY
• Lee HY
• Kim JH
• Lee KE
• Lee HR
• Hwang IG
• Park SH
• Kim WS
• Park YS
• Park K

• KMID: 2129668
• DOI: http://doi.org/10.3904/kjim.2015.30.1.88

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 microg/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 microg/hr vs. 24.8 microg/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.

Keyword

Transdermal patch; Fentanyl; Neoplasms; Pain; Opioids

MeSH Terms

Administration, Cutaneous
Adult
Aged
Aged, 80 and over
Analgesics, Opioid/*administration & dosage/adverse effects
Female
Fentanyl/*administration & dosage/adverse effects
Humans
Intention to Treat Analysis
Male
Middle Aged
Neoplasms/*complications
Pain/diagnosis/*drug therapy/etiology
Pain Measurement
Prospective Studies
Republic of Korea
Severity of Illness Index
Tertiary Care Centers
Time Factors
Transdermal Patch
Treatment Outcome
Analgesics, Opioid
Fentanyl