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

• Published in: The Korean journal of internal medicine pp. 88 - 95
• Main Authors: 강정훈, 오성용, 송서영, 이희영, 김정한, 이경은, 이혜란, 황인규, 박세훈, 김원석, 박근칠, 박영석
• Format: Journal Article
• Language: English
• Published: 대한내과학회 01.01.2015
• Subjects: 내과학
• ISSN: 1226-3303; 2005-6648
• DOI: 10.3904/kjim.2015.30.1.88

Background/Aims: Little is known about the efficacy of low-dose transdermalfentanyl (TDF) patches in opioid-naive patients with moderate-to-severe cancerpain. Methods: This study had an open-label, prospective design, and was conductedbetween April 2007 and February 2009 in seven tertiary cancer hospitals; 98patients 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 individualpatients. Pain intensity, the TDF doses used, and adverse events (AEs) were monitoredover 4 weeks. Data were analyzed using the intent-to-treat and per-protocolprinciples. Results: Of the 98 patients enrolled, 64 (65%) completed the study. The medianpain intensity decreased from 6.0 to 3.0 (p < 0.001) at the follow-up visit. Theefficacy of low-dose TDF on pain relief was consistent across groups separatedaccording to gender (p < 0.001), age (p < 0.001), metastasis (p < 0.001), previoustreatment (p < 0.001), and baseline pain intensity (p < 0.001). The decrease in painintensity was significantly greater in the severe group compared with the moderategroup (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-intensitygroups. 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 cancerpain of moderate-to-severe intensity. Further randomized trials assessing the efficacyof TDF for severe pain and/or optimal starting doses are warranted. KCI Citation Count: 4