title: The efficacy of low-dose transdermal fentanyl in opioid-naïve cancer patients with moderate-to-severe pain.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Korea.
authors.forename: Jung Hun
authors.initials: JH
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
authors.forename: Sung Yong
authors.initials: SY
authors.lastname: Oh
authors.affiliation: Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Korea.
authors.forename: Seo-Young
authors.initials: SY
authors.lastname: Song
authors.affiliation: Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Korea.
authors.forename: Hui-Young
authors.initials: HY
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Seoul, Korea.
authors.forename: Jung Han
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
authors.forename: Kyoung Eun
authors.initials: KE
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.
authors.forename: Hye Ran
authors.initials: HR
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
authors.forename: In Gyu
authors.initials: IG
authors.lastname: Hwang
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Won Seok
authors.initials: WS
authors.lastname: Kim
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D011446:Prospective Studies; D056910:Republic of Korea; D012720:Severity of Illness Index; D062606:Tertiary Care Centers; D013997:Time Factors; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl
keywords: Fentanyl; Neoplasms; Opioids; Pain; Transdermal patch