PMID- 19373888
OWN - NLM
STAT- MEDLINE
DCOM- 20090716
LR  - 20220321
IS  - 0008-543X (Print)
IS  - 0008-543X (Linking)
VI  - 115
IP  - 11
DP  - 2009 Jun 1
TI  - Fentanyl buccal tablet for the treatment of breakthrough pain in opioid-tolerant 
      patients with chronic cancer pain: A long-term, open-label safety study.
PG  - 2571-9
LID - 10.1002/cncr.24279 [doi]
AB  - BACKGROUND: This study assessed the long-term safety and tolerability of fentanyl 
      buccal tablet (FBT) in opioid-tolerant patients with cancer and breakthrough pain 
      (BTP) who were either naive to FBT or had completed 1 of 2 previous double-blind, 
      placebo-controlled FBT studies (rollover patients). METHODS: Patients who were 
      FBT-naive underwent titration to find a successful FBT dose. Rollover patients 
      used a previously identified successful dose of FBT. Patients who achieved a 
      successful dose were eligible to enter a maintenance phase (>or=12 months). 
      Safety assessments included adverse events (AEs), physical and neurologic 
      examinations, and clinical laboratory tests. RESULTS: Two hundred thirty-two 
      patients were enrolled. A total of 112 entered titration; 79 identified a 
      successful FBT dose, and 77 of these patients entered the maintenance phase along 
      with 120 rollover patients (n = 197). AEs resulted in discontinuation of therapy 
      for 33% of patients. The most common AEs were generally typical of opioids 
      administered to cancer patients. All serious AEs were considered to be related to 
      the patients' underlying conditions, except for 1 incident of FBT-related drug 
      withdrawal syndrome. Sixty patients died after enrollment because of disease 
      progression. Fifteen (6%) patients experienced >or=1 application-site AE, all of 
      which were considered by investigators to be related to FBT. CONCLUSIONS: FBT was 
      generally well tolerated and had a favorable safety profile in the long-term 
      (>or=12 months) management of patients with persistent cancer pain and BTP. No 
      unexpected AEs occurred. Safety and tolerability was similar to that observed in 
      short-term studies.
CI  - (c) 2009 American Cancer Society.
FAU - Weinstein, Sharon M
AU  - Weinstein SM
AD  - Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah 84112, USA. 
      sharon.weinstein@hci.utah.edu
FAU - Messina, John
AU  - Messina J
FAU - Xie, Fang
AU  - Xie F
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Analgesics, Opioid)
RN  - UF599785JZ (Fentanyl)
SB  - IM
EIN - Cancer. 2009 Jul 15;115(14):3372
MH  - Administration, Buccal
MH  - Analgesics, Opioid/*therapeutic use
MH  - Chronic Disease
MH  - Disease Progression
MH  - Drug Tolerance
MH  - Female
MH  - Fentanyl/*administration & dosage/*adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/*complications/drug therapy
MH  - Pain/*drug therapy/etiology
MH  - Time Factors
EDAT- 2009/04/18 09:00
MHDA- 2009/07/17 09:00
CRDT- 2009/04/18 09:00
PHST- 2009/04/18 09:00 [entrez]
PHST- 2009/04/18 09:00 [pubmed]
PHST- 2009/07/17 09:00 [medline]
AID - 10.1002/cncr.24279 [doi]
PST - ppublish
SO  - Cancer. 2009 Jun 1;115(11):2571-9. doi: 10.1002/cncr.24279.