Multicenter clinical study for evaluation of efficacy and safety of transdermal fentanyl matrix patch in treatment of moderate to severe cancer pain in 474 chinese cancer patients.
OBJECTIVE
Although a new matrix formulation fentanyl has been used throughout the world for cancer pain management, few data about its efficacy and clinical outcomes associated with its use in Chinese patients have been obtained. This study aimed to assess the efficacy and safety of the new system in Chinese patients with moderate to severe cancer pain.


METHODS
A total of 474 patients with moderate to severe cancer pain were enrolled in this study and were treated with the new transdermal fentanyl matrix patch (TDF) up to 2 weeks. All the patients were asked to record pain intensity, side effects, quality of life (QOL), adherence and global satisfaction. The initial dose of fentanyl was 25 μg/h titrated with opioid or according to National Comprehensive Cancer Network (NCCN) guidelines. Transdermal fentanyl was changed every three days.


RESULTS
After 2 weeks. The mean pain intensity of the 459 evaluated patients decreased significantly from 5.63±1.26 to 2.03±1.46 (P<0.0001). The total remission rate was 91.29%, of which moderate remission rate 53.16%, obvious remission rate 25.49% and complete remission rate 12.64%. The rate of adverse events was 33.75%, 18.78% of which were moderate and 3.80% were severe. The most frequent adverse events were constipation and nausea. No fatal events were observed. The quality of life was remarkably improved after the treatment (P<0.0001).


CONCLUSIONS
The new TDF is effective and safe in treating patients with moderate to severe cancer pain, and can significantly improve the quality of life.
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing 100142, China;
Yu-Lin
YL
Zhu
Guo-Hong
GH
Song
Duan-Qi
DQ
Liu
Xi
X
Zhang
Kui-Feng
KF
Liu
Ai-Hua
AH
Zang
Ying
Y
Cheng
Guo-Chun
GC
Cao
Jun
J
Liang
Xue-Zhen
XZ
Ma
Xin
X
Ding
Bin
B
Wang
Wei-Lian
WL
Li
Zuo-Wei
ZW
Hu
Gang
G
Feng
Jiang-Jin
JJ
Huang
Xiao
X
Zheng
Shun-Chang
SC
Jiao
Rong
R
Wu
Jun
J
Ren
Cancer pain; Efficacy; Quality of life; Safety; Transdermal fentanyl matrix patch (TDF)