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Original ArticleOpen Access
Evaluation of Safety and Efficacy of Transdermal Therapeutic System-Fentanyl in Adult Patients with Gynecological Cancer-Related Pain
Lorvidhaya V 
,
Katanyoo K ,
Srisomboon J ,
Suprapaphorn P ,
Cheewakriangkrai C
,
Katanyoo K ,
Srisomboon J ,
Suprapaphorn P ,
Cheewakriangkrai C KANYARAT KATANYOO, MD*,
PRAPAPORN SUPRAPAPHORN, MD**,
Objectives : To assess the analgesic safety and efficacy of Transdermal Therapeutic System
(TIS)-fentanyl in the treatment of chronic gynecological cancer-related pain.
Background : TIS-fentanyl is a Transdermal Therapeutic System, which contains a rate-
limiting membrane that provides constant release of fentanyl. TIS-fentanyl can be properly used to
control pain. Therefore, this trial was designed to establish the analgesic efficacy and safety of TIS-
fentanyl in the treatment of chronic gynecological cancer-related pain.
Material and Method : Thirty patients were recruited into the study. This open study was
comprised of two phases. Phase l : an oral morphine stabilization phase where eligible patients, who
took other opioids and/or analgesic drugs, were entered into the stabilization phase and should be con-
verted to oral morphine according to the conversion chart. The patients were then titrated to a stable
oral morphine dose. Phase 2 : an open TIS-fentanyl treatment phase where the daily dose of oral
morphine was switched to TIS-fentanyl according to the conversion chart. The efficacy parameters
of pain score were assessed by visual analog.ue scale (VAS) and global assessments. The safety was
evaluated by momitoring the patient's clinical conditions and adverse events.
Results: TIS-fentanyl was generally well tolerated. Only one patient was dropped out from
the study due to lacking enrollment in the stabilization phase. The most frequent adverse events were
mild nausea or vomiting (46%) and constipation (33%). The median pain VAS during TIS-fentanyl
treatment was decreased from 8 to 3 and global assessments at the end of the treatment were better than
at the start of the treatment.
Conclusion : The results suggest that TIS-fentanyl is safe and effective in managing chronic
gynecological cancer-related pain.
Key word : TIS-Fentanyl, Gynecological Cancer, Pain, Efficacy
PRAPAPORN SUPRAPAPHORN, MD**,
Objectives : To assess the analgesic safety and efficacy of Transdermal Therapeutic System
(TIS)-fentanyl in the treatment of chronic gynecological cancer-related pain.
Background : TIS-fentanyl is a Transdermal Therapeutic System, which contains a rate-
limiting membrane that provides constant release of fentanyl. TIS-fentanyl can be properly used to
control pain. Therefore, this trial was designed to establish the analgesic efficacy and safety of TIS-
fentanyl in the treatment of chronic gynecological cancer-related pain.
Material and Method : Thirty patients were recruited into the study. This open study was
comprised of two phases. Phase l : an oral morphine stabilization phase where eligible patients, who
took other opioids and/or analgesic drugs, were entered into the stabilization phase and should be con-
verted to oral morphine according to the conversion chart. The patients were then titrated to a stable
oral morphine dose. Phase 2 : an open TIS-fentanyl treatment phase where the daily dose of oral
morphine was switched to TIS-fentanyl according to the conversion chart. The efficacy parameters
of pain score were assessed by visual analog.ue scale (VAS) and global assessments. The safety was
evaluated by momitoring the patient's clinical conditions and adverse events.
Results: TIS-fentanyl was generally well tolerated. Only one patient was dropped out from
the study due to lacking enrollment in the stabilization phase. The most frequent adverse events were
mild nausea or vomiting (46%) and constipation (33%). The median pain VAS during TIS-fentanyl
treatment was decreased from 8 to 3 and global assessments at the end of the treatment were better than
at the start of the treatment.
Conclusion : The results suggest that TIS-fentanyl is safe and effective in managing chronic
gynecological cancer-related pain.
Key word : TIS-Fentanyl, Gynecological Cancer, Pain, Efficacy
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