Evaluation of Safety and Efficacy of Transdermal Thera peutic System-Fentanyl in Adult Patients with Gyneco logical Cancer-Related Pain
VICHARN LORVIDHAYA,MD*, KANYARAT KATANYOO, MD*, JATUPHOL SRISOMBOON, MD**, PRAPAPORN SUPRAPAPHORN, MD**, CHALONG CHEEWAKRIANGKRAI, MD**
Affiliation : * Division of Therapeutic Radiology and Oncology, ** Division of Gynecologic oncoJogy, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.
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.
Materials and Methods : 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.
Keywords : TIS-Fentanyl, Gynecological Cancer, Pain, Efficacy
