Evaluation of efficacy and safety of fentanyl-TTS in adult patients with cancer-related pain

Kim, Hoon Kyo; Lee, Kyung Shik; Hong, Young Seon; Lee, Bok Keun; Song, Chi Won; Park, Jin No; Cho, Suk Ku; Kim, Jae Yoo

Abstract

The transdermal administration of narcotics is one of the alternative ways of providing adequate pain relief for the patients with chronic cancer pain. A Phase 4 trial was conducted to evaluate the efficacy and safety of Fentanyl-TTS in adult patients with cancer-related pain in Korea.
METHODS
Patients with histologically confirmed malignancy, who have pain related to the cancer and/or therapy, pain necessitating the use of opoid analgesics, age of 18 yr or older, ability to communicate effectively with study personnel, and signed on informed consent were included. The patients were titrated with a short-acting narcotic to control their cancer pain before they are converted to a fentanyl-transdermal therapeutic system(TTS). Short acting parenteral morphine and MS contin were used as rescue medications. All patients were evaluated initially and were followed up with a pain visual analogue scale(VAS), quality of life(QOL)-VAS. Patients were asked to keep the daily record for 21 days about pain VAS, QOL-VAS, amount of rescue morphine used, and side effects.
RESULTS
Twenth two patients were enrolled from January 1996 to October 1997. The dose of fentanyl-TTS required, ranged between 25 and 75 ug/hr (25 microgram/hr in 13, 50 microgram/hr in 4, and 75 microgram/hr in 2). The mean dose of morphine required before the use of the fentanyl-TTS was 135.3 mg (20-285 mg/day), but it was decreased after the use of the fentanyl-TTS. Pain VAS and QOL-VAS were in adquate level during the fentanyl- TTS treatment. Patients favored continuous use of fentanyl after the study was finished. Side effect of fentanyl-TTS was minimal. CONCLUSION: Transdermal fentanyl seems to be a convenient and effective analgesic for the control of cancer related pain in Korean. A controlled trial comparing fentanyl-TTS to morphine needs to be followed.