PP071 A prospective, single-arm, open, multi-center, observational study of sublingual fentanyl for breakthrough cancer pain: Efficacy, safety, and tolerability in Korean cancer patients

Sublingual fentanyl has been developed to provide rapid-onset opioid in breakthrough cancer pain (BTcP). The efficacy and safety of the fentanyl tablets have already been confirmed in clinical trials, however, little is known for Korean cancer patients. Therefore, the purpose of this study is to evaluate the effectiveness, safety, and tolerability of sublingual fentanyl for the alleviation of BTcP in Korean patients. This study was a prospective, single-arm, open, multi-center, observational study which was conducted with cancer patients at 13 study centers in Korea. Patients who were naïve or who had uncontrolled BTcP with other fentanyl tablets were included. Patients received fentanyl sublingual tablets whenever BTcP occurred and the initial dose was 100mcg, titrated to an effective dose of 100 to 800mcg. Dose titration, NRS goal achievement, pain intensity, quality of life, and safety were evaluated at baseline, week 1, 4, and 12. Among an enrolled 136 patients, 133 patients were analyzed. The mean age of patients was 60.4±11.5 years; majority were under 65 years old and 63.2% were males. The most common cancer history were head and neck cancer (15%), and pancreatic cancer (12%). The mean baseline around-the-clock opioid dose was 277.8 ± 248.7 mg morphine equivalent. Using criteria for determining successful dose titration, 91% (n=103) of total patients had successfully dose titration and most of the patients were titrated at week 1. 85 patients (75%) achieved their individual NRS goal at week1. A significant pain intensity differences was observed at 30 min and 60 min after treatment from the baseline (p<0.0001). The significant difference was identified in quality of life (mood, normal work, sleep, and enjoyment of life, p<0.05). Overall adverse drug reactions were 9%; the most common were vomiting (3.0%), nausea (2.3%), and headache (1.5%). Most patients had successful dose titration as well as achievement of individual NRS goal at week 1. The sublingual fentanyl had meaningful effects on quality of life including mood, normal work, sleep, and enjoyment of life. This study indicates the fentanyl sublingual tablet offers a well-tolerated treatment option and clinical benefits for Korean cancer patient with BTcP.