472P - The reasons and timing of the oral transmucosal fentanyl administration in Japan

Abstract

Background: The oral transmucosal fentanyl tablet, Abstral, is a formulation by which fentanyl can be rapidly absorbed across the oral mucosa producing rapid onset of analgesia, and which may be effective for breakthrough cancer pain (BTcP). It has been marketed since 2014 in Japan. It is called rapid onset opioid (ROO) because of rapid onset of analgesia effect, whereas immediate release preparations of oxycodone and hydrochloric acid morphine are called short acting opioid (SAO). Abstral can also be administered for the patients who cannot take the oral medicine. Methods: We selected patients who were administered Abstral for BTcP between 2014 and 2016 at Toyama University Hospital in Japan. We retrospectively investigated administration reasons and timing based on medical records of those patients. Results: There were 111 patients who were administered Abstral. Primary cancer lesions of lung/Gastrointestine/others were 43/52/16, respectively. ECOG PS 0-2/3-4 were 27/84, respectively. The median age was 66 y.o. (range 35-91 y.o.). Regularly used opioids were fentanyl patch prescribed for all patients. Median dose of fentanyl patch was 25mcg/hr (range 12.5-250mcg/hr). 90 patients (81%) had difficulties in the administration of oral medicine, which was the main reason of Abstral administration. Four patients (4%) were to reduce constipation and vomiting as side effects of SAO. Seven patients (6%) were to start a fentanyl patch. Three patients (3%) were assessed poor effect for SAO. Only seven patients (6%) were expected of rapid onset of analgesia effect. Abstral was administered in 27 patients (24%) during aggressive treatment such as chemotherapy administration. Median survival time from Abstral administration of these patients was 159 days. And Abstral was administered in 84 patients (76%) after aggressive treatment. Median survival time of these patients was only 32 days. Conclusions: ROO was administered for the patients who cannot take the oral medicine while it is supposed to be administered to those who want to relieve BTcP fast. In addition, it was administered after aggressive treatment in many patients. The study results represented the short prognosis of these patients. Affirming a common understanding of the efficacy of ROO and BTcP is necessary in Japan. Legal entity responsible for the study: N/A Funding: None Disclosure: All authors have declared no conflicts of interest.