Observational study of efficacy, safety, and tolerability of fentanyl in Korean cancer patients (OASIS)

Abstract

Abstract Background: Sublingual fentanyl (Abstral) has been developed to provide rapid-onset analgesia in breakthrough cancer pain (BTcP). While the efficacy and safety of the fentanyl tablet have been already confirmed in clinical trials, there is no real-world evidence regarding the effectiveness and safety of this agent in the control of BTcP. Aims: To observe the effectiveness, safety and tolerability of Abstral for the alleviation of BTcP in Korean patients. Methods: The study is a non-interventional, observational study conducted in 13 hospitals in the Republic of Korea. Cancer patients (targeted number: 309), prescribed with Abstral due to the inability to control BTcP with other fentanyl products, are to be followed up for 12 weeks to collect the information about dose titration, pain status, quality of life, and adverse events. Conclusions: The list of inclusion and exclusion criteria is relatively short, which will likely make the study group more representative for the entire population of cancer patients with BTcP. All treatment-related decisions are left solely on the investigator's discretion, which will enable to analyze the treatment outcomes in various clinical scenarios, unlikely to be tested in a traditional clinical trial. These two features seem to be essential for the successful management of BTcP, a highly heterogeneous condition requiring an individualized approach. Further, the study includes patients who did not respond to other fentanyl formulations, and hence, it might explain whether switching from one immediate-release fentanyl to another is associated with a clinical benefit and/or specific risk. Trial registration: ClinicalTrials.gov with the identifier NCT03895762.