A Prospective, Single-Cohort, Open, Multi-center, Observational Study of Sublingual Fentanyl for Breakthrough Cancer Pain: Effectiveness, Safety, and Tolerability in Korean Cancer Patients
Year: 2024
Type: article
Study design: Observational Study
Abstract: PURPOSE: Fentanyl, a highly lipophilic opioid, was developed as a sublingual fentanyl tablet (SFT) for the management of breakthrough cancer pain (BTcP), and its efficacy and safety were confirmed in a randomized, controlled study. We investigated the effectiveness and safety of SFT administered to alleviate BTcP in a real-world setting. MATERIALS AND METHODS: In this prospective, open, single-cohort study, conducted in 13 referral hospitals in South Korea, opioid-tolerant cancer patients receiving around-the-clock opioids for persistent cancer pain were enrolled if the individual had BTcP ≥ 1 episode/day during the preceding week. The primary outcome was the SFT titration success rate. RESULTS: Among 113 patients evaluated for effectiveness, 103 patients (91.2%) had a successful titration of SFT, with an effective dose range between 100 μg and 400 μg. The most frequent dose was 100 μg, administered to 65.0%, 72.1%, and 81.8% of the patients at week 1, 4, and 12, respectively. The proportion of patients achieving the personalized pain goal assessed in the first week was 75.2%. The mean change in pain intensity measured with a numeric rating scale at 30 and 60 minutes after taking SFT was -2.57 and -3.62, respectively (p < 0.001 for both). The incidence rate of adverse events related to SFT among 133 patients included for safety evaluation was 9.0% (12/133), which included vomiting (3.0%), nausea (2.3%), and headache (1.5%). CONCLUSION: In a real-world setting, SFT provides rapid and effective analgesia in BTcP, even at the lowest dose (100 μg), and the safety profile was acceptable.
Source: Cancer Research and Treatment
DOI: 10.4143/crt.2024.557
Institutions: Korea University Guro Hospital, University of Ulsan, Ulsan University Hospital, Chonnam National University, Chonnam National University Hwasun Hospital, Soonchunhyang University Hospital Bucheon, Kosin University Gospel Hospital, Pusan National University Yangsan Hospital, Soonchunhyang University, Soonchunhyang University Hospital Cheonan, Chungbuk National University, Chungbuk National University Hospital, Jeonbuk National University Hospital, Jeonbuk National University, Daegu Catholic University, Daegu Catholic University Medical Center, Seoul National University, Seoul National University Bundang Hospital, Gangneung Asan Hospital, Samsung Medical Center, Sungkyunkwan University
Language: English
Subfield: Anesthesiology and Pain Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4405782177