Division of Transfusion Medicine, Department of Medicine, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan.
Division of Medical Oncology, Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Cancer Rep (Hoboken). 2019 Oct;2(5):e1179. doi: 10.1002/cnr2.1179. Epub 2019 Apr 23.
Fentanyl buccal soluble film (FBSF), a new formulation of fentanyl, is developed for the treatment of breakthrough pain (BTP) in opioid-tolerant patients with cancer.
This study aimed to assess the feasible dose range of FBSF required for Taiwanese population.
This was an open-label, multicenter, noncomparative study. Cancer patients who were aged 20 years or older and had a stable regimen equivalent to 60 to 1000 mg/day of oral morphine, 20 to 120 mg/day of intravenous morphine, or 25 to 300 μg/h of transdermal fentanyl for at least 1 week were enrolled. The primary endpoint was the feasible dose range of FBSF. Secondary endpoints included difference in pain intensity at 30 minutes (PID30), percentage of episodes requiring rescue medication, and overall satisfaction. Adverse events (AEs) and serious AEs (SAEs) were recorded for safety measurements. The final effective dose in the per-protocol (PP) population (n = 30) ranged from 200 to 800 μg, of which 26 subjects (86.7%) achieved an effective dose range of 200 to 400 μg. Among the 283 BTP episodes recorded in the maintenance period, the mean PID30 was 4.0, and only 13 events (4.6%) required rescue medication. For 63.6% of the BTP episodes, patients rated their satisfaction as good to excellent. Only 5% of AEs were considered drug-related.
Individualized dose titration is recommended for BTP management for patients' benefit. Overall, FBSF was effective and well tolerated and was positively correlated with patients' background opioid dose for persistent pain management.
芬太尼颊膜（FBSF）是一种新型芬太尼制剂，用于治疗阿片类药物耐受的癌症患者的爆发性疼痛（BTP）。
本研究旨在评估 FBSF 在台湾人群中所需的可行剂量范围。
这是一项开放性、多中心、非对照研究。入组标准为年龄 20 岁或以上且稳定用药至少 1 周的癌症患者，等效于 60 至 1000mg/天口服吗啡、20 至 120mg/天静脉注射吗啡或 25 至 300μg/h 透皮芬太尼。主要终点是 FBSF 的可行剂量范围。次要终点包括 30 分钟时疼痛强度的差异（PID30）、需要解救药物的发作比例以及总体满意度。记录不良事件（AE）和严重不良事件（SAE）以进行安全性测量。在符合方案（PP）人群（n=30）中，最终有效剂量范围为 200 至 800μg，其中 26 例（86.7%）达到 200 至 400μg 的有效剂量范围。在维持期记录的 283 次 BTP 发作中，PID30 的平均值为 4.0，仅 13 次（4.6%）需要解救药物。对于 63.6%的 BTP 发作，患者对满意度的评价为好到极好。仅有 5%的 AE 被认为与药物相关。
建议对 BTP 管理进行个体化剂量滴定，以确保患者受益。总的来说，FBSF 有效且耐受良好，与患者背景阿片类药物治疗持续性疼痛的剂量呈正相关。
