Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2010
Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study.
Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03669263 (Fentanyl Buccal Soluble Films Feasible Dose Range Study for Breakthrough Pain in Taiwanese Cancer Patients), which is not on this map. Cited by 30 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Fentanyl Buccal Soluble Films Feasible Dose Range Study for Breakthrough Pain in Taiwanese Cancer Patients
Who cites it
30 citing papers in PubMed, 102 citations in OpenAlex.
- Efficacy and safety of fentanyl inhalant for the treatment of breakthrough cancer pain: a multicenter, randomized, double-blind, placebo-controlled trial.BMC palliative care · 2024Trial
- A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan.Cancer reports (Hoboken, N.J.) · 2019Trial
- Breakthrough pain management using fentanyl buccal tablet (FBT) in combination with around-the-clock (ATC) opioids based on the efficacy and safety of FBT, and its relationship with ATC opioids: results from an open-label, multi-center study in Japanese cancer patients with detailed evaluation.Japanese journal of clinical oncology · 2015Trial
- Establishing an efficacy hierarchy for breakthrough cancer pain management: a network meta-analysis of rapid-onset fentanyl formulations and morphine.BMC medicine · 2026Article
- A Prospective, Single-Cohort, Open, Multi-center, Observational Study of Sublingual Fentanyl for Breakthrough Cancer Pain: Effectiveness, Safety, and Tolerability in Korean Cancer Patients.Cancer research and treatment · 2025Observational
- Effectiveness of fentanyl buccal soluble film in cancer patients with inadequate breakthrough pain control.BMC palliative care · 2024Article
- Effects of age and gender in patients receiving doses of opioids for breakthrough pain proportional to background opioid doses.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Article
- Breakthrough cancer pain: review and calls to action to improve its management.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020Review
- Demonstrating Heterogeneity of Treatment Effects Among Patients: An Overlooked but Important Step Toward Precision Medicine.Clinical pharmacology and therapeutics · 2019Article
- Rapid acting fentanyl formulations in breakthrough pain in cancer. Drug selection by means of the System of Objectified Judgement Analysis.European journal of hospital pharmacy : science and practice · 2018Article
- Fentanyl buccal tablet for breakthrough cancer pain in clinical practice: results of the non-interventional prospective study ErkentNIS.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018Article
- Fentanyl Inhibits Tumorigenesis from Human Breast Stem Cells by Inducing ApoptosisAsian Pacific journal of cancer prevention : APJCP · 2017Article
- Fentanyl Buccal Soluble Film: A Review in Breakthrough Cancer Pain.Clinical drug investigation · 2016Review
- Review
- Breakthrough cancer pain (BTcP): a synthesis of taxonomy, pathogenesis, therapy, and good clinical practice in adult patients in Italy.Advances in therapy · 2014Review
- Breakthrough cancer pain.Current pain and headache reports · 2014Review
- Breast cancer pain management - a review of current & novel therapies.The Indian journal of medical research · 2014Review
- Considerations in selecting rapid-onset opioids for the management of breakthrough pain.Journal of pain research · 2013Article
- Pharmacokinetics of non-intravenous formulations of fentanyl.Clinical pharmacokinetics · 2013Review
- Single-dose fentanyl sublingual spray for breakthrough cancer pain.Clinical pharmacology : advances and applications · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFentanyl buccal soluble film (FBSF) has been developed as a treatment of breakthrough pain in opioid-tolerant patients with cancer. The objective of this study was to evaluate the efficacy of FBSF at doses of 200-1200 microg in the management of breakthrough pain in patients with cancer receiving ongoing opioid therapy. PATIENTS AND
methodsThis was a multicenter, randomized, double-blind, placebo-controlled, multiple-crossover study that included opioid-tolerant adult patients with chronic cancer pain who experienced one to four daily episodes of breakthrough pain. The primary efficacy assessment was the sum of pain intensity differences at 30 min (SPID30) postdose.
resultsThe intent-to-treat population consisted of 80 patients with > or =1 post-baseline efficacy assessment. The least-squares mean (LSM +/- SEM) of the SPID30 was significantly greater for FBSF-treated episodes of breakthrough pain than for placebo-treated episodes (47.9 +/- 3.9 versus 38.1 +/- 4.3; P = 0.004). There was statistical separation from placebo starting at 15 min up through 60 min (last time point assessed). There were no unexpected adverse events (AEs) or clinically significant safety findings.
conclusionsFBSF is an effective option for control of breakthrough pain in patients receiving ongoing opioid therapy. In this study, FBSF was well tolerated in the oral cavity, with no reports of treatment-related oral AEs.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.