• Andrew Davies, Ulrich R Kleeberg, Jerzy Jarosz, Sebastiano Mercadante, Philippe Poulain, Tony O'Brien, Hélène Schneid, and Hans G Kress.
• Royal Surrey County Hospital NHS Foundation Trust, Egerton Road, Guildford, GU2 7XX, Surrey, UK, adavies12@nhs.net.
• Support Care Cancer. 2015 Jul 1;23(7):2135-43.

PurposeThis open-label study evaluated the effects of fentanyl buccal tablet (FBT) on functioning and mood in cancer patients with breakthrough cancer pain (BTcP).MethodsOpioid-tolerant patients in seven European countries with up to four BTcP episodes/day received FBT doses (100-800 μg) identified during open-label titration to treat up to eight BTcP episodes during an open-label treatment period. In countries where FBT was not commercially available, patients could enter an open-label continuation phase. Functionality and satisfaction assessments included change from baseline to the end of the treatment period in the modified Brief Pain Inventory (BPI-7S) seven-item interference subscale, patient's global assessment of satisfaction and ease of use, and Patient's Global Impression of Change (PGIC). Safety was also assessed.ResultsOf 330 randomized patients, 218 completed the treatment period and 88 entered the continuation phase. Median background pain intensity was 4.0 (mild) throughout the study. After the treatment period, mean (SD) global modified BPI-7S score improved from 39.7 (15.9) at baseline to 31.6 (16.8) for a mean change of -8.6 (95% confidence interval CI -10.5, -6.7; P < 0.0001), and 74.5% of patients reported improvement in overall status (PGIC) compared with 25.5% who reported no change or worsening (P < 0.001). Treatment-related adverse events (≥2 patients) during the continuation phase were application site erythema (6.9%), application site swelling (4.6%), and vertigo (4.6%).ConclusionsFBT may improve patient functioning, mood, and overall satisfaction in the management of BTcP. Long-term data did not indicate new safety concerns with FBT doses up to 800 μg.

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