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Improved patient functioning after treatment of breakthrough cancer pain: an open-label study of fentanyl buccal tablet in patients with cancer pain

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Abstract

Purpose

This open-label study evaluated the effects of fentanyl buccal tablet (FBT) on functioning and mood in cancer patients with breakthrough cancer pain (BTcP).

Methods

Opioid-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.

Results

Of 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 %).

Conclusions

FBT 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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Acknowledgments

This study was sponsored by Cephalon, Inc. (Frazer, PA), now a wholly owned subsidiary of Teva Pharmaceuticals Industries Ltd. Writing support was provided by Bina J. Patel, PharmD, of Peloton Advantage, LLC, funded by Teva Pharmaceuticals. The authors wish to thank Ronghua Yang, PhD, of Teva Pharmaceuticals for assistance with the statistical analysis and acknowledge the 135 investigators for their contributions to the study.

Conflict of interest

The authors have full control of all primary data and allow the journal to review these data if requested. A. Davies has received honoraria from Cephalon and Teva Pharmaceuticals for speaking at symposia and attending advisory boards, as well as unrestricted funding to support research. H. G. Kress has received honoraria as a speaker and consultant from Cephalon/Teva Pharmaceuticals. At the time of this study, H. Schneid was an employee of Cephalon, Inc. (Maisons-Alfort, France), now a wholly owned subsidiary of Teva Pharmaceuticals (Petah Tikva, Israel).

Author information

Authors and Affiliations

  1. Royal Surrey County Hospital NHS Foundation Trust, Egerton Road, Guildford, GU2 7XX, Surrey, UK

    Andrew Davies

  2. Hämatologisch-Onkologische Praxis Altona, Struenseehaus, Hamburg, Germany

    Ulrich R. Kleeberg

  3. Mossakowski Medical Research Centre Polish Academy of Sciences, Warsaw, Poland

    Jerzy Jarosz

  4. Casa di Cura di Alta Specialità, La Maddalena, Terapia del Dolore e Cure Palliative, Palermo, Italy

    Sebastiano Mercadante

  5. Polyclinique de l’Ormeau, Tarbes, France

    Philippe Poulain

  6. Department of Palliative Medicine, Marymount Hospice and Cork University Hospital, Cork, Ireland

    Tony O’Brien

  7. Teva Laboratoires, La Défense, France

    Hélène Schneid

  8. Department of Special Anaesthesia and Pain Therapy, Medical University/AKH, Vienna, Austria

    Hans G. Kress

Authors
  1. Andrew Davies
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  2. Ulrich R. Kleeberg
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  3. Jerzy Jarosz
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  4. Sebastiano Mercadante
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  5. Philippe Poulain
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  6. Tony O’Brien
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  7. Hélène Schneid
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  8. Hans G. Kress
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Corresponding author

Correspondence to Andrew Davies.

Additional information

This study was previously presented at (1) The 15th World Congress of Pain Clinicians (WSPC); June 27-30, 2012; Granada, Spain; (2) The International Association for the Study of Pain’s (IASP) 14th World Congress on Pain; August 27-31, 2012; Milan, Italy; and (3) The European Society for Medical Oncology (ESMO) 2012 Congress; September 28-October 2, 2012; Vienna, Austria.

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Davies, A., Kleeberg, U.R., Jarosz, J. et al. Improved patient functioning after treatment of breakthrough cancer pain: an open-label study of fentanyl buccal tablet in patients with cancer pain. Support Care Cancer 23, 2135–2143 (2015). https://doi.org/10.1007/s00520-014-2590-8

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  • DOI: https://doi.org/10.1007/s00520-014-2590-8

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