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New Perspectives to closely match the BTcP Profile

New Perspectives to closely match the BTcP Profile. Berlin 20 th March 2009 Conference Feedback Dr David Plume. Morning session. Early start! Stand up breakfast! Introduction by Portnoy via video message. Morning chaired by Dr Giovambattista Zeppetella (St Claires Hospice, Essex).

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New Perspectives to closely match the BTcP Profile

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  1. New Perspectives to closely match the BTcP Profile Berlin 20th March 2009 Conference Feedback Dr David Plume

  2. Morning session • Early start! • Stand up breakfast! • Introduction by Portnoy via video message. • Morning chaired by Dr Giovambattista Zeppetella (St Claires Hospice, Essex)

  3. Dr Giovambattista Zeppetella • Looked at definitions. • Portnoy: transitory exacerbation of pain experienced by a patient who has relatively stable and adequately controlled background pain. • Often rapid onset, severe intensity and generally last 30 min only. • Component of cancer pain usually, often met pain. • Location usually matches normal pain • >persistent pain then >episodes of BTcP

  4. Dr Giovambattista Zeppetella • Spontaneous ( idiopathic) • Incident (incident, volitional, non-volitional, procedural) • Needs assessment separate to background pain. • Significant burden to patients ( function/social/psych) and health systems.

  5. Sebastiano Mercadente ( Palermo) • Variability in characteristics. • Three categories: • Spontaneous with no precipitant • Incident pain with precipitant • End of dose failure (though this is not BTcP) • Usually incident pain. • Different mechanisms need different approaches,

  6. Andrew Davies (Royal Marsden) • BTcP not a single entity • Mx depends on patient/disease/pain/treatment factors. • Needs to match the patient • If patient has BGP assess for BTcP • BGP= pain present for >12 hours/day during the previous week (or would have been if no analgesia)

  7. Andrew Davies • Assess BTcP separately- A.R.T • Hx and Exam, detailed pain Hx (not going to insult you!) • Assess aetiology, pathophysiology and indications or contraindications to particular treatments. • Number of tools exist inc. Episodic pain documentation chart, Alberta Breakthrough Pain Assessment Tool etc, but none are clinically validated.

  8. Marilene Filbert (Lyon Sud) • Depending how BTcP is defined the incidence could be 95% of cancer patients. • UnderRx and underDx • Some guidelines exist: • EAPC Consensus Expert Group 2002 • Bennets 2005-Types of BTcP • Davis 2008 (APM)-systematic review of recommendations for treatment. • However this is an evolving field.

  9. Joseph Porta-Sales (Barcelona) • Opioids effective in 50% patients • Need for drug to match BTcP profile • Rapid onset • Potent enough • Short duration of action • IV/SC/Spinal-will achieve the Tmax required but non-parentral cant. Slow onset and long duration of action :. unsuitable.

  10. Joseph Porta-Sales • Fentanyl ideal drug for this • Lipophillic • Rapid oral mucosal absorption • High potency • Fast onset • Short duration • We are already using buccal fentanyl and Actiq with good effect. • Novel delivery system seems to work well.

  11. Afternoon Session • Chaired by Neil Hagen ( Professor of Palliative Medicine at University of Calgary, and co-author with Portnoy) • Drug company speakers on pharmacodynamics, review of the clinical data, and a mention of the phase IV study.

  12. Mona Darwish ( Head of Clinical Pharmacology at Cephlon) • Fentanyl has 40 year hx of documented efficiency. • Absorb formulation dependent, elimination not. • Effentora-effervescent and pH changes alter solubility and absorption of drug. • Buccal method better than transmucosal • Buccal may be as good as sublingual (no published research) • Cmax higher, Tmax shorter and AUC greater. • This is not effected by dwell time • Site specific AEs are usually transitory and can be minimized by changing site daily.

  13. John Messina (VP Clinical and Strategic Planning and Ops at Cephlon) • Rx with Fentanyl Buccal Tablet at doses 100-800mcg gives pain relief in 10 mins in some patients. This analgesic effect may persist for up to 2 hours. • Portnoy et al in Clinical Journal of Pain 2006 showed statistically significant effects at 15 mins. • Slater et al in The Journal of Supportive Oncology showed significant effects from 10 mins to 2 hours. • Adverse effects are as with fentanyl (nausea, dizziness, constipation, fatigue, headaches, vomit and nausea) and the number reported or severity doesn’t seem to change with dose or speed of absorption.

  14. Ulrich R Kleeberg (Hamburg) • Large phase IV study in eight European countries with 280 investigators recruiting 1120 patients. • BTcP treatment with FBT in adult cancer patients already receiving maintenance opioid treatment. • Primary focus is titration period with efficacy and safety assessed in treatment period and longer-term follow up.

  15. Take Home Messages • BTcP is often rapid onset, severe intensity and generally last 30 min or so and occurs on a background of adequately controlled background pain. • Usually provoked by movement, and is therefore commonest with bone mets. • Need detailed pain history and examination. • Guidance is still being firmed up regarding best treatment practice. • Fentanyl is an ideal drug to match the BTcP profile. • The new formulation may be quicker than other, even very similar, methods of delivery. • The new formulation appears as safe as other preparations.

  16. Few days in Berlin! Any Questions?

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