The U&lity of Opioids for Breakthrough Cancer Pain
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1 The U&lity of Opioids for Breakthrough Cancer Pain John Zeppetella MD(Res), FRCGP, FRCP Medical Director, St Clare Hospice Josep Porta Sales MD, PhD InsFtut Català d Oncologia jporta@iconcologia.net
2 Disclosures J. Zeppetella Grünenthal Ltd Kyowa Kirin Takeda Teva UK J. Porta-Sales Ferrer Kyowa Kirin Grünenthal Ltd Takeda Wyeth
3 Definition Breakthrough pain is a transient exacerba4on of pain that occurs either spontaneously or in rela4on to a specific predictable or unpredictable trigger despite rela4vely stable and adequately controlled background pain. Breakthrough pain Background analgesia (ATC) Background pain Davies et al. 2009
4 Diagnostic Algorithm Davies et al. 2009
5 Subtypes Breakthrough Pain Spontaneous Pain Incident Pain Volitional Non-Volitional
6 Breakthrough Pain Prevalence Overall prevalence 59% Deandrea et al. 2014
7 BTcP Characteristics European Survey of 1000 oncology pafents 44% incident pain, 41.5% spontaneous pain, 14.5% combinafon. The median number of episodes was three a day. The median Fme to peak intensity was 10 minutes, The median durafon of untreated episodes was 60 minutes 893 pafents stated that pain stopped them doing something, 980 pafents were receiving an opioid to treat their pain Davies et al. 2009
8 Time to Peak Intensity Davies et al. 2013
9 BTcP Duration Davies et al. 2013
10 BTcP Intra-patient Variability Pain intensity Pain duration Pain relief Pérez Cajaraville et al. 2016
11 Interference with Aspects of Daily Living Davies et al. 2013
12 Breakthrough Pain Impact Anxiety Depression Healthcare Costs Relationships Activities Sleep Working Quality of Life Walking Rx satisfaction Zeppetella, 2011
13 Management Challenges Common Heterogeneous Related to background pain Fast onset Short durafon Burdensome
14 APM Recommendations 1. PaFents with pain should be assessed for the presence of breakthrough pain 2. PaFents with breakthrough pain should have this pain specifically assessed 3. The management of breakthrough pain should be individualized 4. ConsideraFon should be given to treatment of the underlying cause of the pain 5. ConsideraFon should be given to avoidance / treatment of the precipita&ng factors of the pain Davies et al. 2009
15 Decision Making Pain Aetiology Analgesia Condition Co-morbidities Patient Preference Clinical Situation
16 APM Recommendations 6. ConsideraFon should be given to modificafon of the background analgesic regimen around the clock medica&on Davies et al. 2009
17 Background Analgesic Regimen Op&mising background analgesia ( increase 33%) Are sfll ATC analgesics useful? Is frequently used the rescue medicafon without side-effects? Overdose and side-effect risk Hwang et al. 2003/ Mercadante et al Pharmacological treatment Co-analgesics Opioids SOOs Route of administrafon Portenoy et al /William & MacLeod /Davies et al. 2009/ Zeppetella et al. 2009
18 Pain Intensity Time
19 Management Strategies Multimodal Approach Soares & Chan
20 APM Recommendations 7. Opioids are the rescue medicafon of choice in the management of breakthrough pain episodes Davies et al. 2009
21 EAPC Guidance Breakthrough pain (e.g. incident pain) can be effec4vely managed with oral, immediaterelease opioids or with buccal or intranasal fentanyl prepara1ons. In some cases the buccal or intranasal fentanyl prepara1ons are preferable to immediate-release oral opioids because of morerapid onset of ac4on and shorter dura4on of effect. Caraceni et al 2012
22 Breakthrough Pain in Cancer Patients 64% of all BTcP < 60 min 64% incident BTcP < 60 min 61% spontaneous BTcP < 60 min Davies et al. 2013
23 Symptomatic management
24 Transmucosal Opioids
25 Mixed Treatment Comparisons Jansen et al., 2008; Vissers et al. 2010
26 Mixed Treatment Comparisons Zeppetella et al., 2014
27 EAPC guidance Addi4onally, the data permit a weak recommenda4on that immediate-release formula1ons of opioids with short half-lives should be used to treat preemp1vely predictable episodes of breakthrough pain in the min preceding the provoking manoeuvre. Caraceni et al 2012
28 APM Recommendations 8. The dose of opioid rescue medicafon should be determined by individual &tra&on STARTING OPIOID DOSE PAIN CONTROLLED/NO ADVERSE EFFECTS PAIN CONTROLLED/ ADVERSE EFFECTS PAIN NOT CONTROLLED/ NO ADVERSE EFFECTS PAIN NOT CONTROLLED/ ADVERSE EFFECTS CONTINUE CURRENT DOSE DECREASE OPIOID DOSE INCREASE OPIOID DOSE CHANGE TREATMENT Davies et al. 2009
29 APM Recommendations 9. Non-pharmacological methods may be useful in the management of breakthrough pain episodes 10. Non-opioid analgesics may be useful in the management of breakthrough pain episodes 11. Interven&onal techniques may be useful in the management of breakthrough pain 12. PaFents with breakthrough pain should have this pain specifically re-assessed Davies et al. 2009
30 Re-assessment after initiation To assure an efficacious and safe 4tra4on, a close follow up (every h) of pa4ents star4ng any strong opioids, including transmucosal fentanyl prepara4ons, must be carried out un4l appropriate 4tra4on is reached. (1) analgesia (pain relief) inifal effect ( 15 )* and complete relieve (2) acfvifes of daily living (psychosocial funcfoning) (3) adverse effects sedafon, NV (4) aberrant drug taking (addicfon related outcomes). Op1miza1on of background analgesia should be considered if the pa4ents experience 3 BTcP episodes for >2 consecu1ve days. Porta-Sales et al / *Boceta et al. 2016
31 Drugs to Review for Optimised Prescribing Offer oral NR- morphine first line TM fentanyl when other short-acfng opioids are unsuitable. Due to numerous formulafons, prescribe by brand to reduce this risk and restrict local formularies. An individual s circumstances should be considered carefully to before prescribing a TM product Bulletin 132 April 2016
32 Drugs to Review for Optimised Prescribing PaFents receiving TM fentanyl who are suitable for NR morphine (and haven t had it first line) could be considered for a switch. PaFents receiving the most costly TM fentanyl products could be considered for a switch to a less costly IR fentanyl product. IdenFfy pafents regularly using more than 2-4 doses of TM fentanyl for breakthrough pain/24 hours for review. TM fentanyl products are licensed only for the management of breakthrough pain in adult pa&ents using opioid therapy for chronic cancer pain. Bulletin 132 April 2016
33 Summary Breakthrough pain is a common heterogeneous problem Aim to reduce the intensity and frequency of episodes Oral opioids have not been formally tested The strongest evidence is for uflity of transmucosal fentanyl Buccal, sublingual and nasal preparafons are available No simple relafonship between the effecfve dose of transmucosal opioid and ATC or rescue opioid medicafon Close follow up pafents on opioids
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