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. π υ - α
α υ
α πα (BTcP):
π υ α α;
Γ : • α Ν • α α υ BTcP • υ α • π π •
:
• Θ απ υ α π • Φ α α ω (rescue medications) • α υ υ Ν υ
Ό π υ α α α π υ π υ υ απ
υ υ υ υ α α α α α π
α α π υ
α Montreal
IASP 2010
84 250
α π π Γα α Ρ99 α α Ρ10
υ . α / π
Η Δ π αΕ υ α υ υ Σ90 α
α π υ α υ υ
απα α π π α
α π υ π υ υ α πα α
΄84:
΄89: ΄02: ΄09:
α:
1. Review of Prevalence, characteristics and managemend of
BTcP: 38 α Mischra Σ09 2. EPCRC: 51 α Ρ11
α π φ Breakthrough Cancer Pain (BTcP)
π π α π αφ υ (Postenoy, Hagen) ΟepisodicΠ, ΟtransientΠ (EAPC task force) απ υ υ breakthrough (πα υ ) α απ φ (Hagen, Davis
Mercadante)
BTcP: α 1,2
α πα υ π υ π υ φα α αυ α α, α π π π α, πα
α π α α υ υπ π (BP)*
΄89 Portenoy: ΄02 Svenden Swandic
α:
Ρ14 α α 1:
Δ α Ε, Δ πα υ Ε BP αφ Δ υ υΕ Δ υ υΕ BP
Δπ π : α π , α υ υπ υ π υ π α α Ε α π υ BP7NRS
αφ BTcP-BP>3NRS
*BP: background pain 1. BTcP: a synthesis of taxonomy, pathogenesis,
therapy and good clinical parctice in Italy
F. Zucco, Adv.Ther., 2014
BTcP:
α: π πα (65%-76%) Ν απ α (10%-20%) Ν α Ν Ν υ πα Ν α
υχ α: 19%-95% α πα 1
φ α
υ υπ 2
α 3 ( . α (-30%) vs α Φ)
2
α υ 4
α α υ 5
υ υ α α α 6
1 Zeppetella, Ribeiro Ρ03, Zeppetella Ρ11 2 Caraceni et al: Pain prevalence in a population of cancer patients (QYDEI) J. Pain Sympt Manage
2012
3 Mercadante Ρ02, Greco Σ11, Margarit Ρ12 (Eur. J. Pain) 4 Caraceni et al Ρ99 5 Bruera et al Σ99 6 Saini A: A Circadian variation of BTcP Eur J.Pain 2012
χ : π π α π : π π Ν υ α π Ν 1 , 123
α , 47 , 76 π α α α: ECOG-PS, VAS, POS, QUDEI (Italian version of BPQ), BTcP
diary
π α α: 60% π υ α υ α 10π Ν 6 ( :9:45, π α 10:30)
α α α: υ φ α π . π 1
ς φ υα α π Φ -Φ π υ α α π π
1σaberet et al Ρ81 Yoshida Ρ06
Asai Ρ07
Circadian variation of BTcP A. Saini et al. Eur.J.Pain, May 2012
Prevalence of BTcP (controlled - uncontrolled) background pain in the Cancer population
A. Davis, Full publication planned for 2014
π : α α υ α υ BTcP υ π υ α , α α α υ α α υ
Η υ α υ χ α
• π υ • α α α α α α α , α π • Χ profil • Έ α : α 4% α 34% υ 62% • π : 3/
• α 38%-53%
• υ πα 10%-54% • 20%-52%
• π α 29% • α 45%
Davis et al2013
Eur J Pain
Mischra et al 2009
Zeppetella, Ribeiro
2003
2009
BTcP: χα α - α
2 α
υ α , αυ , πα (spontaneous, idiopathic)
Davis et al, 2013
υ α 41,5% α 10Σ
α 60Σ
, π α (incident)
υ α 44% α 5Σ
α 45Σ
Δα Ε BTcP
Δ Ε BTcP
(volitional) (non volitional)
Θ απ υ ς πα α ς (procedural)
A
BTcP: α
• 17%-30%: υ α • απ π υπ π υ BTcP
( υ )1
• Δ Ε α α π 2
1 EPCRC Ρ11 2 εercadante Ρ11
Δ - απ υχ α Ε π
α χ υ υπ υ π υ (Οend of doseΠ failure pain)
• αφ πα χα α υ υπ π υ BTcP
1. υ α α απ π υ υ
2. φ υα π Ν π (α υ α Ν υπ α α)
3. υα π (αφ π Δ π υπ Ν C Ν π α )
4. π υ . υ . υ α ( )
• (incident):
• υ (spontaneous):
1 & 2
π υ υ 3 & 4
α α φ υ υ
BTcP: χα - πα α
α Ά
α *
ADL
α α
π
π π
α
α α π απ Θ απ α
* + BTcP: 12.000 $ / / - BTcP: 2.400 $ / /
αυ
BTcP
BTcP: π π
αφ α: • Webber V. et al: BTcP, a qualitative study involving patients with advanced cancer
Supp. Care Cancer 2011
• Davis et al: Multi- center Eur Study of BTcP Eur J Pain 2013
• Rutsoen et al: how nurses assess BTcP and the impact of this painΖ, an Eur. Survey Eur. J. Nurs. Onc 2012
• Fortner et al: A survey of pain related hospitalization J. Pain Sympt. Manage, 2003
• Abenethy AP: A health economic model of BTcP Am J Man Care, 2008
• Breivic H et al: Cancer related Pain: a pan Eur survey of prevalence, treatment and patient altitude
Ann Onc, 2009
• Current and historical ratio tablets: www.xe.com/currentlytablets2013
• Meriggi et al: BTcP: where we are; Rev on Clin Trials, 2013
π π ( υ χ α)
13 υ πα 28 υ & Φ 1.000 α
α α:
υ π α α:
α α Ρ09 α Ρ09
ADL (activities of daily life)
53% α α Θ α BTcP 19% α α α α α
αφ α α απ α 65.5%
10.5%
23.5% α α ADL
81% α π α α 11% α α π α 7% π α
: α π α ADL υ : α π α α π αφ α α υπ π BTcP1
1 Deadrea, Corlio, Commendary on Davis, 2013
Davis et al 2013: π υ Eur J Pain
Bedard et al 2013
MONO TO 33% α Φ α (rescue medication) α BTcP
• Ό π α υ α π 33% • Φ α 23% • π α 17% • Φ 12% • α α υφ α 10% • α α Φ 8% • Φ πα 7% • Γ α / υ υ α 2%
A survey of Canadian Cancer patients, perspectives on the characeristics and treatment of BTcP
Supp. Care Cancer
:
BTcP υπ απ α
Ν ( αφ )
ωπ π απ α
• υπ π • α φ π
πα
αφ
BTcP: α α π
• υπ π (survivors)
Alberta BTcP assessment tool (Delfi project validated, υ ) BPQ (Breef pain quest.) 2009
QUDEI (Italian Quest. for intense episodic Pain) 2012
Episodic Pain Doc Sheet (1 Hospice, Zeppetella)
BTP assessment tool (validated, A. Davis oral presentation) 2013
• Ν α • 2009 ( Ν αφ
απ BP) • α α BTcP
10 α α (tools) 7 υπ
BTcP : ω -
• α π υ π υ α profil υ
BTcP
• υ α π • π α
:
BTcP : απ υ α π
• α π υ • α α α α • π π πα α α α • φα α υ α π ( υ υπ Ν υ π α
απ )
• Φα α υ α π
• α α
Φ α α ω (Rescue medications)
υ Φ α α
BTcP : απ υ α π
φ * υ *
φ α (1 )
* α α α α PO (per os): απ α
Η
π α α (PO) (Short Acting Opioids: SAO)
π α α Έ α (Rapid Onset Opioids: ROO)
. α α (IV,SC) φ (IR) . α α Φα α
(Fast Fentanyls:FF)
- α -
OTFC (Actiq)*
SLF (Abstral)*
FBT (Effentora)
SLFS (Subsys)
FBSF (Breacyl)
INFS (Instanyl)*
FPNS (Pecfent)
BTcP : φ α α ω
• FC inhaler ( φ ) • FNS cytosan, FNS cytosan Ν poloxamer • SL υ φ • SL α • S φ • S α •
BTcP : φ α α ω υπ
υπ υ απ α υ απ α α α υ
BTcP, πα α π α α α, α υ α ,
(Rescue Dose), α π α υ υπ υ, α π υ
( α RD:1/6 24 υ α π )
EBM reviews
BTcP : π αχ α (PO): SAO
α χ α π (IV, SC) • φ • Θ α Δφ α α αφ Ε ( α ROO) • φ IV,SC RD: 15% -20% 24
εercadante et al Σ04 IV φ > FF α 30Σ IV φ = FF α 60Σ • IV φ + PCA: χ α Σ , Mercadante Ρ07 PCA : α α υ υ
Jamagushi Σ13
BTcP : π αχ α Έ α : ROO
Mercadante et al ‘07
H. Smith, A comprehensive review of ROO for BTcP CNS Drugs, 2012
BTcP : υ α α α α Φα α
( α – ), Fast Fentanyls
H. Smith, A comprehensive
review of ROO for BTcP CNS Drugs,
2012
BTcP : Φα α profil ω FF
α υ α υ • υ α α α π π υ α α (OTFC) • υ α α α Ν α • π • α • πα υ
α υ υ • υ α α π αυ α - - α • α α • α απ Φ (INFC) • πα υ • α Ν υ α • φ υ α
π α
π
α
BTcP : χ FF
• Φ α α • α α BTcP • α α ( α ) • α αυ α , π υ α α α • α ( υ α ) • α • πα υ (42% π π )* • α α •
* Corli C., OIPC, res. group, 2011
BTcP : π - υ α
α
IV,SC
Farrar et al Ρ98 Coluzzi et al Ρ01 (OTFC vs MS IR) Mercadante et al Ρ07 Shaiova Ρ04 (mucosities) Rayne et al Σ01 Taylor et al Ρ07 (QOL-non-cancer)
OTFC Portenoy Ρ06 Portenoy Ρ07 (Low back pain) Simpson Ρ07 (Neur Pain) Slatkin Ρ07 Farrar Ρ10 (non-cancer) Ashburn Ρ11 (vs Oxydone IR)
FBT
Rauck Ρ10 Diaz del Consuelo Ρ07
FBSF
Rauck Ρ09 Lennernas Ρ10 Nalamatzu Σ11 (QOL, DAPOS, PGEM: 6 )1
Uberall Ρ11 (PRD, HADS)1
( α: 12 )
SLF
1. DAPOS: Depression, Anxiety and positive outlook scale
PGEM: PatientΣs global evaluation of medication PRD: Pain related disability
HADS: Hamilton Anxiety, Depression Scale
π υ υ α FF
Kress Ρ09 Cristrup Σ08 (INFS vs Fent iv) Foster Ρ08 Mercadante Ρ09 (INFS vs OTFC) Kaasa Ρ10 (FF vs MSIR) Vissers Ρ10 (INFS vs OTFC, FBT, MSIR):
α υ Mercadante Ρ14 (INFS vs FPNS) Konsgaard Ρ14 (QOL) Thrones Ρ14 (400 INFS) Plock Ρ13 (400 INFS) Nave Ρ09 (cold, rhinitis, ozymetazoline) Nolte Ρ09 ( , π α ) Jacobsen Ρ10 (π α ) Registry studies 5 υ . : α off-label (overdose, abuse, misuse, diversion)
Ruggers Ρ13 ( / φ ) Vissers Ρ11 (INFS vs OTFC QALYs: quality adjust life years
INFS Portenoy Ρ10 Taylor Ρ10 Davis Ρ11 (FPNS vs MSIR
FPNS
Parikh N. Ρ13 Rauck R. Ρ12
FSLS
π υ υ α FF
Streisand ‘λ1 Egan ‘ίί
όarrar ‘λκ Coluzzi ‘ί1*** Mercadante ‘ίι****
Shaiova ‘ί4 (mucositis)
Taylor ‘ίι (non cancer)
----------------
----------------
Lennernas ‘λκ
Lenernas ‘1ί Rauck ‘ίλ
Rauck ‘ίλ
σalamatsu ‘11 Uberall ‘11
-----------------
-----------------
όoster ‘ί1 Kaasa ‘1ί
Kress ‘ίλ
Mercadante ‘ίλ
Mercadante ‘ίλ
Mercadante ‘ίλ* Vissers ‘1ί**
Vissers ‘11* QALYs
Φε
Κζδθδεά Απο εζε ηα- δεσ β α
Α φΪζεδα - Αθεε δεσ β α
Ιεαθοποέβ β απσ γελαπεέα
Συγελδ δεΫμ
Κσ ομ ή Ώφεζομ
*Mercadante ’ίλ INFS vs OTFC **Vissers ’1ί Ϋηηε β τγελδ β ωθ FF ***Coluzzi ‘ί1 OTFC vs MSJR (PO) ****Mercadante ‘ίι OTFC vs M(IV)
OTFC
5
5
3
SLF
5
5
INFS
5
3
OTFC SLF INFS Jadad score
• Fentanyl transmucosal, Towycross R. et al J. Pain Management, 1012
• Opioids for the management of BTcP, G Zeppetella, A. Davis
Cochrane database syst. Review, 2013
EBM: evidence based medicine
Fast Fentanyls: EBM reviews
4 RCTs 393 α OTFC 15 RCTs 1699 α 7 αφ FF (5 α , 2 ) 8 RCTs FF vs Placebo
4 RCTs FF vs π 1 RCT φ υ 2 RCTs π
2006 2013
*Έ π α : Jadad scoring system Σ96 χ : α α απ α α ROO
α απ π α α π
Opioids for the management of BTcP: systemic Review Zeppetella G, Davis A. Cochrane Library 2013
• α FFs α φ IV υ α α υ BTcP
• Ό α α ROO υπ υ υ Placebo • υ α α NNTs FFs • α π υ α
απ α απ αυ υ α π
• υ α α FFs
π α α:
Opioids for the management of BTcP: systemic Review Zeppetella G, Davis A. Cochrane Library 2013
• α υ π απ υ α FF (fast fentanyls)
• α πα : PID Placebo α 60΄
χ :
10 RCTs (INFS, FPNS, FBT, FSL, OTFC, FBSF, oral MSIR)
INFS = FPNS > placebo α π FF α 5Σ INFS > π FF α 10Σ INFS > FPNS = FBT = OTFC > π FF α 15Σ INFS > FPNS = FBT = OTFC = FST =FBSF > oral morphine and placebo α 30Σ Oral Morphine > placebo α 45Σ
• Ό α α FF > oral morphine > placebo • INFS α α π ( ) BTcP
υ π α α:
A network metaanalysis of the efficacy of opioid analgesics for the management of BTcP episodes
Zepetella G, Davies A., Eijgelshoven I, Jansen JP J. Pain Sympt.Manage 2014 47:772-785
Φ α α FF α α π υ α υ BTcP, υ
χ υ profil
χ :
Pubmed 64 α Ρ99 Ρ12 100 INFS
400 FBT
600 OTFC
:
Cmax 0,7 Ν 0,95 /ml
α πα (Darwish Ρ07, Kaasa Ρ10, Lennernes Ρ05)
υ α α :
BTcP: FF, α π BTcP A review of the pharmacokinetic profil of transmucosal fentanyl formulations N. Moore et al Curr Med. Rep Opin, 2012
• Φ πα αφ υ α α α, , α Ν φ
• 3 Φ π
π α α:
α α α C max 15Σ α α απ
α α α C max 30Σ α α αυ . υ / C max 60Σ
απ
π
π π
BTcP: FF, α π BTcP A review of the pharmacokinetic profil of transmucosal fentanyl formulations N. Moore et al Curr Med. Rep Opin, 2012
α υ α υ υ (slow):
α υ υ (fast):
σuneΣz Olarte EAPCRC, 2014 Lleida
BTcP: π FF, α π BTcP;
• αφ α • :
α α υ α α α α α
α α φα α α π υ α α
α α υ υ
α α υ υ α α α α π υ BTcP:
WHO 2012
Ρ90 α
AssPM of GBr. and Ireland
Davis et al 2009
ESMO 2012
BTcP
Γα α 2012 FSSTP
FSAPL
FASCP
NCCN
2013
2011
απω α 2012 JPCS
πα α 2013 SEOM
SSPC
SSP
EONS 2013
Eur. Ong. Nurs. Soc.
EAPC 2012
Caraceni, Hans, Kaasa
Delphy cons
EPCRC 2011
α υ υ α υ
• υπ π π π α α υ α π α α
• α π π α α υ π ( : φ 60mg, Fent TTs 25 , υ
30mg, φ 8mg, υ φ 25mg) (FDA Ρ11, REεS Ρ11)
• α ROO (IV φ α FF) π α π α απ α α υ BTcP
• π α BTcP π π απα α α α α π α υπ π
• α α α =1/6 24 , α SAO (Zeppetella Σ11, Σ13)
χυ υ (Grading system α Guyatt Ρ08)
BTcP: π α υ υ ω α υ ω
• υπ α α α FF 24 υ π α υπ π
( 1-72% 24 ) (Davis Ρ09)
• υπ α α α α FF • πα α π α FF α α
α (εercadante Σ09)
• π π α υ υ (FDA Ρ12)
• π π α α υ π α π Σ α
χυ υ (Grading system α Guyatt Ρ08)
• FF: REMS (Risk Evaluation and Mitigation Strategy)
BTcP: π α υ υ ω α υ ω ( υ χ α)
• α α FF (Zeppetella Ρ11) • υ απ FF α π
( ercadante Σ13, α Σ ) • υ απ υ FF α α
>120 mg M/24 α α π (εercadante Σ11)
• >5 π α BTcP/ = α απ α 24
• 20΄ π • α Ν 20Σ Ν 30Σ π
BTcP
• υ α Ν 20Σ -30Σ π π απ υ πα α
• α < 4 = monitoring • α :
- π - απ υ πα α - π - υ
• ESετ Σ12: SAτ: • E PC Σ12: Rττ:
• Γα α Σ12: Rττ:
• πα α Σ13: SAO:
ROO:
BTcP: φυ α χ SAO - ROO
• π υ BTcP - α
• α π υπ υ - α α (fast – slow BTcP)
• φα α υ - α φ α α • Θ Θ Γ
α Φ . α α
υ
BTcP: π π ;
• π φ α α 2009
• π φ α 2014
• α υ υ α υ πα 2013
α α Θ απ α υ α α Φ α ( Η. . . )
• α α α α 1
- απ α α α πα - υ (head to head) FF - π - α - υ / φ υ
• BTcP υπ π (survivors);
1. Davis A, Zeppetella G 2014
A review article that high lights reduced pain indencity / meaningful pain relief
as parameter across FF studies
BTcP: π π ω;
υχα
α υ α πα (BTcP):
π υ α α;