Invloed van anti-epileptica op de behandeling van gliomen

Laatst beoordeeld: 15-04-2015

Uitgangsvraag

Wat is de invloed van anti-epileptica op de (chemotherapeutische) behandeling?

Aanbeveling

De werkgroep is van mening dat het voorschrijven van enzym-inducerende anti-epileptica als fenytoïne, carbamazepine, oxcarbazepine en topiramaat niet gewenst is bij patiënten die worden behandeld voor een glioom.

De werkgroep is van mening dat er nog onvoldoende data zijn om een behandeladvies te baseren op de aanwijzingen dat het gebruik van valproaat in combinatie met temozolomide de overleving positief zou kunnen beïnvloeden.

Conclusies

Er zijn aanwijzingen dat valproaat de overleving van patiënten met een glioblastoom positief zou kunnen beïnvloeden.
Weller 2011380, Simo 2013313, Tsai 2012345, Guthrie 2013121, Kerkhof 2013169

Er zijn geen prospectieve gerandomiseerde onderzoeken die de invloed van specifieke anti-epileptica op de chemotherapeutische behandeling beschrijven.

Samenvatting literatuur

Er zijn interacties beschreven tussen anti-epileptica en chemotherapeutica, gebaseerd op het gedeelde cytochroom P450-metabolisme. Enzym-inducerende anti-epileptica als fenobarbital, fenytoïne en carbamazepine geven verlaging van de spiegels van sommige chemotherapeutica en tevens een verhoogd metabolisme van corticosteroïden en verdienen dus niet de voorkeur tijdens chemotherapeutische behandeling [Brodie 201333, Oberndorfer 2005233].
Valproaat heeft een complexe invloed op de tumorcelproliferatie, waarbij theoretisch zowel stopzetten van de celcyclus als tumorproliferatie op kan treden. Preklinisch onderzoek toont een remmend effect van valproaat aan op DNA-repair mechanismen. Hierdoor kan het cytotoxische effect van chemotherapie of radiotherapie versterkt worden. Er worden in vitro geen aanwijzingen gevonden voor een remmend effect van valproaat op het cytotoxisch effect van temozolomide [Chen 201255, Ryu 2012286, Van Nifterik 2012361, Berendsen 201215].
In een retrospectieve analyse naar het gebruik van anti-epileptica bij patiënten met een glioblastoom die tussen 2000 en 2002 deelnamen aan een studie waarin radiotherapie werd vergeleken met chemoradiotherapie, hadden patiënten in de chemoradiatie-groep die werden behandeld met valproaat monotherapie een significant betere mediane overleving (17 maanden, versus 14 maanden bij patiënten zonder anti-epileptica of alleen enzym inducerende anti-epileptica) [Weller 2011380]. In de groep die alleen behandeld werd met radiotherapie werd geen significant verschil gevonden in overleving. Wel trad bij het gebruik van valproaat in combinatie met temozolomide vaker trombocytopenie, neutropenie en leukopenie op [Weller 2011380, Simo 2012313].
Ook in andere retrospectieve studies zijn er aanwijzingen dat valproaat de overleving positief zou kunnen beïnvloeden. Er zijn echter geen gerandomiseerde trials die deze bevindingen bevestigen [Tsai 2012345, Guthrie 2013121, Kerkhof 2013169].

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Autorisatiedatum en geldigheid

Laatst beoordeeld : 15-04-2015

Laatst geautoriseerd : 15-04-2015

De geldigheid van richtlijnmodules zal bij herbeoordeling komen te vervallen wanneer nieuwe ontwikkelingen aanleiding geven om een herzieningstraject te starten. De Nederlandse Vereniging voor Neurologie is regiehouder van deze richtlijn en eindverantwoordelijke op het gebied van de actualiteitsbeoordeling van de richtlijnmodules. De andere aan deze richtlijn deelnemende wetenschappelijke verenigingen of gebruikers van de richtlijn delen de verantwoordelijkheid en informeren de regiehouder over relevante ontwikkelingen binnen hun vakgebied.

Initiatief en autorisatie

Initiatief : Landelijke Werkgroep Neuro-Oncologie

Geautoriseerd door:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging voor Medische Oncologie
  • Nederlandse Vereniging voor Neurochirurgie
  • Nederlandse Vereniging voor Neurologie
  • Nederlandse Vereniging voor Pathologie
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging voor Radiotherapie en Oncologie
  • Verpleegkundigen en Verzorgenden Nederland
  • Landelijke Werkgroep Neuro-Oncologie

Algemene gegevens

De richtlijnontwikkeling werd ondersteund door het Integraal Kankercentrum Nederland IKNL).

Doel en doelgroep

De richtlijn gliomen geeft aanbevelingen over diagnostiek, behandeling, nazorg en organisatie van zorg bij patiënten met een glioom. De richtlijn beoogt hiermee de kwaliteit van de zorgverlening te verbeteren, het klinisch handelen meer te baseren op wetenschappelijk bewijs dan op ervaringen en meningen, de transparantie te vergroten en de diversiteit van handelen door professionals te verminderen.

De richtlijn is bestemd voor alle professionals die betrokken zijn bij de diagnostiek, behandeling en begeleiding van patiënten met een (verdenking op een) glioom. Deze zorg vereist een multidisciplinaire aanpak waarbij neuroloog, neurochirurg, radioloog, patholoog, radiotherapeut, internist-oncoloog, verpleegkundigen, verpleegkundig specialisten, klinisch neuropsychologen, huisartsen, IKNL-consulenten palliatieve zorg en het palliatief consult team betrokken kunnen zijn.

Samenstelling werkgroep

Voor de herziening van de richtlijn is in 2013 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen. De werkgroepleden zijn door hun beroepsverenigingen gemandateerd voor deelname. De werkgroep is verantwoordelijk voor de integrale tekst van deze richtlijn.

 

Werkgroep

  • Mw. dr. T. Seute, neuroloog, Universitair Medisch Centrum Utrecht, gemandateerd namens de NVN (voorzitter)
  • Mw. drs. M.A.B. Bakker-van der Jagt (namens NVRO - Radiotherapeutisch Instituut Friesland)
  • Mw. S. Bossmann (namens V&VN - Radboudumc Nijmegen)
  • Mw. dr. J.E.C. Bromberg (namens NVN, Erasmus MC - Daniel den Hoed Oncologisch Centrum)
  • Mw. dr. A.M.E. Bruynzeel (namens NVRO - VU medisch centrum)
  • Dhr. dr. W.F.A. Dunnen (namens NVVP - Universitair Medisch Centrum Groningen)
  • Mw. drs. R.E.M. Fleischeuer (namens NVVP - Stg. Elisabeth Ziekenhuis)
  • Mw. E. Gortmaker (namens V&VN - Medisch Centrum Haaglanden)
  • Dhr. dr. Hendrikse (namens NVVR - Universitair Medisch Centrum Utrecht)
  • Dhr. dr. M. Klein (namens NVN - VU medisch centrum)
  • Mw. drs. J.H.F. Leemhuis (namens Leven met kanker-beweging (voorheen NFK)
  • Dhr. J. Moonen (namens Leven met kanker-beweging (voorheen NFK)
  • Mw. drs. S. Polman (namens NVN - Isala)
  • Mw. dr. M. Smits (namens NVVR - Erasmus MC)
  • Dhr. dr. A.J.P.E. Vincent (namens NVvN - Erasmus MC)
  • Dhr. dr. F.Y.F.L. de Vos (namens NVMO - Universitair Medisch Centrum Utrecht)
  • Mw. dr. A.M.E. Walenkamp (namens NVMO - Universitair Medisch Centrum Groningen)
  • Mw. drs. H.L. Weide (namens NVRO - Universitair Medisch Centrum Groningen)
  • Dhr. dr. P.C. de Witt Hamer (namens NVvN - VU Medisch Centrum)

 

Ondersteuning

  • Mw. T.T.M. Bluemink-Holkenborg, secretaresse IKNL
  • Mw. G.H. Schrier, MSc, adviseur richtlijnen IKNL, procesbegeleider

Inbreng patiëntenperspectief

Bij de ontwikkeling van deze richtlijn is tijdens alle fasen gebruik gemaakt van de input van patiënten. Twee patiëntvertegenwoordigers namen zitting in de richtlijnwerkgroep (één ervaringsdeskundige op het gebied van gliomen en één deskundige op het gebied van richtlijnontwikkeling). Deze input is nodig voor de ontwikkeling van kwalitatief goede richtlijnen. Goede zorg voldoet immers aan de wensen en eisen van zowel zorgverlener als patiënt. Door middel van onderstaande werkwijze is informatie verkregen en zijn de belangen van de patiënt meegenomen:

  • Bij aanvang van het richtlijntraject hebben de patiëntvertegenwoordigers knelpunten aangeleverd. De gemandateerde patiëntvertegenwoordigers hebben in augustus 2013 ervaringen van patiënten met de zorgverlening geïnventariseerd door ervaringsdeskundigen te bevragen op een bijeenkomst van de patiëntenvereniging Cerebraal. De patiëntvertegenwoordigers waren aanwezig bij alle vergaderingen van de richtlijnwerkgroep.
  • De patiëntvertegenwoordigers hebben de conceptteksten beoordeeld ten einde het patiëntenperspectief in de formulering van de definitieve tekst te optimaliseren.
  • De Leven met kanker-beweging (voorheen NFK) is geconsulteerd in de landelijke commentaarronde.

Methode ontwikkeling

Evidence based

Implementatie

In de verschillende fasen van het ontwikkelproces is rekening gehouden met de implementatie van de richtlijnmodule en de praktische uitvoerbaarheid van de aanbevelingen. Daarbij is uitdrukkelijk gelet op factoren die de invoering van de module in de praktijk kunnen bevorderen of belemmeren. De implementatietabel is te vinden bij de aanverwante producten.

Werkwijze

De werkgroep is in juni 2013 voor de eerste maal bijeengekomen. Op basis van een eerste inventarisatie van de knelpunten door de werkgroepleden is door middel van een enquête onder professionals die betrokken zijn bij patiënten met gliomen een knelpunteninventarisatie gehouden. Na het versturen van de enquête hebben 101 professionals gerespondeerd en knelpunten geprioriteerd en/of ingebracht. De meest relevante knelpunten zijn uitgewerkt tot drie uitgangsvragen die evidence based zijn uitgewerkt. Voor iedere uitgangsvraag werd uit de richtlijnwerkgroep een subgroep geformeerd. Bij de evidence-based beantwoording van de drie uitgangsvragen verzorgde een externe methodoloog het literatuuronderzoek, de critical appraisal, de evidence tabellen en een concept literatuurbespreking. De werkgroepleden pasten vervolgens de conceptliteratuurbespreking en -conclusies aan en stelden overwegingen en aanbevelingen op volgens de checklist ‘overwegingen en formuleren van aanbevelingen’.
Voor de consensus-based beantwoording van de resterende uitgangsvragen raadpleegden de werkgroepleden de relevante bestaande literatuur. Op basis hiervan hebben de werkgroepleden de wetenschappelijke conclusies, overwegingen en aanbevelingen geformuleerd. Er is voor de consensus-based beantwoording geen verder systematisch literatuuronderzoek verricht.