Radiotherapie bij progressie hooggradig glioom/recidief
Uitgangsvraag
Wat is de indicatie voor radiotherapie bij een patiënt met een recidief of progressie van een hooggradig glioom in een eerder bestraald gebied en hoe dient deze uitgevoerd te worden?
Aanbeveling
Patiënten met een recidief hooggradig glioom dienen in een multidisciplinair neuro-oncologisch overleg besproken te worden. In de recidiefsetting dienen alle palliatieve behandelingen, waaronder radiotherapie en chirurgie, telkens mede in overweging genomen te worden.
De werkgroep is van mening dat behandeling in studieverband de voorkeur verdient.
De werkgroep is van mening dat een minimaal interval van zes tot twaalf maanden aangehouden dient te worden tussen de initiële bestraling en re-irradiatie.
Bij de afweging of re-irradiatie een reële optie is, speelt de definitie van het doelgebied de belangrijkste rol. De toepassing van kleinere marges dan in de primaire setting wordt geadviseerd.
Om het risico op radiatie-geïnduceerde complicaties zoveel mogelijk te beperken wordt geadviseerd re-irradiatie te plannen met moderne bestralingstechnieken zoals stereotactische radiotherapie, intensity modulated radiotherapy (IMRT) of volumetric modulated arc therapy (VMAT).
De werkgroep is van mening dat er vanuit de literatuur geen optimaal fractioneringsschema vast te stellen is. Voor zowel conventioneel gefractioneerde schema's, hypofractionering of een enkele fractie radiochirurgie zijn series in de literatuur beschreven.
Overwegingen
Er bestaat geen standaardbehandeling voor een recidief hooggradig glioom (HGG), zodat de werkgroep van mening is dat de eerste keuze voor patiënten in goede conditie een behandeling in studieverband is.
Patiënten met een recidief HGG dienen in een neuro-oncologisch multidisciplinair overleg besproken te worden, temeer daar er verschillende behandelopties, zoals reresectie, (tweedelijns)chemotherapie, gerichte medische therapieën, re-irradiatie of combinaties bestaan.
Onderbouwing
Conclusies
Vanwege het ontbreken van gerandomiseerde studies die reresectie, re-irradiatie, (tweedelijns) chemotherapie of gerichte medische therapieën met elkaar hebben vergeleken, bestaat er geen standaardbehandeling voor patiënten met een recidief hooggradig glioom.
Amichetti 20115
Er zijn aanwijzingen dat een minimaal interval van zes tot twaalf maanden moet worden aangehouden tussen de initiële bestraling en re-irradiatie.
Niyazi 2011231
Het is aannemelijk dat de definitie van het doelgebied de belangrijkste afweging is met betrekking tot de mogelijkheid en verwachte toxiciteit van re-irradiatie [Nieder 2011[220]]. In de meeste series wordt het doelgebied bepaald door de contrast-aankleurende gebieden op MRI met geringe marges van 0,5-1 cm.
Henke 2009133, Fokas 2009101, Combs 200564, Vordermark 2005369
Er zijn aanwijzingen dat moderne bestralingstechnieken zoals stereotactische radiotherapie,intensity modulated radiotherapy (IMRT) of (volumetric modulated arc therapy) VMAT, het eerder bestraalde hersenweefsel minder belasten, waardoor het risico op radiatie-geïnduceerde complicaties kleiner wordt.
Fogh 2010100
Gezien de diversiteit van de studies is er geen goede aanbeveling voor het optimale fractioneringschema te verkrijgen uit de literatuur.
Hoewel niet gerandomiseerd onderzocht, lijkt de toevoeging van chemotherapie aan re-irradiatie de overleving niet te verbeteren.
Amichetti 20115
Samenvatting literatuur
Hoewel er de laatste jaren vooruitgang is geboekt in de behandeling van geselecteerde patiënten met een hooggradig glioom (HGG) met de combinatiebehandeling bestaande uit chirurgie, radiotherapie en chemotherapie, ontstaat een recidief in ongeveer 90% van de patiënten binnen het eerdere bestralingsgebied [Niyazi 2011231, Amichetti 20115, Weller 2013378]. Het onderscheid tussen radiatie-geïnduceerde veranderingen en tumorprogressie op grond van de beeldvorming kan lastig zijn en wordt besproken in evidence based vraag 1. Bij blijvende twijfel is histologische verificatie noodzakelijk voor het starten van tweedelijnsbehandeling, zeker ook indien re-irradiatie wordt overwogen.
Omdat bij een recidief HGG verschillende palliatieve behandelingsmogelijkheden voorhanden zijn zoals reresectie, (tweedelijns)chemotherapie, re-irradiatie of combinaties hiervan, dient bespreking in een neuro-oncologisch MDO plaats te vinden. Er bestaan geen gerandomiseerde studies in de recidief HGG setting die de genoemde behandelingsmodaliteiten vergelijken. In module 2.1 en 2.2 wordt ingegaan op de rol van reresectie en (tweedelijns)chemotherapie en gerichte medische therapieën bij een recidief HGG. De keuze van behandeling wordt vooral bepaald door factoren als klinische conditie, interval tussen initiële behandeling en diagnose van recidief, en de uitgebreidheid en lokatie van het recidief. Door het bovenstaande bestaat er geen standaardbehandeling voor patiënten met een recidief HGG en is de eerste keuze voor patiënten in goede conditie een behandeling in studieverband [Amichetti 20115].
In tegenstelling tot de radiotherapie voor het primair HGG bestaat er geen consensus in de literatuur over het optimale fractioneringsschema of de vaststelling van doelgebieden bij re-irradiatie van HGG. Wel wordt in de meeste studies een minimaal interval van zes tot twaalf maanden aangehouden tussen de eerdere bestraling en re-irradiatie [Niyazi 2011231]. De belangrijkste afweging met betrekking tot de mogelijkheid en verwachte toxiciteit van re-irradiatie betreft niet zozeer de gebruikte bestralingsdosis, maar de definitie van het doelgebied [Nieder 2011228]. In de meeste gerapporteerde studies wordt het doelgebied bepaald door de contrast-aankleurende gebieden op MRI met geringe marges van 0,5-1 cm, zonder de witte stof afwijkingen op de T2 sequenties te includeren zoals gebruikelijk in de primaire behandeling [Henke 2009133, Fokas 2009101, Combs 200564, Vordermark 2005369]. Moderne bestralingstechnieken zoals stereotactische radiotherapie, intensity modulated radiotherapy (IMRT) of volumetric modulated arc therapy (VMAT) maken precisiebestraling mogelijk, waardoor de dosis van het eerder bestraalde hersenweefsel en daarmee het risico op radiatie-geïnduceerde complicaties kleiner wordt. Een belangrijke ondersteunende studie voor het belang van moderne technieken en beperkte doelgebieden is de studie van Fogh et al, waarbij re-irradiatie van recidief HGG werd uitgevoerd in 147 patiënten met behulp van hypofractionering met stereotactische precisie tot een mediane totale dosis van 35 Gy in fracties van 3,5 Gy. In deze studie werd uitsluitend het aankleurende gebied op de T1-contrast MRI als doelgebied gebruikt. Niet alleen toonde deze relatief grote studie een mediane overleving van tien tot elf maanden in zowel anaplastische gliomen als glioblastomen, maar werd er eveneens vrijwel geen graad ≥3 toxiciteit gezien (slechts in 1 patiënt behandeld met een dosis boven de 40 Gy) [Fogh 2010100]. Bij de afweging of re-irradiatie een reële optie is, speelt naast de tumorlokatie ten opzichte van kritische normale organen, de definitie van de RTH doelgebieden, ook de grootte van het contrast-aankleurende gebied op de MRI een rol, waarbij er in de literatuur geen consensus is over de maximale grootte hiervan. In de praktijk blijkt men terughoudend te zijn bij re-irradiatie van een aankleurend tumorrecidief dat groter is dan 5 cm.
Wat betreft het optimale fractioneringsschema is geen goede aanbeveling te verkrijgen uit de literatuur. Niet-gerandomiseerde, veelal retrospectieve studies zijn gepubliceerd voor een enkele fractie radiochirurgie, extreme of minder extreme hypofractionering, of conventioneel gefractioneerde (stereotactische) schema's met uiteenlopende doses, en de resultaten hiervan zijn over het algemeen vergelijkbaar, evenals de toxiciteit. Een vergelijkende studie tussen deze radiotherapie technieken ontbreekt echter, zodat het niet goed mogelijk is een aanbeveling te doen. Een aantal studies rapporteren over de toepassing van brachytherapie (meestal 125I of 192Ir), met eveneens wisselende resultaten en toxiciteit [Amichetti 20115]. Het risico op (symptomatische) radionecrose waarvoor reresectie noodzakelijk blijkt te zijn wordt zeer wisselend gerapporteerd voor de verschillende behandelingen, maar kan oplopen tot 31% [Amichetti 20115].
Herbestraling met ge(hypo)fractioneerde stereotactische radiotherapie werd in een aantal series gecombineerd met chemotherapie, meestal temozolomide. Hoewel ook dit niet gerandomiseerd werd vergeleken, verbeterde de toevoeging van chemotherapie de overleving niet ten opzichte van radiotherapie alleen [Amichetti 20115, Fogh 2010100].
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Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 15-04-2015
Laatst geautoriseerd : 15-04-2015
Geplande herbeoordeling :
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.
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.