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Indicatie radiotherapie glioblastoom

Beoordeeld: 15-04-2015
ZonMw logo
Project nr: 852002028
Einddatum 05-2026

Uitgangsvraag

Wat is de indicatie voor radiotherapie bij een patiënt met een glioblastoom (WHO graad IV) en hoe dient dit uitgevoerd te worden?

Aanbeveling

Bij patiënten met een glioblastoom in goede klinische conditie, jonger dan 61 jaar dient post-operatief een radiotherapiedosis van 30 x 2 Gy gegeven te worden, gecombineerd met concomitant en adjuvant temozolomide. Voor de behandeling van oudere patiënten met een glioblastoom wordt verwezen naar de module Behandeling van ouderen.

Er wordt geadviseerd geen hogere bestralingsdosis toe te dienen. De werkgroep adviseert hypofractionering te overwegen bij patiënten die in een matige conditie zijn.

De werkgroep is van mening dat het doelgebied van de bestraling de resectieholte, het (resterende) aankleurende gebied op de T1-sequentie met contrast van de postoperatieve MRI, met een marge van 1,5-2 cm voor microscopische ziekte, het doelgebied zou moeten zijn. Hierbij wordt rekening gehouden met het hyperintense gebied op de T2- en FLAIR-sequenties en de anatomische barrières.

Overwegingen

De gecombineerde behandeling van hoge dosis radiotherapie en temozolomide toont de meeste winst in overleving in de groep patiënten <50 jaar in een goede postoperatieve conditie. Bij patiënten met een KPS <70 en een leeftijd ≥50 jaar is de winst van de gecombineerde behandeling beperkt.

Als er tijdens het behandelen klachten ontstaan die veroorzaakt worden door (radiotherapie-geïnduceerd) oedeem, kan het starten met (een lage dosis) dexamethason geïndiceerd zijn.

De planning en uitvoering van de bestraling dient tenminste plaats te vinden met behulp van een 3DCRT-techniek. Teneinde het hoge dosis gebied zoveel mogelijk te beperken tot het doelgebied, wordt het gebruik van meer geavanceerde technieken zoals intensity modulated radiotherapy (IMRT), volumetric arc therapy of tomotherapie, aangemoedigd. Er bestaat echter geen bewijs dat geavanceerde planningstechnieken de prognose verbeteren of het risico op toxiciteit verminderen. Vanwege vroege veranderingen in het operatiegebied en de mogelijkheid van snelle progressie bij het GBM is het aan te bevelen de MRI zo kort mogelijk aan te laten sluiten bij het begin van de radiotherapie. In gevallen waarbij er een langer interval tussen de operatie en start radiotherapie bestaat, dient de postoperatieve MRI dan ook herhaald te worden ten behoeve van accurate vaststelling van doelgebieden.

Onderbouwing

Postoperatieve radiotherapie is standaardbeleid na resectie van een glioblastoom, indien de klinische situatie van de patiënt dit toelaat. Een overlevingsvoordeel is aangetoond bij een dosis van 60 Gy ten opzichte van 45 Gy, echter de mediane overleving lijkt niet te verbeteren bij verdere ophoging van de totale bestralingsdosis.
Walker 1979374, Bleehen 198119, Nelson 1988226, Nakagaya 1998224, Chan 200250

Er zijn aanwijzingen dat postoperatieve hypofractionering een gelijkwaardige uitkomst geeft als conventioneel gefractioneerde radiotherapie, maar dit is met name onderzocht bij patiënten met een ongunstige prognose in een niet gerandomiseerde setting en bij oudere patiënten.
Slotman 1996317, Sayin 2007299, Hingorani 2012135

Het is aangetoond dat een hogere lokale bestralingsdosis met behulp van een stereotactische radiochirurgie of brachytherapieboost geen voordeel biedt ten opzichte van standaarddosis bestraling.
Souhami 2004324, Laperriere 1998192

Het is aangetoond dat gecombineerd postoperatieve radiotherapie (60 Gy/30 fracties) met gelijktijdig en adjuvant temozolomide een voordeel in overleving biedt ten opzichte van radiotherapie alleen.
Stupp 2005331, 2009330

Bij ongeveer 80% van de patiënten die zich presenteren met een hooggradig glioom is sprake van een glioblastoom (WHO graad IV) [Omuro 2013238]. Zowel tumor- als patiëntgerelateerde factoren, zoals de mate van resectie, de leeftijd en de klinische/neurologische conditie (Karnofsky performance score, KPS), hebben een impact op de prognose en dienen meegenomen te worden bij het afstemmen van de postoperatieve behandeling en het bestralingsschema. Gezien het palliatieve karakter van de behandeling moet overlevingswinst worden afgewogen tegen de morbiditeit van de behandeling en het effect op de kwaliteit van leven. De behandeling van het glioblastoom bij de oudere patiënt wordt afzonderlijk in de module Behandeling van ouderen besproken.
De waarde van postoperatieve radiotherapie bij de behandeling van patiënten met een glioblastoom is in meerdere gerandomiseerde studies aangetoond, waarbij er een winst in mediane overleving wordt gezien van rond de 5 maanden ten opzichte van resectie alleen [Walker 1979374, Kristiansen 1981183].

Het bestralingsvolume omvat de resectieholte, het (resterende) aankleurende gebied op de T1- sequentie met contrast van de postoperatieve MRI. Een marge van 1,5-2 cm voor microscopische ziekte (clinical target volume, CTV) wordt aangehouden, waarbij het hyperintense gebied op de T2- en FLAIR-sequenties wordt geïncludeerd. Het CTV kan worden aangepast op basis van anatomische barrières. Er zijn echter geen aanwijzingen dat krappere marges het patroon van recidiveren van het glioblastoom beïnvloedt (80% recidiveert binnen 2 cm van de oorspronkelijke tumor) [McDonald 2011213, Paulsson 2014252]. Wanneer er alleen een biopsie is verricht volstaat de preoperatieve MRI-scan.

In oudere gerandomiseerde studies is een overlevingsvoordeel aangetoond van een dosis van 60 Gy ten opzichte van een dosis van 45 Gy [Walker 1979374, Bleehen 198119]. De mediane overleving werd niet verbeterd bij het verhogen van de dosis van 60 naar 70 Gy (9.3 versus 8.2 maanden) [Nelson 1988226, Nakagaya 1998224, Chan 200250]. In een gerandomiseerde studie werd geen voordeel gezien van de toevoeging van stereotactische radiochirurgie (SRS) als boost aan conventionele radiotherapie [Souhami 2004324]. Evenmin kon een gerandomiseerde studie een verbetering van de overleving door de toevoeging van brachytherapie aan conventionele radiotherapie aantonen [Laperriere 1998192]. Gezien de beperkte levensverwachting van patiënten met een glioblastoom heeft men in verschillende studies gekeken naar het verkorten van de behandelduur met behulp van hypofractionering, vooral bij patiënten met een ongunstige prognose [Slotman 1996317, Sayin 2007299]. Een overzichtsartikel over hypofractionering bij het glioblastoom concludeert aan de hand van studies met verschillende bestralingsschema's, uiteenlopend van 30 Gy in 6 fracties tot 54 Gy in 18 fracties, dat hiermee een gelijkwaardige uitkomst wordt gezien als met conventionele fractionering; dit ondanks een lagere totale bestralingsdosis. Er werd geen toename van toxiciteit gezien van hypofractionering [Hingorani 2012135]. In de groep patiënten van 60 jaar of ouder met een glioblastoom is behandeling met hypofractionering in een gerandomiseerde setting vergeleken met conventionele fractionering, waarbij een vergelijkbare overleving werd gezien [Roa 2004279]. In de module Behandeling van ouderen wordt verder ingegaan op de Nordic trial die bij patiënten van 60 jaar of ouder met een glioblastoom gerandomiseerd heeft tussen behandeling met een gehypofractioneerd bestralingsschema, conventionele fractionering en TMZ [Hingorani 2012135].

De toevoeging van chemotherapie in de vorm van temozolomide (TMZ) aan postoperatieve radiotherapie in een dosis van 60 Gy in fracties van 2 Gy, is sinds de uitkomst van de EORTC- 26981/22981-NCIC CE3-studie de standaardbehandeling na resectie van het glioblastoom [Stupp 2005331]. In een update van de resultaten van de genoemde EORTC-studie werd het significante voordeel van de gecombineerde behandeling bevestigd met een 5-jaars overleving van 10% voor de gecombineerde behandeling versus 2% met radiotherapie alleen. Het overlevingsvoordeel van de gecombineerde behandeling was het grootst in de groep patiënten jonger dan 50 jaar met een KPS van 90-100, waarbij de 2-jaars overleving toenam van 20% naar 43% en de 5-jaars overleving 28% was [Mirimanoff 2006220, Stupp 2009330]. Bij patiënten, waarbij zowel de KPS <70 was als de leeftijd ≥50 jaar,en bij patiënten met neurologische uitval, was de winst van de gecombineerde behandeling beperkt: 10 maanden ten opzichte van 9 maanden voor radiotherapie alleen [Mirimanoff 2006220, Stupp 2009330]. In enkele kleine prospectieve- en retrospectieve studies is gehypofractioneerde radiotherapie gecombineerd met TMZ bestudeerd, vooral bij oudere patiënten [Hingorani 2012135].

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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.

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.

Volgende:
Behandeling van ouderen