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Behandeling van ouderen bij glioblastoom

Beoordeeld: 15-04-2015

Uitgangsvraag

Wat is de beste behandeling voor oudere patiënten met een glioblastoom?

Aanbeveling

Bij oudere patiënten (> 60 jaar) in slechte conditie (KPS < 70;) en met cognitieve functiestoornissen (MMSE <27/30) is de levensverwachting ≤ 4-5 maanden en lijkt de beperkte potentiële overlevingswinst van behandeling niet op te wegen tegen de belasting van de behandeling. De werkgroep is van mening dat in deze groep afzien van behandeling een realistische optie is.

Bij patiënten van 60-70 jaar, bij wie het behandelteam verwacht dat chemoradiatie volgens het Stupp-protocol te zwaar uitvalt (bijvoorbeeld door comorbiditeit, minder goede conditie en/of afwijkende MMSE),is de werkgroep van mening dat MGMT-promotoranalyse ingezet kan worden. Bij gemethyleerde promotor wordt de patiënt dan monotherapie met temozolomide aangeraden, bij een niet gemethyleerde promotor een kort schema radiotherapie. Er is een risico op een foutpositieve uitslag van de MGMT-promotormethylering waardoor voor een individuele patiënt het weglaten van radiotherapie zou kunnen betekenen dat hem/haar een effectieve behandeling wordt onthouden.

Bij patiënten ouder dan 70 jaar wordt geadviseerd MGMT-promotoranalyse in te zetten. Bij een gemethyleerde promotor wordt de patiënt dan monotherapie met temozolomide aangeraden, bij een niet gemethyleerde promotor een kort schema radiotherapie. Slechts in uitzonderlijke gevallen (zeer goede conditie en MMSE én resectie ondergaan én geen comorbiditeit) kan het behandelteam overwegen om in overleg met de patiënt alsnog chemoradiatie volgens het Stupp-protocol toe te dienen.

Overwegingen

In het algemeen leidt behandeling van het glioblastoom met radiotherapie en/of chemotherapie niet tot verbetering van de klinische toestand, wel mogelijk tot verlenging van de overleving. De klinische conditie en levenskwaliteit van de patiënt op het moment van aanvang van de behandeling bepalen daarom in sterke mate of en op welke manier de patiënt behandeld dient te worden. Diverse geriatrische beoordelingsschalen zijn onderzocht in de oncologie en kunnen wellicht aanvullende informatie geven betreffende prognose, maar de toegevoegde waarde hiervan staat niet vast [Puts 2014266. Leeftijd is een belangrijke prognostische factor en gemiddeld hebben oudere patiënten een slechtere prognose dan jongere patiënten, hoewel oudere patiënten met overigens gunstige prognostische factoren ook baat kunnen hebben van intensieve behandeling. Over de leeftijd waarop een patiënt oud of ouder is, bestaat geen consensus en ook in studies worden verschillende leeftijden aangehouden. Doorgaans wordt met ‘ouder' een leeftijd bedoeld vanaf 60 tot 70 jaar.
Bij patiënten tot 70 jaar is de meerwaarde van gecombineerde bestraling en temozolomide chemotherapie aangetoond. Bij oudere patiënten is alleen monotherapie bestraling vergeleken met monotherapie temozolomide. Combinatiebehandeling bij ouderen, met een kort schema radiotherapie gecombineerd met temozolomide, is onderzocht in de EORTC/NCIC-ouderenstudie maar hiervan zijn de resultaten nog niet bekend. Eventueel kan in afwachting van de resultaten van deze studie bij oudere patiënten met een gemethyleerde MGMT promotor ook temozolomide met een kort schema radiotherapie worden overwogen.

Onderbouwing

Het is aangetoond dat bij oudere patiënten (> 60 jaar) in slechte conditie (KPS < 70;) en/of met cognitieve functiestoornissen (MMSE <27/30) de levensverwachting kort is (≤ 4-5 maanden).
Curran 199365, Mirimanoff 2006220, Stupp 2009330

Het is aannemelijk dat bij oudere patiënten (> 60 jaar)in slechte conditie (KPS < 70;) en/of met cognitieve functiestoornissen (MMSE <27/30) de beperkte potentiële overlevingswinst van de behandeling niet opweegt tegen de belasting van de behandeling.
Roa 2004279, Slotman 1996317, McAleese 2003212

Het is aannemelijk dat voor patiënten van 60-70 jaar met gunstige prognostische factoren (goede performance status, KPS>70 én MMSE ≥27/30 én resectie ondergaan) behandeling met standaard 60 Gy radiotherapie met gelijktijdig en adjuvant temozolomide zinvol kan zijn. Voor deze groep geldt dat de mediane overleving langer is dan 12 maanden en dat bij hen, evenals bij jongere patiënten, de kans op levensverlenging met standaard 60Gy gecombineerde chemoradiotherapie groter is dan bij radiotherapie alleen.
Stupp 2009330, Stupp 2005331, Yin 2013398

Het is aangetoond dat de methyleringsstatus van de MGMT-promotor bij oudere patiënten (> 60-65 jaar) predictieve waarde heeft ten aanzien van behandeling met temozolomide.
Malmstrom 2012208, Yin 2014a/b397 400

Het is aannemelijk dat een lang schema radiotherapie geen voordeel biedt boven een kort schema bij oudere patiënten.
Roa 2004279, Malmstrom 2012208

Het is aannemelijk dat bij patiënten vanaf 60-65 jaar, in geval van een gemethyleerde promotor, temozolomide chemotherapie tenminste gelijkwaardig is aan bestraling.
Malmstrom 2012208, Wick 2012387, Yin 2014397

Het is aannemelijk dat ook oudere patiënten in een suboptimale conditie temozolomide chemotherapie kunnen verdragen.
Gallego Perez-Larraya 2011105

Het is aangetoond dat de bepaling van de methyleringsstatus van de MGMT-promotor geen volmaakte sensitiviteit en specificiteit heeft. Er is een risico op een foutpositieve uitslag van de MGMT-promotormethylering waardoor voor een individuele patiënt het weglaten van radiotherapie zou kunnen betekenen dat hem/haar een effectieve behandeling wordt onthouden.
Quillien 2012268, Vlassenbroeck 2008367

De prognose voor oudere patiënten met een glioblastoom is slechter dan voor jonge patiënten, zeker wanneer de algehele conditie of mentale status verminderd is. Het is de vraag of standaardbehandeling met radiotherapie en gelijktijdig en adjuvant temozolomide haalbaar en zinvol is bij deze patiëntenpopulatie [Curran 199365, Mirimanoff 2006220, Stupp 2009330]. Bij aanwezigheid van de volgende prognostisch ongunstige variabelen; leeftijd > 60 jaar, Karnofsky performance status (KPS) < 70, MMSE < 27/30, niet hebben ondergaan van een resectie, wordt de prognose slechter en neemt de winst van aanvullende behandelingen af [Mirimanoff 2006220, Stupp 2009330]. Subgroepanalyses van de gerandomiseerde fase III-EORTC/NCIC-studie 26981, waarin behandeling met 60 Gy radiotherapie vergeleken werd met gecombineerd 60 Gy radiotherapie en temozolomide, laten echter zien dat ook bij oudere patiënten (60-70 jaar) met gunstige prognostische factoren (ruime resectie, goede performance status en MMSE > 27/30) de mediane overleving meer dan twaalf maanden is [Stupp 2009330, Stupp 2005331]. In een prospectieve serie van 42 opeenvolgende patiënten ouder dan 65 jaar (mediaan 71,3 jaar) bleek deze behandeling haalbaar bij 70% van de patiënten, zonder behandelinggeïnduceerde toxiciteit, en was de prognose significant beter bij patiënten met een KPS ≥ 80% [Fiorica 201099]. Hoewel er geen andere gerandomiseerde studies beschikbaar zijn, ondersteunt een recente meta-analyse van niet gerandomiseerde studies overlevingswinst met deze behandeling ook voor patiënten ouder dan 65 jaar. In deze meta-analyse zijn ook patiënten boven de 80 jaar geïncludeerd en, overeenkomstig de subgroepanalyse van de EORTC-26981-studie, was de winst van de gecombineerde behandeling het grootste bij de patiënten met een goede performance status die een resectie hadden ondergaan [Yin 2013398].Veel oudere patiënten zijn echter in een minder goede conditie of hebben geen resectie ondergaan, waardoor de prognose beduidend slechter is [Curran 199365, Chaichana 201147].

Om deze patiënten een acceptabele maar minder belastende behandeling te kunnen aanbieden is een aantal studies verricht. Behandeling met een kort schema radiotherapie is vergeleken met een lang schema (standaard, 60 Gy) in een gerandomiseerde studie bij 100 patiënten van 60 jaar of ouder. Er werd geen verschil gevonden in overleving na behandeling met 40 Gy in 15 fracties in vergelijking met 60 Gy in 30 fracties [Roa 2004279]. Enkele niet-gerandomiseerde studies toonden een vergelijkbaar resultaat met een mediane overleving van 4-6 maanden [Roa 2004280, Slotman 1996317, McAleese 2003212]. Behandeling met radiotherapie werd vergeleken met alleen ondersteunende therapie in een gerandomiseerde studie bij 85 patiënten van ≥ 70 jaar met een KPS van ≥ 70. Na alleen ondersteunende therapie werd een mediane overleving gevonden van 16,9 weken en na 50 Gy gefractioneerde radiotherapie was de mediane overleving 29.3 weken [Keime-Guibert 2007166]. Oudere patiënten in een minder goede conditie (KPS < 70) zijn in deze studies niet geïncludeerd; wel bleek uit een fase II-studie met 70 patiënten dat deze populatie behandeling met temozolomide kan verdragen (13-14% neutro- en thrombopenie) en dat dit leidt tot een mediane overleving van 25 weken (95%CI 19 tot 28 weken) [Gallego Perez-Larraya 2011105].

Of radiotherapie of temozolomide de voorkeur verdient bij oudere patiënten met een glioblastoom werd onderzocht in twee gerandomiseerde fase III-studies. In de Nordic-studie werden 342 patiënten van 60 jaar of ouder gerandomiseerd voor behandeling met een kort schema radiotherapie (10 x 3.4 Gy), TMZ chemotherapie (tot 6 kuren, 200 mg/d op dag 1-5/28) of een standaardschema radiotherapie (30 x 2 Gy) [Malmstrom 2012208]. De overleving was langer voor patiënten die met temozolomide werden behandeld, dan met een lang schema radiotherapie (8,5 vs. 6 mnd.; hazard ratio [HR] 0·70; 95%CI 0·52-0·93, p=0·01). Bij patiënten boven de 70 jaar leidde bovendien een kort schema radiotherapie tot een langere overleving dan een lang schema radiotherapie. Van de patiënten die werden behandeld met temozolomide hadden degenen met een gemethyleerde MGMT- promotor een langere overleving dan die met een niet-gemethyleerde MGMT-promotor (9,7 maanden [95%CI 8,0-11,4] vs.6,8 maanden [5,9-7,7]; HR 0,56 [95%CI 0,34-0,93], p=0·02) [Malmstrom 2012208]. In de NOA 08-studie werden 373 patiënten van 65 jaar of ouder gerandomiseerd tussen standaard radiotherapie (30 x 2 Gy) en dose-dense temozolomide (100 mg/m2/d op dag1-7 en 15-21/28) [Wick 2012387]. Er was geen verschil in mediane overleving tussen de twee groepen, getest volgens non-inferiority principe: 8,6 mnd. (95%CI 7,3-10,2) in de TMZ-groep versus 9,6 mnd. (95%CI 8,2-10,8) in de radiotherapiegroep (hazard ratio [HR] 1,09; 95%CI 0,84-1,42, p-non-inferiority=0,033). Hoewel deze twee studies een verschillende dosering temozolomide gebruikten, is het niet waarschijnlijk dat dat de resultaten heeft beïnvloed: een gerandomiseerde fase III-studie toonde geen verschil in effectiviteit aan tussen adjuvant dose-dense temozolomide en adjuvante standaard dosering bij patiënten met een glioblastoom [Gilbert 2013110].
In deze studies is de combinatie van een kort schema radiotherapie met chemotherapie niet onderzocht; hiertoe is de EORTC/NCI-ouderenstudie (clinicaltrials.gov NCT00482677) opgezet, waarvan de inclusie compleet is maar de resultaten nog niet bekend zijn.

In een meta-analyses van studies naar radiotherapie en temozolomide bij oudere glioblastoompatiënten blijkt dat bij patiënten met gemethyleerde MGMT-promotor in hun tumor temozolomide effectiever was dan radiotherapie voor verbetering van de overleving (temozolomide vs. radiotherapie: HR 0,66; 95%CI 0,47-0,93) terwijl het tegenovergestelde gold voor patiënten met niet-gemethyleerde tumoren (HR 1,32; 95%CI 1.00-1.76) [Yin AA 2014a/b397 400].

Hoewel in diverse studies MGMT-promotormethylering voorspellend was voor effectiviteit van temozolomide is de praktijk van de bepaling niet eenvoudig. Diverse methodes voor het onderzoeken van de methyleringsstatus zijn in gebruik en de uitslagen van de verschillende methodes voor individuele patiënten zijn lang niet altijd in overeenstemming met elkaar [Quillien 2012268]. Bovendien bepaalt de keuze van het afkappunt of de test een hogere sensitiviteit of specificiteit zal hebben [Vlassenbroeck 2008367].

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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 Gliomatosis cerebri