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Waarde en mate van re-resectie glioblastoom

Beoordeeld: 15-04-2015

Uitgangsvraag

  • Wat is de waarde van een re-resectie bij progressie van een glioblastoom?
  • Hoe groot moet de resectie zijn bij een patiënt met progressie van een glioblastoom?

Aanbeveling

Patiënten met een recidief glioblastoom dienen in een multidisciplinair neuro-oncologisch overleg te worden besproken. In de recidiefsetting dienen palliatieve behandelingen zoals chirurgie, radiotherapie en chemotherapie telkens in overweging genomen te worden.

Er wordt geadviseerd een re-resectie bij recidief glioblastoom te overwegen bij een patiënt met gunstige prognostische factoren (lagere leeftijd, betere conditie, localisatie tumor, lagere verwachte morbiditeit).

Voor de indicatiestelling van een re-resectie kan de NIH-schaal (National Institutes of Health) gebruikt worden, waarbij meerdere prognostisch ongunstige factoren (tumor eloquent of nabij arteria cerebri media gelegen, KPS <=80, tumorvolume >= 50 mL) geassocieerd zijn met een kortere levensverwachting en dus een terughoudender beleid voor re-resectie.

Overwegingen

Verschillende oorzaken kunnen bijdragen aan bias in de genoemde publicaties. Ziekteprogressie is niet eenduidig gedefinieerd waardoor patiënten met pseudoprogressie kunnen zijn geïncludeerd. Selectie van patiënten speelt waarschijnlijk een rol, waardoor patiënten met een gunstiger prognose oververtegenwoordigdzijn in de groep die een re-resectie onderging en dus de prognose en niet de re-resectie oorzaak is van de langere overleving.

De morbiditeit en mortaliteit varieert tussen de studies. Er worden percentages gemeld voor morbiditeit van 4,1% [Hoover 2013141] tot 45% [De Bonis 201374]. De oorzaak van deze variatie is niet onderzocht. De mortaliteit varieert van 0 % [Pinsker 2001262] tot 5% [Mandl 2008209].

Het lijkt te overwegen re-resectie te verrichten wanneer post-operatief zinvolle tumorremmende behandeling mogelijk is, al dan niet in studieverband.

Onderbouwing

Er zijn aanwijzingen dat een re-resectie bij progressie van een glioblastoom gepaard gaat met een langere overleving en progressievrije overleving. De mate van selectiebias is onduidelijk en is in de recidief setting groter dan bij de novo tumoren. De resultaten van deze studies moeten daarom met grote voorzichtigheid worden geïnterpreteerd.
Guyotat 2000122, Xu 2011395, De Bonis 201374, Bloch 201220, McGirt 2009215


Er zijn aanwijzingen dat een re-resectie gepaard gaat met morbiditeit en mortaliteit, vergelijkbaar met een eerste resectie.
Dutzman 201286

Voor de indicatiestelling van een re-resectie kan de NIH schaal (National Institutes of Health) gebruikt worden, waarbij meerdere prognostisch ongunstige factoren (tumor eloquent of nabij arteria cerebri media gelegen, KPS <=80, tumorvolume >= 50 mL) geassocieerd zijn met een kortere levensverwachting en dus een terughoudender beleid voor re-resectie.
Park 2010249

Er is geen literatuur over de minimale mate van resectie bij progressie van een glioblastoom.

In de literatuur worden artikelen gevonden die een resectie bij recidief hooggradig glioom hebben onderzocht. Het betreft niet-vergelijkend cohortonderzoek. Vergelijkend gerandomiseerde studies die deze vraag direct beantwoorden, werden niet gevonden. Alleen publicaties waarin specifiek gekeken is naar overleving en/of progressievrije overleving, en/of morbiditeit en/of mortaliteit met betrekking tot resectie bij recidief hooggradig glioom zijn geïncludeerd. Alleen publicaties na 2000 zijn geïncludeerd.

Guyotat vergeleek 2 groepen patiënten met progressief glioblastoom: 18 patiënten kregen een resectie en 36 patiënten kregen geen resectie [Guyotat 2000122]. De groepen werden gematcht voor leeftijd, conditie, mate van resectie bij eerste operatie en het interval tot progressie. Beide groepen kregen de conventionele nabehandeling (chemo-radiatie). De mediane overleving van patiënten na resectie was vijf maanden versus twee maanden zonder resectie. Het verschil was statistisch significant in de univariate analyse. De mediane overleving met een Karnofsky performance status (KPS) score >60, was voor patiënten na resectie vier maanden, vergeleken met één maand voor patiënten zonder resectie.

Pinsker beschreef 38 patiënten met progressief glioblastoom die een resectie ondergingen tussen 1993 en 1998 (17% van 224 patiënten met een glioblastoom) [Pinsker 2001262]. De mediane overleving was 57 weken. Een KPS van meer dan 90 was geassocieerd met een langere overleving. Functionele achteruitgang deed zich niet voor. Er was geen perioperatieve mortaliteit.

Mandl onderzocht de effecten op overleving en complicaties van resectie bij progressief glioblastoom voor 32 (25%) van 126 glioblastoom patiënten tussen 1999 en 2005 [Mandl 2008209]. De mediane overleving na progressie was 34 weken (95%CI 24,7-43,4) voor 11 patiënten die resectie gevolgd door nabehandeling ondergingen, 13 weken (95%CI 1,3-24,7) voor 9 patiënten die resectie zonder nabehandeling ondergingen en 28 weken (95%CI 12,1-43,9) voor 12 patiënten die alleen chemotherapie of bestraling ondergingen (p<0.0005).Chirurgische morbiditeit ontstond bij drie patiënten (15%); één (5%) patiënt overleed na operatie.

Xu beschreef 63 patiënten met progressie van een glioblastoom tussen 2006 en 2008, waarvan 21 patiënten een resectie ondergingen en 42 niet [Xu 2011393]. De mediane overleving was voor de geopereerde patiënten zeven maanden en voor de niet geopereerde patiënten vier maanden (p<0.001). De tijd tot progressie van tumorgroei was voor de geopereerde patiënten vijf maanden en voor de niet geopereerde patiënten 2,5 maanden (p<0.001).

Clarke beschreef een posthocanalyse van gecombineerde data van fase II studies naar chemotherapie bij progressie van een glioblastoom [Clarke 201160]. Oudere studies (1998-2005) bevatten 105 patiënten van 511 die een operatie (biopt of resectie) ondergingen en nieuwere studies (2005-2008) bevatten 103 patiënten van 247 die een operatie (biopt of resectie) ondergingen. De overleving of progressievrije overleving van patiënten die een operatie (biopt of resectie) ondergingen verschilde niet van patiënten die geen operatie ondergingen.

Dutzman onderzocht het risico op ischemie en neurologische uitval bij re-resectie bij recidief groei van het glioblastoom [Dutzman 201286]. Van de 177 beschreven patiënten werden 130 patiënten (73,3%) één maal geopereerd en 47 (26,5%) twee of meerdere malen geopereerd. Bekende prognostica waren evenredig verdeeld over beide groepen. 46 patiënten (26%) hadden ischemie (DWI) op de postoperatieve MRI. Bij 18 patiënten (10,2%) was de ischemie groter dan 4 cm3. Elf van deze patiënten (6,2%) hadden ook neurologische uitval. Er was echter geen verschil in ontstaan van ischemie (27.7 vs. 21.3%, p=0.77) en neurologische uitval (10.0 vs. 10.6%, p=1.0) tussen de groepen die één maal of meer dan één maal werd geopereerd. Tumorlocatie in de insula, operculum en temporaalkwab was wel geassocieerd met ontstaan van nieuwe ischemische laesies.

Moiyadi onderzocht in een cohort de postoperatieve complicaties bij patiënten met progressie van een glioblastoom [Moiyadi 2012221]. Er werden 41 re-operaties in een database van 196 operaties voor gliomen geëvalueerd. Neurologische achteruitgang werd beschreven bij 22,2% van de patiënten. Bij 44% van de patiënten was er sprake van neurologische verbetering na de re-operatie. Bij 14,2% van de patiënten werden regionale en bij 4,8 % werden systemische complicaties gemeld. De morbiditeit was 29,3% en de mortaliteit was 2,4%.

De Bonis onderzocht de effectiviteit van resectie en adjuvante behandeling op overleving bij 76 patiënten met progressie van een glioblastoom behandeld tussen 2002 en 2008 [De Bonis 201374]. Zeventien patiënten ondergingen alleen een resectie, 24 alleen adjuvantetherapie,16 resectie en adjuvante therapie, en19 geen behandeling. Dit ging gepaard met een mediane overleving van 6, 8, 14 en 5 maanden (p=0.01). Patiënten met een KPS <70 hadden een significant hoger risico om te overlijden (HR 2.8; p=0.001). Subgroepanalyse toonde geen significante verschillen in overleving tussen een radiologisch complete of incomplete resectie. Ook was er geen verschil in patiënten die verschillende adjuvante therapieën kregen. Postoperatieve complicaties deden zich voor bij 16 (48%) van de 33 geopereerde patiënten.

Bloch onderzocht de relatie tussen de mate van resectie en de overleving bij 107 patiënten, die een tweede resectie ondergingen bij progressie van een glioblastoom tussen 2005 en 2009 [Bloch 201220]. De mediane overleving vanaf de eerste diagnose was voor 31 patiënten met een radiologisch complete resectie bij zowel eerste als tweede resectie 20,4 maanden. Voor 21 patiënten met een radiologisch complete resectie bij eerste en een partiële resectie bij tweede operatie was deze18,4 maanden. Voor 26 patiënten met een partiële resectie bij eerste en een radiologisch complete resectie bij tweede operatie was deze 19 maanden. En voor 29 patiënten met zowel bij eerste als tweede operatie een partiële resectie was deze 15,9 maanden (p = 0.004). De mediane overleving vanaf progressie verschilde eveneens: respectievelijk 11.5, 8.5, 16.7 en 7.4 maanden (p = 0.001). In multivariate analyse was een uitgebreidere resectie geassocieerd met een langere overleving (HR: 0.62, 95%CI 0.41-0.93, p = 0.03) na correctie voor leeftijd, conditie bij eerste resectie, conditie bij tweede resectie en mate van eerste resectie.

Hong beschreef 42 patiënten met progressief gioblastoom die werden geopereerd tussen 2006 en 2010, waarvan 34 patiënten een radiologisch complete re-resectie ondergingen en 10 patiënten met herhaalde re-resecties [Hong 2013140]. De overleving na radiologisch complete re-resectie was 16 maanden en na incomplete resectie 14 maanden (HR 1.86, 95%CI 0.86-3.92; p=0.112).

Park beschreef 34 patiënten met een progressief glioblastoom op basis waarvan een prognostisch model voor overleving na re-resectie werd opgesteld [Park 2010249]. Een kortere overleving na re-resectie was geassocieerd met tumor in eloquente of kritische gebieden, een KPS <= 80, en een tumorvolume >= 50 mL. Met deze drie factoren werden een totaalscore samengesteld van 0 tot 3 (voor aan-/afwezigheid van elk van deze factoren). Een score van 0, 1-2 en 3 was respectievelijk geassocieerd met een postoperatieve overleving van 10.8, 4.5 en 1.0 maanden (p <0.001). In een validatie cohort van 109 patiënten met een progressief glioblastoom werd deze score geverifieerd, waarbij de prognostische waarde bevestigd werd met 9.2, 6.3 en 1.9 maanden, respectievelijk (HR 3.0, 95%CI 1.54-5.83, p<0.001).

McGirt beschreef 949 patiënten met een WHO-graad III of IV astrocytoom die geopereerd werden tussen 1996 en 2006, waarvan 400 een re-resectie ondergingen [McGirt 2009215]. Na een radiologisch complete re-resectie was de mediane overleving elf maanden, na een bijna complete re-resectie negen maanden en na een subtotale resectie vijf maanden. In multivariate analyse was een uitgebreidere re-resectie geassocieerd met langere overleving (radiologisch complete resectie vergeleken met een subtotale resectie HR 0.566, p = 0.002; radiologisch bijna-complete resectie vergeleken met een subtotale resectie HR 0.630, p = 0.004) na correctie voor leeftijd, conditie, motorische uitval, temozolomide en vervolgoperaties.

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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