Terapeutický manažment malígnych gliómov
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1 268 Terapeutický manažment malígnych gliómov MUDr. Elena Bolješíková, CSc., MUDr. Martin Chorváth, PhD. Klinika radiačnej onkológie SZU a OÚSA, Bratislava V práci sa rozoberajú liečebné postupy pri malígnych gliómoch na podklade onkologických štúdií. Analyzuje sa prínos novej WHO klasifikácie 2016, ktorá doplnila tradičné princípy klasifikácie na podklade histologických kritérií o molekulárne markery. Identifikácia genetických a epigenetických profilov pri rozličných gliómoch upravila klasifikáciu gliómov a zlepšila predikciu liečebnej odpovede. Kľúčové slová: high-grade gliómy, rádioterapia, chemoterapia, molekulárne markery, WHO klasifikácia 2016 Therapeutical management in high-grade gliomas The paper analyses treatment procedures for malignant gliomas based on oncologic studies. It discusses the benefits of the new 2016 WHO classification, which complemented traditional classification principles based on histological criteria with molecular markers. The identification of genetic and epigenetic profiles in different gliomas has adjusted the glioma classification and improved prediction of treatment response. Key words: high-grade gliomas, radiotherapy, chemotherapy, molecular markers, WHO classification 2016 Onkológia (Bratisl.), 2016; roč. 11(5): Úvod Gliómy predstavujú heterogénnu skupinu nádorov CNS, ktorá bola tradične klasifikovaná podľa histologického typu a gradingu (1). Väčšina gliómov vykazuje extenzívnu infiltráciu a neohraničený rast. High-grade gliómy (HGG WHO 2007) tvoria 70,5 % zo všetkých gliómov. Ich incidencia je 5/ (2). Patrí sem anaplastický oligodendroglióm, anaplastický astrocytóm, anaplastický oligoastrocytóm (10 30 % zo všetkých gliómov) a glioblastóm (40 50 % zo všetkých gliómov) (2). Medián prežitia pre anaplastický oligodendroglióm je 5 7 rokov, pre anaplastický astrocytóm 3 5 rokov a pre glioblastóm 1 1,5 roku. WHO klasifikácia z roku 2007 mala určité limity, nezohľadňovala molekulárnu heterogenitu a patogenézu tumoru, neumožňovala Obrázok 1. Nová klasifikácia gliómov Obrázok 2. Vplyv molekulárnych markerov na prežitie Obrázok 3. GBM štandardná liečba/2005 Obrázok 4. Prežívanie pacientov s GBM
2 269 Obrázok 5. Abscesy pľúc po kombinovanej RT+CHT/TMZ (materiál OÚSA) Obrázok 6. Abscesy mozgové po kombinovanej RT+CHT/TMZ (materiál OÚSA) Obrázok 7. Pseudoprogresia kazuistika (materiál OÚSA) Obrázok 8. Zásady rádioterapie HGG Obrázok 9. Zásady rádioterapie HGG, RTOG 0525 vs EORTC špecifikáciu podtypov podľa molekulárnych biomarkerov (3, 4, 5, 6, 7). Identifikácia genetických a epigenetických profilov pri rozličných typoch gliómov spresnila klasifikáciu gliómov, zlepšila predikciu liečebnej odpovede. Nová WHO klasifikácia 2016 doplnila tradičné princípy klasifikácie na podklade histologických kritérií o molekulárne markery. Molekulárne profily gliómov sú založené zväčša na identifikácii štyroch markerov: IDH mutácií, 1p/19q kodelécií, H3 K 27M mutácií a identifikácií MGMT promótora metylácie. Nová klasifikácia gliómov 2016 je uvedená na obrázku 1 (8), na obrázku 2 je vplyv molekulárnych markerov na prežitie (9). Štandardnou liečbou glioblastómu (GBM) na podklade výsledkov randomizovanej štúdie fázy III EORTC-NCIC sa od roku 2005 stal Stuppov režim, t. j. konkomitantná chemorádioterapia v konvenčnej frakcionácii 60 Gy/6 t so simultánnym podávaním temozolomidu (TMZ) v dávke 75 mg/m 2 a následným adjuvantným podávaním TMZ po obdobie 6 mesiacov v dávke mg/m dni à 28 (9, 10). Prežitie pacientov bolo signifikantne vyššie pri kombinovanej terapii ako v skupine pacientov liečených samostatnou rádioterapiou. Celkové prežitie po 2 rokoch bolo 27,2 vs 10,9 % po 3 rokoch 16,0 % vs 4,4 %, po 4 rokoch 12,1 % vs 3 %, ; 11(5) Onkológia
3 270 Obrázok 10. Antiangiogénna terapia v liečbe primárnych GBM/bevacizumab Obrázok 12. Výsledky RTOG AVAGLIO Obrázok 11. Antiangiogénna terapia v liečbe primárnych GBM/cilengitid po 5 rokoch 9,8 vs 1,9 % (obrázky 3, 4). Medzi najdôležitejšie prognostické faktory patrila radikalita chirurgie a výkonnostný stav pacienta. Retrospektívna analýza pacientov ukázala, že prítomnosť promótora metylácie MGMT bola spojená s lepšou prognózou. Celkové 5-ročné prežitie pri kombinovanej rádiochemoterapii u pacientov s metylovaným MGMT bolo 13,8 % vs 5,2 %. Metylácia MGMT bola potvrdená ako prediktívny faktor účinnosti systémovej terapie TMZ. Intenzívnejšia liečba zlepšila liečebné výsledky, ale zvýšila riziko nežiaducich účinkov oportunistických infekcií, imunosupresie, hematologickej a hepatálnej toxicity (obrázky 5, 6). Kombinovaná rádioterapia a liečba temozolomidom viedla k objaveniu sa nového fenoménu, tzv. pseudoprogresie, ktorá v MRI obraze môže pripomínať recidívu procesu (4, 11). Mechanizmus jej vzniku súvisí s väčšou nekrózou nádorových a endoteliálnych buniek, pričom sa zvýrazňujú sekundárne reakcie, edém a zvýšená cievna permeabilita v oblasti lézie, ktoré sú dôsledkom liečby. Pseudoprogresia sa vyskytuje bezprostredne po skončení rádiochemoterapie, najčastejšie do troch mesiacov. Klinicky môže byť bez príznakov, môže spontánne regredovať alebo, naopak, progredovať do typického obrazu rádionekrózy. Vyskytuje sa od 9 do 30 % pacientov, častejšie u pacientov s metylovaným MGMT (4, 11). K diferenciálnej diagnóze je možné použiť rozšírené MR vyšetrenie (DWI difúzne vážené obrazy, PMR perfúzne vyšetrenie, MRS-MR spektroskopia), PET vyšetrenia: 18 F-FDG, 11 C metionín, 18 F-FET (obrázok 7). Pri asymptomatickej pseudoprogresii je potrebné pokračovať v terapii TMZ. Pri symptomatickej alebo pri podozrení na skorú progresiu je indikovaná kortikoterapia, event. je možné zvážiť chirurgickú revíziu, ktorá môže zlepšiť stav pacienta a poskytne histologickú verifikáciu. Pri prevahe nekrotických hmôt nad tumoróznymi bunkami je vhodné pokračovať v TMZ. Pri stanovení cieľových objemov rádioterapie nie je jednoznačný konsenzus, t. j. aplikácia rádioterapie technikou redukujúcich sa polí (shrinking field technika) alebo použitie jedného objemu po celý cyklus rádioterapie. Zásady rádioterapie HGG sú uvedené na obrázku 8. Najväčšími kontraverziami je edém. Tradičné lemy sú 2 3 cm pri GBM, 1,5 2 cm pri anaplastických gliómoch. Pretrváva požiadavka redukcie ožarovaných objemov z dôvodu zníženia postradiačnej neurotoxicity. Porovnanie radiačných objemov podľa pôvodných odporučení RTOG, ktoré zahŕňalo aj edém a EORTC, je uvedené na obrázku 9 (12). Na spresnenie cieľového objemu sa využíva aj PET ( 11 C-MET, 18 F-FET). Ďalšie trendy v liečbe primárneho GBM, eskalácia dávky formou stereorádiochirurgického boostu, boostu frakcionovanou stereotaktickou rádioterapiou, intersticiálnym brachyterapeutickým boostom, ako aj SIB pri IMRT nepriniesli benefit. Aplikácia polyméru obsahujúceho cytostatikum BCNU do OP kavity s následnou rádioterapiou nepreukázala zlepšenie prežitia. Alternatívne dávkovacie schémy TMZ fázy III RTOG štúdia 0525, EORTC štúdia nepriniesli benefit (13). Na obrázkoch 10, 11 sú uvedené štúdie fázy III s antiangiogénnymi agensami pri primárnych GBM. Štúdie s bevacizumabom a cilengitidom boli ukonče-
4 271 Obrázok 13. Difúzna invazívna recidíva po antiangiogennej terapii GBM Obrázok 14. Difúzna invazívna recidíva po antiangiogennej terapii GBM Obrázok 15. Výsledky randomizovaných štúdií GBM, seniori né, výsledky nepriniesli benefit (obrázok 12) v zmysle zlepšenia celkového prežitia (4, 5). Bevacizumab nebol schválený do prvolíniovej liečby primárnych GBM v Európe ani v USA. Po aplikácii antiangiogénnej terapie bola pozorovaná výrazná regresia na zobrazovacích vyšetreniach, ako aj zlepšenie klinického stavu so znížením dávkovania kortikoterapie. Zároveň boli pozorované zmeny v správaní sa relapsu. Dochádza k DIR (difúznej invazívnej recidíve), k postihnutiu viacerých lalokov i corpus callosum so zlou prognózou, čo pravdepodobne súvisí so zmenou biológie tumoru po predchádzajúcej antiangiogénnej liečbe (obrázky 13, 14) (14). Dôležitou kapitolou je manažment GBM u pacientov vo vyššom veku (> 65 rokov). K dispozícii sú výsledky randomizovaných štúdií fázy III NORDIC štúdia, NOA O8, ANOCEF, NCIC/EORTC (obrázky 15, 16, 17) (15). Z uvedených štúdií je možné konštatovať, že GBM sa vyskytuje u pacientov > 65 rokov v 50 %, rádioterapia je spojená so zvýšenou neurotoxicitou, hypofrakcionácia (40 Gy/15 fr ev. 10 krát 3,4 Gy, ev. 5 krát 5 Gy) je efektívnejšia ako konvenčná frakcionácia. TMZ je vhodnejší u pacientov MGMT+, rádioterapia u pacientov MGMT-. MGMT je prediktívnym biomarkerom (15). Faktory zvyšujúce neurotoxicitu u seniorov sú: jednotlivá TD a celková TD RT, predchádzajúca CHT, metabolické ochorenia, trauma, vaskulitídy, hypertenzia, ateroskleróza. Pri recidivujúcich GBM neexistuje štandardný postup, medián prežitia je 6 12 m, (obrázok 18). Liečebné postupy ako aj výsledky sú uvedené na obrázkoch 19, 20, 21, 22, 23, 24, 25 (16, 17, 18, 19). Na podklade randomizovanej klinickej štúdie (20) sa TTF ako neinvazívna lokoregionálna liečebná modalita využívajúca aplikáciu striedavých prúdov nízkej intenzity, intermediálnej frekvencie 200 khz dostala aj do prvolíniovej liečby GBM po aplikácii štandardnej CHT/RT NCCN TTF inhibuje replikáciu nádorových buniek a vedie k mitotickej smrti, autofágii a apoptóze. V kombinácii s TMZ zlepšuje bezrelapsové i celkové prežitie v porovnaní so sólo TMZ v adjuvancii (obrázok 26) (20). Nejednoznačný konsenzus bol aj v liečbe anaplastických gliómov. Klinická prax bola rôzna. Do toho času štandardnou liečbou bola OP s následnou rádioterapiou. Niektoré pracoviská používali kombinovanú rádiochemoterapiu ako pri GBM napriek tomu, že neboli k dispozícii výsledky randomizovanej štúdie. Pri anaplastických gliómoch boli vykonané dve štúdie fázy: III RTOG 9402 porovnávajúca rádioterapiu vs neoadjuvantnú PCV + RT a EORTC štúdia porovnávajúca RT vs RT + adjuvantnú PCV (prokarbazín, lomustín, vinkristín). V oboch štúdiách bolo zlepšené bezrelapsové prežitie, ale nie celkové, pri výraznej toxicite PCV. Na ASCO 2012 bola prezentovaná aktualizovaná analýza oboch štúdií u pacientov s 1p/19q kodeléciou s dosiahnutím aj zlepšeného celkového prežitia (obrázok 27) (21, 22). Liečebné výsledky anaplastických gliómov v klinických štúdiách fázy III pri stratifikácii molekulárnych markerov sú uvedené na obrázkoch ; 11(5) Onkológia
5 272 Obrázok 16. Štúdia NOA 08 schéma GBM, seniori Obrázok 18. Th postupy u rec GBM Obrázok 19. Antiangiogénna terapia pri recidivujúcich GBM Obrázok 17. Výsledky štúdie NOA 08, seniori Obrázok 20. Alternatívne dávkovacie schémy TMZ 28, 29, 30, 31. Dosiahnuté prežitie po sekvenčnej RT/CHT pri oligodendrogliómoch IDHm & 1p/19q kodel je > 14 rokov, pri astrocytóme IDHm 7 8 rokov a pri astrocytóme IDH wt 1 4,7 roku (23, 24, 25). Na objasnenie efektivity CHT pri anaplastických gliómoch (PCV vs TMZ) ako aj úlohy rádioterapie, mali prispieť ukončené štúdie fázy III, CATNON (bez kodel 1p/19q) a CODEL štúdia (u 1p/19q kodel), ako aj poznatky zo štúdie NOA 04. Novým štandardom v liečbe anaplastických gliómov 1p/19q kodel sa stala sekvenčná RT/PCV ev PCV/RT (kategória 1) alebo RT + TMZ. Pri anaplastických gliómoch bez kodelécie je štandardom sólo adjuvantná RT (kategória 1) alebo RT + TMZ, alebo PCV/TMZ. Adjuvantná liečba TMZ zlepšovala výsledky aj u pacientov bez kodelécie 1p/19 q. Benefit bol pozorovaný aj pri gradingu II (26) (EANO 2016). Záver Na podklade aktuálnych poznatkov a výsledkov štúdií EANO odporúča terapeutický algoritmus pri astrocytárnych a olidendrogliových tumoroch uvedený na obrázku 32 (EANO 2016). Literatúra 1. Louis DN. WHO classification of tumours of the central nervous system. 4th ed. Lyon: International Agency for Research on Cancer Central Brain Tumor Registry of the United States (CB- TRUS) Statistical Report Cme.medscape. com/viewarticle/ Colman H, Zhang L, Sulman EP, et al. A multigene predictor of outcome in glioblastoma. Neuro Oncol. 2010;12: Colman H: Future Directions in Glioblastoma Therapy. ASCO Educational book, Gilbert MR. Establishing the Standard of Care for Patients with Newly Diagnosed and Recurrent Glioblastoma. ASCO Educational book, Verhaak RG, Hoadley KA, Purdom E, et al. Integrated genomic analysis identifies clinically relevant subtypes of glioblastoma characterized by abnormalities in PDGFRA, IDH1, EGFR, and NF1. Cancer Cell. 2010;17: Figarella-Branger D, Matellus P. Phenotypic and molecular heterogeneity in gliomas: shifting the Paradigm in diagnosis strategy. EANO 2012, Marseille, Sept 6-9, Educational book, abstract Louis DN. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016;131: Stupp R, Hegi ME, Mason WP, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomi-
6 273 Obrázok 21. Alternatívne dávkovacie schémy TMZ, RTOG 0525/EORTC26052/22053 Obrázok 23. Recidivujúci GBM/CHT Obrázok 22. Alternatívne dávkovacie schémy TMZ/výsledky sed phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet. 2009;10: Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352: Brandsma D, van den Bent MJ. Pseudoprogression and pseudoresponse in the treatment of gliomas. Curr Opin Neurol Neurosurg. 2009;22: Chang EL, et al. Evaluation of peritumoral edema in the delineation of radiotherapy clinical target volume for glioblastoma. Int J Radiat Oncol Biol Phys. 2007;68(1) Gilbert MR, Wang M, Aldape K, et al. RTOG 0502: A randomized phase III trial comparing standard adjuvant temozolomide (TMZ) with a dose-dense (dd) schedule in newly diagnosed glioblastoma (GBM). J Clin Oncol. 2011;29(suppl 15:141). 14. Narayana A, et al. Change in pattern of relapse after antiangiogenic therapy in HGG. Int J Radiat Oncol Biol Phys. 2012,82(1): Wick W, et al. MGMT promoter methylation as a predictive biomarker for response to radiotherapy versus chemotherapy in malignant astrocytomas in the elderly: The NOA- 08 trial. ASCO 2012, abstract Stupp R, et al. Novo TTF-100A versus physician s choice chemotherapy in recurrent glioblastoma: A randomised phase III trial of a novel treatment modality. EJC. 2012;48(14): Perry JR, et al. Phase II Trial of Continuous Dose-Intense Temozolomide in Recurrent Malignant Glioma: RESCUE Study. 2010;28(12) Kreisl TN, Kim L, Moore K, et al. Phase II trial of single- -agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol. 2009;27: Gutin PH, Wong ET. Noninvasive Application of Alternating Electric Fields in Glioblastoma: A Fourth Cancer Treatment Modality. ASCO 2012 Educational book. 48th Annual Meeting, Chicago, June 1-5, Stupp R. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma. A Randomized Clinical Trial. JAMA. 2015;314(23): Cairncross JG, et al. Phase III trial Chemoradiotherapy for anaplastic oligodendroglioma:long- term results of RTOG 9402, J Clin Oncol. 2013;31(3): Van Den Bent MJ, et al.adjuvant procarbazine,lomustine and vincristine chemotherapy in newly diagnosed anaplastic oligodendroglioma:long term follow-up of EORTC brain group study J Clin Oncol. 2013;31(3) Shouwei Li, et al. Molecular prognostic factors of anaplastic oligodendroglial tumors and its relationschip: a single institutional review of 77 patients from China. Neuro-Oncology. 2012;14(1): Holdhoff M, Grossman SA. Controversies in the Adjuvant Therapy of High-Grade Gliomas. The Oncologist. 2011;16: Wick W, et al. Long-term analysis of the NOA-04 randomized phase III trial of sequential radiochemotherapy of anaplastic glioma with PCV or temozolomide. Neuro-Oncology 2016;18(11): Buckner JC, et al. Radiation plus procarbazine, CCNU and vincristine in low-grade glioma. N Engl J Med. 2016;374(14): MUDr. Elena Bolješíková, CSc. Klinika radiačnej onkológie SZU a OÚSA Heydukova 10, Bratislava elena.boljesikova@ousa.sk ; 11(5) Onkológia
7 274 Obrázok 24. Schéma Novo TTF pri recidivujúcich GBM Obrázok 25. Liečebné výsledky Novo TTF pri recidivujúcich GBM Obrázok 26. PFS, OS pri TTF + TMZ verzus TMZ sólo
8 275 Obrázok 27. Aktualizované výsledky RTOG štúdie 9402 a EORTC pri stratifikácii 1p19q delécií, IDH Obrázok 28. Aktualizované výsledky RTOG štúdie 9402 a EORTC pri stratifikácii 1p19q delécií, IDH Obrázok 29. Aktualizované výsledky RTOG štúdie 9402 a EORTC pri stratifikácii 1p19q delécií, IDH Obrázok 30. Aktualizované výsledky RTOG štúdie 9402 a EORTC pri stratifikácii 1p19q delécií, IDH ; 11(5) Onkológia
9 276 Obrázok 31. Aktualizované výsledky RTOG štúdie 9402 a EORTC 26951, NOA 04 pri stratifikácii 1p19q delécií, IDH Obrázok 32. Th management astrocytárnych a olidendrogliových tumorov (Guidelines EANO 2016)
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