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References: Glioblastoma

113 sources cited on this page. Links open the primary source.

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  5. US Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, NDA 21-029, Temodar (temozolomide) capsules, Schering Corporation; signed by Robert Temple, Director, Office of Drug Evaluation I. The letter states that approval is effective on the date of the letter and prints no date; the Drugs@FDA overview and openFDA list the original-approval action date as 11 August 1999. Source
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  7. Lacroix M, Abi-Said D, Fourney DR, Gokaslan ZL, Shi W, DeMonte F, et al. A multivariate analysis of 416 patients with glioblastoma multiforme: prognosis, extent of resection, and survival. J Neurosurg. 2001;95(2):190-8. PubMedDOI
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  8. US Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, NDA 21-029/S-008, Temodar (temozolomide) capsules, Schering Corporation; electronic signature of Richard Pazdur dated 3/15/05. Source
  9. Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, et al. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005;352(10):997-1003. PubMedDOI
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  10. Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987-96. PubMedDOI
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  11. Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006;7(5):392-401. PubMedDOI
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  12. Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, et al. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007;356(15):1527-35. PubMedDOI
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  13. Louis DN, Ohgaki H, Wiestler OD, Cavenee WK, Burger PC, Jouvet A, et al. The 2007 WHO classification of tumours of the central nervous system. Acta Neuropathol. 2007;114(2):97-109. PubMedDOI
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  14. Parsons DW, Jones S, Zhang X, Lin JC, Leary RJ, Angenendt P, et al. An integrated genomic analysis of human glioblastoma multiforme. Science. 2008;321(5897):1807-12. PubMedDOI
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  15. Cancer Genome Atlas Research Network. Comprehensive genomic characterization defines human glioblastoma genes and core pathways. Nature. 2008;455(7216):1061-8. PubMedDOI
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  16. Dang L, White DW, Gross S, Bennett BD, Bittinger MA, Driggers EM, et al. Cancer-associated IDH1 mutations produce 2-hydroxyglutarate. Nature. 2009;462(7274):739-44. PubMedDOI
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  17. US Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, BL 125085/169, Avastin (bevacizumab), Genentech; accelerated approval under 21 CFR 601.40-46. The letter text carries no signature date. Source
  18. Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D, Abrey LE, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009;27(28):4733-40. PubMedDOI
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  19. Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009;10(5):459-66. PubMedDOI
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  20. Yan H, Parsons DW, Jin G, McLendon R, Rasheed BA, Yuan W, et al. IDH1 and IDH2 mutations in gliomas. N Engl J Med. 2009;360(8):765-73. PubMedDOI
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  21. Verhaak RG, Hoadley KA, Purdom E, Wang V, Qi Y, Wilkerson MD, et al. Integrated genomic analysis identifies clinically relevant subtypes of glioblastoma characterized by abnormalities in PDGFRA, IDH1, EGFR, and NF1. Cancer Cell. 2010;17(1):98-110. PubMedDOI
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  22. Sanai N, Polley MY, McDermott MW, Parsa AT, Berger MS. An extent of resection threshold for newly diagnosed glioblastomas. J Neurosurg. 2011;115(1):3-8. PubMedDOI
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  23. Brennan CW, Verhaak RG, McKenna A, Campos B, Noushmehr H, Salama SR, et al. The somatic genomic landscape of glioblastoma. Cell. 2013;155(2):462-77. PubMedDOI
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  24. Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, et al. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013;31(32):4085-91. PubMedDOI
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  25. Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, et al. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014;370(8):709-22. PubMedDOI
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  26. Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, et al. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014;370(8):699-708. PubMedDOI
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  27. Stupp R, Hegi ME, Gorlia T, Erridge SC, Perry J, Hong YK, et al. Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma with methylated MGMT promoter (CENTRIC EORTC 26071-22072 study): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2014;15(10):1100-8. PubMedDOI
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  28. Eckel-Passow JE, Lachance DH, Molinaro AM, Walsh KM, Decker PA, Sicotte H, et al. Glioma Groups Based on 1p/19q, IDH, and TERT Promoter Mutations in Tumors. N Engl J Med. 2015;372(26):2499-508. PubMedDOI
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  29. US Food and Drug Administration, Center for Devices and Radiological Health. PMA supplement approval order, P100034/S013, Optune (formerly the NovoTTF-100A System), Novocure; order dated October 05, 2015; signed by Carlos L. Peña, Director, Division of Neurological and Physical Medicine Devices. FDA PMA database record P100034/S013 gives decision date 10/05/2015 (Panel Track). Source
  30. Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, et al. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015;314(23):2535-43. PubMedDOI
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  31. Cancer Genome Atlas Research Network. Comprehensive, Integrative Genomic Analysis of Diffuse Lower-Grade Gliomas. N Engl J Med. 2015;372(26):2481-98. PubMedDOI
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  32. Brown TJ, Brennan MC, Li M, Church EW, Brandmeir NJ, Rakszawski KL, et al. Association of the Extent of Resection With Survival in Glioblastoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2016;2(11):1460-1469. PubMedDOI
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  33. Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, et al. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016;131(6):803-20. PubMedDOI
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  34. US Food and Drug Administration, Center for Drug Evaluation and Research. Supplement approval / fulfillment of postmarketing requirement, BLA 125085/S-319, Avastin (bevacizumab), Genentech; Reference ID 4190806. The appended signature page was not in the retrieved file. Source
  35. US Food and Drug Administration, Center for Drug Evaluation and Research. Approval package for BLA 125085/S-319 (Avastin, bevacizumab, Genentech): cross-discipline team leader review and clinical review of the efficacy supplement dated 1 February 2017; approval date 5 December 2017. Posted on Drugs@FDA in 2022. Source
  36. US Food and Drug Administration, Center for Drug Evaluation and Research. Approval letter, NDA 208630, Gleolan (aminolevulinic acid hydrochloride) for oral solution, NX Development Corp; electronic signature of Libero Marzella dated 06/06/2017. Source
  37. Mehta M, Wen P, Nishikawa R, Reardon D, Peters K. Critical review of the addition of tumor treating fields (TTFields) to the existing standard of care for newly diagnosed glioblastoma patients. Crit Rev Oncol Hematol. 2017;111:60-65. PubMedDOI
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  38. Perry JR, Laperriere N, O'Callaghan CJ, Brandes AA, Menten J, Phillips C, et al. Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma. N Engl J Med. 2017;376(11):1027-1037. PubMedDOI
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  39. Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, et al. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017;318(23):2306-2316. PubMedDOI
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  40. Weller M, Butowski N, Tran DD, Recht LD, Lim M, Hirte H, et al. Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial. Lancet Oncol. 2017;18(10):1373-1385. PubMedDOI
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  41. Wick W, Gorlia T, Bendszus M, Taphoorn M, Sahm F, Harting I, et al. Lomustine and Bevacizumab in Progressive Glioblastoma. N Engl J Med. 2017;377(20):1954-1963. PubMedDOI
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  42. Brat DJ, Aldape K, Colman H, Holland EC, Louis DN, Jenkins RB, et al. cIMPACT-NOW update 3: recommended diagnostic criteria for "Diffuse astrocytic glioma, IDH-wildtype, with molecular features of glioblastoma, WHO grade IV". Acta Neuropathol. 2018;136(5):805-810. PubMedDOI
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  43. Stoyanov GS, Dzhenkov DL. On the Concepts and History of Glioblastoma Multiforme - Morphology, Genetics and Epigenetics. Folia Med (Plovdiv). 2018;60(1):48-66. PubMedDOI
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  44. Cloughesy TF, Mochizuki AY, Orpilla JR, Hugo W, Lee AH, Davidson TB, et al. Neoadjuvant anti-PD-1 immunotherapy promotes a survival benefit with intratumoral and systemic immune responses in recurrent glioblastoma. Nat Med. 2019;25(3):477-486. PubMedDOI
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  45. Herrlinger U, Tzaridis T, Mack F, Steinbach JP, Schlegel U, Sabel M, et al. Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09): a randomised, open-label, phase 3 trial. Lancet. 2019;393(10172):678-688. PubMedDOI
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  46. Lassman AB, Joanta-Gomez AE, Pan PC, Wick W. Current usage of tumor treating fields for glioblastoma. Neurooncol Adv. 2020;2(1):vdaa069. PubMedDOI
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  47. Reardon DA, Brandes AA, Omuro A, Mulholland P, Lim M, Wick A, et al. Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020;6(7):1003-1010. PubMedDOI
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  48. Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021;23(8):1231-1251. PubMedDOI
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  49. McCutcheon IE, Preul MC. Historical Perspective on Surgery and Survival with Glioblastoma: How Far Have We Come?. World Neurosurg. 2021;149:148-168. PubMedDOI
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  50. Weller M, van den Bent M, Preusser M, Le Rhun E, Tonn JC, Minniti G, et al. EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood. Nat Rev Clin Oncol. 2021;18(3):170-186. PubMedDOI
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  53. Wen PY, Stein A, van den Bent M, De Greve J, Wick A, de Vos FYFL, et al. Dabrafenib plus trametinib in patients with BRAF(V600E)-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial. Lancet Oncol. 2022;23(1):53-64. PubMedDOI
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  54. Bouffet E, Hansford JR, Garrè ML, Hara J, Plant-Fox A, Aerts I, et al. Dabrafenib plus Trametinib in Pediatric Glioma with BRAF V600 Mutations. N Engl J Med. 2023;389(12):1108-1120. PubMedDOI
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  57. Karschnia P, Young JS, Dono A, Häni L, Sciortino T, Bruno F, et al. Prognostic validation of a new classification system for extent of resection in glioblastoma: A report of the RANO resect group. Neuro Oncol. 2023;25(5):940-954. PubMedDOI
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  58. Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, et al. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023;389(7):589-601. PubMedDOI
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  59. Omuro A, Brandes AA, Carpentier AF, Idbaih A, Reardon DA, Cloughesy T, et al. Radiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial. Neuro Oncol. 2023;25(1):123-134. PubMedDOI
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