The following bibliography was provided to the Contractor Advisory Committee (CAC) for their consideration of Tumor Treatment Field Therapy for the treatment of newly diagnosed glioblastoma multiforme.
Submitted by Novocure with Reconsideration Request
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Central Nervous System Cancers. NCCN Flash Card™. Version 1.2018 March 20, 2018.
Stupp R, Taillibert S, Kanner AA, et al. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015;314(23):2535-2543.
Stupp R, Taillibert S, Kanner A, 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.
Taphoorn MJB, Dirven L, Kanner AA, et al. Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018;4(4):495-504.
Provided by DME MACs
Batchelor T, Shih HA, Wen PY. Management of glioblastoma in older adults UpToDate. Waltham, Ma.: UpToDate; 2017. https://www.uptodate.com/contents/management-of-glioblastoma-in-older-adults. Accessed April 23, 2018
Bhandari M, Gandhi AK, Devnani B, Kumar P, Sharma DN, Julka PK. Comparative Study of Adjuvant Temozolomide Six Cycles Versus Extended 12 Cycles in Newly Diagnosed Glioblastoma Multiforme. J Clin Diagn Res. 2017;11(5):XC04-XC08.
Cloughesy TF, Lassman AB. NovoTTF: where to go from here? Neuro Oncol. 2017;19(5):605-608.
Food and Drug Administration. Novocure Submission to Neurological Devices Panel. NovoTTF-100A. March 17, 2011.
Food and Drug Administration. Summary of Safety and Effectiveness Data. PMA P100034. Novocure TTF-100A. April 8, 2011.
Food and Drug Administration. Summary of Safety and Effectiveness Data. PMA P100034/S013. Novocure TTF-100A. October 5, 2015.
Kesari S, Ram Z, Investigators EFT. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017;6(3):185-193.
Kirson ED, Dbaly V, Tovarys F, et al. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007;104(24):10152-10157.
Kirson ED, Gurvich Z, Schneiderman R, et al. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004;64(9):3288-3295.
Martinez-Garcia M, Alvarez-Linera J, Carrato C, et al. SEOM clinical guidelines for diagnosis and treatment of glioblastoma (2017). Clin Transl Oncol. 2018;20(1):22-28.
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.
Mittal S, Klinger NV, Michelhaugh SK, Barger GR, Pannullo SC, Juhasz C. Alternating electric tumor treating fields for treatment of glioblastoma: rationale, preclinical, and clinical studies. J Neurosurg. 2018;128(2):414-421.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Central Nervous System Cancers. Version 2.2018 November 26, 2018. Accessed January 3, 2019.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Central Nervous System Cancers. NCCN Evidence Blocks™. Version 2.2018 November 26, 2018. Accessed January 3, 2019.
Palmer JD, Bhamidipati D, Mehta M, et al. Treatment recommendations for elderly patients with newly diagnosed glioblastoma lack worldwide consensus. J Neurooncol. 2018;140(2):421-426.
Sampson JH. Alternating Electric Fields for the Treatment of Glioblastoma. JAMA. 2015;314(23):2511-2513.
Sulman EP, Ismaila N, Armstrong TS, et al. Radiation Therapy for Glioblastoma: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Society for Radiation Oncology Guideline. J Clin Oncol. 2017;35(3):361-369.
Toms SA, Kim CY, Nicholas G, Ram Z. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. J Neurooncol. 2019;141(2):467-473.
Weller M, van den Bent M, Tonn JC, et al. European Association for Neuro-Oncology (EANO) guideline on the diagnosis and treatment of adult astrocytic and oligodendroglial gliomas. Lancet Oncol. 2017;18(6):e315-e329.
Wick W. TTFields: where does all the skepticism come from? Neuro Oncol. 2016;18(3):303-305.
Wick W, Osswald M, Wick A, Winkler F. Treatment of glioblastoma in adults. Ther Adv Neurol Disord. 2018;11:1756286418790452.
Wick W, Platten M. Understanding and Treating Glioblastoma. Neurol Clin. 2018;36(3):485-499.
Provided by CAC Members
Chang E, Patel CB, Pohling C, et al. Tumor treating fields increases membrane permeability in glioblastoma cells. Cell Death Discov. 2018;4:113.
Kim EH, Kim YH, Song HS, et al. Biological effect of an alternating electric field on cell proliferation and synergistic antimitotic effect in combination with ionizing radiation. Oncotarget. 2016;7(38):62267-62279.
Kim EH, Song HS, Yoo SH, Yoon M. Tumor treating fields inhibit glioblastoma cell migration, invasion and angiogenesis. Oncotarget. 2016;7(40):65125-65136.