Deputy Director, Miami Cancer Institute, and Chief of Radiation Oncology, Miami, Florida.
Department of Neurology, Harvard University, Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA.
Crit Rev Oncol Hematol. 2017 Mar;111:60-65. doi: 10.1016/j.critrevonc.2017.01.005. Epub 2017 Jan 22.
Since 2005, the standard of care for patients with newly diagnosed glioblastoma (GBM) has consisted of maximal resection followed by radiotherapy plus daily temozolomide (TMZ), followed by maintenance TMZ. In patients selected for clinical trials, median overall survival (OS) and progression-free survival (PFS) with this regimen is 15-17 months and 6-7 months, respectively. There have been various, largely unsuccessful attempts to improve on this standard of care. With the FDA approval of the tumor-treating fields (TTFields) device, Optune, for recurrent GBM (2011), and the more recent EF-14 interim trial results and approval for newly diagnosed GBM patients, several questions have arisen. A roundtable of experts was convened at the 2015 ASCO meeting to engage in an open conversation and debate of the EF-14 results presented at that meeting and their implications for neuro-oncology practice and clinical research. In October 2015, subsequent to the roundtable discussion, TTFields received FDA approval for newly diagnosed GBM.
自 2005 年以来,新诊断的胶质母细胞瘤(GBM)患者的标准治疗方法包括最大限度的切除,然后进行放疗加替莫唑胺(TMZ)治疗,然后进行维持 TMZ 治疗。在选择参加临床试验的患者中,该方案的中位总生存期(OS)和无进展生存期(PFS)分别为 15-17 个月和 6-7 个月。人们曾多次试图改进这种标准治疗方法,但都没有成功。随着肿瘤治疗电场(TTFields)设备 Optune 被 FDA 批准用于复发性 GBM(2011 年),以及最近 EF-14 中期试验结果和新诊断 GBM 患者的批准,出现了一些问题。在 2015 年 ASCO 会议上,召集了一个专家组,就会议上提出的 EF-14 结果进行公开对话和辩论,并探讨其对神经肿瘤学实践和临床研究的影响。2015 年 10 月,在小组讨论之后,TTFields 获得了 FDA 对新诊断 GBM 的批准。