[要闻]TTF电场联合替莫唑胺治疗胶质母细胞瘤III临床结果公布: 总生存期明显延长37%

神外前沿讯，据新浪医药编译，NovoCure公司日前宣布，头戴设备TTF电场治疗（Optune）联合替莫唑胺治疗新诊断胶质母细胞瘤（GBM）III期临床关键试验的最终分析结果已经发表于美国医学会杂志（JAMA）。 最后的分析证明，与单独使用替莫唑胺的患者相比，接受TTF电场联合替莫唑胺治疗患者的总生存期和无进展生存期均明显延长了37％。

相关报道：

该多国、随机、开放标签的试验（EF-14）包含从2009年7月至2016年12月期间在83个医疗中心招募的695名新诊断胶质母细胞瘤患者。接受TTF电场联合替莫唑胺的患者具有20.9个月的总生存期，而只接受替莫唑胺的患者的总生存期为16个月（HR，0.63; 95％CI，0.53-0.76; P <.001），这也确认并改善了2015年发表于JAMA杂志的该试验中期分析结果。

接受TTF电场联合替莫唑胺患者组的5年生存率从5％上升到13％，而单用替莫唑胺的患者组只提高了5％。

这些是迄今为止在新诊断胶质母细胞瘤患者III期临床试验中所报道的最佳结果，并且代表了这一难治疾病5年存活率的新里程碑。

据神外前沿了解，目前世界上只有美国和日本拥有TTF电场技术，还未正式进入中国。中国国产化的TTF设备正在加紧研发，并获得了301医院、华山医院等多家医院及神外专家的支持。

原文如下：

Novocure Release: JAMA Publishes Final Analysis of EF-14 Phase III Pivotal Trial of Optune Together With Temozolomide Demonstrating Unprecedented Survival Results for Newly Diagnosed Glioblastoma

NovoCure Ltd. (NASDAQ: NVCR) announced today that the final analysis of its phase 3 pivotal trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) has been published in the Journal of the American Medical Association (JAMA). The final analysis proved that overall survival and progression free survival were each significantly extended by 37 percent for patients who received Optune plus temozolomide compared to patients who received temozolomide alone. The analysis demonstrated a greater than one in eight chance of five-year survival for patients with newly diagnosed GBM treated with the Optune and temozolomide. The statistically significant benefit of Optune with temozolomide on overall survival was seen in all pre-specified patient subgroups, regardless of prognostic factors such as age, performance status, MGMT promotor methylation and extent of resection.

“This is the first positive phase 3 trial in newly diagnosed GBM since the efficacy of temozolomide was demonstrated in 2005,” said EF-14 Investigator Jay-Jiguang Zhu, M.D., Ph.D., Director of Neuro-Oncology at UTHealth and Memorial Hermann Hospital, McGovern Medical School, in Houston. “The introduction of Optune with temozolomide gives newly diagnosed GBM patients the potential for long term survival. The results demonstrated that Tumor Treating Fields are an effective antimitotic treatment modality, which could change the way we treat a variety of solid cancers in the future.”

The multi-national, randomized, open-label trial included 695 newly diagnosed GBM patients who were enrolled at 83 centers from July 2009 to December 2016. Patients treated with Optune plus temozolomide experienced overall survival of 20.9 months versus 16 months for patients treated with temozolomide alone (HR, 0.63; 95 percent Cl, 0.53-0.76; P<.001), confirming and improving upon the results of the interim analysis of the trial published in JAMA in 2015.

The five-year survival rate increased from five percent to 13 percent for patients treated with Optune together with temozolomide versus patients treated with temozolomide alone. These are the best results reported for newly diagnosed GBM patients in a phase 3 trial to date and represent a new landmark for five-year survival rate in this difficult to treat disease.

The overall survival benefit of Optune together with temozolomide compared to temozolomide alone was seen across all patient subgroups including subgroups with the worst prognosis who have benefitted less from previous therapies – patients 65 years of age or older and patients with unmethylated MGMT promoter. There was no increase in systemic adverse events from Optune plus temozolomide versus temozolomide alone. The only common adverse reaction from Optune treatment noted in the final analysis was mild to moderate skin irritation beneath the system’s transducer arrays.

“GBM is a very difficult to treat disease where over 20 large randomized phase 3 studies have failed to show a survival benefit over the past decade. We are proud of the EF-14 final analysis and what it means to patients living with GBM,” said Novocure CEO Asaf Danziger. “We are honored to have the final analysis published in such a prestigious medical journal and believe it will help us to continue to effectively educate the medical community about the benefits of Optune with temozolomide for the treatment of newly diagnosed GBM.”

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