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P14.62 Safety and adverse event profile post-market surveillance analysis of Tumor Treating Fields (TTFields) in EMEA

机译:P14.62 EMEA中肿瘤治疗领域(TTFIELDS)的肿瘤治疗后市场监测分析的安全和不良事件概况

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摘要

Tumor Treating Fields (TTFields) are established as modality in glioblastoma (GBM) therapy. GBM is the most aggressive brain tumor in adults, constituting approximately 15 % of all primary brain tumors. At diagnosis, a considerable subgroup of GBM patients is ≥65 years of age. The phase 3 EF-14 trial demonstrated a significant improvement of progression free, overall and longterm survival in newly diagnosed GBM (ndGBM) patients by the addition of TTFields compared temozolomide therapy. No treatment limiting systemic adverse events in the EF-14 trial for ndGBM or in the EF-11 trial for recurrent GBM (rGBM) were observable. Here, we present post-market surveillance data from patients in the EMEA region including elderly patients (≥ 65 years) treated with TTFields.
机译:肿瘤治疗田间(TTFIELDS)被建立为胶质母细胞瘤(GBM)治疗中的偶数。 GBM是成人中最具侵略性的脑肿瘤,构成了所有原发性脑肿瘤的约15%。在诊断时,GBM患者的相当大的亚组≥65岁。第3阶段EF-14试验表明,通过添加TTFIELDS对新诊断的GBM(NDGBM)患者进行了显着提高,总体和长期存活率通过添加TTFIELDS比较TTFIELDS。可观察到NDGBM的EF-14试验中的任何治疗系统性不良事件,或在反复性GBM(RGBM)的EF-11试验中,是可观察到的。在这里,我们向emea地区的患者呈现出市场后监测数据,包括用TTFIELS治疗的老年患者(≥65岁)。

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