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Endoscopic electrochemotherapy for esophageal cancer: a phase I clinical study

机译:食管癌的内镜电化学疗法:I期临床研究

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Background and study aims Esophageal cancer is on the rise in the western world and the disease has a poor 5-year survival prognosis below 20?%. Electrochemotherapy is a treatment where a chemotherapeutic drug is combined with locally applied electrical pulses, in order to increase the drug’s cytotoxicity in malignant cells. This study presents the first results with electrochemotherapy treatment in esophageal cancer. Patients and methods In this first-in-human trial, six patients with advanced esophageal cancer were treated with electrochemotherapy using intravenous bleomycin. All side effects and adverse events (AEs) were registered and the patients were later evaluated with gastroscopy and 18F-fluorodeoxyglucose positron emission tomography/magnetic resonance imaging (18F-FDG PET/MRI). Results Treatment were well tolerated, main AEs being nausea, vomiting, oral thrush, pneumonia, retrosternal pain, fever, and hoarseness. No serious complications were observed. Five patients had a visual tumor response confirmed by gastroscopy. In two cases, these findings were confirmed with 18F-FDG PET/MRI as it revealed a reduction of total tumor mass. Conclusion Electrochemotherapy in patients with advanced esophageal cancer was conducted without major safety concerns. This study paves the way for larger studies, which may further elucidate response rates for and side effects of this new treatment.
机译:背景和研究目的食管癌在西方世界正在上升,该病的5年生存预后很差,低于20%。电化学疗法是将化疗药物与局部施加的电脉冲结合使用的一种疗法,目的是增加该药物在恶性细胞中的细胞毒性。这项研究提出了食管癌的电化学疗法的第一个结果。患者和方法在这项首次人类试验中,对六名晚期食道癌患者进行了电化学治疗,并使用了博来霉素静脉注射。记录所有副作用和不良事件(AE),随后通过胃镜检查和18F-氟脱氧葡萄糖正电子发射断层扫描/磁共振成像(18F-FDG PET / MRI)对患者进行评估。结果治疗耐受良好,主要不良事件为恶心,呕吐,鹅口疮,肺炎,胸骨后疼痛,发烧和声音嘶哑。没有观察到严重的并发症。胃镜检查证实有五例患者有视觉肿瘤反应。在两个病例中,18F-FDG PET / MRI证实了这些发现,因为它揭示了总肿瘤量的减少。结论晚期食管癌患者进行了电化学疗法,无重大安全隐患。这项研究为更大的研究铺平了道路,这可能进一步阐明这种新疗法的反应率和副作用。

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