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Vandetanib and indwelling pleural catheter for non-small-cell lung cancer with recurrent malignant pleural effusion

机译:Vandetanib和留置胸膜导管治疗非小细胞肺癌伴恶性胸腔积液

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Patients and Methods Non-small-cell lung cancer patients with proven metastatic disease to the pleural space using pleural fluid cytology or pleural biopsy who required intrapleural catheter placement were eligible for enrollment. On the same day of the intrapleural catheter insertion, the patients were started on a daily oral dose of 300 mg vandetanib, for a maximum of 10 weeks. The primary end point was time to pleurodesis, with response rate as the secondary end point. Exploratory analyses included measurement of pleural fluid cytokines and angiogenic factors before and during therapy.Results Twenty eligible patients were included in the trial. Eleven patients completed 10 weeks of treatment. Median time to pleurodesis was 35 days (95% confidence interval, 15-not applicable). Median time to pleurodesis in the historical cohort was 63 days (95% confidence interval, 45-86) when adjusted for Eastern Cooperative Oncology Group performance status ≤ 2.Conclusion Vandetanib therapy was well tolerated; however, it did not significantly reduce time to pleurodesis.Introduction/Background Non-small-cell lung cancer patients with malignant pleural effusion have a poor overall median survival (4.3 months). VEGF is a key regulator of pleural effusion production. It is unknown if pharmacological inhibition of VEGF signaling modifies the disease course of non-small-cell lung cancer patients with recurrent malignant pleural effusion. We report the final results of a single-arm phase II clinical trial of the VEGF receptor inhibitor, vandetanib, combined with intrapleural catheter placement in patients with non-small-cell lung cancer and recurrent malignant pleural effusion, to determine whether vandetanib reduces time to pleurodesis. copy;2014 Elsevier Inc.
机译:患者和方法非小细胞肺癌患者经胸膜液细胞学或胸膜活检证实有转移至胸膜腔的疾病,需要放置胸膜内导管,即可入组。在插入胸膜内导管的同一天,患者开始以每日口服300 mg vandetanib的剂量口服,最多10周。主要终点为胸膜固定术的时间,反应率为次要终点。探索性分析包括在治疗前和治疗过程中测量胸水细胞因子和血管生成因子。结果该试验纳入了20名合格患者。 11名患者完成了10周的治疗。胸膜固定术的中位时间为35天(95%置信区间,15不适用)。调整东方合作肿瘤小组的工作状态≤2后,历史队列中的胸膜固定术的中位时间为63天(95%置信区间为45-86)。结论Vandetanib治疗耐受性良好。引言/背景恶性胸腔积液的非小细胞肺癌患者的总体中位生存期较差(4.3个月)。 VEGF是胸腔积液产生的关键调节剂。 VEGF信号转导的药理学抑制作用是否能改变患有恶性胸腔积液的非小细胞肺癌患者的病程尚不清楚。我们报告了VEGF受体抑制剂vandetanib的单臂II期临床试验的最终结果,结合非小细胞肺癌和恶性胸腔积液复发患者的胸膜内导管置入,以确定vandetanib是否能缩短治疗时间胸膜固定术。复制; 2014 Elsevier Inc.

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