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Learning from the past to design better trials in second-line treatment for mesothelioma patients

机译:借鉴以往经验为间皮瘤患者设计更好的二线治疗试验

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摘要

Malignant pleural mesothelioma (MPM) is an aggressive cancer characterised by modest sensitivity to systemic chemotherapy. The standard treatment remains platinum-based chemotherapy with pemetrexed. Recently, the addition of an antiangiogenic drug, bevacizumab, to first-line chemotherapy has been shown to improve overall survival. All the patients, unfortunately, will progress, and currently, there is no standard treatment approved in second-line. Recently, the results of the NGR015 phase III randomised with NGR-hTNF plus chemotherapy versus placebo in addition to physician’s choice second-line chemotherapy for MPM have been published. Despite encouraging data achieved in previous phase I and phase II studies, the NGR-hTNF drug failed to meet the primary endpoint of the study, although a signal of activity was observed in the group of patients who had a shorter treatment failure interval from the first-line treatment.Hereby, we start from this recent trial to highlight once more the importance of thoroughly investigating possible predictive factors during the early drug development phase to allow more efficient phase III trial design, thus avoiding the possibility of potentially effective molecules like NGR-hTNF, continuing to be wasted.
机译:恶性胸膜间皮瘤(MPM)是一种侵袭性癌症,其特征在于对全身化疗的敏感性中等。标准治疗仍然是培美曲塞的铂类化疗。最近,已显示在一线化疗中添加抗血管生成药物贝伐单抗可改善总体生存率。不幸的是,所有患者都将进展,目前,第二线尚无标准治疗被批准。最近,已经公布了NGR015 III期结果的随机结果,该结果与NGR-hTNF加化疗相对于安慰剂的随机分组,以及医师为MPM选择的二线化疗。尽管在先前的I期和II期研究中获得了令人鼓舞的数据,但NGR-hTNF药物未能达到该研究的主要终点,尽管在第一次治疗中间隔较短的患者中观察到了活动信号因此,我们从最近的这项试验开始,再次强调在药物开发早期阶段彻底研究可能的预测因素的重要性,以允许进行更有效的III期试验设计,从而避免了可能有效的分子(如NGR- hTNF,继续浪费。

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