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首页> 外文期刊>Expert opinion on biological therapy >Is there still room for large registrative trials in unselected cancer patients? The case of anti-epidermal growth factor receptor antibodies in advanced non-small-cell lung cancer.
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Is there still room for large registrative trials in unselected cancer patients? The case of anti-epidermal growth factor receptor antibodies in advanced non-small-cell lung cancer.

机译：未选出的癌症患者是否仍有进行大型注册研究的空间？抗表皮生长因子受体抗体在晚期非小细胞肺癌中的情况。

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Necitumumab, a monoclonal antibody directed against EGFR, is currently under development as a treatment for advanced NSCLC. Two Phase III randomized trials are ongoing, testing the addition of necitumumab to first-line platinum-based chemotherapy. In the same setting, cetuximab produced a statistically significant but clinically modest benefit in the whole study population, and no solid data have been produced about predictive factors of efficacy. Will the difference in structure between the two antibodies be enough to obtain a clinically relevant advantage, making real progress in the treatment of advanced NSCLC? Large Phase III trials in unselected patients risk demonstrating statistically significant results with debatable clinical relevance in the whole population, and the study of predictive factors is often left to subgroup analysis performed after the conduction of the trial. We do not need further 'me-too' drugs, or drugs that produce a small benefit in the unselected population. On the contrary, the oncologic community needs drugs to be used with a proper selection of patients, to obtain larger, relevant benefits in molecularly characterized subgroups. Final results of randomized trials with necitumumab in advanced NSCLC are expected in a couple of years.
机译：Necitumumab是一种针对EGFR的单克隆抗体，目前正在开发中，用于治疗晚期NSCLC。正在进行两项III期随机试验，测试将尼西单抗添加到基于铂的一线化疗中。在相同的情况下，西妥昔单抗在整个研究人群中产生了统计学上显着但临床上适度的获益，并且尚未产生有关疗效预测因素的可靠数据。两种抗体之间的结构差异是否足以获得临床相关的优势，从而使晚期NSCLC的治疗取得真正的进展？在未选患者中进行的大型III期试验可能会在整个人群中显示出具有统计学意义的有意义的临床相关结果，而且对预测因素的研究通常留待试验进行后再进行亚组分析。我们不需要其他的“我也这样”的药物，也不需要在未选定人群中产生较小收益的药物。相反，肿瘤学界需要在适当选择患者的情况下使用药物，以在分子特征化的亚组中获得更大的相关益处。尼妥珠单抗在晚期NSCLC中的随机试验的最终结果预计将在几年后出现。

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