Rolfo Christian, Passiglia Francesco, Russo Antonio, Pauwels Patrick
Antwerp University Hospital, Oncology Department, Phase I-Early Clinical Trials Unit , Wilrijkstraat 10, 2650 Edegem , Belgium +3238213646 ; +3238251592 ;
Expert Opin Ther Targets. 2014 Sep;18(9):983-5. doi: 10.1517/14728222.2014.936383. Epub 2014 Jul 5.
In the past decade, the advent of targeted therapy led to a silent revolution in the war against lung cancer and a significant evolution on the concept of Phase I clinical trials design. Thanks to the specificity of their target, the new drugs have radically changed NSCLC treatment, leading to the development of personalized strategies. The accelerated approval of the first ALK-inhibitor, Crizotinib and more recently Ceritinib, without a Phase III randomized, clinical trial, has been an amazing success story in lung cancer research, marking the beginning of a new decade of targeted drugs development, characterized by modern, biomarker-driven, early clinical trial design and shorter times for clinical approval. Is Ceritinib a new panacea for the treatment of ALK-rearranged NSCLC? We aimed to discuss the reasons of such success, including the new emerging questions, regarding mechanisms of acquired resistance, and the best treatment algorithm for ALK-rearranged NSCLC patients.
在过去十年中，靶向治疗的出现引发了肺癌治疗领域的一场悄然变革，也使I期临床试验设计理念发生了重大演变。由于其靶点的特异性，这些新药彻底改变了非小细胞肺癌（NSCLC）的治疗方式，推动了个性化治疗策略的发展。首个ALK抑制剂克唑替尼以及最近的色瑞替尼在未进行III期随机临床试验的情况下就加速获批，这在肺癌研究中是一个了不起的成功案例，标志着靶向药物开发新时代的开始，其特点是采用现代的、生物标志物驱动的早期临床试验设计以及更短的临床获批时间。色瑞替尼会成为治疗ALK重排NSCLC的新万能药吗？我们旨在探讨取得如此成功的原因，包括关于获得性耐药机制的新出现问题，以及ALK重排NSCLC患者的最佳治疗方案。
