Ades Felipe, Yamaguchi Nise
Centro de Oncologia e Hematologia, Hospital Israelita Albert Einstein, Avenida Albert Einsten, 627/701, 3º SS-Morumbi, São Paulo-SP, CEP05652-900, Brazil.
Ecancermedicalscience. 2015 Dec 3;9:604. doi: 10.3332/ecancer.2015.604. eCollection 2015.
In recent years, with the rise of immunotherapeutic agents for cancer treatment, we have observed a paradigm shift in oncology drug development. One common problem accompanying such paradigm shifts is how to build research strategies to fit the mechanism of action of the newer compounds. Developing immunotherapy in oncology requires us to address the unique characteristics of immunotherapeutic agents and to provide adequate tools for their evaluation, including the adjustment of clinical trial endpoints. Immunotherapy creates patterns of response different from those of chemotherapy, and thus they are not captured by the traditional World Health Organisation (WHO) tumour response criteria or the RECIST. Revisiting the results of pembrolizumab in patients with melanoma can help to evaluate the efficacy of the immune-related response criteria (irRC) as the gold standard for evaluating the clinical response of immunologic agents in oncology.
近年来,随着用于癌症治疗的免疫治疗药物的兴起,我们观察到肿瘤学药物研发出现了范式转变。伴随这种范式转变的一个常见问题是如何构建研究策略以适应新型化合物的作用机制。在肿瘤学中开展免疫治疗要求我们应对免疫治疗药物的独特特性,并为其评估提供充分的工具,包括调整临床试验终点。免疫治疗产生的反应模式与化疗不同,因此传统的世界卫生组织(WHO)肿瘤反应标准或RECIST无法涵盖这些反应。回顾帕博利珠单抗治疗黑色素瘤患者的结果有助于评估免疫相关反应标准(irRC)作为评估肿瘤学中免疫药物临床反应的金标准的疗效。