Cell Therapy Unit and Laboratory of Tumor Immunology, Department of Experimental Medicine, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
Division of Medical Oncology B, Department of Radiological, Oncological and Pathological Sciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
Cancer Immunol Immunother. 2018 May;67(5):703-711. doi: 10.1007/s00262-018-2146-8. Epub 2018 Mar 8.
The exclusion of "real-world" patients from registration clinical trials of cancer immunotherapy represents a significant emerging issue. For instance, a large fraction of cancer patients develops brain metastases during the course of the disease, but results from large prospective clinical trials investigating this considerable proportion of the cancer patient population are currently lacking. To provide a useful tool for the clinician in a "real-world" setting, we have reviewed the available literature regarding the safety and efficacy of immune check-point inhibitors in patients with cancer metastatic to the brain. Overall, these data provide encouraging evidence that these therapeutic agents can induce intracranial objective responses, particularly in patients with asymptomatic and previously untreated brain metastases. Larger prospective studies are needed to confirm these initial results.
将“真实世界”患者排除在癌症免疫治疗的注册临床试验之外,是一个新出现的重大问题。例如,很大一部分癌症患者在疾病过程中会发展为脑转移,但目前缺乏针对这部分相当大比例癌症患者人群的大型前瞻性临床试验结果。为了在“真实世界”环境中为临床医生提供有用的工具,我们复习了关于免疫检查点抑制剂在脑转移癌症患者中的安全性和有效性的现有文献。总体而言,这些数据提供了令人鼓舞的证据,表明这些治疗药物可以诱导颅内客观反应,特别是在无症状和未经治疗的脑转移患者中。需要更大规模的前瞻性研究来证实这些初步结果。