Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.
Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Future Oncol. 2021 Dec 1;17(35):4827-4835. doi: 10.2217/fon-2021-0752. Epub 2021 Nov 1.
Here, we summarize the initial results from the ADAURA clinical study looking at treatment with osimertinib in patients with a specific type of non-small cell lung cancer (also called NSCLC). Osimertinib (TAGRISSO®) is a medication used to treat a type of NSCLC with a change (mutation) in the EGFR gene, known as EGFR-mutated NSCLC. EGFR stands for 'epidermal growth factor receptor'. It is a protein present on the surface of both healthy and cancer cells that can regulate how cells grow and divide. Sometimes, certain mutations in EGFR can result in the EGFR protein malfunctioning, which can lead to the formation of cancer, like EGFR-mutated NSCLC. Based on previous clinical studies, osimertinib is already approved for use in patients with EGFR-mutated NSCLC that has spread beyond the lung (metastatic disease). This medication works to stop, prevent, or slow the growth of EGFR-mutated NSCLC tumors, by specifically blocking the activity of EGFR. In the ADAURA clinical study, participants had resectable EGFR-mutated NSCLC, which means they had tumors that can be removed by surgery. Participants took either osimertinib or a placebo (a dummy drug with no active ingredient) after having their tumors removed by surgery. Post-surgery chemotherapy was allowed, but not compulsory (this was decided by the participant and their doctor). To date, the study has shown that osimertinib could be beneficial for patients with resectable EGFR-mutated NSCLC. Participants who took osimertinib have stayed cancer-free for longer than those who took the placebo, regardless of whether or not they received chemotherapy after surgery. Osimertinib treatment also reduced the risk of tumors spreading to the brain and spinal cord, otherwise known as the central nervous system (also called CNS). The side effects experienced by the participants taking osimertinib have been consistent with what we already know. Based on the results from ADAURA, osimertinib has been approved for the treatment of resectable EGFR-mutated NSCLC after tumor removal. The ADAURA study is still ongoing and more results are expected to be released in the future. ClinicalTrials.gov NCT number: NCT02511106.
在这里，我们总结了 ADAURA 临床研究的初步结果，该研究观察了奥希替尼在具有特定类型非小细胞肺癌（也称为 NSCLC）患者中的治疗效果。奥希替尼（TAGRISSO®）是一种用于治疗 EGFR 基因发生改变（突变）的 NSCLC 类型的药物，称为 EGFR 突变型 NSCLC。EGFR 代表“表皮生长因子受体”。它是存在于健康细胞和癌细胞表面的一种蛋白质，可以调节细胞的生长和分裂。有时，EGFR 的某些突变会导致 EGFR 蛋白功能失常，从而导致癌症的形成，如 EGFR 突变型 NSCLC。基于先前的临床研究，奥希替尼已被批准用于 EGFR 突变型 NSCLC 患者，这些患者的肿瘤已经扩散到肺部以外（转移性疾病）。该药物通过特异性阻断 EGFR 的活性，来阻止、预防或减缓 EGFR 突变型 NSCLC 肿瘤的生长。在 ADAURA 临床研究中，参与者患有可切除的 EGFR 突变型 NSCLC，这意味着他们的肿瘤可以通过手术切除。参与者在手术切除肿瘤后，要么服用奥希替尼，要么服用安慰剂（一种无活性成分的假药物）。手术后允许接受化疗，但不是强制性的（这是由参与者及其医生决定的）。迄今为止，该研究表明奥希替尼可能对可切除的 EGFR 突变型 NSCLC 患者有益。服用奥希替尼的参与者比服用安慰剂的参与者癌症无进展期更长，无论他们是否在手术后接受化疗。奥希替尼治疗还降低了肿瘤扩散到大脑和脊髓（也称为中枢神经系统，简称 CNS）的风险。服用奥希替尼的参与者经历的副作用与我们已经了解的副作用一致。基于 ADAURA 的结果，奥希替尼已被批准用于治疗手术后切除的可切除 EGFR 突变型 NSCLC。ADAURA 研究仍在进行中，预计未来会有更多结果发布。ClinicalTrials.gov NCT02511106。
