BACKGROUND:The prognosis of non-small-cell lung cancer (NSCLC) with brain metastases is very poor. Currently, therapeutic methods for this patient population include whole-brain radiation therapy (WBRT), surgery, radiosurgery and systemic treatment. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) could be effective on cerebral metastases of mutated NSCLC. However, which EGFR-TKIs is more appropriate is still unknown. METHODS:We conducted a retrospective analysis of advanced NSCLC patients with brain metastases for EGFR targeted therapy from November 2013 to April 2018 at Dongguan People's Hospital, Southern Medical University, China. A total of 43 patients were recruit in this study. Among them, 21 cases received icotinib (125 mg, thrice a day) and 22 cases received gefitinib (250 mg, once a day) until disease progression or unacceptable toxicity. The primary end point of this study was intracranial PFS (iPFS). The relationships between therapeutic arms and patients characteristics were performed using Pearson's chi-square test or Fisher's exact test. The differences in PFS among the two arms were analyzed using Kaplan-Meier curves and log rank tests. RESULTS:There was no significant difference of intracranial ORR (66.6% versus 59.1%, P = 0.62) and DCR (85.7% versus 81.8%, P = 0.73) between the two arms. The median intracranial PFS (iPFS) for icotinib and gefitinib arms were 8.4 months (95% CI, 5.4 to 11.3 months) and 10.6 months (95% CI, 6.3 to 14.8 months), respectively (P = 0.17). Adverse events of the two study arms were generally mild. None of the patients experienced dose reduction of EGFR-TKIs. CONCLUSIONS:Our study showed that icotinib and gefitinib had similar efficacy for brain metastasis of EGFR mutated NSCLC. Large randomized studies are suggested to further illuminate the effect of these two EGFR-TKIs on cerebral lesions of NSCLC.

译文

背景:非小细胞肺癌(NSCLC)伴脑转移的预后很差。当前,针对该患者群体的治疗方法包括全脑放射治疗(WBRT),手术,放射外科手术和全身治疗。表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)可能对突变的NSCLC的脑转移有效。但是,哪种EGFR-TKIs更合适仍是未知的。
方法:我们对2013年11月至2018年4月在中​​国南方医科大学附属东莞人民医院进行EGFR靶向治疗的晚期NSCLC脑转移患者进行了回顾性分析。本研究共招募了43名患者。其中21例接受艾替尼(125毫克,每天三次),22例接受吉非替尼(250毫克,每天一次),直到疾病进展或出现不可接受的毒性。这项研究的主要终点是颅内PFS(iPFS)。治疗组与患者特征之间的关系使用皮尔逊卡方检验或费舍尔精确检验进行。使用Kaplan-Meier曲线和对数秩检验分析了两组之间PFS的差异。
结果:两组之间的颅内ORR(66.6%比59.1%,P = 0.62)和DCR(85.7%比81.8%,P = 0.73)无显着差异。 icotinib和gefitinib组的颅内PFS(iPFS)中位数分别为8.4个月(95%CI,5.4至11.3个月)和10.6个月(95%CI,6.3至14.8个月)(P = 0.17)。两个研究组的不良反应一般较轻。没有患者的EGFR-TKIs剂量降低。
结论:我们的研究表明,icotinib和gefitinib在EGFR突变的NSCLC的脑转移中具有相似的疗效。建议进行大规模的随机研究,以进一步阐明这两种EGFR-TKI对NSCLC脑损伤的影响。

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