Abstract：
Early stereotactic body radiation therapy (SBRT) to the primary tumor combined with epidermal growth factor receptor tyrosine kinase inhibitor (EFGR-TKI) treatment may increase progression-free survival (PFS) by delaying resistance in patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). In this prospective, single arm, phase II study, patients with advanced NSCLC were treated with EGFR-TKI (icotinib 125 mg tid or gefitinib 250 mg qd) for one month followed by SBRT (40-60 Gy/5-8 F/5-10 d) to the primary tumor with concurrent EGFR-TKI until disease progression. The primary endpoint was PFS and the patterns of failure. Overall survival (OS) and adverse effects (AEs) were secondary endpoints. Overall, 41 advanced NSCLC patients with EGFR mutations received treatment with 24.42 months of median follow-up time. On average, SBRT was initiated 1.49 months after EGFR-TKI administration. Tumors were found to have an average shrinkage rate of 42.50%. Median PFS was 15.23 months (95% CI 13.10-17.36), while median OS was 27.57 months (95% CI 23.05-32.09). Thirty-three patients were found to have disease progression, of which new site failure (NF) (22 patients, 66.66%) was the most common pattern, followed by original site failure (OF) (7 patients, 21.21%) and simultaneous OF/NF (ONF) (4 patients, 12.12%). There were no Aes equal to or greater than grade 3, with the most frequent AE being radiation pneumonitis. Therefore, administering therapy targeted at the primary tumor using early SBRT after EGFR-TKI initiation is a new potentially safe and effective approach to treat EGFR-mutant advanced NSCLC.
摘要：
对原发性肿瘤进行早期立体定向放射治疗（SBRT）联合表皮生长因子受体酪氨酸激酶抑制剂（EFGR-TKI）治疗可能会延迟晚期EGFR突变型非小细胞肺癌（NSCLC）患者的耐药，从而提高无进展生存期（PFS）。在这个前景中，单臂,第二阶段研究，晚期NSCLC患者接受EGFR-TKI(埃克替尼125mgtid或吉非替尼250mgqd)治疗1个月,随后接受SBRT(40-60Gy/5-8F/5-10d)治疗原发肿瘤,同时接受EGFR-TKI治疗,直至疾病进展.主要终点是PFS和失败模式。总生存期（OS）和不良反应（AE）是次要终点。总的来说,41例EGFR突变的晚期NSCLC患者接受治疗，中位随访时间24.42个月。平均而言,SBRT在EGFR-TKI给药后1.49个月开始。发现肿瘤的平均收缩率为42.50%。中位PFS为15.23个月（95%CI13.10-17.36），而中位OS为27.57个月（95%CI23.05-32.09）。33名患者被发现疾病进展，其中新部位失效(NF)(22例患者，66.66%)是最常见的模式，其次是原始部位失败（OF）（7例患者，21.21%）和同时OF/NF（ONF）（4例，12.12%）。没有Aes等于或大于3级，最常见的AE是放射性肺炎。因此,EGFR-TKI启动后使用早期SBRT靶向原发肿瘤治疗是治疗EGFR突变型晚期NSCLC的一种潜在安全有效的新方法.
